Boots Bite & Sting Relief 2 Years Plus Antihistamine Cream


Boots Bite & Sting Relief 2 Years Plus Antihistamine Cream

(Mepyramine Maleate)

From 2 years

Relieves pain, itching and swelling

20 g e

Read all of this carton for full instructions.

What this medicine is for

A soothing antihistamine cream for the relief of pain, itching and swelling caused by insect bites and stings, and nettle stings.

Before you use this medicine X Do not use: If you are allergic to any of the ingredients or other antihistamines If you have eczema or other skin conditions If you are pregnant or breastfeeding, unless your doctor tells you to On broken skin, sunburnt skin or on large areas of skin

Cetostearyl alcohol and lanolin may cause skin reactions (e.g. contact dermatitis).

How to use this medicine

Check the tube seal is not broken before first use. If it is, do not use the cream. Pierce tube seal with end of cap.

Apply to the skin only.

Adults and children of 2 years and over:

Smooth a very small amount on the affected area. Use the cream 2 or 3 times a day, for a maximum of 3 days.

Do not use on children under 2 years.

If a rash develops, or the condition gets worse, stop using the cream.

If symptoms do not go away talk to your doctor.

! If anyone accidentally swallows some:

Talk to a doctor straight away.

Possible side effects

Most people will not have problems.

If you get these side effects stop using the cream and see a doctor.

Allergic reaction (e.g. skin rash, red or itchy skin, worsening of the condition you are treating)

If you notice any side effect not listed here, please tell your pharmacist or doctor.

How to store this medicine

Do not store above 25°C.

Keep all medicines out of the sight and reach of children.

Use by the date on the end flap of the carton.

Active ingredient

This cream contains Mepyramine Maleate 2% w/w.

Also contains: purified water, cetostearyl alcohol, white soft paraffin, liquid paraffin, cetomacrogol 1000, anhydrous hypoallergenic lanolin, sorbitan sesquioleate, sodium citrate, citric acid monohydrate.

PL 00014/0440

Text prepared 2/07

Manufactured by the Marketing Authorisation holder The Boots Company PLC Nottingham NG2 3AA

If you need more advice ask your pharmacist.

BTC14991 vD 15-06-07


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Boots Antifungal Cream


Boots Antifungal Cream

(Clotrimazole)

for fungal infections of the skin

20 g

Read all of this carton for full instructions.

What this medicine is for

An antifungal cream for the treatment of fungal skin infections including ringworm, athlete’s foot, fungal nappy rash, infections of the armpit, groin, toes and skin folds and thrush of the vulva or penis.

Before you use this medicine Do not use: If you are allergic to any of the ingredients If you are pregnant or breastfeeding, unless your doctor or midwife tells you to

Information about some of the ingredients: The ingredients in the cream may affect the latex used in contraceptives such as condoms and diaphragms. This may reduce the effectiveness of the contraceptives. You should therefore use other methods of contraception for at least 5 days after using this medicine in the genital area. You may, for example, use a spermicide gel in addition to the condom or diaphragm. If you need more advice about this speak to your pharmacist.

Cetyl alcohol and stearyl alcohol in this medicine may cause skin reactions (e.g. contact dermatitis).

How to use this medicine

Check the tube seal is not broken before first use. If it is, do not use the cream.

Pierce tube seal with end of cap.

Adults and children: Apply to the affected area two or three times a day. Use the cream for at least 2 weeks. In some cases it may be necessary to continue to use the cream for more than 4 weeks.

If you are using the cream for a foot infection, make sure your feet, especially between the toes, are washed and thoroughly dried before applying the cream. Apply to the skin only.

Do not use more than the amount recommended above.

If symptoms do not go away talk to your doctor.

If anyone accidentally swallows some: Talk to a doctor straight away.

Possible side effects

Most people will not have problems, but some may get some.

If you get these side effects, stop using the cream and see a doctor: Allergic reaction (e.g. skin rash, red or itchy skin) These other effects are less serious. If they bother you talk to a pharmacist: Rarely, mild burning or irritation immediately after using the cream Pain

If any side effect becomes severe, or you notice any side effect not listed here, please tell your pharmacist or doctor.

Keep all medicines out of the sight and reach of children.

Use by the date on the end flap of the carton.

Active ingredient

This topical cream contains Clotrimazole 1% w/w.

Also contains: purified water, 2-octyldodecanol, stearyl alcohol, cetyl alcohol, cetyl esters wax, sorbitan stearate, polysorbate 60, benzyl alcohol.

PL 10622/0004 [P]

Text prepared 8/08

Manufactured for The Boots Company PLC Nottingham NG2 3AA

by

Thornton & Ross Ltd Linthwaite Huddersfield West Yorkshire HD7 5QH Marketing Authorisation held by PLIVA Pharma Ltd Vision House Bedford Road Petersfield Hampshire GU32 2QB

If you need more advice ask your pharmacist.

1498cXPil


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Boots Dual Action Athlete's Foot Spray


Boots Dual Action Athlete’s Foot Spray

(Tolnaftate)

Effectively treats athlete’s foot

Relieves skin irritation

Fast drying

150 ml e

Read all of this label for full instructions.

What this medicine is for

An anti-fungal spray for the treatment and prevention of athlete’s foot. Also effective for other skin conditions where tenderness and sweating cause skin irritation, such as dhobie itch (groin ringworm), prickly heat.

Before you use this medicine Do not use: If you are allergic to any of the ingredients

You can use this medicine if you are pregnant or breastfeeding.

How to use this medicine

Shake well before use. Hold the can 15 cm (6 inches) from the skin before spraying.

Wash and thoroughly dry the affected area Spray the affected area liberally If suffering from athlete’s foot, spray the socks and inside of shoes with powder as well Adults and children of 2 years and over:

Apply morning and night.

Continue treatment for at least one week after the condition has cleared up, to stop it coming back.

For use on the skin only.

Avoid contact with eyes.

Do not use on children under 2 years, unless your doctor tells you to.

If symptoms worsen talk to your doctor.

If symptoms do not go away within 10 days, talk to your doctor.

Possible side effects

Most people will not have problems, but some may get some.

If you get any of these stop using the spray and see a doctor: Skin irritation Contact dermatitis (redness and swelling of the skin)

If you notice any side effect not listed here, please tell your pharmacist or doctor.

Do not store above 25°C.

Keep all medicines out of the sight and reach of children.

Use by the date on the base of can.

Active ingredients

This spray powder contains Tolnaftate 1% w/w.

Also contains: dimethyl ether, denatured alcohol, talc, disteardimonium hectorite.

PL 00014/0520

Text prepared 8/07

Manufactured for the Marketing Authorisation holder The Boots Company PLC Nottingham NG2 3AA

by

ColepCCL UK Limited Atkinson’s Way Foxhills Industrial Park Scunthorpe North Lincolnshire DN15 8QJ

Caution: Pressurised container. Protect from sunlight and do not expose to temperatures exceeding 50°C. Do not pierce or burn even when empty. Do not use in confined areas. Do not use near or place on painted or polished surfaces. Avoid inhalation.

EXTREMELY FLAMMABLE

SOLVENT ABUSE CAN KILL INSTANTLY

210

Э

Do not spray on or near naked flame or any incandescent material.

Keep away from sources of ignition. No smoking.

If you need more advice ask your pharmacist.

BTC29774 vA 14/04/08


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Boots Dual Action Athlete's Foot Powder


Boots Dual Action Athlete's Foot Powder

(Chlorhexidine Hydrochloride, Tolnaftate)

Effectively treats athlete's foot

Relieves skin irritation

75 g e

Please read this label carefully. It contains important information for you. Keep this label you may need to read it again Ask your pharmacist if you need more information or advice What this medicine is for

An anti-fungal and antibacterial powder for the treatment and prevention of athlete's foot. Also effective for other skin conditions where tenderness and sweating cause skin irritation, such as dhobie itch (groin ringworm).

Before you use this medicine Do not use: If you are allergic to any of the ingredients

You can use this medicine if you are pregnant or breastfeeding.

How to use this medicine Wash and thoroughly dry the affected area Apply the powder liberally to the affected area If suffering from athlete's foot, apply the powder between the toes and also dust socks and inside of shoes with powder Adults and children:

Apply morning and night.

Continue treatment for at least one week after the condition has cleared up, to stop it coming back.

If you are treating athlete's foot it is recommended that an athlete's foot cream is used together with this product.

For use on the skin only.

Possible side effects

Most people will not have problems, but some may get some of these:

Allergic reactions (red, itchy skin) Skin irritation Contact dermatitis (redness and swelling of the skin)

If any side effect becomes severe, or you notice any side effect not listed here, please tell your pharmacist or doctor.

What is in this medicine

This powder contains Chlorhexidine Hydrochloride 0.25% w/w, Tolnaftate 1% w/w.

Also contains: purified talc, maize starch, colloidal silicon dioxide.

This pack contains 75 g powder

Who makes this medicine

Manufactured by the Marketing Authorisation Holder

The Boots Company PLC Nottingham NG2 3AA

Leaflet prepared July 2007

If you would like any further information about this medicine please contact

The Boots Company PLC Nottingham NG2 3AA

Keep all medicines out of the sight and reach of children.

Use by the date on the label edge.

PL 00014/0456

The Boots Company PLC Nottingham NG2 3AA

If you need more advice ask your pharmacist.

BTC13414 vC 03-12-07


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Flumadine


Generic Name: rimantadine (ri MAN ta deen)
Brand Names: Flumadine

What is Flumadine (rimantadine)?

Rimantadine is an antiviral medication. It blocks the actions of viruses in your body.

Rimantadine is used to treat and prevent influenza A (a viral infection) in adults. It is also used to prevent influenza A in children.

There may be some flu seasons during which rimantadine is not recommended because certain flu strains may be resistant to this drug.

Rimantadine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Flumadine (rimantadine)? Do not use this medicine if you are allergic to rimantadine or a similar medicine called amantadine (Symmetrel).

Before taking rimantadine, tell your doctor if you are allergic to any drugs, or if you have a seizure disorder, kidney disease, or liver disease.

Take this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Do not use FluMist nasal influenza "live vaccine" while you are being treated with rimantadine and for at least 48 hours after you stop taking rimantadine. The nasal vaccine may not be as effective if you receive it while you are taking rimantadine. Before taking rimantadine, tell your doctor if you have received a nasal flu vaccine within the past 14 days.

Avoid coming into close contact with someone who has a weak immune system, such as a person who is taking steroids, being treated for cancer, or has a bone marrow disorder or an illness such as HIV or AIDS. If you have a type of influenza that is resistant to rimantadine, your body may actually shed that virus and a person with a weak immune system could easily become ill from being near you.

What should I discuss with my healthcare provider before taking Flumadine (rimantadine)? Do not use this medicine if you are allergic to rimantadine or a similar medicine called amantadine (Symmetrel).

Before taking rimantadine, tell your doctor if you are allergic to any drugs, or if you have:

epilepsy or other seizure disorder;

kidney disease; or liver disease.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take this medication.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether rimantadine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I take Flumadine (rimantadine)?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

If you are taking rimantadine to treat influenza A, take it within 48 hours of when you notice your first flu symptoms.

Take this medication with a full glass of water.

Measure the liquid form of rimantadine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Take this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Store rimantadine at room temperature away from moisture and heat. What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include agitation, confusion, hallucinations, or uneven heart rate.

What should I avoid while taking Flumadine (rimantadine)? Do not use FluMist nasal influenza "live vaccine" while you are being treated with rimantadine and for at least 48 hours after you stop taking rimantadine. The nasal vaccine may not be as effective if you receive it while you are taking rimantadine. Before taking rimantadine, tell your doctor if you have received a nasal flu vaccine within the past 14 days.

Avoid coming into close contact with someone who has a weak immune system, such as a person who is taking steroids, being treated for cancer, or has a bone marrow disorder or an illness such as HIV or AIDS. If you have a type of influenza that is resistant to rimantadine, your body may actually shed that virus and a person with a weak immune system could easily become ill from being near you.

Flumadine (rimantadine) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using rimantadine and call your doctor at once if you have a seizure (black-out or convulsions).

Less serious side effects may include:

nausea, vomiting, diarrhea, loss of appetite, stomach pain;

dry mouth;

sleep problems (insomnia);

dizziness;

headache; or

anxiety, trouble concentrating.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Flumadine (rimantadine)?

Before taking rimantadine, tell your doctor if you are using any of the following drugs:

cimetidine (Tagamet);

aspirin or acetaminophen (Tylenol); or

nasal flu vaccine (FluMist).

This list is not complete and there may be other drugs that can interact with rimantadine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More Flumadine resources Flumadine Side Effects (in more detail) Flumadine Use in Pregnancy & Breastfeeding Drug Images Flumadine Drug Interactions Flumadine Support Group 0 Reviews for Flumadine - Add your own review/rating Flumadine Prescribing Information (FDA) Flumadine MedFacts Consumer Leaflet (Wolters Kluwer) Flumadine Monograph (AHFS DI) Flumadine Advanced Consumer (Micromedex) - Includes Dosage Information Rimantadine Prescribing Information (FDA) Compare Flumadine with other medications Influenza A Influenza Prophylaxis Where can I get more information? Your pharmacist can provide more information about rimantadine.

See also: Flumadine side effects (in more detail)


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Boots Soothing Eye Drops


Boots Soothing Eye Drops

(Cetrimide, Hamamelis Water)

Soothing & antiseptic

10 ml e

Read all of this carton for full instructions.

Uses: A soothing and antiseptic sterile solution for the relief of minor eye irritation. It can be used to soothe eyes irritated by smoke and dust. Before you use this medicine Do not use: If you are allergic to any of the ingredients If you wear soft contact lenses

You can use this medicine if you are pregnant or breastfeeding.

How to use this medicine

Check the cap seal is not broken before first use. If it is, do not use the drops.

Tilt head back and hold down lower eye lid. Squeeze the bottle to put drops into the corner (lower sac) of the eye.

For use in the eyes only.

Age: Adults and children How much: One or two drops How often: Morning and night, or when you need to

If anyone accidentally swallows some: Talk to a doctor

Possible side effects

Most people will not have problems, but some may get some of these:

Red, swollen or itchy eyes (signs of allergic reaction) – if this happens stop using the drops

If any side effect becomes severe, or you notice any side effect not listed here, please tell your pharmacist or doctor.

Keep all medicines out of the sight and reach of children.

Use by the date on the end flap of the carton. Throw away any unused drops 28 days after first opening.

Active ingredients

These eye drops contain Cetrimide 0.01% w/v, Hamamelis Water 5% v/v.

Also contains: purified water, boric acid, borax.

PL 00014/5237

[P]

Text prepared 11/07

Manufactured for the Marketing Authorisation holder The Boots Company PLC Nottingham NG2 3AA

by

Hamol Limited Nottingham NG90 2DB

If you need more advice ask your pharmacist.

BTC16394 vE 28/02/08


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Boots Heartburn Relief Aniseed Flavour (500ml)


Boots Heartburn Relief Aniseed Flavour

(Calcium Carbonate, Sodium Alginate, Sodium Bicarbonate)

For fast, effective relief of Heartburn and Acid Indigestion Sugar Free

e 500 ml

Read all of this label for full instructions.

Uses: This medicine contains an antacid to relieve the symptoms of indigestion and heartburn. It can be used for the relief of heartburn in pregnancy, and other conditions, which cause acid reflux.

Before you take this medicine Do not take: If you are allergic to any of the ingredients Talk to your pharmacist or doctor: If you are on a low salt (sodium) diet (each 5 ml spoonful contains 71 mg of sodium, which may be harmful to you) If you take other medicines ACE inhibitors (for high blood pressure) Quinidine (for heart problems) Medicines to treat infections or malaria Lithium (for mood disorders) Antipsychotics (for mental health conditions) Medicines for epilepsy Medicines for osteoporosis, pain or rheumatoid arthritis

Do not take this medicine within 1 to 2 hours of taking any other medicine.

Information about some of the ingredients: This medicine contains E214 and E216 which may cause allergic reactions such as skin rash (possibly delayed).

How to take this medicine

Check the cap seal is not broken before first use. If it is, do not take the medicine.

Shake the bottle well before use.

Adults and children of 12 years and over: Two to four 5 ml spoonfuls.
Children of 6 to 11 years: One or two 5 ml spoonfuls.
Swallow the medicine after meals and at bedtime.

Do not give to children under 6 years.

Do not take more than the amount recommended.

If symptoms do not go away within 2 weeks talk to your doctor.

If you take too much: You may get a bloated stomach. If this happens talk to your pharmacist or doctor.

Possible side effects

Most people will not have problems, but some may get some of these:

Constipation, wind, stomach cramps, burping

If any side effect becomes severe, or you notice any side effect not listed here, please tell your pharmacist or doctor.

How to store this medicine

Do not store above 25°C.

Do not refrigerate.

Keep all medicines out of the sight and reach of children.

Use by the date on the label edge.

Active ingredients

Each 5 ml of oral suspension contains Calcium Carbonate 80 mg, Sodium Alginate 250 mg, Sodium Bicarbonate 133.5 mg.

Also contains: carbomer, sodium hydroxide, saccharin sodium, ethyl hydroxybenzoate (E214), propyl hydroxybenzoate (E216), butyl hydroxybenzoate, isopropyl alcohol, erythrosine (E127), aniseed oil, purified water.

PL04917/0021

Text prepared 11/08

Manufactured for The Boots Company PLC Nottingham NG2 3AA by the Marketing Authorisation holder Pinewood Laboratories Limited Ballymacarbry Clonmel Co. Tipperary Ireland

If you need more advice ask your pharmacist

3581eMC


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Fanatrex


gabapentin
Dosage Form: oral suspension - kit
Fanatrex Fanatrex Description

NDC 43093-105-01
Rx only
FusePaq™
Fanatrex™
(gabapentin 25 mg/mL, in oral suspension - kit)
FusePaq™ kits provide a convenient approach to rapidly prepare prescription medications, as all components are pre-measured. This kit is manufactured according to US FDA current Good Manufacturing Practices (cGMP).
Description:
This kit contains active and inactive bulk materials to prepare 420 mL of a gabapentin oral suspension containing 25 mg/mL gabapentin.  This kit may only be used for the extemporaneous mixing of these ingredients by an appropriate licensed medical professional, in response to a physician's prescription, to create a medication tailored to the specialized needs of an individual patient.
Contents:

10.5 g gabapentin, USP 420 mL oral suspension vehicle (water, banana flavor, N-acetyl-D-glucosamine, strawberry flavor, marshmallow flavor, glycerin, stevia powder, acesulfame potassium, xanthan gum, monoammonium glycyrrhizinate, sodium saccharin, sodium benzoate, potassium sorbate, dibasic sodium phosphate) Disposable funnel Press-in bottle adaptor for oral dispenser Oral dispenser Instructions SUGGESTED PREPARATION

Suggested Preparation
Gabapentin, 25 mg/mL oral suspension


1    Remove and Inspect the Contents of the Kit
Remove kit contents. Ensure that seals are present and intact on the gabapentin and oral suspension vehicle bottles. If the seals are not intact, do not use the kit.


2    Prepare for Mixing
Wear gloves and eye protection during mixing operations. Remove the seal from the oral suspension bottle. Break the seal and remove the cap from the gabapentin bottle.


3    Transfer Gabapentin to the Suspension Bottle
Uncap the suspension bottle. Using the included funnel, carefully transfer the gabapentin powder to the suspension bottle. Cap the suspension bottle and mix thoroughly by inverting and shaking until all contents are dissolved. Uncap the suspension bottle. Pour a small amount of the mixed suspension back into the gabapentin bottle. Cap the gabapentin bottle and shake to ensure that all residual gabapentin has been dissolved. Pour the liquid through the funnel into the suspension bottle. Discard the funnel and gabapentin powder bottle.


4    Complete the Mixing Process
Insert the press-in bottle adaptor into the suspension bottle. Recap the suspension bottle. Mix well by inverting repeatedly several times. Visually ensure that all contents are dissolved.


5    Re-label the Suspension
Label the mixed suspension as required for prescription products. Ensure that the original oral suspension vehicle label is removed or obscured, since the original label is no longer accurate once the suspension is prepared.


Store the unused kit at room temperature of 15-30°C (59-86°F). Once prepared, store the mixed suspension between 15-30°C (59-86°F). The mixed suspension is stable for at least eight weeks, based upon real-time and accelerated stability studies.

Each lot of suspension vehicle is tested to meet microbial limits per USP Microbial Limit Test <61>. In addition, the suspension vehicle formulation has passed the USP <51> Antimicrobial Effectiveness Test.
An oral dispenser is provided in the kit and may be used to facilitate delivery of the suspension.


U.S. Patents Pending


Manufactured by:
Fusion Pharmaceuticals, LLC
768 Calle Plano
Camarillo, CA 93012


CS75-A1 rev 0

DRUG BOTTLE LABEL

Do not use if safety seal is broken
Gabapentin
1-(Aminomethyl)cyclohexaneacetic acid
CAS #60142-96-3
CAUTION: For manufacturing, processing, repacking, or prescription compounding
Net contents: 10.5 g
Repackaged by Fusion Pharmaceuticals, LLC
Camarillo, CA 93012
CS73-A1 rev 0

SUSPENSION BOTTLE LABEL

Do not use if safety seal is broken
For Prescription Compounding Only
Oral Suspension Vehicle
Dye and paraben free
Ingredients: water, banana flavor, N-acetyl-D-glucosamine, strawberry flavor, marshmallow flavor, glycerin, stevia powder, acesulfame potassium, xanthan gum, monoammonium glycyrrhizinate, sodium saccharin, potassium sorbate, sodium benzoate, dibasic sodium phosphate
Net Contents: 420 mL (14.2 fl oz)
Manufactured for:
Fusion Pharmaceuticals, LLC
Camarillo, CA 93012
CS74-A1 rev 0

Carton Box Label

Do not use if safety seal is broken
NDC 43093-105-01
Rx only
FusePaq™  Kit for Oral Suspension
Fanatrex™
(gabapentin 25 mg/mL, in oral suspension - kit)
Description:
This kit contains active and inactive bulk materials to prepare 420 mL of a gabapentin oral suspension containing 25 mg/mL gabapentin. This kit may only be used for the extemporaneous mixing of these ingredients by an appropriate licensed medical professional, in response to a physician's prescription, to create a medication tailored to the specialized needs of an individual patient.
Active Ingredient:

10.5 g gabapentin, USP


Inactive Ingredients:

420 mL oral suspension vehicle (water, banana flavor, N-acetyl-D-glucosamine, strawberry flavor, marshmallow flavor, glycerin, stevia powder, acesulfame potassium, xanthan gum, monoammonium glycyrrhizinate, sodium saccharin, potassium sorbate, sodium benzoate, dibasic sodium phosphate) Disposable funnel Press-in bottle adaptor for oral dispenser Oral dispenser Instructions


CAUTION: For manufacturing, processing, repacking, or presciption compounding. Federal law prohibits dispensing without prescription.
U.S. Patents Pending
CS72-A1 rev 0



Fanatrex 
gabapentin  kit Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 43093-105 Packaging # NDC Package Description Multilevel Packaging 1 43093-105-01 1 KIT In 1 KIT None QUANTITY OF PARTS Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE, GLASS   10.5 g Part 2 1 BOTTLE, PLASTIC   420 mL Part 1 of 2 GABAPENTIN 
gabapentin  powder, for suspension Product Information       Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Gabapentin (Gabapentin) Gabapentin 10.5 g  in 10.5 g Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 10.5 g In 1 BOTTLE, GLASS None Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 05/15/2010
Part 2 of 2 ORAL SUSPENSION VEHICLE 
suspension  liquid Product Information       Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength No Active Ingredients Found Inactive Ingredients Ingredient Name Strength Water   Banana   N-Acetylglucosamine   Strawberry   ALTHAEA OFFICINALIS LEAF   Glycerin   Stevia Leaf   Acesulfame Potassium   Xanthan Gum   GLYCYRRHIZIN, AMMONIATED   Saccharin Sodium   Potassium Sorbate   Sodium Benzoate   Sodium Phosphate, Dibasic   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 420 mL In 1 BOTTLE, PLASTIC None Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 05/15/2010
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 05/15/2010
Labeler - Fusion Pharmaceuticals LLC (021420944) Establishment Name Address ID/FEI Operations Fusion Pharmaceuticals LLC 021420944 manufacture Revised: 05/2010Fusion Pharmaceuticals LLC
More Fanatrex resources Fanatrex Side Effects (in more detail) Fanatrex Use in Pregnancy & Breastfeeding Fanatrex Drug Interactions Fanatrex Support Group 0 Reviews for Fanatrex - Add your own review/rating Compare Fanatrex with other medications Alcohol Withdrawal Anxiety Benign Essential Tremor Bipolar Disorder Burning Mouth Syndrome Diabetic Nerve Damage Epilepsy Erythromelalgia Fibromyalgia Hiccups Hot Flashes Hyperhidrosis Insomnia Migraine Nausea/Vomiting, Chemotherapy Induced Pain Periodic Limb Movement Disorder Peripheral Neuropathy Persisting Pain, Shingles Postmenopausal Symptoms Pruritus Reflex Sympathetic Dystrophy Syndrome Restless Legs Syndrome Trigeminal Neuralgia Vulvodynia
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Mixtard 30 100 IU / ml Suspension for Injection in a vial


Mixtard 30

100 IU/ml suspension for injection in a vial

Insulin human (rDNA)

Read all of this leaflet carefully before you start using your insulin.

Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor, diabetes nurse or your pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, diabetes nurse or your pharmacist. What Mixtard is and what it is used for

Mixtard is human insulin to treat diabetes. Mixtard is a mixture of fast-acting insulin and long-acting insulin. This means that it will start to lower your blood sugar about half an hour after you take it, and the effect will last for approximately 24 hours.

Before you use Mixtard Do not use Mixtard If you are allergic (hypersensitive) to this insulin product, metacresol or any of the other ingredients (see 7 Further information). Look out for the signs of allergy in 5 Possible side effects If you feel a hypo coming on (a hypo is short for a hypoglycaemic reaction and is a symptom of low blood sugar).
See 4 What to do in an emergency for more about hypos. Take special care with Mixtard If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands If you are drinking alcohol: watch for signs of a hypo and never drink alcohol on an empty stomach If you are exercising more than usual or if you want to change your usual diet If you are ill: carry on taking your insulin If you are going abroad: travelling over time zones may affect your insulin needs and the timing of your injections. Using other medicines

Many medicines affect the way glucose works in your body and they may influence your insulin dose. Listed below are the most common medicines which may affect your insulin treatment. Talk to your doctor or pharmacist if you take or have recently taken any other medicines, even those not prescribed.

Your need for insulin may change if you also take: oral antidiabetic products; monoamine oxidase inhibitors (MAOI); beta-blockers; ACE-inhibitors; acetylsalicylic acid; anabolic steroids; sulphonamides; oral contraceptives; thiazides; glucocorticoids; thyroid hormone therapy; beta-sympathomimetics; growth hormone; danazol; octreotide or lanreotide.

Pregnancy and breast-feeding

If you are pregnant, planning a pregnancy or breast-feeding: please contact your doctor for advice.

Driving and using machines

If you drive or use tools or machines: watch out for signs of a hypo. Your ability to concentrate or to react will be less during a hypo. Never drive or use machinery if you feel a hypo coming on. Discuss with your doctor whether you can drive or use machines at all, if you have a lot of hypos or if you find it hard to recognise hypos.

How to use Mixtard

Talk about your insulin needs with your doctor and diabetes nurse. Follow their advice carefully. This leaflet is a general guide.

If your doctor has switched you from one type or brand of insulin to another, your dose may have to be adjusted by your doctor.

Eat a meal or snack containing carbohydrates within 30 minutes of the injection.

It is recommended that you measure your blood glucose regularly.

Before using Mixtard Check the label to make sure it is the right type of insulin Disinfect the rubber membrane with a medicinal swab. Do not use Mixtard In insulin infusion pumps If the protective cap is loose or missing.
Each vial has a protective, tamper-proof plastic cap. If it isn’t in perfect condition when you get the vial, return the vial to your supplier If it hasn’t been stored correctly or been frozen (see 6 How to store Mixtard) If it’s not uniformly white and cloudy when it’s resuspended. How to use this insulin

Mixtard is for injection under the skin (subcutaneously). Never inject your insulin directly into a vein or muscle. Always vary the sites you inject, to avoid lumps (see 5 Possible side effects). The best places to give yourself an injection are: the front of your waist (abdomen); your buttocks; the front of your thighs or upper arms. Your insulin will work more quickly if you inject it around the waist. Mixtard vials are for use with insulin syringes with the corresponding unit scale.

Just before injecting this insulin 1. Roll the vial between your hands until the liquid is uniformly white and cloudy.
Resuspending is easier if the insulin has reached room temperature 2. Draw air into the syringe, in the same amount as the dose of insulin you need 3. Inject the air into the vial: push the needle through the rubber stopper and press the plunger 4. Turn the vial and syringe upside down 5. Draw the right dose of insulin into the syringe 6. Pull the needle out of the vial 7. Make sure there is no air left in the syringe: point the needle upwards and push the air out 8. Check you have the right dose 9. Inject straight away. Inject the insulin Inject the insulin under the skin. Use the injection technique advised by your doctor or diabetes nurse Keep the needle under your skin for at least 6 seconds to make sure that the full dose has been delivered. What to do in an emergency If you get a hypo

A hypo means your blood sugar level is too low.

The warning signs of a hypo may come on suddenly and can include: cold sweat; cool pale skin; headache; rapid heart beat; feeling sick; feeling very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.

If you get any of these signs, eat glucose tablets or a high sugar snack (sweets, biscuits, fruit juice), then rest.

Don’t take any insulin if you feel a hypo coming on.

Carry glucose tablets, sweets, biscuits or fruit juice with you, just in case.

Tell your relatives, friends and close colleagues that if you pass out (become unconscious), they must: turn you on your side and seek medical advice straight away. They must not give you any food or drink as it could choke you.

If severe hypoglycaemia is not treated, it can cause brain damage (temporary or permanent) and even death If you have a hypo that makes you pass out, or a lot of hypos, talk to your doctor. The amount or timing of insulin, food or exercise may need to be adjusted. Using glucagon

You may recover more quickly from unconsciousness with an injection of the hormone glucagon by someone who knows how to use it. If you are given glucagon you will need glucose or a sugary snack as soon as you are conscious. If you do not respond to glucagon treatment, you will have to be treated in a hospital. Seek medical advice after an injection of glucagon; you need to find the reason for your hypo to avoid getting more.

Causes of a hypo

You get a hypo if your blood sugar gets too low. This might happen:

If you take too much insulin If you eat too little or miss a meal If you exercise more than usual. If your blood sugar gets too high

Your blood sugar may get too high (this is called hyperglycaemia).

The warning signs appear gradually. They include: increased urination; feeling thirsty; losing your appetite; feeling sick (nausea or vomiting); feeling drowsy or tired; flushed, dry skin; dry mouth and a fruity (acetone) smell of the breath.

If you get any of these signs, test your blood sugar level and test your urine for ketones if you can. Then seek medical advice straight away.

These may be signs of a very serious condition called diabetic ketoacidosis. If you don’t treat it, this could lead to diabetic coma and death.

Causes of hyperglycaemia Having forgotten to take your insulin Repeatedly taking less insulin than you need An infection or a fever Eating more than usual Less exercise than usual. Possible side effects

Like all medicines, Mixtard can cause side effects, although not everybody gets them. Mixtard may cause hypoglycaemia (low blood sugar). See the advice in 4 What to do in an emergency.

Side effects reported uncommonly

(in less than 1 patient in 100)

Changes at the injection site (Lipodystrophy). If you inject yourself too often at the same site, fatty tissue under the skin at this site may shrink (lipoatrophy) or thicken (lipohypertrophy). Changing the site with each injection may help to prevent such skin changes. If you notice your skin pitting or thickening at the injection site, tell your doctor or diabetes nurse because these reactions can become more severe, or they may change the absorption of your insulin if you inject in such a site.

Signs of allergy. Reactions (redness, swelling, itching) at the injection site may occur (local allergic reactions). These usually disappear after a few weeks of taking your insulin. If they do not disappear, see your doctor.

Seek medical advice immediately:

if signs of allergy spread to other parts of the body, or if you suddenly feel unwell and you start sweating; start being sick (vomiting); have difficulty in breathing; have a rapid heart beat; feel dizzy; feel like fainting.

You may have a very rare serious allergic reaction to Mixtard or one of its ingredients (called a systemic allergic reaction). See also warning in 2 Before you use Mixtard.

Diabetic retinopathy (eye background changes). If you have diabetic retinopathy and your blood glucose levels improve very fast, the retinopathy may get worse. Ask your doctor about this.

Swollen joints. When you start taking insulin, water retention may cause swelling around your ankles and other joints. This soon disappears.

Painful neuropathy (nerve related pain). If your blood glucose levels improve very fast it may cause a burning, tingling or electric pain. This is called acute painful neuropathy and it usually disappears. If it does not disappear, see your doctor.

Side effects reported very rarely

(in less than 1 patient in 10,000)

Vision problems. When you first start your treatment, it may disturb your vision, but the reaction usually disappears.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, diabetes nurse or pharmacist.

How to store Mixtard

Keep out of the reach and sight of children. Do not use Mixtard after the expiry date which is stated on the label and the carton. The expiry date refers to the last day of that month.

The vials that are not being used are to be stored in a refrigerator (2°C - 8°C).

Do not store them in or too near the freezer section or cooling element.

Do not freeze. Keep the vials in the original package.

The vials that are being used or about to be used are not to be kept in a refrigerator. After removing the vial from the refrigerator it is recommended to let it reach room temperature before resuspending the insulin as instructed for the first time use. See 3 How to use Mixtard. You can carry them with you and keep them at room temperature (not above 25°C) for up to 6 weeks.

Always keep the vial in the outer carton when you’re not using it in order to protect it from light.

Mixtard must be protected from excessive heat and sunlight.

Mixtard should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further information What Mixtard 30 contains The active substance is insulin human made by recombinant biotechnology (30% as soluble insulin and 70% as isophane insulin). 1 ml contains 100 IU of insulin human. 1 vial contains 10 ml equivalent to 1000 IU The other ingredients are zinc chloride, glycerol, metacresol, phenol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid, protamine sulphate and water for injections. What Mixtard looks like and contents of the pack

The suspension for injection comes as a cloudy, white, aqueous suspension.

It is supplied in packs of 1 or 5 vials of 10 ml or in a multipack of 5 ? (1 ? 10 ml) vials.

Not all packs may be marketed.

Marketing Authorisation Holder and Manufacturer Novo Nordisk A/S Novo All? DK-2880 Bagsv?rd Denmark

This leaflet was last approved in 09/2007

Mixtard is a trademark owned by Novo Nordisk A/S, Denmark

© 1998/2007

Novo Nordisk A/S

8-0191-01-086-3


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Boots Antiseptic Gel


Boots Antiseptic Gel

(Cetylpyridinium Chloride)

Prevents Infection Helps Healing Process Effective Cleansing Action

e 30 g

Read all of this carton for full instructions.

What this medicine is for

This medicine contains Cetylpyridinium Chloride which belongs to a group of medicines called antiseptics, which act to prevent infection.

It can be used on cuts, grazes, insect bites, minor wounds, spots, minor burns and scalds.

Before you use this medicine

Do not use:

If you are allergic to any of the ingredients On weeping or badly inflamed skin Frequently or for long periods of time (you may become sensitive to the medicine)

You can use this medicine if you are pregnant or breastfeeding.

How to use this medicine

Check the seal is not broken before first use. If it is, do not use the gel.

Apply to the skin only.

Avoid contact with the eyes.

Children and adults:

Apply to the affected area of skin 2 or 3 times a day.

Do not use more than the amount recommended above.

If the skin does not appear to heal talk to your doctor.

If anyone accidentally swallows some:

Talk to a doctor straight away.

Possible side effects

Most people will not have problems, but some may get some.

If you get any of these side effects, stop using the gel and see a doctor:

Allergic reaction (e.g. skin rash, red or itchy skin)

These other effects are less serious. If they bother you talk to a pharmacist:

Skin irritation

If any side effect becomes severe, or you notice any side effect not listed here, please tell your pharmacist or doctor.

Keep all medicines out of the sight and reach of children.

Use by the date on the end flap of the carton.

Active ingredient

This gel contains Cetylpyridinium Chloride 0.025% w/w.

Also contains: purified water, glycerol, hypromellose, sodium citrate, citric acid.

PL 00014/0556

Text prepared 3/07

Manufactured by the Marketing Authorisation holder The Boots Company PLC Nottingham NG2 3AA

If you need more advice ask your pharmacist.

BTC14517 vD 12-12-07


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Insulatard Penfill


Insulatard Penfill

100 IU/ml suspension for injection in a cartridge

Insulin human (rDNA)

Read all of this leaflet carefully before you start using your insulin. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor, diabetes nurse or your pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, diabetes nurse or your pharmacist. What Insulatard is and what it is used for

Insulatard is human insulin to treat diabetes. Insulatard is a long-acting insulin. This means that it will start to lower your blood sugar about 1? hours after you take it, and the effect will last for approximately 24 hours. Insulatard is often given in combination with fast-acting insulin products.

Before you use Insulatard Do not use Insulatard If you are allergic (hypersensitive) to this insulin product, metacresol or any of the other ingredients (see 7 Further information). Look out for the signs of allergy in 5 Possible side effects If you feel a hypo coming on (a hypo is short for a hypoglycaemic reaction and is a symptom of low blood sugar). See 4 What to do in an emergency for more about hypos. Take special care with Insulatard If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands If you are drinking alcohol: watch for signs of a hypo and never drink alcohol on an empty stomach If you are exercising more than usual or if you want to change your usual diet If you are ill: carry on taking your insulin If you are going abroad: travelling over time zones may affect your insulin needs and the timing of your injections. Using other medicines

Many medicines affect the way glucose works in your body and they may influence your insulin dose. Listed below are the most common medicines which may affect your insulin treatment. Talk to your doctor or pharmacist if you take or have recently taken any other medicines, even those not prescribed.

Your need for insulin may change if you also take: oral antidiabetic products; monoamine oxidase inhibitors (MAOI); beta-blockers; ACE-inhibitors; acetylsalicylic acid; anabolic steroids; sulphonamides; oral contraceptives; thiazides; glucocorticoids; thyroid hormone therapy; beta-sympathomimetics; growth hormone; danazol; octreotide or lanreotide.

Pregnancy and breast-feeding

If you are pregnant, planning a pregnancy or breast-feeding: please contact your doctor for advice.

Driving and using machines

If you drive or use tools or machines: watch out for signs of a hypo. Your ability to concentrate or to react will be less during a hypo. Never drive or use machinery if you feel a hypo coming on. Discuss with your doctor whether you can drive or use machines at all, if you have a lot of hypos or if you find it hard to recognise hypos.

How to use Insulatard

Talk about your insulin needs with your doctor and diabetes nurse. Follow their advice carefully. This leaflet is a general guide. If your doctor has switched you from one type or brand of insulin to another, your dose may have to be adjusted by your doctor. It is recommended that you measure your blood glucose regularly.

Before using Insulatard Check the label to make sure it is the right type of insulin Always check the cartridge, including the rubber plunger (stopper). Don’t use it if any damage is seen or if there is a gap between the rubber plunger and the white label band. Take it back to your supplier. See your delivery system manual for further instructions Disinfect the rubber membrane with a medicinal swab Always use a new needle for each injection to prevent contamination. Do not use Insulatard In insulin infusion pumps If Penfill or the device containing Penfill is dropped, damaged or crushed there is a risk of leakage of insulin If it hasn’t been stored correctly or been frozen (see 6 How to store Insulatard) If it’s not uniformly white and cloudy when it’s resuspended.

Do not refill Insulatard Penfill.

Penfill cartridges are designed to be used with Novo Nordisk insulin delivery systems and NovoFine needles.

If you are treated with Insulatard Penfill and another insulin Penfill cartridge, you should use two insulin delivery systems, one for each type of insulin.

Resuspending the insulin

Resuspending is easier when the insulin has reached room temperature.

Before you put the Penfill cartridge into the insulin delivery system, move it up and down between positions a and b and back (see the picture) so that the glass ball moves from one end of the cartridge to the other at least 20 times. Repeat this movement at least 10 times before each injection. The movement must always be repeated until the liquid appears uniformly white and cloudy. Complete the other stages of injection without delay.

Check there are at least 12 units of insulin left in the cartridge to allow even resuspending. If there are less than 12 units left, use a new one.

How to use this insulin

Insulatard is for injection under the skin (subcutaneously). Never inject your insulin directly into a vein or muscle. Always vary the sites you inject, to avoid lumps (see 5 Possible side effects). The best place to give yourself an injection are: the front of your waist (abdomen); your buttocks: the front of your thighs or upper arms may be used. Your insulin will work more quickly if you inject it around the waist.

How to inject this insulin Inject the insulin under the skin. Use the injection technique advised by your doctor or diabetes nurse and described in your delivery system manual Keep the needle under your skin for at least 6 seconds to make sure that the full dose has been delivered After each injection be sure to remove and discard the needle and store Insulatard without the needle attached. Otherwise, the liquid may leak out which can cause inaccurate dosing. What to do in an emergency If you get a hypo

A hypo means your blood sugar level is too low.

The warning signs of a hypo may come on suddenly and can include: cold sweat; cool pale skin; headache; rapid heart beat; feeling sick; feeling very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.

If you get any of these signs. eat glucose tablets or a high sugar snack (sweets, biscuits, fruit juice), then rest.

Don’t take any insulin if you feel a hypo coming on.

Carry glucose tablets, sweets, biscuits or fruit juice with you, just in case.

Tell your relatives, friends and close colleagues that if you pass out (become unconscious), they must: turn you on your side and seek medical advice straight away. They must not give you any food or drink as it could choke you.

If severe hypoglycaemia is not treated, it can cause brain damage (temporary or permanent) and even death If you have a hypo that makes you pass out, or a lot of hypos, talk to your doctor. The amount or timing of insulin, food or exercise may need to be adjusted. Using glucagon

You may recover more quickly from unconsciousness with an injection of the hormone glucagon by someone who knows how to use it. If you are given glucagon you will need glucose or a sugary snack as soon as you are conscious. If you do not respond to glucagon treatment, you will have to be treated in a hospital. Seek medical advice after an injection of glucagon; you need to find the reason for your hypo to avoid getting more.

Causes of a hypo

You get a hypo if your blood sugar gets too low. This might happen:

If you take too much insulin If you eat too little or miss a meal If you exercise more than usual. If your blood sugar gets too high

Your blood sugar may get too high (this is called hyperglycaemia).

The warning signs appear gradually. They include: increased urination; feeling thirsty; losing your appetite; feeling sick (nausea or vomiting); feeling drowsy or tired; flushed, dry skin; dry mouth and a fruity (acetone) smell of the breath.

If you get any of these signs. test your blood sugar level and test your urine for ketones if you can. Then seek medical advice straight away.

These may be signs of a very serious condition called diabetic ketoacidosis. If you don’t treat it, this could lead to diabetic coma and death.

Causes of hyperglycaemia Having forgotten to take your insulin Repeatedly taking less insulin than you need An infection or a fever Eating more than usual Less exercise than usual. Insulatard Penfill Side Effects

Like all medicines, Insulatard can cause side effects, although not everybody gets them. Insulatard may cause hypoglycaemia (low blood sugar). See the advice in 4 What to do in an emergency.

Side effects reported uncommonly

(in less than 1 patient in 100)

Changes at the injection site (Lipodystrophy). If you inject yourself too often at the same site, fatty tissue under the skin at this site may shrink (lipoatrophy) or thicken (lipohypertrophy). Changing the site with each injection may help to prevent such skin changes. If you notice your skin pitting or thickening at the injection site, tell your doctor or diabetes nurse because these reactions can become more severe, or they may change the absorption of your insulin if you inject in such a site.

Signs of allergy. Reactions (redness, swelling, itching) at the injection site may occur (local allergic reactions). These reactions usually disappear after a few weeks of taking your insulin. If they do not disappear, see your doctor.

Seek medical advice immediately:

if signs of allergy spread to other parts of the body, or if you suddenly feel unwell and you start sweating; start being sick (vomiting); have difficulty in breathing; have a rapid heart beat; feel dizzy; feel like fainting.

You may have a very rare serious allergic reaction to Insulatard or one of its ingredients (called a systemic allergic reaction). See also warning in 2 Before you use Insulatard.

Diabetic retinopathy (eye background changes). If you have diabetic retinopathy and your blood glucose levels improve very fast, the retinopathy may get worse. Ask your doctor about this.

Swollen joints. When you start taking insulin, water retention may cause swelling around your ankles and other joints. This soon disappears.

Side effects reported very rarely

(in less than 1 patient in 10,000)

Vision problems. When you first start your insulin treatment, it may disturb your vision, but the reaction usually disappears.

Painful neuropathy (nerve related pain). If your blood glucose levels improve very fast it may cause a burning, tingling or electric pain. This is called acute painful neuropathy and it usually disappears. If it does not disappear, see your doctor.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, diabetes nurse or pharmacist.

How to store Insulatard

Keep out of the reach and sight of children.

Do not use Insulatard after the expiry date which is stated on the label and the carton. The expiry date refers to the last day of that month.

The Penfill that is not being used is to be stored in a refrigerator (2°C - 8°C).

Do not store them in or too near the freezer section or cooling element.

Do not freeze.

Keep the Penfill in the original package.

The Penfill that is being used or about to be used is not to be kept in a refrigerator. After removing the Penfill from the refrigerator it is recommended to let it reach room temperature before resuspending the insulin as instructed for the first time use. See 3 How to use Insulatard. You can carry it with you and keep it at room temperature (not above 30°C) for up to 6 weeks.

Always keep your cartridge in the outer carton when you’re not using it in order to protect it from light.

Insulatard must be protected from excessive heat and sunlight.

Insulatard should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further information What Insulatard contains The active substance is insulin human made by recombinant biotechnology. Insulatard is an isophane insulin suspension (NPH). 1 ml contains 100 IU of insulin human. 1 cartridge contains 3 ml equivalent to 300 IU The other ingredients are zinc chloride, glycerol, metacresol, phenol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid, protamine sulphate and water for injections. What Insulatard looks like and contents of the pack

The suspension for injection comes as a cloudy, white, aqueous suspension.

It is supplied in packs of 1, 5 or 10 cartridges of 3 ml. Not all packs may be marketed.

Marketing Authorisation Holder Novo Nordisk A/S Novo All? DK-2880 Bagsv?rd Denmark Manufacturer

The manufacturer can be identified by the batch number printed on the slip of the carton and on the label:

If the second and third characters are S6, P5, K7, R7 or ZF Novo Nordisk A/S Novo All? DK-2880 Bagsv?rd Denmark

is the manufacturer.

If the second and third characters are H7 or T6 Novo Nordisk Production SAS 45 Avenue d’Orl?ans F-28002 Chartres France

is the manufacturer

This leaflet was last approved in 11/2009

Insulatard Penfill and NovoFine are trademarks owned by Novo Nordisk A/S, Denmark

© 2010

Novo Nordisk A/S

8-0264-01-084-9


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Teruflex Blood Bag System


Generic Name: anticoagulant citrate phosphate dextrose (cpd) and as-5 red cell preservative
TERUFLEX® BLOOD BAG SYSTEM WITH BLOOD SAMPLING ARM® CPD/OPTISOL® SOLUTION Issued 8/96
TERUFLEX® BLOOD BAG SYSTEM With Blood Sampling Arm® CPD/OPTISOL® SOLUTION
Read these instructions carefully before use.
INSTRUCTIONS FOR BLOOD COLLECTION: Use aseptic technique
Materials Needed:
VENOJECT® ll Tube Holder (code P-1316R)
VENOJECT® ll Multi-Sample Luer Adapter (code MN *2000)
VENOJECT® ll Plastic Blood Collection Tubes (or equivalent glass or plastic evacuated blood collection tube)
1. Confirm that all numbered tubing of each blood bag unit contains segment numbers.
2. Make a loose knot in donor tubing below "Y" unless alternate methods are used to seal tubing.
3. Clamp donor tubing.
4. Suspend primary bag as far as possible below the donor's arm.
5. Apply blood pressure cuff or tourniquet to donor's arm. Disinfect site of phlebotomy. If blood pressure cuff is used, inflate cuff to approximately 60 mmHg.
6. Remove needle protector and perform phlebotomy. Remove clamp to permit blood flow into primary bag.
CAUTION Do not touch needle after removing the needle protector.
7. Appropriately secure donor tubing to donor's arm.
8. MIX BLOOD WITH ANTICOAGULANT AT SEVERAL INTERVALS DURING COLLECTION.
9. Collect labeled volume of blood (+/–10%).
10. Tighten knot firmly after collection. Clamp between knot and "Y". Sever donor tubing between the knot and clamp. Alternate methods may be used to seal tubing.
CAUTION Do not use the dielectric tube sealer while the needle is connected to the donor's body.
Anytime before Step #13 below, sever donor tubing between the two seals.
Collect blood samples as follows:
a) Connect VENOJECT II Multi-Sample Luer Adapter to VENOJECT II Tube Holder (Fig. 1).
b) Remove covers and connect multi-sample luer adapter to female luer at end of donor sampling tubing (Fig. 2).
c) Snap CLIKTIP in donor sampling tubing to open blood pathway.
Insert Fig. 1 here
Insert Fig. 2 here
d) Insert blood collection tube (VENOJECT II or equivalent) firmly into VENOJECT II Tube Holder : when full, remove sample tube from holder. Repeat to collect additional samples.
11. Reapply clamp to donor tubing between phlebotomy needle and "Y"; release pressure on donor's arm and remove needle.
CAUTION Discard tubing/phlebotomy needle unit according to institutional procedures.
12. Immediately after collection, invert bag several times to assure blood and anticoagulant are well mixed.
13. Strip blood from the donor tubing into bag, mix well, and allow tubing to refill. Seal on or near X marks on donor tubing to provide numbered aliquots of anticoagulated blood for testing.
14. The time of addition of OPTISOL Solution may vary depending on the processing option selected. Add the solution under one of the following conditions.
a) After removal of plasma from freshly collected blood.
b) Within 8 hours of blood collection if components are prepared.
c) Within 72 hours of collection if blood is refrigerated immediately following collection.
15. Centrifuge the unit to separate red cells from plasma.
16. Snap CLlKTIP (inline closure device) of primary collection bag and transfer plasma into satellite bag. Clamp transfer tubing of satellite bag.
17. Snap CLlKTIP of OPTlSOL Solution bag and drain contents into primary bag containing red blood cells. Seal tubing of primary bag in two places, and cut between seals and separate from satellite bag(s).
NOTE: For TERUFLEX double bags, seal OPTISOL Solution bag tubing in two places and cut between seals. Discard OPTISOL Solution container.
18. Invert the red cell- OPTISOL mixture several times to insure the final AS-5 red cell product is well suspended.
19. Store AS-5 Red Blood Cells between 1-6°C.
20. Infuse AS-5 Red Blood Cells within 42 days of collection.
For further processing, use standard component processing techniques.
To open blister package, peel cover film back four fifths of its length.
After opening, unused bags may be stored for 30 days by returning cover film to original position and sealing with tape to prevent possible loss of moisture.
Insert Fig. 3 here
CAUTIONS
•THE PACKET OF AGELESS CONTAINED IN THIS PACKAGE ABSORBS OXYGEN AND GENERATES HEAT ON REMOVAL AND SHOULD BE HANDLED WITH CARE.
• DISPOSE WITH PACKET IN TRAY.
• DO NOT DISPOSE WITH WASTES CONTAINING VOLATILE OR FLAMMABLE MATERIALS.
• DISCARD AGELESS PACKET WITHOUT OPENING.
TERUMO® TERUMO CORPORATION 44-1, 2-CHOME, HATAGAYA, SHIBUYA-KU, TOKYO, JAPAN
®: Registered Trademark
N-BB-OP-A(SP) 3


Tray/Case Label

TERUFLEX® BLOOD BAG SYSTEM with
BLOOD SAMPLING ARM®
CPD WITH OPTISOL® RED CELL PRESERVATIVE SOLUTION
FOR COLLECTION OF 500mL OF BLOOD
Each unit consists of a collection bag containing 70mL of Anticoagulant
CPD solution, with a satellite bag containing 111mL of OPTlSOL Red
Cell Preservative Solution.
Each 70mL Anticoagulant CPD solution USP contains 1.79g Dextrose
(monohydrate) USP, 1.84g Sodium Citrate (dihydrate) USP, 209mg Citric
Acid (anhydrous) USP, 156mg Monobasic Sodium Phosphate
(monohydrate) USP.
Each 111mL OPTISOL Red Cell Preservative Solution contains 974mg
Sodium Chloride USP, 1.00g Dextrose (monohydrate) USP, 583mg
Mannitol USP, 33.3mg Adenine USP.
STERILE, NON-PYROGENIC FLUID PATH.
DO NOT USE UNLESS ANTICOAGULANT IS CLEAR.
CODE
LOT No.
EXPIRY
UNITS
DONOR NEEDLE 16G x 1 1/2? (1.60 x 38mm)
Rx ONLY
RECOMMENDED STORAGE: Room Temperature (15-30°C/59-86°F).
Avoid excessive heat. Protect from freezing.
After opening, unused bags may be stored for 30 days by returning cover film to original
position and sealing with tape to prevent possible loss of moisture.
See Instructions For Blood Collection.
Manufactured by : TERUMO CORPORATION Tokyo, Japan
® : Registered Trademark
Blood Sampling Arm is a trademark of TERUMO CORPORATION.
Rev. 01/03
B-4-H6-A4 2
Place Label here



Teruflex Blood Bag System WITH BLOOD SAMPLING ARM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL (AS-5) RED CELL PRESERVATIVE 
anticoagulant citrate phosphate dextrose (cpd) and as-5 red cell preservative  kit Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 53877-009 Packaging # NDC Package Description Multilevel Packaging 1 53877-009-41 24 BAG In 1 CASE contains a BAG 1 1 KIT In 1 BAG This package is contained within the CASE (53877-009-41) QUANTITY OF PARTS Part # Package Quantity Total Product Quantity Part 1 1 BAG   70 mL Part 2 1 BAG   111 mL Part 1 of 2 ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD)  
anticoagulant citrate phosphate dextrose (cpd)  solution Product Information       Route of Administration INTRAVENOUS DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Trisodium Citrate Dihydrate (Citric Acid) Trisodium Citrate Dihydrate 26.3 g  in 1000 mL Sodium Phosphate, Monobasic (Phosphoric Acid) Sodium Phosphate, Monobasic 2.22 g  in 1000 mL Dextrose Monohydrate (Dextrose) Dextrose Monohydrate 25.5 g  in 1000 mL Anhydrous Citric Acid (Citric Acid) Anhydrous Citric Acid 2.99 g  in 1000 mL Inactive Ingredients Ingredient Name Strength Water   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 70 mL In 1 BAG None Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA880217 05/05/2010
Part 2 of 2 OPTISOL RED CELL PRESERVATIVE  
as-5 red cell preservative  solution Product Information       Route of Administration INTRAVENOUS DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Chloride (SODIUM CATION) Sodium Chloride 877 mg  in 100 mL Dextrose Monohydrate (Dextrose) Dextrose Monohydrate 900 mg  in 100 mL Mannitol (Mannitol) Mannitol 525 mg  in 100 mL Adenine (Adenine) Adenine 30 mg  in 100 mL Inactive Ingredients Ingredient Name Strength Water   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 111 mL In 1 BAG None Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA880217 05/05/2010
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA880217 05/05/2010
Labeler - Terumo Corporation (690543319) Establishment Name Address ID/FEI Operations Terumo Corp. - Fujinomiya Factory 695214015 manufacture Revised: 06/2011Terumo Corporation

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Hycamtin


Generic Name: topotecan (TOE poe TEE kan)
Brand Names: Hycamtin

What is Hycamtin (topotecan)?

Topotecan is a cancer medication that interferes with the growth and spread of cancer cells in the body.

Topotecan is used to treat ovarian cancer, small cell lung cancer, and certain types of cervical cancer.

Topotecan may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Hycamtin (topotecan)? Do not use topotecan if you are pregnant. It could harm the unborn baby.

Topotecan can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Your blood may need to be tested often. Visit your doctor regularly.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Do not receive a "live" vaccine while using topotecan, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you. Call your doctor at once if you have fever, chills, body aches, flu symptoms, pale skin, easy bruising or bleeding, severe diarrhea with fever or stomach pain, unusual weakness, white patches or sores inside your mouth or on your lips, or other signs of infection. What should I discuss with my healthcare provider before using Hycamtin (topotecan)? You should not use topotecan if you have:

severe bone marrow depression; or

if you are pregnant or breast-feeding.

To make sure you can safely use topotecan, tell your doctor if you have any of these other conditions:

kidney disease;

lung disease or lung cancer; or

if you have had a chest x-ray or radiation treatment of your chest area.

FDA pregnancy category D. Do not use topotecan if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment. It is not known whether topotecan passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using topotecan. How should I use Hycamtin (topotecan)?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Topotecan is usually given once daily for 5 days in a row. This treatment is then repeated every 21 days, usually for at least 4 treatments. It may take several weeks for your body to respond to the medication.

Topotecan capsules are taken by mouth. You may need to take two different colored capsules at one time. Make sure you know the difference between capsules because one contains 4 times as much topotecan as the other, even though they may look the same in size.

Take the topotecan capsule with a full glass (8 ounces) of water. You may take the medicine with or without food.

If you vomit after taking a topotecan capsule, do not take another dose that same day. Call your doctor for instructions.

Do not crush or break a topotecan capsule, or use a capsule that has been accidentally broken. The medicine from a broken capsule can be dangerous if it gets in your eyes or on your skin. If this occurs, wash your skin with soap and water or rinse the eyes for at least 15 minutes with plain water. Ask your doctor or pharmacist how to safely handle and dispose of a broken tablet or capsule. Store topotecan capsules in the refrigerator and protect them from light.

Topotecan injection is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting. Topotecan must be given slowly, and the IV infusion can take up to 30 minutes to complete.

Tell your doctor right away if any of this medicine gets on your skin during the injection. If this does happen, the exposed skin should be rinsed thoroughly with soap and warm water.

Topotecan can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Your blood may need to be tested often. Visit your doctor regularly.

What happens if I miss a dose?

Call your doctor for instructions if you miss any of your topotecan doses.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose can cause bone marrow depression (fever, chills, body aches, flu symptoms, sores or white patches in your mouth, or other signs of infection).

What should I avoid while using Hycamtin (topotecan)?

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Do not receive a "live" vaccine while using topotecan, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you. Live vaccines include measles, mumps, rubella (MMR), oral polio, typhoid, chickenpox (varicella), BCG (Bacillus Calmette and Gu?rin), and nasal flu vaccine. Topotecan may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Hycamtin (topotecan) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

wheezing, feeling short of breath, chest pain, dry cough;

fever, chills, flu symptoms, mouth and throat ulcers, rapid and shallow breathing, fainting;

pale skin, feeling light-headed, rapid heart rate, trouble concentrating;

easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

diarrhea with fever and stomach cramps;

pain or burning when you urinate; or

skin changes or severe irritation where the needle is placed.

Less serious side effects may include:

nausea, diarrhea, vomiting;

tired feeling; or

temporary hair loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Hycamtin (topotecan)?

Tell your doctor about all other cancer medicines you use, especially:

filgrastim (Neupogen), pegfilgrastim (Neulasta), or sargramostim (Leukine); or

cisplatin (Platinol), carboplatin (Paraplatin), or oxaliplatin (Eloxatin).

This list is not complete and other drugs may interact with topotecan. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Hycamtin resources Hycamtin Side Effects (in more detail) Hycamtin Use in Pregnancy & Breastfeeding Hycamtin Drug Interactions Hycamtin Support Group 0 Reviews for Hycamtin - Add your own review/rating Hycamtin Prescribing Information (FDA) Hycamtin MedFacts Consumer Leaflet (Wolters Kluwer) Hycamtin Monograph (AHFS DI) Hycamtin Advanced Consumer (Micromedex) - Includes Dosage Information Topotecan Prescribing Information (FDA) Compare Hycamtin with other medications Cancer Cervical Cancer Ovarian Cancer Small Cell Lung Cancer Where can I get more information? Your doctor or pharmacist can provide more information about topotecan.

See also: Hycamtin side effects (in more detail)


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E45 Cream (Forum Health Products Limited )


1. Name Of The Medicinal Product

E45 Cream

2. Qualitative And Quantitative Composition

Anhydrous Lanolin

 

1.0%

w/w

White Soft Paraffin

BP

14.5%

w/w

Light Liquid Paraffin

PhEur

12.6%

w/w

3. Pharmaceutical Form

A cream

4. Clinical Particulars 4.1 Therapeutic Indications

For the symptomatic relief of dry skin conditions, where the use of an emollient is indicated, such as flaking, chapped skin, ichthyosis, traumatic dermatitis, sunburn, the dry stage of eczema and certain dry cases of psoriasis.

4.2 Posology And Method Of Administration

For topical application.

Adults, Children, Babies and the Elderly - Apply to the affected part two or three times daily.

4.3 Contraindications

Hypersensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

The labelling states:

For external use only.

If symptoms persist, consult your doctor.

Keep all medicines out of the reach of children.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No clinically significant interactions known.

4.6 Pregnancy And Lactation

The safety of E45 Cream in pregnancy and lactation has not been assessed but is thought unlikely to constitute a hazard.

4.7 Effects On Ability To Drive And Use Machines

No adverse effects known.

4.8 Undesirable Effects

Occasionally, hypersensitivity reactions, otherwise adverse effects are unlikely, but should they occur, may take the form of an allergic rash. Should this occur, use of the product should be discontinued.

4.9 Overdose

E45 cream is of low toxicity. If accidental ingestion occurs, conservative treatment only is required.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Lanolin, light liquid paraffin and white soft paraffin have emollient moisturising properties.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

There are no pre-clinical safety data of relevance to the consumer.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Empilan GMS, cetyl alcohol, sodium cetostearyl sulphate, carbomer, methyl hydroxybenzoate, propyl hydroxybenzoate, sodium hydroxide, citric acid monohydrate, purified water.

6.2 Incompatibilities

Compatibility problems may be encountered with the stronger acids, calcium, magnesium and aluminium salts, quaternary compounds, acridines, basic dyestuffs and alkaloids.

6.3 Shelf Life

Aluminium tubes and polypropylene tubs: 3 years.

All other containers: 2 years.

6.4 Special Precautions For Storage

Store below 25°C for polyethylene tubes and pump pack, made of polypropylene and polyethylene and consisting of a plastic bottle and a pump system with a dip tube. None for aluminium tubes and polypropylene tubs.

6.5 Nature And Contents Of Container

A collapsible aluminium tube, internally lacquered with a membrane seal and plastic screw cap. Pack sizes: 15, 50 or 100 g.

(The 100 g tube is for dispensing only. One hundred tubes will be packed in an outer carton, labelled with the same wording as an OTC pack and the additional statement 'For dispensing only - not for retail sale'.)

A polyethylene tube with membrane seal and plastic screw cap. Pack sizes 15 or 50 g.

A polypropylene securipot with a white polythene pilfer-proof screw cap. Pack sizes: 125, 350 or 500 g.

A white polypropylene jar with a white polyethylene push-on, tamper-evident closure. Pack sizes: 250, 300 or 500 g.

((The 500 g jar is for dispensing only. Thirty-six jars will be packed in an outer carton, labelled with the same wording as an OTC pack and the additional statement 'For dispensing only - not for retail sale'.)

A polypropylene securipot with a polythene pilfer-proof screw cap fitted with a HDPE or polypropylene dispenser having a polythene covered follower plate.

Pack sizes: 500 or 900 g.

A pump pack made of polypropylene and polyethylene, consisting of a plastic bottle and a pump system with a dip tube. Pack size: 500 g.

A pump pack made of polypropylene and polyethylene, consisting of a piston pump system with an airless dispenser. Pack size: 500g

Not all pack sizes are necessarily marketed.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Reckitt Benckiser Healthcare (UK) Limited

Wellcroft Road

Slough,

SL1 4AQ

United Kingdom

8. Marketing Authorisation Number(S)

PL 00063/0404

9. Date Of First Authorisation/Renewal Of The Authorisation

25th September 1991

10. Date Of Revision Of The Text

07/10/2011

11 DOSIMETRY

IF APPLICABLE

12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS

IF APPLICABLE


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Emla


Generic Name: lidocaine and prilocaine topical (LY doh kayn and PRIL oh kayn TOP ik al)
Brand Names: Emla

What is lidocaine and prilocaine topical?

Lidocaine and prilocaine topical is a local anesthetic (numbing medication). It works by blocking nerve signals in your body.

Lidocaine and prilocaine topical is used to numb the skin, or surfaces of the penis or vagina, in preparation for a medical procedure or to lessen the pain of inserting a medical instrument such as a tube or speculum.

Lidocaine and prilocaine topical may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about lidocaine and prilocaine? An overdose of numbing medications can cause fatal side effects if too much of the medicine is absorbed through your skin and into your blood. This is more likely to occur when using a numbing medicine without the advice of a medical doctor (such as during a cosmetic procedure like laser hair removal). However, overdose has also occurred in women treated with a numbing medicine before having a mammography. Overdose symptoms may include uneven heartbeats, seizure (convulsions), coma, slowed breathing, or respiratory failure (breathing stops). Your body may absorb more of this medication if you use too much, if you apply it over large skin areas, or if you apply heat, bandages, or plastic wrap to treated skin areas. Skin that is cut or irritated may also absorb more topical medication than healthy skin.

Use the smallest amount of this medication needed to numb the skin or relieve pain. Do not use large amounts of lidocaine and prilocaine topical, or cover treated skin areas with a bandage or plastic wrap without medical advice. Be aware that many cosmetic procedures are performed without a medical doctor present.

Do not use lidocaine and prilocaine topical if you have had an allergic reaction to a numbing medicine in the past.

Before lidocaine and prilocaine topical is applied, tell your doctor if you have liver disease, a history of allergic reaction to lidocaine or prilocaine, or a personal or family history of methemoglobinemia, or any genetic enzyme deficiency.

Lidocaine and prilocaine topical is for use only on the surface of your body. Avoid getting this medication in your eyes.

Avoid accidentally injuring treated skin areas while they are numb. Avoid coming into contact with very hot or very cold surfaces.

What should I discuss with my health care provider before using lidocaine and prilocaine topical? An overdose of numbing medications can cause fatal side effects if too much of the medicine is absorbed through your skin and into your blood.

Overdose is more likely to occur when using a numbing medicine without the advice of a medical doctor (such as during a cosmetic procedure like laser hair removal). However, overdose has also occurred in women treated with a numbing medicine before having a mammography. Symptoms may include uneven heartbeats, seizure (convulsions), coma, slowed breathing, or respiratory failure (breathing stops).

Do not use lidocaine and prilocaine topical if you have a blood cell disorder called methemoglobinemia.

Before lidocaine and prilocaine topical is applied, tell your doctor if you have:

liver disease;

a history of allergic reaction to lidocaine or prilocaine; or

a personal or family history of methemoglobinemia, or any genetic enzyme deficiency.

If you have any of these conditions, you may need a dose adjustment or special tests to safely use lidocaine and prilocaine topical.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Lidocaine and prilocaine topical can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I use lidocaine and prilocaine topical?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts, or use it for longer than recommended.

Your body may absorb more of this medication if you use too much, if you apply it over large skin areas, or if you apply heat, bandages, or plastic wrap to treated skin areas. Skin that is cut or irritated may also absorb more topical medication than healthy skin.

Use the smallest amount of medicine needed to numb the skin or relieve pain. Do not use large amounts of lidocaine and prilocaine topical, or cover treated skin areas with a bandage or plastic wrap without medical advice. Be aware that many cosmetic procedures are performed without a medical doctor present.

This medication comes with instructions for safe and effective application. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

You should be lying down when lidocaine and prilocaine topical cream is applied.

Your medicine may have been supplied with bandages to cover the cream when it is applied to a small area on your skin. If using a bandage dressing, first apply a thick layer of the cream to the skin, taking care not to spread the cream out. Place the bandage over the cream and smooth down the edges until it is completely sealed around the cream.

Lidocaine and prilocaine topical is usually applied 1 to 2 hours before the start of a procedure that requires the treated area to be numb. Follow your doctor's instructions about the length of time the cream should be left on the skin.

Store lidocaine and prilocaine topical at room temperature away from moisture and heat. Do not allow the cream to freeze. What happens if I miss a dose?

Since lidocaine and prilocaine topical is used as needed, it is not likely that you will be on a dosing schedule.

What happens if I overdose? Seek emergency medical attention if you think you have used too much of this medicine. An overdose of lidocaine and prilocaine topical applied to the skin can cause life-threatening side effects such as uneven heartbeats, seizure (convulsions), coma, slowed breathing, or respiratory failure (breathing stops). What should I avoid while taking lidocaine and prilocaine topical? Lidocaine and prilocaine topical is for use only on the surface of your body. Avoid getting this medication in your eyes.

Avoid accidentally injuring treated skin areas while they are numb. Avoid coming into contact with very hot or very cold surfaces.

Lidocaine and prilocaine topical side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using lidocaine and prilocaine topical and call your doctor at once if you have any of these serious side effects:

severe burning, stinging, or sensitivity where the medicine is applied;

swelling or redness;

sudden dizziness or sleepiness after medicine is applied;

bruising or purple appearance of the skin; or

unusual sensations of temperature.

Less serious side effects may include:

mild burning where the medicine is applied;

skin redness; or

changes in skin color where the medicine was applied.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect lidocaine and prilocaine topical?

Before this medication is applied, tell your doctor if you are using any of the following drugs:

heart rhythm medication such as mexiletine (Mexitil);

acetaminophen (Tylenol);

chloroquine (Aralen);

dapsone;

nitrates or nitrites such as Imdur, Isordil, Monoket;

nitrofurantoin (Furadantin, Macrodantin, Macro-Bid);

phenobarbital (Luminal, Solfoton);

primaquine;

quinine; or

a sulfa drug (Bactrim, Gantanol, Gantrisin, Septra, SMX-TMP, and others).

This list is not complete and there may be other drugs that can interact with lidocaine and prilocaine topical. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More Emla resources Emla Side Effects (in more detail) Emla Use in Pregnancy & Breastfeeding Emla Support Group 0 Reviews for Emla - Add your own review/rating Emla Topical Advanced Consumer (Micromedex) - Includes Dosage Information Emla Consumer Overview EMLA Prescribing Information (FDA) EMLA Cream MedFacts Consumer Leaflet (Wolters Kluwer) Compare Emla with other medications Anesthesia Where can I get more information? Your pharmacist can provide more information about lidocaine and prilocaine topical.

See also: Emla side effects (in more detail)


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Lamisil AT


terbinafine hydrochloride
Dosage Form: cream
Drug Facts Active ingredient

Terbinafine hydrochloride

Purpose

Antifungal

Uses cures most athlete’s foot (tinea pedis) cures most jock itch (tinea cruris) and ringworm (tinea corporis) relieves itching, burning, cracking and scaling which accompany these conditions Warnings

For external use only

Do Not Use on nails or scalp in or near the mouth or eyes for vaginal yeast infections When using this product

do not get into eyes. If eye contact occurs, rinse thoroughly with water.

Stop use and ask doctor

if too much irritation occurs or gets worse

Keep out of reach of children

If swallowed, get medical help or contact a poison control center right away.

Directions

• adults and children 12 years and over:

    • use the tip of the cap to break the seal and open the tube

    • wash the affected skin with soap and water and dry completely before applying

    • for athlete’s foot wear well-fitting, ventilated shoes. Change shoes and socks at least once daily

        • between the toes only: apply twice a day (morning and night) for 1 week or as directed by a doctor

1 week between the toes

       • on the bottom or sides of the foot: apply twice a day (morning and night) for 2 weeks or as directed by a doctor

2 weeks on the bottom or sides of the foot

    • for jock itch and ringworm: apply once a day (morning or night) for 1 week or as directed by a doctor

    • wash hands after each use

• children under 12 years: ask a doctor

Other information do not use if seal on tube is broken or is not visible store at controlled room temperature 20-25°C (68-77°F) Inactive ingredients

benzyl alcohol, cetyl alcohol, cetyl palmitate, isopropyl myristate, polysorbate 60, purified water, sodium hydroxide, sorbitan monostearate, stearyl alcohol.

Questions

call 1-800-452-0051

Novartis Consumer Health, Inc.

Parsippany, NJ 07054-0622 ©2008

Principal display panel

Lamisil AT Cream


LAMISIL  AT
terbinafine hydrochloride  cream Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 0067-3998 Route of Administration TOPICAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TERBINAFINE HYDROCHLORIDE (TERBINAFINE) TERBINAFINE HYDROCHLORIDE 10 mg  in 1 g Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL   CETYL ALCOHOL   CETYL PALMITATE   ISOPROPYL MYRISTATE   POLYSORBATE 60   WATER   SODIUM HYDROXIDE   SORBITAN MONOSTEARATE   STEARYL ALCOHOL   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 0067-3998-42 1 TUBE In 1 CARTON contains a TUBE 1 12 g In 1 TUBE This package is contained within the CARTON (0067-3998-42) 2 0067-3998-30 1 TUBE In 1 CARTON contains a TUBE 2 30 g In 1 TUBE This package is contained within the CARTON (0067-3998-30) 3 0067-3998-99 42 g In 1 CARTON None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020980 08/10/2005
Labeler - Novartis Consumer Health, Inc. (879821635) Revised: 01/2010Novartis Consumer Health, Inc.
More Lamisil AT resources Lamisil AT Side Effects (in more detail) Lamisil AT Use in Pregnancy & Breastfeeding Lamisil AT Support Group 4 Reviews for Lamisil AT - Add your own review/rating Lamisil AT Concise Consumer Information (Cerner Multum) Lamisil AT Topical Advanced Consumer (Micromedex) - Includes Dosage Information Lamisil AT Cream MedFacts Consumer Leaflet (Wolters Kluwer) Compare Lamisil AT with other medications Tinea Corporis Tinea Cruris Tinea Pedis
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gemtuzumab


Generic Name: gemtuzumab (jem TOOZ oo mab)
Brand Names: Mylotarg

What is gemtuzumab?

Gemtuzumab is a cancer medication. Gemtuzumab interferes with the growth of cancer cells and slows their growth and spread in the body.

Gemtuzumab is used to treat acute myeloid leukemia, a type of blood cancer. Gemtuzumab is usually given to people who are at least 60 years old and have a relapse of their disease and who cannot receive other cancer medications.

Gemtuzumab may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about gemtuzumab? You should not receive this medication if you are allergic to gemtuzumab Do not receive gemtuzumab without telling your doctor if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

Before receiving gemtuzumab, tell your doctor if you have any type of infection, lung or breathing problems, liver or kidney disease, if you have ever received a stem cell transplant, or if you are being treated with other cancer medications.

Gemtuzumab can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Your kidney or liver function may also need to be tested. Do not miss any follow-up visits to your doctor.

Contact your doctor at once if you develop signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), loss of appetite, nausea and vomiting, mouth sores, or unusual weakness. Do not receive a "live" vaccine while you are being treated with gemtuzumab, and avoid coming into contact with anyone who has recently received a live vaccine. What should I discuss with my healthcare provider before taking gemtuzumab? You should not receive this medication if you are allergic to gemtuzumab

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:

any type of infection;

lung or breathing problems;

liver disease; kidney disease;

if you have ever received a stem cell transplant; or

if you being treated with other cancer medications.

FDA pregnancy category D. Gemtuzumab can cause harm to an unborn baby or cause birth defects. Before you receive gemtuzumab, tell your doctor if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment. It is not known whether gemtuzumab passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How is gemtuzumab given?

Gemtuzumab is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting. The medicine must be given slowly through an IV infusion, and can take at least 2 hours to complete.

Gemtuzumab can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill.

Contact your doctor at once if you develop signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), loss of appetite, nausea and vomiting, mouth sores, or unusual weakness.

To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Your kidney or liver function may also need to be tested. Do not miss any follow-up visits to your doctor.

What happens if I miss a dose?

Contact your doctor if you miss an appointment for your gemtuzumab injection.

What happens if I overdose? Since gemtuzumab is given by a healthcare professional, an overdose is not likely to occur.

Symptoms of a gemtuzumab overdose are not known.

What should I avoid while using gemtuzumab? Do not receive a "live" vaccine while you are being treated with gemtuzumab, and avoid coming into contact with anyone who has recently received a live vaccine. The live vaccine may not work as well during this time, and may not fully protect you from disease. There is also chance that the virus could be passed on to you. Live vaccines include measles, mumps, rubella (MMR), oral polio, chickenpox (varicella), BCG (Bacillus Calmette and Gu?rin), and nasal flu vaccine. Gemtuzumab side effects Some people receiving a gemtuzumab injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, nauseated, light-headed, sweaty, or have fever, chills, or trouble breathing within 24 hours after receiving the injection. Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

pain in your upper right stomach, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

swelling, rapid weight gain;

feeling like you might pass out;

pale skin, easy bruising or bleeding (such as nosebleeds), purple or red pinpoint spots under your skin;

fever, chills, body aches, unusual weakness, flu symptoms;

white patches or sores inside your mouth or on your lips;

chest pain or tightness, feeling short of breath;

lower back pain, blood in your urine;

increased thirst, fruity breath odor, increased urination;

urinating less than usual or not at all;

numbness or tingly feeling around your mouth;

muscle weakness, tightness, or contraction, overactive reflexes;

fast or slow heart rate, weak pulse; or

confusion, uneven heart rate, leg discomfort, muscle weakness or limp feeling.

Less serious side effects may include:

nausea, vomiting;

diarrhea or constipation;

headache;

dizziness, anxiety, depressed mood; or

sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Gemtuzumab Dosing Information

Usual Geriatric Dose for Acute Myeloid Leukemia:

Gemtuzumab was withdrawn from the market as of October 15, 2010. The post-approval study (SWOG S0106) combining chemotherapy and gemtuzumab did not demonstrate improved survival compared with chemotherapy alone in patients with previously untreated AML. Among all patients evaluable for early toxicity the fatal induction toxicity rate was significantly higher in subjects given the combination of standard induction chemotherapy and gemtuzumab than in those treated with chemotherapy alone.
For use in the treatment of patients with CD33 positive acute myeloid leukemia in first relapse who are 60 years of age or older and who are not considered candidates for other cytotoxic chemotherapy:
9 mg/m2 administered as a two hour intravenous infusion once
Vital signs should be monitored during infusion and for four hours following infusion.
The recommended treatment course with gemtuzumab is a total of two doses with fourteen days between the doses. (Full recovery from hematologic toxicities is not a requirement for administration of the second dose.)

Usual Pediatric Dose for Acute Myeloid Leukemia:

Gemtuzumab was withdrawn from the market as of October 15, 2010. The post-approval study (SWOG S0106) combining chemotherapy and gemtuzumab did not demonstrate improved survival compared with chemotherapy alone in patients with previously untreated AML. Among all patients evaluable for early toxicity the fatal induction toxicity rate was significantly higher in subjects given the combination of standard induction chemotherapy and gemtuzumab than in those treated with chemotherapy alone.
As a part of combination therapy:
Relapsed/refractory AML:
Children less than 3 years: 0.07 to 0.1 mg/kg/dose
Children greater than or equal to 3 years: 2 to 3 mg/m2/dose
Newly diagnosed childhood AML: 3 mg/m2/dose (no dose adjustment for age or body surface area less than 0.6 m2)
Children: Monotherapy: Phase I (MTD):
Children less than 3 years: 0.2 mg/kg/dose for a total of 2 doses separated by 14 days
Children greater than 3 years: 6 mg/m2/dose for a total of 2 doses separated by 14 days

What other drugs will affect gemtuzumab?

Tell your doctor about all other chemotherapy treatments you are receiving.

There may be other drugs that can interact with gemtuzumab. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More gemtuzumab resources Gemtuzumab Side Effects (in more detail) Gemtuzumab Dosage Gemtuzumab Use in Pregnancy & Breastfeeding Gemtuzumab Drug Interactions Gemtuzumab Support Group 0 Reviews for Gemtuzumab - Add your own review/rating gemtuzumab Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information Gemtuzumab Ozogamicin Monograph (AHFS DI) Mylotarg Prescribing Information (FDA) Mylotarg MedFacts Consumer Leaflet (Wolters Kluwer) Compare gemtuzumab with other medications Acute Myeloid Leukemia Where can I get more information? Your doctor or pharmacist can provide more information about gemtuzumab.

See also: gemtuzumab side effects (in more detail)


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Boots Nirolex Chesty Cough & Congestion Relief Linctus


Boots Nirolex Chesty Cough & Congestion Relief Linctus (Guaifenesin, Pseudoephedrine Hydrochloride)

Non drowsy

Relieves chesty coughs

Clears nasal congestion

120 ml e

Read all of this carton for full instructions.

What this medicine is for

This medicine contains Guaifenesin and Pseudoephedrine Hydrochloride, which act to relieve coughs and blocked noses.

It can be used to relieve the symptoms of chesty coughs, catarrh and blocked noses, without causing drowsiness.

Before you take this medicine Do not take: If you are allergic to any of the ingredients If you have heart or blood vessel disease, high blood pressure (including that due to a tumour near your kidney), glaucoma If you have severe kidney problems, diabetes, an overactive thyroid If you are taking monoamine oxidase inhibitors (for depression) or have taken them in the last 14 days If you have an intolerance to some sugars, unless your doctor tells you to (this medicine contains sucrose) If you are a man with prostate problems If you are pregnant Talk to your pharmacist or doctor: If you have other kidney problems (see above) If you take other medicines tricyclic antidepressants digoxin (for heart problems) medicines for high blood pressure other decongestants appetite suppressants or stimulants If you are breastfeeding Information about some of the ingredients:

The colour carmoisine (E122) in this medicine may cause allergic reactions.

How to take this medicine

Check the seal is not broken before first use. If it is, do not take the medicine.

Adults and children of 12 years and over
Take two 5ml spoonfuls 4 times a day.

Children of 6 to 11 years
Take one 5ml spoonful 3 times a day.

This medicine should be swallowed.

Do not give to children under 6 years.

Warning: Do not exceed the stated dose

If symptoms do not go away talk to your doctor.

If you take too much: Talk to doctor straight away.

Possible side effects

Most people will not have problems, but some may get some of these:

Feeling sick, being sick, stomach discomfort Headache Irritability, restlessness, confusion, shaking, difficulty sleeping, dizziness Fast heart beat, heart rhythm problems, palpitations, high blood pressure Difficulty in passing urine Skin rashes

If any side effect becomes severe, or you notice any side effect not listed here, please tell your pharmacist or doctor.

How to store this medicine

Do not store above 30°C.

Keep all medicines out of the sight and reach of children.

Use by the date on the end flap of the carton.

Active ingredients

Each 5 ml of oral solution contains Guaifenesin 100 mg, Pseudoephedrine Hydrochloride 30 mg.

Also contains: purified water, liquid sugar (sucrose), glycerol (E422), citric acid, sodium citrate, hyetellose, potassium sorbate (E202), acesulfame potassium, carmoisine (E122), patent V (E131), flavours (strawberry, blackcurrant, menthol, cream).

PL 00014/0555 [P]

Text prepared 11/07

Manufactured by the Marketing Authorisation holder The Boots Company PLC Nottingham England NG2 3AA Other formats

To request a copy of this carton in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK only)

Please be ready to give the following information:

Product name: Boots Nirolex Chesty Cough & Congestion Relief Linctus

Reference number: 00014/0555

This is a service provided by the Royal National Institute of the Blind.

If you need more advice ask your pharmacist.

BTC 23038 vD 28/03/08


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OncoTICE


OncoTICE powder for suspension

2-8 X 108 CFU Tice BCG

Read all of this leaflet carefully before you start using this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, please ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Oncotice is and what it is used for 2. Before you are given Oncotice 3. How Oncotice is given 4. Possible side effects 5. How to store Oncotice 6. Further information What Oncotice is and what it is used for

Oncotice contains something called ‘BCG’ (‘Bacillus Calmette-Gu?rin’). This is a bacteria which has been specially altered, so that it can be used as a medicine.

Oncotice is used to: treat bladder cancer prevent bladder cancer from coming back after bladder surgery.

It comes as a powder which is mixed with saline (salt water). It is then run into your bladder through a tube.

BCG is also used as a vaccine for TB (tuberculosis). Oncotice is a much stronger sort of BCG that can’t be used as a vaccine.

Before you are given Oncotice Oncotice should not be given if: You have a urinary tract infection (UTI). This must be treated first. You have blood in your urine. You have or think you have TB (tuberculosis). Before you have Oncotice, your doctor may do a skin reaction test, to see if you have TB. This is called a Tuberculin Test. If you have had Oncotice before, this may give you a positive result in this test. You are HIV-positive. You may need to have a blood test for HIV. Tell your doctor if any of the following apply to you: you have been a drug user and have shared a needle you have had unsafe sex you have had a blood transfusion. You have problems with your immune system. This could be something which runs in the family, or is caused by an illness or other medicines you are taking.

Do not have Oncotice if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before being given Oncotice.

Take special care with Oncotice

Check with your doctor or pharmacist before being given the medicine if:

Your bladder wall or the tube coming into your bladder from your kidneys (called the ‘ureter’) have been damaged during previous treatment.

Treatment with Oncotice will not be given until this has healed.

If you are not sure if any of the above apply to you talk to your doctor or pharmacist before being given Oncotice.

Taking other medicines

Please tell your doctor or pharmacist if you are taking, or have recently taken any other medicine. This includes medicines obtained without a prescription, including herbal medicines.

Do not have Oncotice and talk to your doctor straight away if:

You are taking medicines for TB.

The following can lower the effect of Oncotice:

antibiotics medicines which affect the immune system (immuno-suppressants) medicines which affect the production of bone marrow cells (bone marrow suppressants) radiation treatment.

If you are having any of these medicines or are having radiation treatment, your doctor will probably delay giving you Oncotice.

Using Oncotice with food and drink Do not drink any liquid for 4 hours before you are given Oncotice. Do not drink any liquid for 2 hours after you have been given Oncotice. Pregnancy and breast-feeding

Do not have Oncotice if you are pregnant or breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.

Driving and using machines

Oncotice will not affect your being able to drive or use any tools or machines.

Important information about some of the ingredients of Oncotice Oncotice contains lactose (a type of sugar). If you have been told by your doctor that you cannot tolerate or digest some sugars, talk to your doctor before being given this medicine. This medicine contains a very small amount of potassium (less than 1mmol or 39mg per dose). This means it is essentially ‘potassium-free’. How Oncotice is given

You will always be given Oncotice by a doctor or nurse.

Before it is given Do not drink any liquid the 4 hours before Oncotice is given to you. You will be asked to pass water immediately before Oncotice is given to you. Being given your medicine First your genital area will be cleaned with a sterile solution. A nurse will then pass a small flexible tube into your bladder. This will remove any urine that is still in your bladder. Oncotice is then run into your bladder through this tube. This will only take a few minutes. The tube will then be removed. After it has been given Oncotice will be left in your bladder for 2 hours. During this time you should move around a little. This makes sure that the Oncotice is spread around all of your bladder. Do not drink any liquid for 2 hours after you have been given Oncotice. After 2 hours you will be asked to pass water, to empty your bladder. You should do this while sitting down to avoid splashing your urine around the toilet. During the next 6 hours If you need to pass water again, also do this while sitting down. Every time you pass water, add two cups of household bleach to the toilet. Leave the bleach and urine to stand in the toilet for 15 minutes before flushing. How often Oncotice is given

Oncotice is usually given once a week for 6 weeks. After this some people have ‘maintenance therapy’, where you may be given more doses. Your doctor will talk to you about this.

Having sex in the week after having Oncotice

If you have sexual intercourse during the week after being given the medicine, you must use a condom. This will lower the chance of the BCG bacteria being passed to your partner.

If you have more Oncotice than you should

Oncotice is made up from a standard bottle by your doctor, pharmacist or nurse. It is unlikely that you will receive too much Oncotice. If you do have too much, your doctor will check carefully to see whether you have BCG infection.

If necessary you will need to have treatment for TB.

OncoTICE Side Effects

Like all medicines, Oncotice can cause side effects, although not everybody gets them.

If you notice the following side effects, see your doctor straight away: a high temperature (fever) above 39 °C that lasts for more than 12 hours, even after taking medicines like paracetamol to lower your temperature. signs of a BCG or TB infection: cough or bronchitis chest pain or tightness sweating sore throat cold in the nose swelling of your lymph glands.

See your doctor straight away if you notice any of these side effects.

Other side effects include:

Very common

(affects more than 1 in 10 people)

bladder infection, pain when passing water, having to pass water often, feeling the need to pass water and bloody urine. Usually this goes away within two days. flu-like symptoms such as fever and feeling off-colour and tired (malaise). This usually happens about 4 hours after treatment and last for 24 to 48 hours.

Common

(affects less than 1 in 10 people)

painful joints or arthritis muscle pain or stiffness feeling sick (nausea) and being sick (vomiting) abdominal pain or diarrhoea chest infection anaemia problems with passing water or having a large amount of blood in your urine shivering with a high temperature (fever).

Uncommon

(affects less than 1 in 100 people)

skin rash jaundice (yellow colour of your skin or eyes) pus in your urine difficulty passing water low blood count (shown in blood tests)

Rare

(affects less than 1 in every 1,000 people)

inflammation of the genitals or prostate.

Very Rare

(affects less than 1 in every 10,000 people)

headache back pain increased muscle tension swollen legs or arms low blood pressure blood problems (shown in blood tests) flatulence or discomfort following meals loss of appetite or weight loss hair loss prickling or itching skin open sores on your skin eye infection feeling confused, sleepy or dizzy kidney problems

Tell your doctor if any side effect is severe or lasts longer than 48 hours.

If you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

How to store Oncotice

Keep Oncotice out of the reach and sight of children.

Oncotice will be stored in the hospital according to the instructions given by the manufacturer on the packaging.

Store at 2 °C to 8 °C (in a refrigerator).

Do not use Oncotice after the expiry date which is stated on the carton and label.

Further information What Oncotice contains The active substance is Bacillus Calmette-Gu?rin (BCG). It is a specially treated bacteria to be used as a medicine. The other ingredients are: lactose, asparagine, citric acid (E330), potassium phosphate, magnesium sulfate, iron ammonium citrate, glycerol (E422), ammonium hydroxide (E527), zinc formate. What Oncotice looks like and contents of the pack

Oncotice is a freeze-dried powder, packed in 2 ml glass vials (available in packs of 1), each containing 1 dose of 12.5 mg (equivalent to 2 to 8 x 108 CFU) of BCG.

The Marketing authorisation holder is: N.V. Organon PO Box 20 5340 BH Oss The Netherlands The Manufacturer is: Organon Teknika Corporation 100 Rodolphe Street Building 1300 Durham NC27712 USA

This leaflet was last updated in December 2007.

To listen to or request a copy of this leaflet in braille, large print or audio please call, free of charge: 0800 198 5000 (UK Only)

Please be ready to give the following information:

Product name: Oncotice

Reference Number: PL 05003/0046

This is a service provided by the Royal National Institute for Blind People

OncoTICE (Tice BCG)

June 2004

REF: USoncviV5.2


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Tylenol Arthritis Pain


acetaminophen
Dosage Form: tablet, film coated, extended release
TYLENOL®
ARTHRITIS
PAIN

Drug Facts

Active ingredient (in each gelcap)

Acetaminophen 650 mg

Purpose

Pain reliever/fever reducer

Uses temporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches backache premenstrual and menstrual cramps the common cold headache toothache temporarily reduces fever Warnings Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take

more than 6 gelcaps in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you have difficulty swallowing large tablets or capsules. People over 65 may have difficulty swallowing these tablets. if you are allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if you have liver disease

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Stop use and ask a doctor if the tablet got stuck in your throat pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present

These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of the reach of children.

Overdose warning

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions do not take more than directed (see overdose warning) adults take 2 gelcaps every 8 hours. Swallow only one gelcap at a time. take a sip of water before swallowing each gelcap and wash each gelcap down with water (up to a full 8 oz glass) swallow whole – do not crush, chew, split or dissolve do not take more than 6 gelcaps in 24 hours do not use for more than 10 days unless directed by a doctor under 18 years of age ask a doctor Other information store at 20–25°C (68–77°F). Avoid high humidity. do not use if carton is opened or neck wrap or foil inner seal imprinted with "Safety Seal®" is broken see end panel for lot number and expiration date Inactive ingredients

benzyl alcohol, butylparaben, castor oil, corn starch, edetate calcium disodium, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, gelatin, hydroxyethyl cellulose, hypromellose, magnesium stearate, methylparaben, microcrystalline cellulose, povidone, powdered cellulose, pregelatinized starch, propylene glycol, propylparaben, shellac, sodium lauryl sulfate, sodium propionate, sodium starch glycolate, titanium dioxide

Questions or comments?

call 1-877-895-3665

PRINCIPAL DISPLAY PANEL

See New Warnings Information

NDC 50580-508-20

Push
& Turn
Cap

TYLENOL®

ARTHRITIS
PAIN
Acetaminophen Extended Release Pain Reliever/Fever Reducer
For The Temporary Relief Of Minor Arthritis Pain

20 GELCAPS-650 mg each

Gelcaps*
*Gelatin-Coated Capsule-Shaped Tablets


TYLENOL   ARTHRITIS PAIN
acetaminophen  tablet, film coated, extended release Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 50580-508 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Acetaminophen (Acetaminophen) Acetaminophen 650 mg Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color WHITE Score no score Shape OVAL Size 19mm Flavor Imprint Code Tylenol;Arthritis;650 Contains          Packaging # NDC Package Description Multilevel Packaging 1 50580-508-20 1 BOTTLE In 1 CARTON contains a BOTTLE, PLASTIC 1 20 TABLET In 1 BOTTLE, PLASTIC This package is contained within the CARTON (50580-508-20) 2 50580-508-40 1 BOTTLE In 1 CARTON contains a BOTTLE, PLASTIC 2 40 TABLET In 1 BOTTLE, PLASTIC This package is contained within the CARTON (50580-508-40) 3 50580-508-80 1 BOTTLE In 1 CARTON contains a BOTTLE, PLASTIC 3 80 TABLET In 1 BOTTLE, PLASTIC This package is contained within the CARTON (50580-508-80)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA019872 01/01/2010
Labeler - McNeil Consumer Healthcare Div McNeil-PPC, Inc (878046358) Revised: 11/2009McNeil Consumer Healthcare Div McNeil-PPC, Inc
More Tylenol Arthritis Pain resources Tylenol Arthritis Pain Side Effects (in more detail) Tylenol Arthritis Pain Dosage Tylenol Arthritis Pain Use in Pregnancy & Breastfeeding Drug Images Tylenol Arthritis Pain Drug Interactions Tylenol Arthritis Pain Support Group 1 Review for Tylenol Arthritis Pain - Add your own review/rating Compare Tylenol Arthritis Pain with other medications Fever Muscle Pain Pain Sciatica
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