Generic Name: phenylpropanolamine (fen ill proe pa NOLE a meen)



Address Wockhardt USA ,



Address Watson Pharmaceuticals, Inc. ,



1. Name Of The Medicinal Product

Warticon 0.15% w/w Cream

2. Qualitative And Quantitative Composition

Podophyllotoxin 1.5 mg/g (0.15% w/w).

The cream also contains the following excipients:

Methyl parahydroxybenzoate E218

Propyl parahydroxybenzoate E216

Sorbic acid

Stearyl alcohol

Cetyl alcohol

Butylhydroxyanisole (BHA) E320

For a full list of excipients, see section 6.1

3. Pharmaceutical Form

Topical cream

A homogenous white cream.

4. Clinical Particulars 4.1 Therapeutic Indications

Route of administration: Topical

For the topical treatment of condylomata acuminata affecting the penis and the external female genitalia.

4.2 Posology And Method Of Administration

The affected area should be thoroughly washed with soap and water, and dried prior to application.

Using a fingertip, the cream is applied twice daily for 3 days using only enough cream to just cover each wart.

Residual warts should be treated with further courses of twice daily applications for three days at weekly intervals, if necessary for a total of 4 weeks of treatment.

Where lesions are greater than 4 cm2 , it is recommended that treatment takes place under the direct supervision of medical staff.

4.3 Contraindications

Known hypersensitivity to any of the ingredients

Open wounds eg. Following surgical procedures.

Use in children.

Hypersensitivity to podophyllotoxin.

Concomitant use with other podophyllotoxin containing preparations.

Pregnancy and lactation.

4.4 Special Warnings And Precautions For Use

Avoid contact with eyes. Should the cream accidentally come into the eye, the eye should be thoroughly rinsed with water.

The hands should be thoroughly washed after each application. Prolonged contact with healthy skin must be avoided since cream contains an active pharmaceutical substance which could be harmful on healthy skin.

This cream contains:

• methyl and propyl parahydroxybenzoate which may cause allergic reactions (possibly delayed).

• sorbic acid, stearyl alcohol and cetyl alcohol which may cause local skin reactions, (e.g. contact dermatitis).

• butylhydroxyanisole which may cause local skin reactions (e.g.contact dermatitis), or irritation to the eyes and mucous membranes.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None presently known.

4.6 Pregnancy And Lactation

The product is not for use in pregnancy or lactation.

Reproduction toxicity studies in animals have not given evidence of an increased incidence of foetal damage or other deleterious effects on the reproductive process. However, since podophyllotoxin is a mitosis inhibitor, Warticon Cream should not be used during pregnancy or lactation.

It is not known if the substance is excreted into breast milk.

Observations in man indicate that podophyllin, a crude mixture of lignans, can be harmful to pregnancy. Such observations have not been reported in patients treated with podophyllotoxin.

4.7 Effects On Ability To Drive And Use Machines

None presently known.

4.8 Undesirable Effects

Local irritation may occur on the second or third day of application associated with the start of wart necrosis. In most cases the reactions are mild. Tenderness, itching, smarting, erythema, superficial epithelial ulceration and balanoposthitis have been reported. Local irritation decreases after treatment.

4.9 Overdose

There have been no reported overdosages with Warticon cream. However, excessive use of podophyllotoxin 0.5% solution has been reported as causing two cases of severe local reactions. In cases of excessive use of Warticon cream resulting in severe local reaction, the treatment should be stopped, the area washed and symptomatic treatment introduced.

No specific antidote is known. In the event of accidental ingestion, give emetic or stomach washout. Treatment should be symptomatic and in severe oral overdose ensure the airway is clear and give fluids. Check and correct electrolyte balance, monitor blood gases and liver function. Blood count should be monitored for at least 5 days.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmaco-therapeutic group, D06BB antivirals

Podophyllotoxin is a metaphase inhibitor in dividing cells binding to at least one binding site on tubulin. Binding prevents tubulin polymerisation required for microtubule assembly. At higher concentrations, podophyllotoxin also inhibits nucleo side transport through the cell membrane.

The chemotherapeutic action of podophyllotoxin is assumed to be due to inhibition of growth and the ability to invade the tissue of the viral infected cells.

5.2 Pharmacokinetic Properties

Systemic absorption of podophyllotoxin after topical application with a higher strength, 0.3% is low. Thus no study was performed on the present strength, 0.15%. The Cmax (1.0 – 4.7 ng/ml) and Tmax (0.5 – 36 hrs) are comparable for the 0.3% cream and 0.5% solution in both males and females.

5.3 Preclinical Safety Data

No relevant findings

6. Pharmaceutical Particulars 6.1 List Of Excipients

Purified Water

Methyl parahydroxybenzoate E218

Propyl parahydroxybenzoate E216

Sorbic acid

Phosphoric acid

Stearyl alcohol

Cetyl alcohol

Isopropyl myristate

Paraffin, liquid

Fractionated coconut oil

Butylhydroxyanisole (BHA) E320

Macrogol –7 stearyl ether

Macrogol – 10 stearyl ether

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

3 years

6.4 Special Precautions For Storage

This medicinal product does not require any special storage conditions.

6.5 Nature And Contents Of Container

A collapsible aluminium tube with imperforate nozzle membrane and internally coated with a protective lacquer. Tube cap of polyethylene with a spike on the upper end aimed to perforate the membrane when opening the tube for the first time. Size 5g and 10g.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

GlaxoSmithKline UK Limited

980 Great West Road

Brentford

Middlesex

TW8 9GS

Trading as Stiefel

Stockley Park West

Uxbridge

Middlesex

UB11 1BT

8. Marketing Authorisation Number(S)

PL 19494/0073

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first authorisation: 26th April 1999

Date of last renewal: 17th January 2010

10. Date Of Revision Of The Text

5th February 2011





1. Name Of The Medicinal Product

Wind-Eze

2. Qualitative And Quantitative Composition

Simeticone [Equivalent to Poly(Dimethylsiloxane)], 11.57% w/w, approx. 125.00mg

3. Pharmaceutical Form

Chewable tablets for oral administration.

4. Clinical Particulars 4.1 Therapeutic Indications

Antiflatulent defoaming agent for the symptomatic relief of flatulence, wind pains, bloating, abdominal distension and other similar symptoms associated with gastrointestinal gas.

4.2 Posology And Method Of Administration

Adults, elderly and children over 12 years:

One tablet to be taken three or four times daily or as required for relief, after meals and upon retiring. The tablets are to be chewed before swallowing.

Not recommended for children under 12 years.

4.3 Contraindications

The product should not be used in patients with known hypersensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

If symptoms persist or worsen, medical advice should be sought.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

Since simeticone is not absorbed by the gastro intestinal tract, Wind-Eze may be taken during pregnancy and lactation.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Rarely hypersensitivity reactions such as rash, pruritus, facial oedema, tongue oedema, respiratory difficulty.

4.9 Overdose

In the unlikely event of deliberate or accidental overdosage, treat symptoms on appearance. There are no special procedures recommended.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Physiologically simeticone is extremely inert, and therefore it will not be pharmacologically active.

5.2 Pharmacokinetic Properties

Simeticone (activated dimeticone) is not absorbed following oral administration. It acts by changing the surface tension of gas bubbles, causing them to coalesce.

5.3 Preclinical Safety Data

Simeticone is physiologically inert and considered to be non-toxic. It is not absorbed following oral administration, nor is it pharmacologically active. Preclinical data reveal no hazard for humans.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Dextrates (hydrated) USNF

Sorbitol Crystalline EP

Tribasic Calcium Phosphate (Powder) USNF

Citric Acid Anhydrous (Powder) EP

Natural and artificial peppermint flavour No. 517

(Spray dried) HSE

Talc (purified) EP

Non-pareil seeds (Starch/Sucrose) HSE

6.2 Incompatibilities

None known.

6.3 Shelf Life

3 years in PVC/PVDC Al foil blister packs. 3 years in PVC/PE/Aclar Al. foil blister packs.

6.4 Special Precautions For Storage

Store below 25oC.

Store in a dry place.

6.5 Nature And Contents Of Container

Blister packs of construction 190 ?m PVC (product contact side)/51?m PE/38?m aclar and 25?m aluminium foil with vinyl sealing coat (product contact side).

or

Blister packs of construction 250?m PVC (product contact side)/PVDC 60 g/m2 and 20 ?m aluminium foil with vinyl heat sealing coat (product contact side).

Pack sizes: 4, 10, 20, 30, 50.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Stafford-Miller Limited

980 Great West Road

Brentford

Middlesex

TW8 9GS

Trading as GlaxoSmithKline Consumer Healthcare, Brentford TW8 9GS, U.K.

8. Marketing Authorisation Number(S)

PL 00036/0084

9. Date Of First Authorisation/Renewal Of The Authorisation

25th May 2001

10. Date Of Revision Of The Text

February 2008



1. Name Of The Medicinal Product

Wasp-Eze Spray.

2. Qualitative And Quantitative Composition

Benzocaine 1.0% w/w

Mepyramine Maleate 0.5% w/w

For excipients, see 6.1.

3. Pharmaceutical Form

Aerosol spray.

4. Clinical Particulars 4.1 Therapeutic Indications

For the treatment of all insect bites and stings, nettle stings and jellyfish stings.

4.2 Posology And Method Of Administration

Route of administration

Topical.

Adults, the elderly and children:

Hold nozzle approximately five inches from the skin and spray once for 2-3 seconds. Stop spraying immediately if a white deposit or “frost” appears. Repeat once after 15 minutes if necessary. If pain persists, seek medical advice.

4.3 Contraindications

Do not apply to broken skin.

Do not use near the eyes.

Do not use if you are sensitive to benzocaine.

4.4 Special Warnings And Precautions For Use

Patients with any known allergy should seek medical advice. If pain persists seek medical advice.

For external use only. Keep out of reach of children.

Flammable. Do not use near fire or flame. Pressurised container. Protect from sunlight and do not expose to temperatures exceeding 50oC. Do not pierce or burn, even after use. Do not spray on a naked flame or any incandescent material. Do not use near or place container on polished or painted surfaces.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

No known effects in pregnancy and lactation. However, as with all medicines, use with caution.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Skin rash. Methaemoglobinaemia, especially in infants and children.

4.9 Overdose

Overdose is unlikely with this dosage form. There are no known effects and no specific treatment.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Antipruritics, incl. Antihistamines, Anesthetics, etc., ATC code: D04A.

The active ingredients, benzocaine and mepyramine maleate, reduce pain and histamine responses to stings. The physical effects of the cooling propellants help reduce pain.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Propylene glycol

Ethanol (denatured)

Iso-butane

N-Pentane

Dimethyl ether

6.2 Incompatibilities

None known.

6.3 Shelf Life

36 months unopened

6.4 Special Precautions For Storage

Do not store above 25oC.

6.5 Nature And Contents Of Container

Aluminium cans (30 and 60 ml) internally coated with epoxyphenolic lacquer fitted with valve assembly and actuator button, protected by a plastic cap.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Seton Products Ltd,

Tubiton House

Oldham

OL1 3HS

8. Marketing Authorisation Number(S)

PL 11314/0032.

9. Date Of First Authorisation/Renewal Of The Authorisation

15/12/94 / 13/03/00 / 13/03/05

10. Date Of Revision Of The Text

15/09/05



Address Wyeth,



Generic Name: phenylpropanolamine (fen ill proe pa NOLE a meen)



Definition of Wilms' Tumor: Wilms' tumor is a cancerous tumor of the kidney that occurs in children.

Drugs associated with Wilms' Tumor

The following drugs and medications are in some way related to, or used in the treatment of Wilms' Tumor. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Learn more about Wilms' Tumor (Nephroblastoma)

Harvard Health Guide:

Symptoms and treatment for Wilms' Tumor



cetirizine hydrochloride and pseudoephedrine hydrochloride



1. Name Of The Medicinal Product

Wind-eze Gel Caps

2. Qualitative And Quantitative Composition

Each soft capsule contains: 125mg Simeticone (activated dimeticone)

For excipients see 6.1

3. Pharmaceutical Form

Capsule, soft.

The capsules are oval gelatin capsules with a white to off white opaque gelatin shell.

4. Clinical Particulars 4.1 Therapeutic Indications

The symptomatic relief of flatulence, wind pains, bloating, abdominal distension and other symptoms associated with gastrointestinal gas.

4.2 Posology And Method Of Administration

For oral administration:

Adults, children (12 years and above) and elderly:

One gel capsule to be taken three or four times daily or as required for relief, after meals and upon retiring.

Not recommended for children under 12 years of age.

4.3 Contraindications

The product should not be used in patients with known hypersensitivity to simeticone or to any excipients of the medicinal product.

4.4 Special Warnings And Precautions For Use

If symptoms persist or worsen, the patient should consult their medical practitioner for further investigation.

This medicinal product contains glycerol. Harmful in high doses. Can cause headache and can cause stomach upset and diarrhoea.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Although no studies have been presented, the concomitant use of this drug and mineral oil (paraffin) based laxatives is not recommended since mixing of these two will diminish the efficacy.

4.6 Pregnancy And Lactation

As thus far known, this drug can be used during pregnancy in compliance with the prescription, without any further restriction.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Minor adverse effects: nausea and constipation. Rarely hypersensitivity reactions such as rash, pruritis, facial oedema, tongue oedema, respiratory difficulty.

4.9 Overdose

In the unlikely event of deliberate overdosage, treat symptoms on appearance. There are no special procedures recommended.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Simeticone is an anti-flatulent with ATC code A03AX13. Physiologically simeticone is extremely inert, and therefore it will not be pharmacologically active. It acts by changing the surface tension of gas bubbles, causing them to coalesce.

5.2 Pharmacokinetic Properties

Simeticone is not absorbed following oral administration.

5.3 Preclinical Safety Data

Simeticone is physiologically inert and considered to be non-toxic. Preclinical data reveal no hazard for humans.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Capsule shell:

Gelatin

Glycerol

Titanium Dioxide (E171)

Purified Water

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

Blister packs of construction PVDC/PVC and aluminium foil with heat sealing coat.

Pack sizes: 10, 20, 30, 50 and 60.

Not all pack sizes may be marketed

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

Administrative Data 7. Marketing Authorisation Holder

Stafford-Miller Limited

980 Great West Road

Brentford

Middlesex

TW8 9GS UK

Trading as :

GlaxoSmithKline Consumer Healthcare

Brentford,

TW8 9GS.

UK

8. Marketing Authorisation Number(S)

PL 00036/0073

9. Date Of First Authorisation/Renewal Of The Authorisation

16 June 1997

10. Date Of Revision Of The Text

August 2006



Generic Name: procaine penicillin (PRO kane PEN i SIL in)



Generic Name: caffeine and ergotamine (oral/rectal) (KAF een and er GOT a meen)



1. Name Of The Medicinal Product

Water for Injections B.P. 2ml, 5ml, 10ml & 20ml.

2. Qualitative And Quantitative Composition

Each 1ml of solution contains 1ml of Water for Injections B.P.

3. Pharmaceutical Form

Clear, colourless, odourless, sterile solution intended for parenteral administration to human beings.

4. Clinical Particulars 4.1 Therapeutic Indications

For the reconstitution, dilution and making-up of appropriate drugs where Water for Injections is the diluent of choice, and for use as an irrigant.

4.2 Posology And Method Of Administration

Route of administration: For S.C., I.M. or IV. injection, or as appropriate to the reconstituted drug.

Dosage: In accordance with the particular situation for which Water for Injections B.P. is being used.

4.3 Contraindications

None known.

4.4 Special Warnings And Precautions For Use

None.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

May be used during this period.

4.7 Effects On Ability To Drive And Use Machines

None.

4.8 Undesirable Effects

None known.

4.9 Overdose

No effects anticipated with the proposed use.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Not applicable.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

No further relevant information other than that which is included in other sections of the Summary of Product Characteristics.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Not applicable.

6.2 Incompatibilities

Water for Injections B.P. should not be mixed with any other agents unless their compatibility has been established.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

2ml, 5ml, 10ml and 20ml hermetically sealed translucent plastic ampoules, polypropylene Ph.Eur., packed in cardboard cartons to contain 10, 20, 50 and 100 ampoules.

6.6 Special Precautions For Disposal And Other Handling

For S/C, I/M or I/V Injection or as appropriate to the reconstituted drug.

If only part of an ampoule is used, discard the remaining solution.

Use as directed by the physician.

Keep out of reach of children.

7. Marketing Authorisation Holder

Antigen International Ltd.,

Roscrea,

Co. Tipperary,

Ireland.

8. Marketing Authorisation Number(S)

PL 2848/0152.

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first authorization : 10/10/91.

10. Date Of Revision Of The Text

August 2001



Pronunciation: roe D i-MUNE GLOB-ue-lin



There are currently no drugs listed for "West Nile Virus".

Definition of West Nile Virus:

The West Nile virus is a type of virus known as a flavivirus. Researchers believe West Nile virus is spread when a mosquito bites an infected bird and then bites a person. Although many people are bitten by mosquitos that carry West Nile virus, most do not know they've been exposed. Few people develop severe disease or even notice any symptoms at all. More severe forms of disease, which can be life threatening, may be called West Nile encephalitis or West Nile meningitis, depending on what part of the body is affected.Learn more about West Nile Virus

Micromedex Care Notes:

West Nile Virus Infection

Medical Encyclopedia:

West Nile virus



Drugs associated with Whipworm Infection

The following drugs and medications are in some way related to, or used in the treatment of Whipworm Infection. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Learn more about Whipworm Infection

Medical Encyclopedia:

Whipworm infection



Definition of Wolff-Parkinson-White Syndrome: This syndrome involves episodes of rapid heart rate (tachycardia) caused by abnormal electrical pathways (circuits) in the heart.

Drugs associated with Wolff-Parkinson-White Syndrome

The following drugs and medications are in some way related to, or used in the treatment of Wolff-Parkinson-White Syndrome. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Learn more about Wolff-Parkinson-White Syndrome

Micromedex Care Notes:

Heart Block

Medical Encyclopedia:

Wolff-Parkinson-White syndrome



1. Name Of The Medicinal Product

Wasp-Eze Bites and Stings Spray

2. Qualitative And Quantitative Composition

Benzocaine 1.0% w/w

Mepyramine Maleate 0.5% w/w

For excipients, see 6.1.

3. Pharmaceutical Form

Cutaneous Spray.

A clear uniform spray.

4. Clinical Particulars 4.1 Therapeutic Indications

For the treatment of all insect bites and stings, nettle stings and jellyfish stings in adults and children aged 2 years and over.

4.2 Posology And Method Of Administration

For cutaneous application.

For adults and children aged 2 years and over:

Hold nozzle approximately five inches from the skin and spray once for 2-3 seconds. Stop spraying immediately if a white deposit or “frost” appears. Repeat once after 15 minutes if necessary. If pain persists, seek medical advice.

4.3 Contraindications

Do not use if you are sensitive to any of the ingredients

Do not apply to large areas of skin, eczematous, sunburnt or broken skin.

Do not use the spray on the face.

4.4 Special Warnings And Precautions For Use

Patients with any known allergy to insect bites or stings should seek medical advice. If pain persists, seek medical advice.

Not for repeated or prolonged use.

For external use only. Keep out of the reach and sight of children.

Flammable. Do not use near fire or flame. Pressurised container. Protect from sunlight and do not expose to temperatures exceeding 50oC. Do not pierce or burn, even after use. Do not spray on a naked flame or any incandescent material. Do not use near or place container on polished or painted surfaces.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

Not for use in pregnancy or lactation unless on medical advice.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Skin rash.

Methaemoglobinaemia especially in infants and children.

4.9 Overdose

Overdose is unlikely with this dosage form. There are no known effects and no specific treatment.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

The ingredients, benzocaine (D04 AB04) and mepyramine maleate (D04 AA02), reduce pain and histamine responses to stings. The physical effects of the cooling propellants help reduce pain.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Propylene glycol

Ethanol, denatured

Iso-butane

N-pentane

Dimethyl ether

6.2 Incompatibilities

None known.

6.3 Shelf Life

Three years.

6.4 Special Precautions For Storage

Do not store above 25oC.

6.5 Nature And Contents Of Container

30 ml Aluminium cans internally coated with epoxyphenolic lacquer fitted with valve assembly and actuator button, protected by a plastic cap.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Seton Products Limited

Tubiton House

Oldham

OL1 3HS

8. Marketing Authorisation Number(S)

PL 11314/0145

9. Date Of First Authorisation/Renewal Of The Authorisation

25th November 2004

10. Date Of Revision Of The Text

January 2005



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