Generic Name: crataegus fruit, arnica montana, potassium phosphate, dibasic and calcium fluoride granule Dosage Form: FOR ANIMAL USE ONLY



Dosage Form: tablet



1. Name Of The Medicinal Product

Oruvail IM Injection

2. Qualitative And Quantitative Composition

In terms of the active ingredient

Ketoprofen BP 100mg in 2 ml.

3. Pharmaceutical Form

Solution for IM injection

4. Clinical Particulars 4.1 Therapeutic Indications

Oruvail injection is recommended in the management of acute exacerbations of:

• Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis.

• Periarticular conditions such as fibrositis, bursitis, capsulitis, tendinitis and tenosynovitis.

• Low back pain of musculoskeletal origin and sciatica.

• Other painful musculoskeletal conditions.

• Acute gout.

• Control of pain and inflammation following orthopaedic surgery.

4.2 Posology And Method Of Administration

Adults: 50 to 100 mg every four hours, repeated up to a maximum of 200 mg in twenty-four hours. Following a satisfactory response, oral therapy should be instituted with ketoprofen capsules. It is recommended that the injection should not normally be continued for longer than three days.

Elderly: The elderly are at increased risk of the serious consequences of adverse reactions. If an NSAID is considered necessary, the lowest effective dose should be used and for the shortest possible duration. The patient should be monitored regularly for GI bleeding during NSAID therapy.

Paediatric dosage: not established.

Oruvail IM Injection is for intramuscular injection only.

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4

4.3 Contraindications

Ketoprofen is contraindicated in patients who have a history of hypersensitivity reactions such as bronchospasm, asthmatic attacks, rhinitis, angioedema, urticaria or other allergic-type reactions to ketoprofen, any other ingredients in this medicine, ASA or other NSAIDs.

Ketoprofen is contraindicated in patients with hypersensitivity to any of the excipients of the drug.

Ketoprofen is also contraindicated in the third trimester of pregnancy.

Ketoprofen is contraindicated in the following cases:

-severe heart failure

-active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding)

-haemorrhagic diathesis

-severe hepatic insufficiency

-severe renal insufficiency

-third trimester of pregnancy

Ketoprofen is contraindicated in cases of cerebrovascular bleeding or any other active bleeding.

Ketoprofen is contraindicated in patients with haemostatic disorders or ongoing anticoagulant therapy.

4.4 Special Warnings And Precautions For Use

Oruvail injection is for intramuscular use only.

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.2 Posology and method of administration, and GI and cardiovascular risks below).

The use of ketoprofen with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided (see section 4.5 Interactions).

Elderly:

The elderly have an increased risk of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation which may be fatal (see Section 4.2 Posology and method of administration).

Cardiovascular, Renal and Hepatic impairment:

At the start of treatment, renal function must be carefully monitored in patients with heart impairment, heart failure, liver dysfunction, cirrhosis and nephrosis, in patients receiving diuretic therapy, in patients with chronic renal impairment, particularly if the patient is elderly. In these patients, administration of ketoprofen may induce a reduction in renal blood flow caused by prostaglandin inhibition and lead to renal decomposition (see Section 4.3 Contra-indications).

Cardiovascular and cerebrovascular effects

Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy.

Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long-term treatment) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). There are insufficient data to exclude such a risk for ketoprofen.

Respiratory disorders:

Patients with asthma combined with chronic rhinitis, chronic sinusitis, and/or nasal polyposis have a higher risk of allergy to aspirin and/or NSAIDs than the rest of the population. Administration of this medicinal product can cause asthma attacks or bronchospasm, particularly in subjects allergic to aspirin or NSAIDs (see section 4.3).

Gastrointestinal bleeding, ulceration and perforation:

GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious GI events.

Some epidemiological evidence suggests that ketoprofen may be associated with a high risk of serious gastrointestinal toxicity, relative to some other NSAIDs, especially at high doses (see also section 4.2 and 4.3).

The risk of GI bleeding, ulceration or perforation is higher with increasing NSAlD doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3), and in the elderly. These patients should commence treatment on the lowest dose available. Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients requiring concomitant low dose aspirin, or other drugs likely to increase gastrointestinal risk (see below and section 4.5).

NSAIDs should only be given with care to patients with a history of gastrointestinal disease (e.g. ulcerative colitis, Crohn's disease) as these conditions may be exacerbated (see Section 4.8 Undesirable effects).

Patients with a history of gastrointestinal toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially GI bleeding), particularly in the initial stages of treatment.

Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin-reuptake inhibitors or anti-platelet agents such as aspirin (see section 4.5).

When GI bleeding or ulceration occurs in patients receiving ketoprofen, the treatment should be withdrawn.

SLE and mixed connective tissue disease:

In patients with systemic lupus erythematosis (SLE) and mixed connective tissue disorders there may be an increased risk of aseptic meningitis (see section 4.8 Undesirable effects).

Impaired female fertility:

The use of ketoprofen, as with other NSAIDs, may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of ketoprofen should be considered.

Skin reactions:

Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAlDs (see section 4.8). Patients appear to be at highest risk for these reactions early in the course of therapy, the onset of the reaction occurring in the majority of cases within the first month of treatment. Treatment should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

Infectious disease:

As with other NSAIDs, in the presence of an infectious disease, it should be noted that the anti-inflammatory, analgesic and the antipyretic properties of ketoprofen may mask the usual signs of infection progression such as fever.

Risk of gastrointestinal bleeding: the relative risk increases in subjects who have a low body weight. If gastrointestinal bleeding or ulcer occur, treatment must be discontinued immediately.

Blood counts and liver and kidney function tests should be carried out during long-term treatment.

Hyperkalaemia:

Hyperkalaemia promoted by diabetes or concomitant treatment with potassium-sparing agents (see section 4.5 Interactions).

Potassium levels must be monitored regularly under these circumstances.

In patients with abnormal liver function tests or with a history of liver disease, transaminase levels should be evaluated periodically, particularly during long-term therapy.

Patients with active or a past history of peptic ulcer.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Anticoagulants (heparin and warfarin) and platelet aggregation inhibitors (i.e. ticlopidine, clopidogrel):

Increased risk of bleeding (see section 4.4).

If co-administration is unavoidable, patient should be closely monitored

Lithium:

Risk of elevation of lithium plasma levels, sometimes reaching toxic levels due to decreased lithium renal excretion. Where necessary, plasma lithium levels should be closely monitored and the lithium dosage levels adjusted during and after NSAIDs therapy.

Other analgesics/NSAIDs (including cyclooxygenase-2 selective inhibitors) and high dose salicylates:

Avoid concomitant use of two or more NSAIDs (including aspirin) as this may increase the risk of adverse effects, particularly gastrointestinal ulceration and bleeding (see section 4.4 Special warnings and precautions for use).

Methotrexate:

Serious interactions have been recorded after the use of high dose methotrexate with NSAIDs, including ketoprofen, due to decreased elimination of methotrexate. At doses greater than 15mg/week: Increased risk of haematologic toxicity of methotrexate, particularly if administered at high doses (> 15mg/week), possibly related to displacement of protein-bound methotrexate and to its decreased renal clearance.

Allow at least 12 hours between the discontinuation or initiation of ketoprofen treatment and the administration of methotrexate.

At doses lower than 15mg/week: During the first weeks of combination treatment, full blood count should be monitored weekly. If there is any alteration of the renal function or if the patient is elderly, monitoring should be done more frequently.

Mifepristone:

NSAlDs should not be used for 8-12 days after mifepristone administration as NSAlDs can reduce the effect of mifepristone.

Antihypertensive agents (beta-blockers, angiotensin converting enzyme inhibitors, diuretics):

Risk of decreased antihypertensive potency (inhibition of vasodilator prostaglandins by NSAIDs).

Diuretics:

Risk of reduced diuretic effect. Patients and particularly dehydrated patients taking diuretics are at a greater risk of developing renal failure secondary to a decrease in renal blood flow caused by prostaglandin inhibition. Such patients should be rehydrated before initiating co-administration therapy and renal function monitored when the treatment is started (see section 4.4 Special warnings and precautions for use).

Cardiac glycosides:

NSAlDs may exacerbate cardiac failure, reduce GFR and increase plasma glycoside levels.

Ciclosporin: Increased risk of nephrotoxicity, particularly in elderly subjects.

Quinolone antibiotics:

Animal data indicate that NSAlDs can increase the risk of convulsions associated with quinolone antibiotics. Patients taking NSAlDs and quinolones may have an increased risk of developing convulsions.

Tacrolimus: Possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus, particularly in elderly subjects.

Thrombolytics:

Increased risk of bleeding.

Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): Increased risk of gastrointestinal bleeding (see section 4.4 Special warnings and precautions for use).

ACE inhibitors and Angiotensin II Antagonists:

In patients with compromised renal function (e.g. dehydrated patients or elderly patients the co-administration of an ACE inhibitor or Angiotensin II antagonist and agents that inhibit cyclooxygenase may result in further deterioration of renal function, including possible acute renal failure.

Zidovudine:

Increased risk of haematological toxicity when NSAlDs are given with zidovudine. There is evidence of an increased risk of haemarthroses and haematoma in HIV(+) haemophiliacs receiving concurrent treatment with zidovudine and ibuprofen.

Risks related to hyperkalaemia:

Certain medicinal products or therapeutic categories can promote hyperkalaemia, i.e. potassium salts, potassium-sparing diuretics, converting enzyme inhibitors, angiotensin II receptor blockers, NSAIDs, heparins (low molecular-weight or unfractioned), ciclosporin, tacrolimus and trimethoprim. The occurrence of hyperkalaemia can depend on the presence of co-factors. This risk is enhanced when the drugs mentioned above are administered concomitantly.

Risks related to antiplatelet effect:

Several substances are involved in interactions due to their antiplatelet effects: tirofiban, eptifibarid, abcixiab, and iloprost. The use of several antiplatelet drugs enhances the risk of bleeding.

4.6 Pregnancy And Lactation

Pregnancy

Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk for cardiovascular malformation was increased from less than 1%, up to approximately 1.5%. The risk is believed to increase with dose and duration of therapy. In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation loss and embryo-foetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period. During the first and second trimester of pregnancy, ketoprofen should not be given unless clearly necessary. If ketoprofen is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible.

During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the foetus to:

- cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension);

- renal dysfunction, which may progress to renal failure with oligo-hydroamniosis; the mother and the neonate, at the end of the pregnancy, to:

- possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses.

- Inhibition of uterine contractions resulting in delayed or prolonged labour.

Consequently, ketoprofen is contraindicated during the third trimester of pregnancy.

Lactation

No data are available on excretion of ketoprofen in human milk. Ketoprofen is not recommended in nursing mothers.

4.7 Effects On Ability To Drive And Use Machines

Patients should be warned about the potential for somnolence, dizziness or convulsions and be advised not to drive or operate machinery if these symptoms occur.

Patients should be warned of possible visual disturbances. If patients experience this, they should not drive or use machines.

4.8 Undesirable Effects

Gastrointestinal: The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or GI bleeding, sometimes fatal, particularly in the elderly, may occur (see section 4.4). Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see section 4.4) have been r3eported following administration. Less frequently, gastritis has been observed. Pancreatitis has been reported very rarely.

Hypersensitivity: Hypersensitivity reactions have been reported following treatment with NSAIDs. These may consist of (a) non-specific allergic reactions and anaphylaxis (b) respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea, or (c) assorted skin disorders, including rashes of various types, pruritus, urticaria, purpura, angiodema and, more rarely exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme).

Local reactions can occur and may include pain or a burning sensation. In all cases of major adverse effects Oruvail should be withdrawn at once.

Cardiovascular and cerebrovascular:

Oedema, hypertension, and cardiac failure, have been reported in association with NSAID treatment.

Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with an increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section 4.4).

Other adverse reactions reported less commonly include:

Renal: Nephrotoxicity in various forms, including interstitial nephritis, nephritic syndrome and renal failure.

Hepatic: abnormal liver function, hepatitis and jaundice.

Neurological and special senses: Visual disturbances, optic neuritis, headaches, paraesthesia, reports of aseptic meningitis (especially in patients with existing autoimmune disorders, such as systemic lupus erythematosus, mixed connective tissue disease), with symptoms such as stiff neck, headache, nausea, vomiting, fever or disorientation (See section 4.4) , depression, confusion, hallucinations, tinnitus, vertigo, dizziness, malaise, fatigue and drowsiness.

Haematological: Thrombocytopenia, neutropenia, agranulocytosis, aplastic anaemia and haemolytic anaemia.

Dermatological: Bullous reactions including Stevens Johnson Syndrome and Toxic Epidermal Necrolysis (very rare). Photosensitivity.

4.9 Overdose

Symptoms

In adults, the principal signs of overdose are headache, dizziness, drowsiness, nausea, vomiting, diarrhoea and abdominal pain. Disorientation, excitation, coma, tinnitus, fainting, occasionally convulsions may also occur. During severe intoxication, hypotension, respiratory depression and gastrointestinal bleeding have been observed.

Adverse effects seen after overdose with propionic acid derivatives such as hypotension, bronchospasm and gastro-intestinal haemorrhage should be anticipated.

In cases of significant poisoning, acute renal failure and liver damage are possible.

Therapeutic measures:

The patient must be transferred immediately to a specialised hospital setting where symptomatic treatment can begin.

There is no specific antidote.

Good urine output should be ensured.

Renal and liver function should be closely monitored.

Frequent or prolonged convulsions should be treated with intravenous diazepam.

Other measures may be indicated by the patient's clinical condition.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Ketoprofen is a pharmacopoeial non-steroidal anti-inflammatory drug (NSAID). It is a strong inhibitor of prostaglandin synthetase and potent analgesic agent. Studies in vitro and in vivo show that ketoprofen possesses powerful anti-inflammatory, antipyretic, antibradykinin and lysosomal membrane stabilising properties.

5.2 Pharmacokinetic Properties

Peak concentrations of approximately 10 mg/L are reached at about 0.5-0.75 H after a 100 mg dose. The elimination half life is approximately 1.88 H. Apart from earlier Tmax values, there are no significant differences between the pharmacokinetics of Oruvail IM injection and conventional release capsules (Orudis).

5.3 Preclinical Safety Data

No additional data of relevance to the prescriber.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Arginine

BP

Benzyl Alcohol

BP

Citric Acid anhydrous (E330)

BP

Water For Injections

BP

6.2 Incompatibilities

None stated

6.3 Shelf Life

36 months

6.4 Special Precautions For Storage

Store below 30°C. Protect from light.

6.5 Nature And Contents Of Container

Cartons containing 10 ampoules each having 2 ml. of injection.

6.6 Special Precautions For Disposal And Other Handling

None stated

7. Marketing Authorisation Holder

Sanofi-aventis

One Onslow Street

Guildford

Surrey, GU1 4YS, UK

8. Marketing Authorisation Number(S)

PL 04425/0377

9. Date Of First Authorisation/Renewal Of The Authorisation

15 November 2005

10. Date Of Revision Of The Text

11 May 2011

LEGAL CATEGORY

POM



Generic Name: Loracarbef (lor-a-KAR-bef)Brand Name: Lorabid



1. Name Of The Medicinal Product

Penbritin 250mg Capsules

2. Qualitative And Quantitative Composition

(Ampicillin Capsules): 250mg ampicillin as Ampicillin Trihydrate

3. Pharmaceutical Form

Black and red capsules overprinted Penbritin 250

4. Clinical Particulars 4.1 Therapeutic Indications

Ampicillin is a broad-spectrum penicillin, indicated for the treatment of a wide range of bacterial infections caused by ampicillin-sensitive organisms. Typical indications include: ear, nose and throat infections, bronchitis, pneumonia, urinary tract infections, gonorrhoea, gynaecological infections, septicaemia, peritonitis, endocarditis, meningitis, enteric fever, gastro-intestinal infections.

Parenteral usage is indicated where oral dosage is inappropriate.

4.2 Posology And Method Of Administration

Usual adult dosage (including elderly patients):

   

Ear, nose and throat infections:

250mg four times a day.

 

Bronchitis:

Routine therapy:

250mg four times a day.

High-dosage therapy:

1 g four times a day.

 

Pneumonia:

500 mg four times a day.

 

Urinary tract infections:

500 mg three times a day.

 

Gonorrhoea:

2 g orally with 1 g probenecid as a single dose.

 

Repeated doses are recommended for the treatment of females.

   

Gastro-intestinal infections:

500-750 mg three to four times daily.

 

Enteric:

Acute:

1-2 g four times a day for two weeks.

Carriers:

1-2 g four times a day for four to twelve weeks

 

Usual children's dosage (under 10 years):

   

Half adult routine dosage.

   

All recommended dosages are a guide only. In severe infections the above dosages may be increased, or ampicillin given by injection. Oral doses of ampicillin should be taken half to one hour before meals.

Renal Impairment

In the presence of severe renal impairment (creatinine clearance <10ml/min) a reduction in dose or extension of dose interval should be considered. In cases of dialysis, an additional dose should be administered after the procedure.

4.3 Contraindications

Ampicillin is a penicillin and should not be given to patients with a history of hypersensitivity to beta-lactam antibiotics (e.g. ampicillin, penicillins, cephalosporins) or excipients.

4.4 Special Warnings And Precautions For Use

Before initiating therapy with ampicillin, careful enquiry should be made concerning previous hypersensitivity reactions to beta-lactam antibiotics.

Serious and occasionally fatal hypersensitivity reactions (anaphylaxis) have been reported in patients receiving beta-lactam antibiotics. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral penicillins. These reactions are more likely to occur in individuals with a history of beta-lactam hypersensitivity.

Ampicillin should be avoided if infectious mononucleosis and/or acute or chronic leukaemia of lymphoid origin are suspected. The occurrence of a skin rash has been associated with these conditions following the administration of ampicillin.

Prolonged use may occasionally result in overgrowth of non-susceptible organisms.

Dosage should be adjusted in patients with renal impairment (see section 4.2).

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Bacteriostatic drugs may interfere with the bactericidal action of ampicillin.

In common with other oral broad-spectrum antibiotics, ampicillin may reduce the efficacy of oral contraceptives and patients should be warned accordingly.

Probenecid decreases the renal tubular secretion of ampicillin. Concurrent use with ampicillin may result in increased and prolonged blood levels of ampicillin.

Concurrent administration of allopurinol during treatment with ampicillin can increase the likelihood of allergic skin reactions.

It is recommended that when testing for the presence of glucose in urine during ampicillin treatment, enzymatic glucose oxidase methods should be used. Due to the high urinary concentrations of ampicillin, false positive readings are common with chemical methods.

4.6 Pregnancy And Lactation

Pregnancy:

Animal studies with Ampicillin have shown no teratogenic effects. The product has been in extensive clinical use since 1961 and its use in human pregnancy has been well documented in clinical studies. When antibiotic therapy is required during pregnancy, Ampicillin may be considered appropriate.

Lactation:

During lactation, trace quantities of penicillins can be detected in breast milk. Adequate human and animal data on use of Ampicillin during lactation are not available.

4.7 Effects On Ability To Drive And Use Machines

Adverse effects on the ability to drive or operate machinery have not been observed.

4.8 Undesirable Effects

Hypersensitivity reactions:

If any hypersensitivity reaction occurs, the treatment should be discontinued.

Skin rash, pruritis and urticaria have been reported occasionally. The incidence is higher in patients suffering from infectious mononucleosis and acute or chronic leukaemia of lymphoid origin. Purpura has also been reported. Rarely, skin reactions such as erythema multiforme and Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported.

As with other antibiotics, anaphylaxis (see Item 4.4 – Warnings) has been reported rarely.

Renal effects:

Interstitial nephritis can occur rarely.

Gastrointestinal reactions:

Effects include nausea, vomiting and diarrhoea. Pseudomembraneous colitis and haemorrhagic colitis have been reported rarely.

Hepatic effects:

As with other beta-lactam antibiotics, hepatitis and cholestatic jaundice have been reported rarely. As with most other antibiotics, a moderate and transient increase in transaminases has been reported.

Haematological effects:

As with other beta-lactams, haematological effects including transient leucopenia, transient thrombocytopenia and haemolytic anaemia have been reported rarely. Prolongation of bleeding time and prothrombin have also been reported rarely.

4.9 Overdose

Gastrointestinal effects such as nausea, vomiting and diarrhoea may be evident and should be treated symptomatically.

Ampicillin may be removed from the circulation by haemodialysis.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Ampicillin is a broad spectrum penicillin, indicated for the treatment of a wide range of bacterial infections caused by ampicillin sensitive organisms.

5.2 Pharmacokinetic Properties

Ampicillin is excreted mainly in the bile and urine with a plasma half life of 1-2 hours.

5.3 Preclinical Safety Data

No further information of relevance to add.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Magnesium stearate, gelatin, black and red iron oxides (E172), titanium dioxide (E171) and erythrosine (E127).

6.2 Incompatibilities

None.

6.3 Shelf Life

Blister packs:

five years

Others:

three years

6.4 Special Precautions For Storage

Containers: Do not store above 25°C. Keep the container tightly closed.

Blisters: Do not store above 25°C. Store in the original package.

6.5 Nature And Contents Of Container

Aluminium canister

Glass bottle fitted with a screw cap

Polypropylene tube with a polyethylene closure

Aluminium foil pack - 4, 16, 50, 100, 500

Aluminium/PVC tray foil blister pack - 28

Aluminium/PVC/PVdC blister pack - 28

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Chemidex Pharma Ltd

Chemidex House

Egham Business Village

Crabtree Road

Egham

Surrey

TW20 8RB

United Kingdom

8. Marketing Authorisation Number(S)

PL 17736/0071

9. Date Of First Authorisation/Renewal Of The Authorisation

4th March 2005

10. Date Of Revision Of The Text

26/09/2007



Pronunciation: VYE-ta-min B/VYE-ta-min C/VYE-ta-min D/BYE-oh-tin/FOE-lik AS-id/zinkGeneric Name: Vitamin B Complex/Vitamin C/Vitamin D/Biotin/Folic Acid/Zinc



1. Name Of The Medicinal Product

KOGENATE Bayer 250 IU powder and solvent for solution for injection.

2. Qualitative And Quantitative Composition

2.1 General description

Each vial contains nominally 250 IU human coagulation factor VIII (octocog alfa).

Human coagulation factor VIII is produced by recombinant DNA technology (rDNA) in baby hamster kidney cells containing the human factor VIII gene.

2.2 Qualitative and quantitative composition

One ml of KOGENATE Bayer 250 IU contains approximately 100 IU (250 IU / 2.5 ml) of human coagulation factor VIII (octocog alfa) after reconstitution.

The potency (IU) is determined using the one-stage clotting assay against the FDA Mega standard which was calibrated against WHO standard in International Units (IU).

The specific activity of KOGENATE Bayer is approximately 4000 IU/mg protein.

Solvent: water for injections.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Powder and solvent for solution for injection.

Powder: dry white to slightly yellow powder or cake.

Solvent: water for injection, a clear, colourless solution.

The reconstituted medicinal product is a clear and colourless solution.

4. Clinical Particulars 4.1 Therapeutic Indications

Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).

This preparation does not contain von Willebrand factor and is therefore not indicated in von Willebrand's disease.

4.2 Posology And Method Of Administration

Treatment should be initiated under the supervision of a physician experienced in the treatment of haemophilia.

Posology

The number of units of factor VIII administered is expressed in International Units (IU), which are related to the current WHO standard for factor VIII products. Factor VIII activity in plasma is expressed either as a percentage (relative to normal human plasma) or in International Units (relative to the International Standard for factor VIII in plasma). One International Unit (IU) of factor VIII activity is equivalent to that quantity of factor VIII in one ml of normal human plasma. The calculation of the required dose of factor VIII is based on the empirical finding that 1 International Unit (IU) factor VIII per kg body weight raises the plasma factor VIII activity by 1.5% to 2.5% of normal activity. The required dose is determined using the following formulae:

I. Required IU = body weight (kg) ? desired factor VIII rise (% of normal) ? 0.5

 

II. Expected factor VIII rise (% of normal) =

2 ? administered IU

body weight (kg)

On demand treatment

The dose, frequency and duration of the substitution therapy must be individualised according to the patient's needs (weight, severity of disorder of the haemostatic function, the site and extent of the bleeding, the presence of inhibitors, and the factor VIII level desired).

The following table provides a guide for factor VIII minimum blood levels. In the case of the haemorrhagic events listed, the factor VIII activity should not fall below the given level (in % of normal) in the corresponding period:

Degree of haemorrhage/ Type of surgical procedure

Factor VIII level required (%) (IU/dl)

Frequency of doses (hours)/ Duration of therapy (days)

Haemorrhage

Early haemarthrosis, muscle bleed or oral bleed

 

20 - 40

 

Repeat every 12 to 24 hours. At least 1 day, until the bleeding episode as indicated by pain is resolved or healing is achieved.

More extensive haemarthrosis, muscle bleed or haematoma

30 - 60

Repeat infusion every 12 - 24 hours for 3 - 4 days or more until pain and disability are resolved.

Life threatening bleeds such as intracranial bleed, throat bleed, severe abdominal bleed

60 - 100

Repeat infusion every 8 to 24 hours until threat is resolved

Surgery

Minor

including tooth extraction

 

30 - 60

 

Every 24 hours, at least 1 day, until healing is achieved.

Major

80 - 100

(pre- and postoperative)

a) By bolus infusions

Repeat infusion every 8 - 24 hours until adequate wound healing occurs, then continue with therapy for at least another 7 days to maintain a factor VIII activity of 30% to 60%

b) By continuous infusion

Raise factor VIII activity pre-surgery with an initial bolus infusion and immediately follow with continuous infusion (in IU/Kg/h) adjusting according to patient's daily clearance and desired factor VIII levels for at least 7 days.

The amount to be administered and the frequency of administration should always be adapted according to the clinical effectiveness in the individual case. Under certain circumstances larger amounts than those calculated may be required, especially in the case of the initial dose.

During the course of treatment, appropriate determination of factor VIII levels is advised in order to guide the dose to be administered and the frequency at which to repeat the infusions. In the case of major surgical interventions in particular, precise monitoring of the substitution therapy by means of coagulation analysis (plasma factor VIII activity) is indispensable. Individual patients may vary in their response to factor VIII, achieving different levels of in vivo recovery and demonstrating different half-lives.

Continuous Infusion

It has been shown in a clinical study performed with adult haemophilia A patients who undergo a major surgery that KOGENATE Bayer can be used for continuous infusion in surgeries (pre-, during and postoperative). In this study heparin was used to prevent thrombophlebitis at the infusion site as with any other long term intravenous infusions. For the calculation of the initial infusion rate, clearance can be obtained by performing a pre-surgery decay curve, or by starting from an average population value (3.0-3.5 ml/h/kg) and then adjust accordingly.

Infusion rate (in IU/kg/h) = Clearance (in ml/h/kg) ? desired factor VIII level (in IU/ml)

For continuous infusion, clinical and in vitro stability has been demonstrated using ambulatory pumps with a PVC reservoir. KOGENATE Bayer contains low level of polysorbate-80 as an excipient, which is known to increase the rate of di-(2-ethylhexyl)phthalate (DEHP) extraction from polyvinyl chloride (PVC) materials. This should be considered for a continuous infusion administration.

Prophylaxis

For long term prophylaxis against bleeding in patients with severe haemophilia A, the usual doses are 20 to 40 IU of KOGENATE Bayer per kg body weight at intervals of 2 to 3 days.

In some cases, especially in younger patients, shorter dose intervals or higher doses may be necessary.

Paediatric population

Data have been obtained from clinical studies in 61 children under 6 years of age and non-interventional studies in children of all ages.

Patients with inhibitors

Patients should be monitored for the development of factor VIII inhibitors. If the expected plasma factor VIII activity levels are not attained, or if bleeding is not controlled with an appropriate dose, an assay should be performed to determine if a factor VIII inhibitor is present. If the inhibitor is present at levels less than 10 Bethesda Units (BU) per ml, administration of additional recombinant coagulation factor VIII may neutralise the inhibitor and permit continued clinically effective therapy with KOGENATE Bayer. However, in the presence of an inhibitor the doses required are variable and must be adjusted according to clinical response and monitoring of plasma factor VIII activity. In patients with inhibitor titres above 10 BU or with high anamnestic response, the use of (activated) prothrombin complex concentrate (PCC) or recombinant activated factor VII (rFVIIa) preparations has to be considered. These therapies should be directed by physicians with experience in the care of patients with haemophilia.

Method of administration

For intravenous use.

KOGENATE Bayer should be injected intravenously over several minutes. The rate of administration should be determined by the patient's comfort level (maximal rate of infusion: 2 ml/min).

Continuous infusion

KOGENATE Bayer can be infused by continuous infusion. The infusion rate should be calculated based on the clearance and the desired FVIII level.

Example: for a 75 kg patient with a clearance of 3 ml/h/kg, the initial infusion rate would be 3 IU/h/kg to achieve a FVIII level of 100%. For calculation of ml/hour, multiply infusion rate in IU/h/kg by kg bw/concentration of solution (IU/ml).

Example for calculation of infusion rate for continuous infusion after initial bolus injection

 

Desired plasma FVIII level

Infusion rate

IU/h/kg

Infusion rate for 75 kg patient

ml/h

   

Clearance: 3 ml/h/kg

   

Concentrations of rFVIII solution

         

100 IU/ml

200 IU/ml

400 IU/ml

 

100 % (1 IU/ml)

3.0

2.25

1.125

0.56

 

60 % (0.6 IU/ml)

1.8

1.35

0.68

0.34

 

40 % (0.4 IU/ml)

1.2

0.9

0.45

0.225

Higher infusion rates may be required in conditions with accelerated clearance during major bleedings or extensive tissue damage during surgical interventions.

After the initial 24 hours of continuous infusion, the clearance should be recalculated every day using the steady state equation with the measured FVIII level and the rate of infusion using the following equation:

clearance = infusion rate/actual FVIII level.

During continuous infusion, infusion bags should be changed every 24 hours.

For instructions on reconstitution of the medicinal product before administration, see section 6.6 and the package leaflet.

4.3 Contraindications

- Known hypersensitivity to the active substance or to any of the excipients.

- Known allergic reactions to mouse or hamster protein.

4.4 Special Warnings And Precautions For Use

Hypersensitivity reactions

As with any intravenous protein product, allergic type hypersensitivity reactions are possible.

Patients should be made aware that the potential occurrence of chest tightness, dizziness, mild hypotension and nausea during infusion can constitute an early warning for hypersensitivity and anaphylactic reactions. Symptomatic treatment and therapy for hypersensitivity should be instituted as appropriate. If allergic or anaphylactic reactions occur, the injection/infusion should be stopped immediately and patient should contact their physician. In case of shock, the current medical standards for shock treatment should be observed.

Antibodies (inhibitors)

The formation of neutralising antibodies (inhibitors) to factor VIII is a known complication in the management of individuals with haemophilia A. These inhibitors are usually IgG immunoglobulins directed against the factor VIII procoagulant activity, which are quantified in Modified Bethesda Units (BU) per ml of plasma. The risk of developing inhibitors is correlated to the exposure to anti-haemophilic factor VIII and to genetic factors among others, this risk being highest within the first 20 exposure days. Rarely, inhibitors may develop after the first 100 exposure days.

Cases of recurrence of inhibitors (low titre) have been observed after switching from one recombinant factor VIII product to another in previously treated patients with more than 100 exposure days who have a history of inhibitor development.

Patients treated with recombinant coagulation factor VIII should be carefully monitored for the development of inhibitors by appropriate clinical observations and laboratory tests. (See also section 4.8)

Continuous infusion

In a clinical study about the use of continuous infusion in surgeries, heparin was used to prevent thrombophlebitis at the infusion site as with any other long term intravenous infusions.

Registration

In the interest of the patients, it is recommended that, whenever possible, every time that KOGENATE Bayer is administered to them, the name and the batch number of the product is registered.

Sodium content

This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially “sodium free”.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No interactions of KOGENATE Bayer with other medicinal products are known.

4.6 Pregnancy And Lactation

Animal reproduction studies have not been conducted with KOGENATE Bayer.

Based on the rare occurrence of haemophilia A in women, experience regarding the use of KOGENATE Bayer during pregnancy and breast-feeding is not available. Therefore, KOGENATE Bayer should be used during pregnancy and breast-feeding only if clearly indicated.

There are no fertility data available.

4.7 Effects On Ability To Drive And Use Machines

KOGENATE Bayer has no influence on the ability to drive or to use machines.

4.8 Undesirable Effects

The most commonly reported adverse drug reaction occurring is the formation of neutralising antibodies (prevalent in previously untreated or minimally treated patients).

The frequencies of adverse reactions reported with KOGENATE Bayer are summarized in the table below. Within each frequency group, undesirable effects are presented in order of decreasing seriousness. Frequencies are defined as common (

MedDRA Standard

System Organ Class

Common

Uncommon

Rare

Blood and the Lymphatic System Disorders

Inhibitor Formation to FVIII

(Reported in PUP and minimally treated patients in clinical trials)*

Inhibitor Formation to FVIII

(Reported in PTP in clinical trials and Post Marketing Studies)*

 

General Disorders and Administration Site Conditions

Infusion site reaction

 

Infusion related febrile reaction (pyrexia)

Immune System Disorders

Skin associated hypersensitivity reactions, (pruritus, urticaria and rash)

 

Systemic Hypersensitivity reactions (including one anaphylactic reaction, nausea, blood pressure abnormal and, dizziness)

* see section below

Description of selected adverse reactions

The formation of neutralising antibodies to factor VIII (inhibitors) is a known complication in the management of individuals with haemophilia A. In studies with recombinant factor VIII preparations, development of inhibitors is predominantly observed in previously untreated haemophiliacs. Patients should be carefully monitored for the development of inhibitors by appropriate clinical observations and laboratory tests.

In clinical studies, KOGENATE Bayer has been used in the treatment of bleeding episodes in 37 previously untreated patients (PUPs) and 23 minimally treated pediatric patients (MTPs, defined as having equal to or less than 4 exposure days). Five out of 37 (14%) PUP and 4 out of 23 (17%) MTP patients treated with KOGENATE Bayer developed inhibitors: Overall, 9 out of 60 (15%) developed inhibitors, 6 out of 60 (10%) with a titre above 10 BU and 3 out of 60 (5%) with a titre below 10 BU. The median number of exposure days at the time of inhibitor detection in these patients was 9 days (range 3 - 18 days).

The median number of exposure days in the clinical studies was 114 (range: 4-478). Four of the five patients, who had not achieved 20 exposure days at the end of the study, ultimately achieved more than 20 exposure days in post-study follow-up and one of them developed a low titre inhibitor. The fifth patient was lost to follow-up.

In clinical studies with 73 previously treated patients (PTP, defined as having more than 100 exposure days), followed over four years, no de-novo inhibitors were observed.

In extensive post-registration studies with KOGENATE Bayer, involving more than 1000 patients the following was observed: Less than 0.2% PTP developed de-novo inhibitors. In a subset defined as having less than 20 exposure days at study entry, less than 11% developed de-novo inhibitors.

During studies, no patient developed clinically relevant antibody titres against the trace amounts of mouse protein and hamster protein present in the preparation. However, the possibility of allergic reactions to constituents, e.g. trace amounts of mouse and hamster protein in the preparation exists in certain predisposed patients (see sections 4.3 and 4.4).

4.9 Overdose

No case of overdose with recombinant coagulation factor VIII has been reported.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: antihemorrhagics: blood coagulation factor VIII, ATC code B02BD02.

The factor VIII/von Willebrand factor (vWF) complex consists of two molecules (factor VIII and vWF) with different physiological functions. When infused into a haemophilic patient, factor VIII binds to vWF in the patient's circulation. Activated factor VIII acts as a cofactor for activated factor IX, accelerating the conversion of factor X to activated factor X. Activated factor X converts prothrombin into thrombin. Thrombin then converts fibrinogen into fibrin and a clot can be formed. Haemophilia A is a sex-linked hereditary disorder of blood coagulation due to decreased levels of factor VIII:C and results in profuse bleeding into joints, muscles or internal organs, either spontaneously or as a result of accidental or surgical trauma. By replacement therapy the plasma levels of factor VIII are increased, thereby enabling a temporary correction of the factor deficiency and correction of the bleeding tendencies.

Determination of activated partial thromboplastin time (aPTT) is a conventional in vitro assay method for biological activity of factor VIII. The aPTT is prolonged in all haemophiliacs. The degree and duration of aPTT normalisation observed after administration of KOGENATE Bayer is similar to that achieved with plasma-derived factor VIII.

5.2 Pharmacokinetic Properties

The analysis of all recorded in vivo recoveries in previously treated patients demonstrated a mean rise of 2 % per IU/kg body weight for KOGENATE Bayer. This result is similar to the reported values for factor VIII derived from human plasma.

After administration of KOGENATE Bayer, peak factor VIII activity decreased by a two-phase exponential decay with a mean terminal half-life of about 15 hours. This is similar to that of plasma-derived factor VIII which has a mean terminal half-life of approx. 13 hours. Additional pharmacokinetic parameters for KOGENATE Bayer for bolus injection are: mean residence time [MRT (0-48)] of about 22 hours and clearance of about 160 ml/h. Mean baseline clearance for 14 adult patients undergoing major surgeries with continuous infusion are 188 ml/h corresponding to 3.0 ml/h/kg (range 1.6-4.6 ml/h/kg).

5.3 Preclinical Safety Data

Even doses several fold higher than the recommended clinical dose (related to body weight) failed to demonstrate any acute or subacute toxic effects for KOGENATE Bayer in laboratory animals (mouse, rat, rabbit, and dog).

Specific studies with repeated administration such as reproduction toxicity, chronic toxicity, and carcinogenicity were not performed with octocog alfa due to the immune response to heterologous proteins in all non-human mammalian species.

No studies were performed on the mutagenic potential of KOGENATE Bayer, since no mutagenic potential could be detected in vitro or in vivo for the predecessor product of KOGENATE Bayer.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Powder

Glycine

Sodium chloride

Calcium chloride

Histidine

Polysorbate 80

Sucrose

Solvent

Water for injections

6.2 Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6..

Only the provided components (powder vial, pre-filled syringe containing solvent, vial adapter and venipuncture set) should be used for reconstitution and injection because treatment failure can occur as a consequence of human recombinant coagulation factor VIII adsorption to the internal surfaces of some infusion equipment.

6.3 Shelf Life

30 months.

After reconstitution, the product should be used immediately.

However, during in vitro studies, the chemical and physical in-use stability has been demonstrated for 24 hours at 30°C in PVC bags for continuous infusion.

Do not refrigerate after reconstitution.

6.4 Special Precautions For Storage

Store in a refrigerator (2°C – 8°C). Do not freeze. Keep the vial and the pre-filled syringe in the outer carton in order to protect from light.

The product when kept in its outer carton may be stored at ambient room temperature (up to 25°C) for a limited period of 12 months. In this case, the product expires at the end of this 12-month period; the new expiry date must be noted on the outer carton.

For storage conditions of the reconstituted medicinal product, see section 6.3.

6.5 Nature And Contents Of Container

Each package of KOGENATE Bayer contains:

• one vial with powder (10 ml clear glass type 1 vial with latex-free grey halogenobutyl rubber blend stopper and aluminium seal)

• one pre-filled syringe with 2.5 ml solvent (clear glass cylinder type 1 with latex-free grey bromobutyl rubber blend stopper)

• syringe plunger rod

• vial adapter

• one venipuncture set

• two sterile alcohol swabs for single use

• two dry swabs

• two plasters

6.6 Special Precautions For Disposal And Other Handling

Detailed instructions for preparation and administration are contained in the package leaflet provided with KOGENATE Bayer.

KOGENATE Bayer powder should only be reconstituted with the supplied solvent (2.5 ml water for injections) in the prefilled syringe and the vial adapter. Reconstitution should be performed in accordance with good practices rules, particularly with attention to asepsis. Gently rotate the vial until all powder is dissolved. After reconstitution the solution is clear. Do not use KOGENATE Bayer if you notice visible particulate matter or turbidity.

After reconstitution, the solution is drawn back into the syringe.

Use the provided venipuncture set for intravenous injection.

For continuous infusion, the product must be prepared under aseptic conditions.

For single use only. Any unused solution must be discarded.

Any unused product or waste material should be disposed of in accordance with local requirements.

7. Marketing Authorisation Holder

Bayer Pharma AG

13342 Berlin

Germany

8. Marketing Authorisation Number(S)

EU/1/00/143/007

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first authorisation: 04 August 2000

Date of latest renewal: 06 August 2010

10. Date Of Revision Of The Text

1 July 2011

Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.



Generic Name: vitamin e (Oral route)

VYE-ta-min E

Commonly used brand name(s)

In the U.S.

Alpha-E Aqua Gem-E Aquasol E D-Alpha Gems E-400 E-600 E-Gems Formula E 400 Gamma E-Gems Gamma E Plus Key-E Natural Vitamin Blend E-400IU Nutr-E-Sol

Available Dosage Forms:

Liquid Solution Tablet Capsule, Liquid Filled Tablet, Chewable Powder for Solution Capsule

Therapeutic Class: Nutritive Agent

Pharmacologic Class: Vitamin E (class)

Uses For Formula E 400

Vitamins are compounds that you must have for growth and health. They are needed in only small amounts and are available in the foods that you eat. Vitamin E prevents a chemical reaction called oxidation, which can sometimes result in harmful effects in your body. It is also important for the proper function of nerves and muscles.

Some conditions may increase your need for vitamin E. These include:

Intestine disease Liver disease Pancreas disease Surgical removal of stomach

Increased need for vitamin E should be determined by your health care professional.

Infants who are receiving a formula that is not fortified with vitamin E may be likely to have a vitamin E deficiency. Also, diets high in polyunsaturated fatty acids may increase your need for vitamin E.

Claims that vitamin E is effective for treatment of cancer and for prevention or treatment of acne, aging, loss of hair, bee stings, liver spots on the hands, bursitis, diaper rash, frostbite, stomach ulcer, heart attacks, labor pains, certain blood diseases, miscarriage, muscular dystrophy, poor posture, sexual impotence, sterility, infertility, menopause, sunburn, and lung damage from air pollution have not been proven. Although vitamin E is being used to prevent certain types of cancer, there is not enough information to show that this is effective.

Lack of vitamin E is extremely rare, except in people who have a disease in which it is not absorbed into the body.

Vitamin E is available without a prescription.

Importance of Diet

For good health, it is important that you eat a balanced and varied diet. Follow carefully any diet program your health care professional may recommend. For your specific dietary vitamin and/or mineral needs, ask your health care professional for a list of appropriate foods. If you think that you are not getting enough vitamins and/or minerals in your diet, you may choose to take a dietary supplement.

Vitamin E is found in various foods including vegetable oils (corn, cottonseed, soybean, safflower), wheat germ, whole-grain cereals, and green leafy vegetables. Cooking and storage may destroy some of the vitamin E in foods.

Vitamin supplements alone will not take the place of a good diet and will not provide energy. Your body also needs other substances found in food such as protein, minerals, carbohydrates, and fat. Vitamins themselves often cannot work without the presence of other foods. For example, small amounts of fat are needed so that vitamin E can be absorbed into the body.

The daily amount of vitamin E needed is defined in several different ways.

For U.S.— Recommended Dietary Allowances (RDAs) are the amount of vitamins and minerals needed to provide for adequate nutrition in most healthy persons. RDAs for a given nutrient may vary depending on a person's age, sex, and physical condition (e.g., pregnancy). Daily Values (DVs) are used on food and dietary supplement labels to indicate the percent of the recommended daily amount of each nutrient that a serving provides. DV replaces the previous designation of United States Recommended Daily Allowances (USRDAs). For Canada— Recommended Nutrient Intakes (RNIs) are used to determine the amounts of vitamins, minerals, and protein needed to provide adequate nutrition and lessen the risk of chronic disease.

Vitamin E is available in various forms, including d- or dl-alpha tocopheryl acetate, d- or dl-alpha tocopherol, and d- or dl-alpha tocopheryl acid succinate. In the past, the RDA for vitamin E have been expressed in Units. This term has been replaced by alpha tocopherol equivalents (alpha-TE) or milligrams (mg) of d-alpha tocopherol. One Unit is equivalent to 1 mg of dl-alpha tocopherol acetate or 0.6 mg d-alpha tocopherol. Most products available in stores continue to be labeled in Units.

Normal daily recommended intakes in milligrams (mg) of alpha tocopherol equivalents (mg alpha-TE) and Units for vitamin E are generally defined as follows:

                                                  Persons U.S. Canada mg alpha-TE Units mg



Generic Name: magnesium oxide (mag NEE see um OCK side) Brand Names: Mag-200, Mag-Ox 400, MagGel, Uro-Mag

What is Mag-200 (magnesium oxide)?

Magnesium is a naturally occurring mineral. Magnesium is important for many systems in the body especially the muscles and nerves.

Magnesium oxide is used as a supplement to maintain adequate magnesium in the body.

Magnesium oxide may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Mag-200 (magnesium oxide)?

Before taking magnesium oxide, tell your doctor if you have any other medical conditions, allergies, or if you take other medicines or other herbal/health supplements. Magnesium oxide may not be recommended in some situations.

Who should not take Mag-200 (magnesium oxide)? Do not take magnesium oxide without first talking to your doctor if you have kidney disease.

Before taking magnesium oxide, tell your doctor if you have any other medical conditions, allergies, or if you take other medicines or other herbal/health supplements. Magnesium oxide may not be recommended in some situations.

It is not known whether magnesium oxide will harm an unborn baby. Do not take magnesium oxide without first talking to your doctor if you are pregnant or planning a pregnancy. It is not known whether magnesium oxide will harm an nursing baby. Do not take magnesium oxide without first talking to your doctor if you are breast-feeding a baby. How should I take Mag-200 (magnesium oxide)?

Take magnesium oxide exactly as directed by your doctor or as directed on the package. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take the tablets and capsules with a full glass of water.

To ensure that you get the correct dose, measure the liquid form of magnesium with a dose-measuring spoon or cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

Do not take more magnesium oxide than is directed. Store magnesium oxide at room temperature away from moisture and heat. What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the dose you missed and take only the next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose? Seek emergency medical attention.

Symptoms of an magnesium oxide overdose include nausea, vomiting, flushing, low blood pressure, a slow heartbeat, drowsiness, coma, and death.

What should I avoid while taking Mag-200 (magnesium oxide)?

There are no restrictions on food, beverages, or activity while taking magnesium oxide unless otherwise directed by your doctor.

Mag-200 (magnesium oxide) side effects Stop taking magnesium oxide and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

Other, less serious side effects may be more likely to occur. Continue to take magnesium oxide and talk to your doctor if you experience diarrhea or an upset stomach.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Mag-200 (magnesium oxide)?

Before taking magnesium oxide, talk to your doctor if you are taking

a tetracycline antibiotic such as tetracycline (Sumycin, Achromycin V, and others), demeclocycline (Declomycin), doxycycline (Vibramycin, Monodox, Doxy, and others), minocycline (Minocin, Dynacin, and others), or oxytetracycline (Terramycin, and others);

a fluoroquinolone antibiotic such as ciprofloxacin (Cipro), ofloxacin (Floxin), enoxacin (Penetrex), norfloxacin (Noroxin), sparfloxacin (Zagam), levofloxacin (Levaquin), lomefloxacin (Maxaquin), grepafloxacin (Raxar), and others;

penicillamine (Cuprimine);

digoxin (Lanoxin, Lanoxicaps); or

nitrofurantoin (Macrodantin, Furadantin, others).

You not be able to take magnesium oxide, or you may require a dosage adjustment or special monitoring during your treatment if you are taking any of the medicines listed above.

Drugs other than those listed here can also interact with magnesium oxide. Talk to your doctor and pharmacist before taking any over-the-counter or prescription medicines.

More Mag-200 resources Mag-200 Side Effects (in more detail) Mag-200 Use in Pregnancy & Breastfeeding Mag-200 Drug Interactions Mag-200 Support Group 0 Reviews for Mag-200 - Add your own review/rating Magnesium Oxide Professional Patient Advice (Wolters Kluwer) Magnesium Oxide MedFacts Consumer Leaflet (Wolters Kluwer) Compare Mag-200 with other medications Constipation Duodenal Ulcer GERD Hypomagnesemia Indigestion Pathological Hypersecretory Disorder Stomach Ulcer Urinary Tract Stones Where can I get more information? Your pharmacist has additional information about magnesium oxide written for health professionals that you may read.

See also: Mag-200 side effects (in more detail)



Pronunciation: zink/VYE-ta-minGeneric Name: Zinc/Vitamin B12/Vitamin C



Generic Name: silybum marianum seed, crotalus horridus horridus venom, artemisia cina flower, aconitum napellus and ferrum phosphoricum granule Dosage Form: FOR ANIMAL USE ONLY



Pronunciation: KEE-toe-PROE-fenGeneric Name: Ketoprofen



1. Name Of The Medicinal Product

Becodisks 200 Micrograms

2. Qualitative And Quantitative Composition

Beclometasone Dipropionate 200micrograms

3. Pharmaceutical Form

Dry Powder for Inhalation via Diskhaler Device

4. Clinical Particulars 4.1 Therapeutic Indications

Clinical Indications

Beclometasone dipropionate provides effective anti-inflammatory action in the lungs, with a lower incidence and severity of adverse effects than those observed when corticosteroids are administered systemically. It also offers preventive treatment of asthma.

Becodisks are indicated for the following:

Adults

Prophylactic management in:

Mild asthma (PEF values greater than 80% predicted at baseline with less than 20% variability):

Patients requiring intermittent symptomatic bronchodilator asthma medication on more than an occasional basis.

Moderate asthma (PEF values 60-80% predicted at baseline with 20-30% variability):

Patients requiring regular asthma medication and patients with unstable or worsening asthma on other prophylactic therapy or bronchodilator alone.

Severe asthma (PEF values less than 60% predicted at baseline with greater than 30% variability):

Patients with severe chronic asthma. On transfer to high dose inhaled beclometasone dipropionate, many patients who are dependent on systemic corticosteroids for adequate control of symptoms may be able to reduce significantly or eliminate their requirement for oral corticosteroids.

4.2 Posology And Method Of Administration

Becodisks are for administration by the inhalation route only using a Diskhaler device.

Patients should be made aware of the prophylactic nature of therapy with inhaled beclometasone dipropionate and that it should be taken regularly everyday even when they are asymptomatic.

Patients should be given a starting dose of inhaled beclometasone dipropionate which is appropriate for severity of their disease. The dose may then be adjusted until control is achieved and should be titrated to the lowest dose at which effective control of asthma is maintained.

Adults

400 microgram twice daily is the usual starting dose. One 400 microgram blister or two 200 micrograms blisters twice daily is the usual maintenance dose. Alternatively, 200 micrograms may be administered three or four times daily.

Children

100 micrograms two, three or four times a day, according to the response. Alternatively, the usual starting dose of 200 micrograms twice daily may be administered.

Special Patient Groups

There is no need to adjust the dose in elderly patients or in those with hepatic or renal impairment.

4.3 Contraindications

Hypersensitivity to Becodisks or any of its compnents is a contraindication. (See Pharmaceutical Particulars – List of Excipients).

Special care is necessary in patients with active or quiescent pulmonary tuberculosis.

4.4 Special Warnings And Precautions For Use

Patients should be instructed in the proper use of the Diskhaler to ensure that the drug reaches the target areas within the lungs. They should be made aware that Becodisks have to be used regularly everyday for optimum benefit. Patients should be made aware of the prophylactic nature of therapy with Becodisks and that they should be used regularly, even when they are asymptomatic.

Becodisks are not designed to relieve acute asthmatic symptoms for which an inhaled short-acting bronchodilator is required. Patients should be advised to have such rescue medication available.

Severe asthma requires regular medical assessment including lung function testing as patients are at risk of severe attacks and even death.

Increasing use of bronchodilators, in particular short-acting inhaled beta2 agonists to relieve symptoms indicates deterioration of asthma control. If patients find that short acting relief bronchodilator treatment becomes less effective or they need more inhalations than usual, medical attention must be sought.

In this situation patients should be reassessed and consideration given to the need for increased anti-inflammatory therapy (e.g. Higher doses of inhaled corticosteroids or a course of oral corticosteroids). Severe exacerbations of asthma must be treated in the normal way.

Systemic effects of inhaled corticosteroids may occur, particularly at high doses prescribed for prolonged periods. These effects are much less likely to occur than with oral corticosteroids. Possible systemic effects include Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children). It is important therefore that the dose of inhaled corticosteroid is titrated to the lowest dose at which effective control of asthma is maintained.

It is recommended that the height of children receiving prolonged treatment with inhaled corticosteroids is regularly monitored. If growth is slowed, therapy should be reviewed with the aim of reducing the dose of inhaled corticosteroid, if possible, to the lowest dose at which effective control of asthma is maintained. In addition, consideration should be given to referring the patient to a paediatric respiratory specialist.

Prolonged treatment with high doses of inhaled corticosteroids, particularly higher than recommended doses, may result in clinically significant adrenal suppression. Additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.

Lack of response or severe exacerbations of asthma should be treated by increasing the dose of inhaled beclometasone dipropionate and, if necessary, by giving a systemic steroid and/or antibiotic if there is an infection, and by use of beta-agonist therapy.

For the transfer of patients being treated with oral corticosteroids:

The transfer of oral steroid-dependent patients to Becodisks and their subsequent management needs special care as recovery from impaired adrenocortical function, caused by prolonged systemic steroid therapy, may take a considerable time.

Patients who have been treated with systemic steroids for long periods of time or at a high dose may have adrenocortical suppression. With these patients adrenocortical function should be monitored regularly and their dose of systemic steroid reduced cautiously.

After approximately a week, gradual withdrawal of the systemic steroid is commenced. Decrements in dosages should be appropriate to the level of maintenance systemic steroid, and introduced at not less than weekly intervals. For maintenance doses of prednisolone (or equivalent) of 10mg daily or less, the decrements in dose should not be greater than 1mg per day, at not less than weekly intervals. For maintenance doses of prednisolone in excess of 10mg daily, it may be appropriate to employ cautiously, larger decrements in dose at weekly intervals.

Some patients feel unwell in a non-specific way during the withdrawal phase despite maintenance or even improvement of the respiratory function. They should be encouraged to persevere with the Diskhaler and withdrawal of systemic steroid continued, unless there are objective signs of adrenal insufficiency.

Patients weaned off oral steroids whose adrenocortical function is impaired should carry a steroid warning card indicating that they may need supplementary systemic steroid during periods of stress, e.g. Worsening asthma attacks, chest infections, major intercurrent illness, surgery, trauma, etc.

Replacement of systemic steroid treatment with inhaled therapy sometimes unmasks allergies such as allergic rhinitis or eczema previously controlled by the systemic drug. These allergies should be symptomatically treated with antihistamine and/or topical preparations, including topical steroids.

Treatment with Becodisks should not be stopped abruptly.

As with all inhaled corticosteroids, special care is necessary in patients with active or quiescent pulmonary tuberculosis

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No interactions have been reported

4.6 Pregnancy And Lactation

There is inadequate evidence of safety in human pregnancy. Administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate and intra-uterine growth retardation. There may therefore be a very small risk of such effects in the human foetus. It should be noted, however, that the foetal changes in animals occur after relatively high systemic exposure. Because beclometasone dipropionate is delivered directly to the lungs by the inhaled route it avoids the high level of exposure that occurs when corticosteroids are given by systemic routes.

The use of beclometasone dipropionate in pregnancy requires that the possible benefits of the drug be weighed against the possible hazards. It should be noted that the drug has been in widespread use for many years without apparent ill consequence.

No specific studies examining the transference of beclometasone dipropionate into the milk of lactating animals have been performed. It is reasonable to assume that beclometasone dipropionate is secreted in milk but at the dosages used for direct inhalation, there is low potential for significant levels in breast milk. The use of beclometasone dipropionate in mothers breast feeding their babies requires that the therapeutic benefits of the drug be weighed against the potential hazards to the mother and baby.

4.7 Effects On Ability To Drive And Use Machines

No adverse effect has been reported.

4.8 Undesirable Effects

Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (

System Organ Class

Adverse Event

Frequency

Infections & Infestations

Candidiasis of the mouth and throat.

Very Common

Immune System Disorders

Hypersensitivity reactions with the following manifestations:

 

Rashes, urticaria, pruritis, erythema.

Uncommon

 

Oedema of the eyes, face, lips and throat

Very Rare

 

Respiratory symptoms (dyspnoea and/or bronchospasm)

Very Rare

 

Anaphylactoid/anaphylactic reactions

Very Rare

 

Endocrine Disorders

Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract, glaucoma

Very Rare

Psychiatric Disorders

Anxiety, sleep disorders, behavioural changes, including hyperactivity and irritability (predominantly in children)

Very Rare

Depression, aggression (predominantly in children)

Not known

 

Respiratory, Thoracic & Mediastinal Disorders

Hoarseness/throat irritation

Common

Paradoxical bronchospasm

Very Rare

 

Candidiasis of the mouth and throat (thrush) occurs in some patients, the incidence of which is increased with doses greater than 400 micrograms beclometasone dipropionate per day. Patients with high blood levels of Candida precipitins, indicating a previous infection, are most likely to develop this complication. Patients may find it helpful to rinse out their mouth with water after using the Diskhaler. Symptomatic candidiasis can be treated with topical anti-fungal therapy whilst still continuing with beclometasone dipropionate treatment.

Systemic effects of inhaled corticosteroids may occur, particularly at high doses prescribed for prolonged periods. Possible systemic effects include Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract, glaucoma (see 4.4 Special Warnings and Precautions for Use).

In some patients inhaled beclometasone dipropionate may cause hoarseness or throat irritation. It may be helpful to rinse out the mouth with water immediately after inhalation.

As with other inhalation therapy, paradoxical bronchospasm may occur with an immediate increase in wheezing after dosing. This should be treated immediately with a fast-acting inhaled bronchodilator. The beclometasone dipropionate preparation should be discontinued immediately, the patient assessed, and if necessary alternative therapy instituted.

4.9 Overdose

Acute - inhalation of the drug in doses in excess of those recommended may lead to temporary suppression of adrenal function. This does not necessitate emergency action being taken. In these patients treatment with beclometasone dipropionate by inhalation should be continued at a dose sufficient to control asthma; adrenal function recovers in a few days and can be verified by measuring plasma cortisol.

Chronic - use of inhaled beclometasone dipropionate in daily doses in excess of 1500 micrograms over prolonged periods may lead to adrenal suppression. Monitoring of adrenal reserve may be indicated. Treatment with inhaled beclometasone dipropionate should be continued at a dose sufficient to control asthma.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

BDP is a pro-drug with weak glucocorticoid receptor binding activity. It is hydrolysed via esterase enzymes to the active metabolite beclometasone-17-monopropionate (B-17-MP), which has high topical anti-inflammatory activity.

5.2 Pharmacokinetic Properties

Absorption

When administered via inhalation (via metered dose inhaler) there is extensive conversion of BDP to the active metabolite B-17-MP within the lungs prior to systemic absorption. The systemic absorption of B-17-MP arises from both lung deposition and oral absorption of the swallowed dose. When administered orally, in healthy male volunteers, the bioavailability of BDP is negligible but pre-systemic conversion to B-17-MP results in 41% (95% CI 27- 62 %) of the dose being available as B-17-MP.

Metabolism

BDP is cleared very rapidly from the systemic circulation, owing to extensive first pass metabolism. The main product of metabolism is the active metabolite (B-17-MP). Minor inactive metabolites, beclometasone-21-monopropionate (B-21-MP) and beclometasone (BOH), are also formed but these contribute little to systemic exposure.

Distribution

The tissue distribution at steady state for BDP is moderate (20L) but more extensive for B-17-MP (424L). Plasma protein binding is moderately high (87%).

Elimination

The elimination of BDP and B-17-MP are characterised by high plasma clearance (150 and 120L/h) with corresponding terminal elimination half lives of 0.5h and 2.7h. Following oral administration of tritiated BDP, approximately 60% of the dose was excreted in the faeces within 96 hours mainly as free and conjugated polar metabolites. Approximately 12% of the dose was excreted as free and conjugated polar metabolites in the urine.

5.3 Preclinical Safety Data

No clinically relevant findings were observed in preclinical studies.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Lactose(which contains milk protein)

6.2 Incompatibilities

No incompatibilities have been reported.

6.3 Shelf Life

2 years

6.4 Special Precautions For Storage

Do not store above 30?C.

6.5 Nature And Contents Of Container

Circular double foil blister pack consisting of:

A) Lidding material (i) polyester over-lacquer/hard tempered aluminium foil/heat seal lacquer of total thickness = 39.4 - 48.6microns or (ii) nitrocellulose over-lacquer/hard tempered aluminium foil/heat seal lacquer of total thickness = 37.0 - 42.0microns.

B) Blister material - pvc film/aluminium foil/orientated polyamide.

Becodisks are supplied as 8 blisters per Becodisk as follows:

-Carton containing 14 disks plus a Diskhaler

-Carton containing 15 disks plus a Diskhaler

-Carton containing 5 disks plus a Diskhaler (Hospital pack)

-Refill packs of 14 disks

-Refill packs of 15 disks

Not all pack sizes may be marketed

6.6 Special Precautions For Disposal And Other Handling

See Patient Information Leaflet

Administrative Data 7. Marketing Authorisation Holder

Glaxo Wellcome UK Ltd.

Trading as Allen & Hanburys,

Stockley Park West,

Uxbridge

Middlesex,

UB11 1BT

8. Marketing Authorisation Number(S)

PL 10949/0056

9. Date Of First Authorisation/Renewal Of The Authorisation

27 September 1993/11 December 1997

10. Date Of Revision Of The Text

23 August 2011

11. Legal Status

POM



Jayacin may be available in the countries listed below.

Ingredient matches for Jayacin Ciprofloxacin

Ciprofloxacin is reported as an ingredient of Jayacin in the following countries:

Indonesia

International Drug Name Search



Definition of Mercury Poisoning: A disease usually caused by the ingestion of mercury or mercury compounds, which are toxic in relation to their ability to produce mercuric ions; usually acute mercury poisoning is associated with ulcerations of the stomach and intestine and toxic changes in the renal tubules; anuria and anaemia may occur; usually chronic mercury poisoning is a result of industrial poisoning and causes gastrointestinal or central nervous system manifestations including stomatitis, diarrhoea, ataxia, tremor, hyperreflexia, sensorineural impairment, and emotional instability

Drugs associated with Mercury Poisoning

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

Drug List: Bal-In-Oil



Generic Name: phenylpropanolamine (fen ill proe pa NOLE a meen) Brand Names: Acutrim 16 Hour, Acutrim II, Maximum Strength, Acutrim Late Day, Control, Dexatrim, Empro, Mega-Trim, Phenyldrine, Propagest, Propan, Rhindecon, Westrim, Westrim LA

What is Westrim (phenylpropanolamine)?

Phenylpropanolamine is a decongestant. It works by constricting (shrinking) blood vessels (veins and arteries) in your body. Constriction of blood vessels in your sinuses, nose, and chest allows drainage of those areas, which decreases congestion.

Phenylpropanolamine is used to treat the congestion associated with allergies, hay fever, sinus irritation, and the common cold. Phenylpropanolamine also causes a decrease in appetite and is used in some over-the-counter diet aids.

Phenylpropanolamine has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.

Phenylpropanolamine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Westrim (phenylpropanolamine)?

Phenylpropanolamine has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.

Do not take phenylpropanolamine for longer than 7 days if your condition does not improve or if your symptoms are accompanied by a high fever.

Do not take more of this medication than is recommended on the package or by your doctor. Use caution when driving, operating machinery, or performing other hazardous activities. Phenylpropanolamine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Who should not take Westrim (phenylpropanolamine)?

Do not take phenylpropanolamine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A very dangerous drug interaction could occur, leading to serious side effects.

Before taking this medication, tell your doctor if you have

high blood pressure;

any type of heart disease, hardening of the arteries, or irregular heartbeat;

thyroid problems;

diabetes;

glaucoma or increased pressure in your eye;

an enlarged prostate or difficulty urinating; or

liver or kidney disease.

You may not be able to take phenylpropanolamine, or you may require a lower dose or special monitoring during treatment if you have any of the conditions listed above.

It is not known whether phenylpropanolamine will harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. Infants are especially sensitive to the effects of phenylpropanolamine. Do not take this drug if you are breast-feeding a baby. If you are over 60 years of age, you may be more likely to experience side effects from phenylpropanolamine. You may require a lower dose of this medication. Using a short-acting formulation of phenylpropanolamine (not a long-acting or a controlled-release formulation) may be safer if you are over 60 years of age. How should I take Westrim (phenylpropanolamine)?

Take phenylpropanolamine exactly as directed by your doctor, or follow the instructions that accompany the package. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water. Never take this medication in larger doses or more often than is recommended. Too much phenylpropanolamine could be very harmful.

If your symptoms are accompanied by a high fever, or if they do not improve in 7 days, see your doctor.

Store phenylpropanolamine at room temperature away from moisture and heat. What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take only your next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose? Seek emergency medical attention.

Symptoms of a phenylpropanolamine overdose include extreme tiredness, sweating, dizziness, a slow heart beat, and a coma.

What should I avoid while taking Westrim (phenylpropanolamine)? Use caution when driving, operating machinery, or performing other hazardous activities. Phenylpropanolamine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Never take this medication in larger doses or more often than is recommended. Too much phenylpropanolamine could be very harmful. Westrim (phenylpropanolamine) side effects

If you experience any of the following serious side effects from this medication, stop taking phenylpropanolamine and seek emergency medical attention:

an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);

seizures;

unusual behavior or hallucinations; or

an irregular or fast heartbeat.

Other, less serious side effects may be more likely to occur. Continue to take phenylpropanolamine and talk to your doctor if you experience

dizziness, lightheadedness, or drowsiness;

headache;

insomnia;

anxiety;

tremor (shaking) or restlessness;

nausea or vomiting; or

sweating.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect Westrim (phenylpropanolamine)?

Do not take phenylpropanolamine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A very dangerous drug interaction could occur, leading to serious side effects.

Phenylpropanolamine may also interact with the following medicines:

furazolidone (Furoxone);

guanethidine (Ismelin);

indomethacin (Indocin);

methyldopa (Aldomet);

bromocriptine (Parlodel);

caffeine in cola, tea, coffee, chocolate, and other products;

theophylline (Theo-Dur, Theochron, Theolair, others);

tricyclic antidepressants such as amitriptyline (Elavil, Endep), doxepin (Sinequan), and nortriptyline (Pamelor); other commonly used tricyclic antidepressants, including amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), imipramine (Tofranil), protriptyline (Vivactil), and trimipramine (Surmontil); phenothiazines such as chlorpromazine (Thorazine), thioridazine (Mellaril), and prochlorperazine (Compazine); and other commonly used phenothiazines, including fluphenazine (Prolixin), perphenazine (Trilafon), mesoridazine (Serentil), and trifluoperazine (Stelazine).

Drugs other than those listed here may also interact with phenylpropanolamine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

More Westrim resources Westrim Side Effects (in more detail) Westrim Use in Pregnancy & Breastfeeding Westrim Drug Interactions Westrim Support Group 0 Reviews for Westrim - Add your own review/rating Propantheline Bromide Monograph (AHFS DI) Compare Westrim with other medications Nasal Congestion Weight Loss Where can I get more information? Your pharmacist has more information about phenylpropanolamine written for health professionals that you may read. What does my medication look like?

Phenylpropanolamine is available over the counter under the brand name Propagest, and with a prescription under the brand name Rhindecon. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

Propagest 25 mg--oval, white, scored tablets

Rhindecon 75 mg--timed-release capsules

See also: Westrim side effects (in more detail)



Pronunciation: KAL-see-uhm/si-METH-i-koneGeneric Name: Calcium/Simethicone



Generic Name: ondansetron (Oral route, Oromucosal route)

on-DAN-se-tron

Commonly used brand name(s)

In the U.S.

Zofran Zofran ODT Zuplenz

Available Dosage Forms:

Film Tablet, Disintegrating Tablet Solution

Therapeutic Class: Antiemetic

Pharmacologic Class: Serotonin Receptor Antagonist, 5-HT3

Uses For Zofran ODT

Ondansetron is used to prevent nausea and vomiting that is caused by cancer medicines (chemotherapy) or radiation. It is also used to prevent nausea and vomiting that may occur after surgery. Ondansetron works in the stomach to block the signals to the brain that cause nausea and vomiting.

This medicine is available only with your doctor's prescription.

Before Using Zofran ODT

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of ondansetron in children under 4 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ondansetron in the elderly.

Pregnancy Pregnancy Category Explanation All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus. Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Apomorphine Cisapride Dronedarone Fluconazole Mesoridazine Pimozide Posaconazole Sparfloxacin Thioridazine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acecainide Alfuzosin Amiodarone Amitriptyline Amoxapine Arsenic Trioxide Asenapine Astemizole Azimilide Azithromycin Bretylium Chloroquine Chlorpromazine Ciprofloxacin Citalopram Clarithromycin Clomipramine Clozapine Crizotinib Dasatinib Desipramine Disopyramide Dofetilide Dolasetron Droperidol Enflurane Erythromycin Flecainide Gatifloxacin Gemifloxacin Granisetron Halofantrine Haloperidol Halothane Ibutilide Iloperidone Isoflurane Isradipine Lapatinib Lopinavir Lumefantrine Mefloquine Methadone Moxifloxacin Nilotinib Norfloxacin Nortriptyline Octreotide Ofloxacin Paliperidone Pazopanib Perflutren Lipid Microsphere Procainamide Prochlorperazine Promethazine Propafenone Protriptyline Quetiapine Quinidine Quinine Salmeterol Saquinavir Sematilide Sodium Phosphate Sodium Phosphate, Dibasic Sodium Phosphate, Monobasic Solifenacin Sorafenib Sotalol Sunitinib Tedisamil Telavancin Telithromycin Terfenadine Tetrabenazine Toremifene Trazodone Trifluoperazine Trimipramine Vandetanib Vardenafil Vemurafenib Voriconazole Ziprasidone

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Cyclophosphamide Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Allergy to other selective 5-HT3 receptor antagonists (alosetron Lotronex], dolasetron [Anzemet], granisetron [Kytril], palonosetron [Aloxi])—Use with caution. It is likely you will also be allergic to ondansetron. Bowel blockage or Gastric distension (enlarged abdomen)—May cover up symptoms of these stomach or intestinal problems. Heart rhythm problems (e.g., prolonged QT interval)—Use with caution. May make this condition worse. Liver disease—May have an increased chance of side effects. Phenylketonuria (PKU)—The oral disintegrating tablets may contain aspartame, which can make your condition worse. Proper Use of ondansetron

This section provides information on the proper use of a number of products that contain ondansetron. It may not be specific to Zofran ODT. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

To use the oral disintegrating tablet:

Make sure your hands are dry. Do not push the tablet through the foil backing of the package. Instead, gently peel back the foil backing and remove the tablet. Immediately place the tablet on top of the tongue. The tablet will dissolve in seconds, and you may swallow it with your saliva. You do not need to drink water or other liquid to swallow the tablet.

To use the oral soluble film:

Make sure your hands are clean and dry before and after using this medicine. Fold the pouch along the dotted line to expose the tear notch. While still folded, tear the pouch carefully along the edge and remove the film out from the pouch. Put the soluble film immediately on top of your tongue where it will dissolve in 4 to 20 seconds. Do not chew or swallow the film whole. Once the film is dissolved, you may swallow with or without water.

If you vomit within 30 minutes after using this medicine, take the same amount of medicine again. If vomiting continues, check with your doctor.

This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage forms (oral disintegrating tablets, solution, or tablets): For prevention of moderate nausea and vomiting after treatment with cancer medicines: Adults, teenagers, and children 12 years of age—At first, 8 milligrams (mg) taken 30 minutes before starting cancer treatment. The 8-mg dose is taken again 8 hours after the first dose. Then, the dose is 8 mg every 12 hours for 1 to 2 days. Children 4 to 11 years of age—At first, 4 mg taken 30 minutes before starting cancer treatment. The 4-mg dose is taken again 4 and 8 hours after the first dose. Then, the dose is 4 mg every 8 hours for 1 to 2 days. Children younger than 4 years of age—Use and dose must be determined by your doctor. For prevention of more severe nausea and vomiting after treatment with cancer medicines: Adults, teenagers, and children 12 years of age—One 24-milligram (mg) tablet taken 30 minutes before starting cancer treatment. Children younger than 12 years of age—Use and dose must be determined by your doctor. For prevention of nausea and vomiting after radiation treatment: Adults—At first, 8 milligrams (mg) taken 1 to 2 hours before radiation treatment. Then, the dose is 8 mg every 8 hours. Children—Use and dose must be determined by your doctor. For prevention of nausea and vomiting after surgery: Adults—16 milligrams (mg) one hour before anesthesia is given. Children—Use and dose must be determined by your doctor. For oral dosage form (soluble film): For prevention of moderate nausea and vomiting after treatment with cancer medicines: Adults, teenagers, and children 12 years of age—At first, one 8-milligram (mg) film taken 30 minutes before starting cancer treatment. The second 8-mg film is taken 8 hours after the first dose. Then, one 8-mg film is taken two times a day (every 12 hours) for 1 to 2 days. Children 4 to 11 years of age—At first, one 4-milligram (mg) film taken 30 minutes before starting cancer treatment. The second and third 4-mg films are taken 4 and 8 hours after the first dose. Then, one 4-mg film is taken three times a day (every 8 hours) for 1 to 2 days. Children younger than 4 years of age—Use and dose must be determined by your doctor. For prevention of more severe nausea and vomiting after treatment with cancer medicines: Adults—24 milligrams (mg) or three 8-mg films taken 30 minutes before starting cancer treatment. Each film should be dissolved in the tongue before taking the next film. Children—Use and dose must be determined by your doctor. For prevention of nausea and vomiting after radiation treatment: Adults—One 8-milligram (mg) film three times a day. Children—Use and dose must be determined by your doctor. For prevention of nausea and vomiting after surgery: Adults—16 milligrams (mg) or two 8-mg films taken 1 hour before anesthesia is given. Each film should be dissolved in the tongue before taking the next film. Children—Use and dose must be determined by your doctor. Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose of this medicine, and you feel nauseated or you vomit, take the missed dose as soon as possible.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep the medicine in the foil pouch until you are ready to use it. Store at room temperature, away from heat and direct light. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Zofran ODT

Check with your doctor if severe nausea and vomiting continue after leaving the hospital or cancer treatment center.

Do not use this medicine if you are receiving apomorphine (Apokyn®). Using these medicines together may increase risk for more serious problems.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using this medicine.

Check with your doctor right away if you start to have pain or swelling in your stomach area. These may be signs of a serious stomach or bowel problem.

Zofran ODT Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common Confusion dizziness fast heartbeat fever headache shortness of breath weakness Less common Decrease in the frequency of urination decrease in urine volume difficulty with passing urine (dribbling) painful urination Rare Arm, back, or jaw pain chest pain or discomfort chest tightness or heaviness convulsions cough decreased urine difficulty with breathing difficulty with swallowing dry mouth fast, pounding, or irregular heartbeat or pulse hives increased thirst itching loss of appetite loss of bladder control loss of consciousness mood changes muscle pain or cramps nausea or vomiting noisy breathing numbness or tingling in the hands, feet, or lips puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue skin rash sweating tightness in the chest total body jerking unusual tiredness or weakness wheezing Incidence not known Blurred vision dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position fixed position of the eye heart stops hoarseness inability to move the eyes increased blinking or spasms of the eyelid large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs no breathing no pulse or blood pressure noisy breathing pounding heartbeat slow or irregular breathing sticking out of the tongue sweating trouble with breathing, speaking, or swallowing unconscious uncontrolled twisting movements of the neck, trunk, arms, or legs unusual facial expressions

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common Anxiety difficulty having a bowel movement (stool) dry mouth general feeling of discomfort or illness hyperventilation irritability restlessness shaking trouble sleeping Rare Difficulty with speaking drooling loss of balance control muscle trembling, jerking, or stiffness shuffling walk stiffness of the limbs twisting movements of the body uncontrolled movements, especially of the face, neck, and back Incidence not known Feeling of warmth hiccups hives or welts redness of the face, neck, arms, and occasionally, upper chest redness of the skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Zofran ODT Oral, Oromucosal side effects (in more detail)

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More Zofran ODT Oral, Oromucosal resources Zofran ODT Oral, Oromucosal Side Effects (in more detail) Zofran ODT Oral, Oromucosal Use in Pregnancy & Breastfeeding Drug Images Zofran ODT Oral, Oromucosal Drug Interactions Zofran ODT Oral, Oromucosal Support Group 9 Reviews for Zofran ODT Oral, Oromucosal - Add your own review/rating Compare Zofran ODT Oral, Oromucosal with other medications Alcohol Dependence Gastroenteritis Nausea/Vomiting Nausea/Vomiting, Chemotherapy Induced Nausea/Vomiting, Postoperative Nausea/Vomiting, Radiation Induced Obsessive Compulsive Disorder Postanesthetic Shivering Pruritus



Generic Name: typhoid vaccine (live), oral (TYE foid vax EEN) Brand Names: Vivotif Berna

What is typhoid vaccine?

Typhoid (also called "typhoid fever") is a serious disease caused by Salmonella typhi bacteria. Typhoid can be fatal if left untreated.

Typhoid can cause high fever, muscle aches, severe headache, weakness, confusion or agitation, loss of appetite, stomach pain, diarrhea or constipation, and rose-colored spots on the skin.

Untreated typhoid infection may lead to kidney failure, or intestinal bleeding caused by perforation (forming of a hole), which can be fatal. If the infection spreads to the gallbladder, the infected person may become a chronic carrier of the bacteria that causes typhoid. A carrier may have no symptoms but is capable of spreading the infection to others.

Typhoid is spread through contact with the stool (bowel movements) of a person infected with the bacteria. This usually occurs by eating food or drinking water that has become contaminated with feces from an infected person. Once in the digestive tract, typhoid infection can spread to the blood and other parts of the body.

Typhoid fever is most common in non-industrialized parts of the world, especially Asia, Africa, and Central or South America. People who travel to those regions are at risk of coming into contact with the disease.

The typhoid vaccine is used to help prevent this disease in adults and children who are at least 6 years old. Although not part of a routine immunization schedule in the U.S., typhoid vaccine is recommended for people who travel to areas where the disease is common.

This vaccine works by exposing you to a small amount of the bacteria, which causes your body to develop immunity to the disease.

Typhoid vaccine will not treat an active infection that has already developed in the body, and will not prevent any disease caused by bacteria other than Salmonella typhi.

Like any vaccine, the typhoid vaccine may not provide protection from disease in every person.

What is the most important information I should know about typhoid vaccine? You should not receive this vaccine if you have ever had an allergic reaction to typhoid vaccine in the past, or if you have fever with any type of infection or illness, or a weak immune system caused by disease or by using certain medicines such as chemotherapy. Typhoid vaccine should not be used in a person who is a typhoid carrier.

Before you receive this vaccine, tell the doctor if you have any illness with vomiting or diarrhea, if you are taking an antibiotic or sulfa drug (Azulfidine, Bactrim, Cotrim, Gantrisin, Septra, SMX-TMP, Sulfazine), or if you plan to start taking an anti-malaria medication within 10 days after receiving typhoid vaccine.

You can still receive a vaccine if you have a minor cold. In the case of a more severe illness with a fever or any type of infection, the doctor may ask you to wait until you get better before you can receive the vaccine.

The typhoid oral vaccine is given in a series of 4 capsules that are taken 1 per day on alternating days (days 1, 3, 5, and 7). On this alternating-day schedule, you will take 1 capsule every 48 hours for 7 days. You must take each capsule according to the recommended schedule for this vaccine to be effective.

You should complete all doses at least 1 week before your scheduled travel or possible exposure to typhoid.

You must keep typhoid vaccine capsules cold when not in use. Once you receive the capsules from your doctor or pharmacy, take them directly home and place them in the refrigerator. Keep each capsule in the foil blister pack in the refrigerator until you are ready to take it. Do not allow the capsules to freeze.

Like any vaccine, the typhoid vaccine may not provide protection from disease in every person.

In addition to receiving typhoid vaccine, take precautions while traveling such as avoiding raw fruits or vegetables that cannot be peeled, drinks that contain ice, flavored ices that may have been made with contaminated water, unbottled or unboiled water, or any food or beverage purchased from a street vendor.

What should I discuss with my healthcare provider before receiving typhoid vaccine? Typhoid vaccine should not be used in a person who is a typhoid carrier. You should not receive this vaccine if you have ever had an allergic reaction to typhoid vaccine in the past, or if you have:

fever with any type of infection or illness;

a weak immune system caused by disease such as HIV/AIDS or cancer; or

a weak immune system caused by using certain medicines such as chemotherapy.

You may not be able to receive this vaccine if you have:

stomach flu or any illness with vomiting or diarrhea;

if you are taking an antibiotic, especially a sulfa drug such as sulfasalazine (Azulfidine, Sulfazine), sulfamethoxazole (Bactrim, Cotrim, Septra, SMX-TMP), or sulfisoxazole (Gantrisin); or

if you plan to start taking an anti-malaria medication within 10 days after receiving a typhoid oral vaccine.

You can still receive a vaccine if you have a minor cold. In the case of a more severe illness with a fever or any type of infection, the doctor may ask you to wait until you get better before you can receive the vaccine.

Vaccines may be harmful to an unborn baby and generally should not be given to a pregnant woman. However, not vaccinating the mother could be more harmful to the baby if the mother becomes infected with a disease that this vaccine could prevent. Your doctor will decide whether you should receive this vaccine, especially if you have a high risk of infection with typhoid. It is not known whether typhoid vaccine passes into breast milk, or if it could harm a nursing baby. Do not receive this vaccine without telling your doctor if you are breast-feeding a baby. How is typhoid vaccine given?

Typhoid vaccine is recommended for adults and children in the following situations:

people who travel to countries where typhoid fever is common;

people who will have long-term exposure to food or water that may be contaminated with typhoid;

people who live with someone who is a typhoid carrier; and

laboratory workers who may come into contact with Salmonella typhi in a work setting.

The typhoid oral vaccine is given in a series of 4 capsules that are taken 1 per day on alternating days (days 1, 3, 5, and 7). On this alternating-day schedule, you will take 1 capsule every 48 hours for 7 days. You must take each capsule according to the recommended schedule for this vaccine to be effective.

You should complete all doses at least 1 week before your scheduled travel or possible exposure to typhoid.

You must keep typhoid vaccine capsules cold when not in use. Once you receive the capsules from your doctor or pharmacy, take them directly home and place them in the refrigerator. Keep each capsule in the foil blister pack in the refrigerator until you are ready to take it. Do not allow the capsules to freeze. Take the capsule on an empty stomach, at least 1 hour before a meal.

Swallow the capsule as quickly as possible after placing it in your mouth. Take with a full glass of cold or lukewarm water or other beverage. Do not use warm or hot drinks such as coffee, tea, or warm milk. The liquid you use to help swallow the typhoid vaccine capsule should not be warmer than your body temperature (98.6 degrees F).

Do not crush, chew, or break a typhoid vaccine capsule. Swallow the pill whole. The enteric-coated pill has a special coating to release the vaccine slowly into your body. Breaking the pill could damage this coating.

The complete series of 4 vaccine capsules should provide protection against typhoid for up to 5 years. Another series of 4 capsules is then recommended every 5 years during possible exposure to typhoid. Your individual booster schedule may be different from these guidelines. Follow your doctor's instructions or the schedule recommended by the Centers for Disease Control and Prevention (CDC).

Be sure you receive all recommended doses of this vaccine. If you do not receive the full series of capsules every 5 years during continued exposure, you may not be fully protected against the disease.

Wash your hands often to help prevent typhoid when you are in an area where contamination is possible. What happens if I miss a dose?

Contact your doctor if you forget to take a capsule on the scheduled day. You may need to start over to make sure you are fully protected against the disease.

Be sure to receive another series of 4 capsules every 5 years during continued exposure to typhoid.

What happens if I overdose?

An overdose of this vaccine is unlikely to occur when taken as directed.

What should I avoid before or after getting typhoid vaccine?

In addition to receiving typhoid vaccine, take precautions while traveling to further prevent coming into contact with bacteria that cause typhoid fever:

Avoid eating leafy vegetables such as spinach or lettuce, which are harder to wash properly.

Avoid eating raw fruits or vegetables that cannot be peeled, or that have been peeled by another person.

Avoid drinks that contain ice, or frozen treats and flavored ices that may have been made with contaminated water.

Avoid eating foods you have not cooked or prepared yourself. Use clean surfaces and utensils when preparing food.

Drink only bottled water (carbonated is best) or water that has been boiled for at least 1 minute.

Avoid any food or beverage purchased from a street vendor.

Typhoid vaccine side effects You should not receive a booster dose if you had a life-threatening allergic reaction after taking a typhoid vaccine capsule.

Becoming infected with typhoid is much more dangerous to your health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

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.

Less serious side effects include:

low fever;

headache;

nausea, vomiting, diarrhea, stomach pain; or

mild skin rash.

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.

Typhoid vaccine (live), oral Dosing Information

Usual Adult Dose for Typhoid Prophylaxis:

One capsule orally 1 hour before a meal with a cold or lukewarm drink [temperature not to exceed body temperature, e.g., 37 ?°C (98.6 ?°F)] on alternate days, e.g., days 1, 3, 5 and 7.



Pronunciation: am-foe-TER-ih-sin BGeneric Name: Amphotericin B Liposome



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