Drugs Index
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Drugs Information:
Drugs List
WAXSOL Ear Drops
Docusate Sodium BP 0.5% w/v
For the easy removal of ear wax
Please read this leaflet carefully before using this medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.
What is this medicine?
The name of this medicine is Waxsol Ear Drops. The liquid in the bottle contains the active ingredient 0.5% Docusate sodium. Waxsol also contains glycerin, water and a preservative (Phenonip).
Each bottle contains 10 ml of solution.
Waxsol softens ear wax and breaks it up.
The marketing authorisation holder is
It is made by
What is Waxsol used for?
The drops help to clear your ear is it is blocked with wax.
Before you use Waxsol
Do not use the drops if:
- you have a perforated (burst) ear drum.
- your ear is sore inside.
How to use Waxsol
1. Name Of The Medicinal Product
Winfex XL 150mg Prolonged Release Capsules
2. Qualitative And Quantitative Composition
Each prolonged release capsule contains venlafaxine hydrochloride equivalent to 150mg of venlafaxine.
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Prolonged Release capsules
Winfex XL 150mg Capsules are opaque scarlet capsules containing three 50mg tablets.
4. Clinical Particulars
4.1 Therapeutic Indications
Treatment of major depressive episodes.
For prevention of recurrence of major depressive episodes.
Treatment of social anxiety disorder.
4.2 Posology And Method Of Administration
Major depressive episodes
The recommended starting dose for prolonged-release venlafaxine is 75mg given once daily. Patients not responding to the initial 75mg/day dose may benefit from dose increases up to a maximum dose of 375mg/day. Dosage increases can be made at intervals of 2 weeks or more. If clinically warranted due to symptom severity, dose increases can be made at more frequent intervals, but not less than 4 days.
Because of the risk of dose-related adverse effects, dose increments should be made only after a clinical evaluation (see section 4.4). The lowest effective dose should be maintained.
Patients should be treated for a sufficient period of time, usually several months or longer. Treatment should be reassessed regularly on a case-by-case basis. Longer-term treatment may also be appropriate for prevention of recurrence of major depressive episodes (MDE). In most of the cases, the recommended dose in prevention of recurrence of MDE is the same as the one used during t
1. Name Of The Medicinal Product
Welldorm Tablets 707mg
2. Qualitative And Quantitative Composition
Welldorm
Tablets contain 707mg cloral betaine, equivalent to 414mg of Chloral Hydrate.
For excipients see 6.1
3. Pharmaceutical Form
Elongated oval, bluish purple, film coated tablets
4. Clinical Particulars
4.1 Therapeutic Indications
Welldorm tablets are used for the short-term treatment of severe insomnia which is interfering with normal daily life and where other therapies have failed.
Welldorm should be used as an adjunct to non pharmacological therapies.
The use of hypnotics in adolescents is not generally recommended and if used should be under the supervision of a medical specialist
4.2 Posology And Method Of Administration
Route of administration: oral. Welldorm should be administered as a single daily dose, 15-30 minutes before bedtime with water or milk
Adults and children 12 years and over: The usual dose is one to two tablets (414 828 mg). Higher doses should not exceed a maximum of 4 tablets (2g chloral hydrate) per dose.
Elderly: Dosage as for adults except for the frail elderly or those with hepatic impairment, where a reduction in dose may be appropriate.
Children: Welldorm tablets are not suitable for use in children under 12 years of age; for children between 2 and 11 years Welldorm Elixir is recommended.
4.3 Contraindications
Welldorm Tablets should not be used in patients with a marked hepatic or renal impairment, or in patients with severe cardiac disease. Should not be used in patients susceptible to acute
1. Name Of The Medicinal Product
Water for Injections BP 1.2ml, 2ml, 5ml, 10ml and 20ml glass ampoules.
2. Qualitative And Quantitative Composition
Water for Injections BP/Ph. Eur. 1.2ml, 2ml, 5ml, 10ml and 20ml ampoules.
3. Pharmaceutical Form
Solvent for parenteral use.
Clear, colourless, odourless, sterile solution intended for parenteral administration to human beings.
4. Clinical Particulars
4.1 Therapeutic Indications
For the reconstitution, dilution and making-up of appropriate drugs where Water for Injections is the diluent of choice, and for use as an irrigant.
4.2 Posology And Method Of Administration
Route of administration: As appropriate to the reconstituted drug.
Dosage: In accordance with the particular situation for which Water for Injections BP is being used.
4.3 Contraindications
None known.
4.4 Special Warnings And Precautions For Use
None known.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
None known.
4.6 Pregnancy And Lactation
May be used during this period.
4.7 Effects On Ability To Drive And Use Machines
None known.
4.8 Undesirable Effects
None known.
4.9 Overdose
No effects anticipated with the proposed use.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Not applicable.
5.2 Pharmacokinetic Properties
Not applicable.
5.3 Preclinical Safety Data
No further relevant informati
1. Name Of The Medicinal Product
Warfarin 1mg Tablets
2. Qualitative And Quantitative Composition
Each tablet contains 1mg Warfarin Sodium Ph. Eur.
3. Pharmaceutical Form
Tablet
4. Clinical Particulars
4.1 Therapeutic Indications
Prophylaxis of systemic embolism in patients with rheumatic heart disease and atrial fibrillation.
Prophylaxis after insertion of prosthetic heart valves.
Prophylaxis and treatment of venous thrombosis and pulmonary embolism.
Transient attacks of cerebral ischaemia.
4.2 Posology And Method Of Administration
Adults: The typical induction dose is 10mg daily for 2 days but this should be tailored to individual requirements. The daily maintenance dose is usually 3 to 9mg taken at the same time each day. The exact maintenance dose depends on the prothrombin time or other appropriate coagulation tests.
Control tests should be made at regular intervals and the maintenance dose should be adjusted according to the results obtained. Once the maintenance dose is established, it is rarely necessary to alter it.
In emergencies, anticoagulant therapy should be initiated with heparin and warfarin together.
Concomitant therapy with heparin affects the results of control tests, and should be discontinued at least six hours before the first test is carried out.
Elderly: As for adults, but dosage may need to be lowered.
Children: Dosage for children has not been established.
Method of administration: Oral.
4.3 Contraindications
Known hypersensitivity to warfarin or to any of the excipients
Haemorrhagic stro
1. Name Of The Medicinal Product
Warfarin Tablets 5mg
2. Qualitative And Quantitative Composition
Each tablet contains 5 mg warfarin sodium ( as clathrate).
3. Pharmaceutical Form
Round pink uncoated tablet, scored and marked 'W5' on one side with company logo on reverse.
4. Clinical Particulars
4.1 Therapeutic Indications
For prophylaxis against venous thrombosis and pulmonary embolism, and for use in the treatment of these conditions to prevent their extension. For the prophylaxis of systemic embolisation in patients with rheumatic heart disease and atrial fibrillation.
4.2 Posology And Method Of Administration
Warfarin tablets are for oral administration.
An initial daily dose of 10mg on the first two days. Subsequent daily doses should be adjusted according to the results of the prothrombin time or other appropriate coagulation tests. The single daily maintenance requirement is usually between 5mg and 12mg, but can vary between 2mg and 30mg.
The maintenance dose is omitted if the prothrombin time is excessively prolonged.
Use in elderly patients: The elderly are generally more sensitive to the effects of warfarin and often require a smaller dose on a weight for weight basis than younger patients.
Target INR
By referring to the target INR (see below), the dosage of warfarin can be adjusted depending on the deviation of the patient's INR from the target value. An INR within 0.5 INR units of the target is considered to be generally satisfactory.
The following target INR values are based on guidelines from The British Society for Haematology:
1. Name Of The Medicinal Product
Warfarin 3mg Tablets
2. Qualitative And Quantitative Composition
Each tablet contains 3mg Warfarin Sodium Ph.Eur.
3. Pharmaceutical Form
Tablet
4. Clinical Particulars
4.1 Therapeutic Indications
Prophylaxis of systemic embolism in patients with rheumatic heart disease and atrial fibrillation.
Prophylaxis after insertion of prosthetic heart valves.
Prophylaxis and treatment of venous thrombosis and pulmonary embolism.
Transient attacks of cerebral ischaemia.
4.2 Posology And Method Of Administration
Adults: The typical induction dose is 10mg daily for 2 days but this should be tailored to individual requirements. The daily maintenance dose is usually 3 to 9mg taken at the same time each day. The exact maintenance dose depends on the prothrombin time or other appropriate coagulation tests.
Control tests should be made at regular intervals and the maintenance dose should be adjusted according to the results obtained. Once the maintenance dose is established, it is rarely necessary to alter it.
In emergencies, anticoagulant therapy should be initiated with heparin and warfarin together.
Concomitant therapy with heparin affects the results of control tests, and should be discontinued at least six hours before the first test is carried out.
Elderly: As for adults, but dosage may need to be lowered.
Children: Dosage for children has not been established.
Method of administration: Oral.
4.3 Contraindications
Known hypersensitivity to warfarin or to any of the excipients
Haemorrhagic stroke (see
1. Name Of The Medicinal Product
Wasp-Eze Bites and Stings Spray
2. Qualitative And Quantitative Composition
Benzocaine 1.0% w/w
Mepyramine Maleate 0.5% w/w
For excipients, see 6.1.
3. Pharmaceutical Form
Cutaneous Spray.
A clear uniform spray.
4. Clinical Particulars
4.1 Therapeutic Indications
For the treatment of all insect bites and stings, nettle stings and jellyfish stings in adults and children aged 2 years and over.
4.2 Posology And Method Of Administration
For cutaneous application.
For adults and children aged 2 years and over:
Hold nozzle approximately five inches from the skin and spray once for 2-3 seconds. Stop spraying immediately if a white deposit or frost appears. Repeat once after 15 minutes if necessary. If pain persists, seek medical advice.
4.3 Contraindications
Do not use if you are sensitive to any of the ingredients
Do not apply to large areas of skin, eczematous, sunburnt or broken skin.
Do not use the spray on the face.
4.4 Special Warnings And Precautions For Use
Patients with any known allergy to insect bites or stings should seek medical advice. If pain persists, seek medical advice.
Not for repeated or prolonged use.
For external use only. Keep out of the reach and sight of children.
Flammable. Do not use near fire or flame. Pressurised container. Protect from sunlight and do not expose to temperatures exceeding 50oC. Do not pierce or burn, even after use. Do not spray on a naked flame or any incandescent material. Do not use near or place c
1. Name Of The Medicinal Product
Welldorm Elixir
2. Qualitative And Quantitative Composition
Each 5ml of Welldorm Elixir contains 143.3mg of Chloral Hydrate BP.
For excipients see 6.1
3. Pharmaceutical Form
Oral Solution
4. Clinical Particulars
4.1 Therapeutic Indications
Welldorm elixir is used for the short-term treatment of severe insomnia which is interfering with normal daily life and where other therapies have failed.
Welldorm should be used as an adjunct to non pharmacological therapies.
In children aged 2-11 years treatment should be as an adjunct to behavioural therapy and sleep hygiene management, and usually for duration of less than 2 weeks
The use of hypnotics in children and adolescents is not generally recommended and if used should be under the supervision of a medical specialist
4.2 Posology And Method Of Administration
Route of administration: oral. Welldorm should be administered as a single daily dose, 15-30 minutes before bedtime with water or milk.
Adults and children 12 years and over: The usual dose is 15-30ml (430 860 mg). Higher doses should not exceed a maximum of 70ml of elixir (2g chloral hydrate) per dose.
Elderly: Dosage as for adults except for the frail elderly or those with hepatic impairment, where a reduction in dose may be appropriate.
Children (between 2 and 11 years): 11.75 ml/kg (30-50mg/kg) of bodyweight. The dose should not exceed 35ml (1g) chloral hydrate.
Children (under 2 years): not recommended
4.3 Contraindications
Welldorm Elixir should not be used in patients with a
1. Name Of The Medicinal Product
Woodward's Gripe Water- Alcohol Free & Sugar Free.
2. Qualitative And Quantitative Composition
Terpeneless Dill Seed Oil 2.3mg/5ml; Sodium Hydrogen Carbonate 52.5mg/5ml.
3. Pharmaceutical Form
Oral solution.
4. Clinical Particulars
4.1 Therapeutic Indications
For the symptomatic relief of distress associated with wind in infants up to one year old.
4.2 Posology And Method Of Administration
For oral use.
Adults including the elderly: not applicable.
Children 1-6 months: one 5ml spoonful.
Children 6-12 months: two 5ml spoonsful.
Children under 1 month: not to be used.
These doses may be given during or after each feed or up to six times in 24 hours.
4.3 Contraindications
Should not be used where impaired kidney function or hypersensitivity to hydroxybenzoates exists.
4.4 Special Warnings And Precautions For Use
If symptoms persist, medical advice should be sought. Keep all medicines out of the reach of children.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
None known.
4.6 Pregnancy And Lactation
Not applicable.
4.7 Effects On Ability To Drive And Use Machines
Not applicable.
4.8 Undesirable Effects
None known.
4.9 Overdose
Symptoms following overdose are rare and are generally due to the effects of sodium hydrogen carbonate. These may include diarrhoea, metabolic alkalosis and hypernatraemia. In the event of severe overdosing, medical advice should be
1. Name Of The Medicinal Product
Witch Doctor 81.5%w/w Gel
2. Qualitative And Quantitative Composition
Contains Liquid Extract of Witch Hazel 81.539% w/w
For excipients, see 6.1
3. Pharmaceutical Form
Gel
4. Clinical Particulars
4.1 Therapeutic Indications
Itching, insect bites, stings, sunburn, minor burns, grazes, personal irritation, chafing, minor rashes and skin irritations.
4.2 Posology And Method Of Administration
Squeeze gel directly onto affected area. Smooth over gently. Allow to dry.
4.3 Contraindications
Do not use in eyes.
4.4 Special Warnings And Precautions For Use
If symptoms persist consult doctor.
Keep out of the reach of children
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
None known
4.6 Pregnancy And Lactation
Not applicable
4.7 Effects On Ability To Drive And Use Machines
Not applicable
4.8 Undesirable Effects
None stated
4.9 Overdose
Not applicable
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Liquid Extract Witch Hazel Astringent
Ethanol bactericidal, antiseptic and disinfectant, astringent and skin-cooling properties.
5.2 Pharmacokinetic Properties
Not applicable
5.3 Preclinical Safety Data
Not applicable
6. Pharmaceutical Particulars
6.1 List Of Excipients
Ethanol
Propylene glyco
1. Name Of The Medicinal Product
Warticon 0.15% w/w Cream
2. Qualitative And Quantitative Composition
Podophyllotoxin 1.5 mg/g (0.15% w/w).
The cream also contains the following excipients:
Methyl parahydroxybenzoate E218
Propyl parahydroxybenzoate E216
Sorbic acid
Stearyl alcohol
Cetyl alcohol
Butylhydroxyanisole (BHA) E320
For a full list of excipients, see section 6.1
3. Pharmaceutical Form
Topical cream
A homogenous white cream.
4. Clinical Particulars
4.1 Therapeutic Indications
Route of administration: Topical
For the topical treatment of condylomata acuminata affecting the penis and the external female genitalia.
4.2 Posology And Method Of Administration
The affected area should be thoroughly washed with soap and water, and dried prior to application.
Using a fingertip, the cream is applied twice daily for 3 days using only enough cream to just cover each wart.
Residual warts should be treated with further courses of twice daily applications for three days at weekly intervals, if necessary for a total of 4 weeks of treatment.
Where lesions are greater than 4 cm2 , it is recommended that treatment takes place under the direct supervision of medical staff.
4.3 Contraindications
Known hypersensitivity to any of the ingredients
Open wounds eg. Following surgical procedures.
Use in children.
Hypersensitivity to podophyllotoxin.
Concomitant use with other podophyllotoxin containing preparat
1. Name Of The Medicinal Product
Wilzin 50 mg hard capsules
2. Qualitative And Quantitative Composition
Each hard capsule contains 50 mg of zinc (corresponding to 167.84 mg of zinc acetate dihydrate).
For excipients, see section 6.1.
3. Pharmaceutical Form
Hard capsule.
Size 1 hard capsule with orange opaque cap and body, imprinted "93-377.
4. Clinical Particulars
4.1 Therapeutic Indications
Treatment of Wilson's disease.
4.2 Posology And Method Of Administration
Wilzin treatment should be initiated under the supervision of a physician experienced in the treatment of Wilson's disease (see section 4.4). Wilzin is a life-long therapy.
There is no difference in dosage between symptomatic and presymptomatic patients.
Wilzin is available in hard capsules of 25 mg or 50 mg.
Adults:
The usual dosage is 50 mg 3 times daily with a maximum dose of 50 mg 5 times daily.
Children and adolescents:
Data are very limited in children under 6 years but since the disease is fully penetrant, prophylactic treatment should be considered as early as possible. The recommended dosage is as follows:
- from 1 to 6 years: 25 mg twice daily
- from 6 to 16 years if bodyweight under 57 kg: 25 mg three times daily
- from 16 years or if bodyweight above 57 kg: 50 mg three times daily.
Pregnant women:
A dosage of 25 mg 3 times daily is usually effective but the dosage should be adjusted to copper levels (see
1. Name Of The Medicinal Product
Warfarin 3 mg Tablets.
2. Qualitative And Quantitative Composition
Each tablet contains 3.0 mg of Warfarin sodium.
For excipients, see 6.1.
3. Pharmaceutical Form
Tablet.
Warfarin tablets are presented as flat bevelled edged, blue tablets engraved with company logo or plain on one side and with a breakline and A324 on the other side.
4. Clinical Particulars
4.1 Therapeutic Indications
Prophylaxis of systemic embolism in rheumatic heart disease and atrial fibrillation. Prophylaxis and treatment of venous thrombosis and pulmonary embolism. Transient cerebral ischaemic attacks. Prophylaxis of thromboembolism after insertion of prosthetic heart valve.
4.2 Posology And Method Of Administration
Route of administration : Oral
Adults
Whenever possible, base-line prothrombin time should be determined before the initial dose is given. An initial loading dose for warfarin is usually in the order of 0.45 - 0.50 mg/kg for adults, tailored to individual requirements for the desired degree of anticoagulant effect. The maintenance dose is usually started after 48 hours and depends upon the prothrombin time - reported as international normalised ratio (INR). Currently recommmended ranges of therapeutic anticoagulation are the following:
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prophylaxis of deep-vein thrombosis including surgery in high risk patients (INR 2 -2.5) |
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Water for Injections BP
Important information about your medicine
- Your doctor or nurse will give you the injection
- If this injection causes you any problems talk to your doctor, nurse or pharmacist
- Please tell your doctor or pharmacist, if you have any other medical conditions or have an allergy to any of the ingredients of this medicine
- Please tell your doctor or pharmacist, if you are taking any other medicines
- Read all of this leaflet carefully before you start using this medicine. In some circumstances this may not be possible and this leaflet will be kept in a safe place should you wish to read it.
- Keep this leaflet. You may need to read it again
- If you have any further questions, please ask your doctor or your pharmacist.
- This medicine has been prescribed for you personally and you should not pass it on to others.
It may harm them, even if their symptoms are the same as yours.
Where to find information in this leaflet
- 1. What Water for Injections BP is and what it is used for
- 2. Before you are given Water for Injections BP
- 3. How to use Water for Injections BP
- 4. Possible side effects
- 5. Storing Water for Injections BP
- 6. Further information
What Water for Injections BP is and what it is used for
Water for Injections BP contains water that has been very carefully cleaned and purified so there are no chemicals, bacteria or moulds in it. It is used to:
1. Name Of The Medicinal Product
Water for Injections BP.
2. Qualitative And Quantitative Composition
Each ml contains 100% Water for Injections Ph. Eur.
3. Pharmaceutical Form
Sterile injection.
4. Clinical Particulars
4.1 Therapeutic Indications
Water for Injections BP is used as a dissolvent and diluent for injectable medicines.
4.2 Posology And Method Of Administration
Water for Injections BP is administered by Intravenous Injection. Dosage for Adults (including the elderly) and Children:- as required, by intravenous injection.
4.3 Contraindications
None known.
4.4 Special Warnings And Precautions For Use
None known.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
None known.
4.6 Pregnancy And Lactation
None known.
4.7 Effects On Ability To Drive And Use Machines
None known.
4.8 Undesirable Effects
None known.
4.9 Overdose
None known.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Water for Injections BP is used as a dissolvent and diluent for injectable medicines.
5.2 Pharmacokinetic Properties
Not Applicable.
5.3 Preclinical Safety Data
No further information other than that which is included in the Summary of Product Characteristics.
6. Pharmaceutical Particulars
6.1 List Of Excipients
None.
6.2 Incompatibilities
None known.
1. Name Of The Medicinal Product
Winfex XL 75mg Prolonged Release Capsules
2. Qualitative And Quantitative Composition
Each prolonged release capsule contains venlafaxine hydrochloride equivalent to 75mg of venlafaxine.
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Prolonged Release capsules
Winfex XL 75mg Capsules are opaque flesh capsules containing two 37.5mg tablets.
4. Clinical Particulars
4.1 Therapeutic Indications
Treatment of major depressive episodes.
For prevention of recurrence of major depressive episodes.
Treatment of social anxiety disorder.
4.2 Posology And Method Of Administration
Major depressive episodes
The recommended starting dose for prolonged-release venlafaxine is 75mg given once daily. Patients not responding to the initial 75mg/day dose may benefit from dose increases up to a maximum dose of 375mg/day. Dosage increases can be made at intervals of 2 weeks or more. If clinically warranted due to symptom severity, dose increases can be made at more frequent intervals, but not less than 4 days.
Because of the risk of dose-related adverse effects, dose increments should be made only after a clinical evaluation (see section 4.4). The lowest effective dose should be maintained.
Patients should be treated for a sufficient period of time, usually several months or longer. Treatment should be reassessed regularly on a case-by-case basis. Longer-term treatment may also be appropriate for prevention of recurrence of major depressive episodes (MDE). In most of the cases, the recommended dose in prevention of recurrence of MDE is the same as the one used during the cu
1. Name Of The Medicinal Product
Welldorm Elixir
2. Qualitative And Quantitative Composition
Each 5ml of Welldorm Elixir contains 143.3mg of Chloral Hydrate BP.
For excipients see 6.1
3. Pharmaceutical Form
Oral Solution
4. Clinical Particulars
4.1 Therapeutic Indications
Welldorm elixir is used for the short-term treatment of severe insomnia which is interfering with normal daily life and where other therapies have failed.
Welldorm should be used as an adjunct to non pharmacological therapies.
In children aged 2-11 years treatment should be as an adjunct to behavioural therapy and sleep hygiene management, and usually for duration of less than 2 weeks
The use of hypnotics in children and adolescents is not generally recommended and if used should be under the supervision of a medical specialist
4.2 Posology And Method Of Administration
Route of administration: oral. Welldorm should be administered as a single daily dose, 15-30 minutes before bedtime with water or milk.
Adults and children 12 years and over: The usual dose is 15-30ml (430 860 mg). Higher doses should not exceed a maximum of 70ml of elixir (2g chloral hydrate) per dose.
Elderly: Dosage as for adults except for the frail elderly or those with hepatic impairment, where a reduction in dose may be appropriate.
Children (between 2 and 11 years): 11.75 ml/kg (30-50mg/kg) of bodyweight. The dose should not exceed 35ml (1g) chloral hydrate.
Children (under 2 years): not recommended
4.3 Contraindications
Welldorm Elixir should not be used in patients with a
1. Name Of The Medicinal Product
Wilate
Wilate
2. Qualitative And Quantitative Composition
Wilate is presented as a powder and solvent for solution for injection containing nominally 450 IU/900 IU human coagulation factor VIII and 400 IU/800 IU human von Willebrand factor (VWF) per vial.
The product contains approximately 80 IU/ml human von Willebrand factor when reconstituted with 5 ml/10 ml Water for Injections with 0.1 % Polysorbat 80.
The specific activity of Wilate is approximately
The VWF potency (IU) is measured according to ristocetin cofactor activity (VWF:RCo) compared to the International Standard for von Willebrand Factor Concentrate (WHO).
The product contains approximately 90 IU/ml human coagulation factor VIII when reconstituted with 5 ml/10 ml Water for Injections with 0.1% Polysorbate 80.
The FVIII potency (IU) is determined using the European Pharmacopoeia chromogenic assay. The specific activity of Wilate is approximately
For a full list of excipients, see 6.1.
3. Pharmaceutical Form
Powder and solvent for solution for injection.
4. Clinical Particulars
4.1 Therapeutic Indications
Von Willebrand disease (VWD)
Prevention and treatment of haemorrhage or surgical bleeding in von Willebrand disease (VWD), when desmopressin (DDAVP) treatment alone is ineffective or contra-indicated.
Haemophilia A
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital FVIII deficiency) .
4.2 Posology And Method Of Administration
Treatment should b
1. Name Of The Medicinal Product
Wellvone 750 mg/5 ml oral suspension
2. Qualitative And Quantitative Composition
Each ml of suspension contains 150 mg atovaquone
A unit dose of 5 ml contains 750 mg atovaquone.
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Oral suspension.
Wellvone oral suspension is a bright yellow liquid
4. Clinical Particulars
4.1 Therapeutic Indications
Wellvone Suspension is indicated for:
Acute treatment of mild to moderate Pneumocystis pneumonia (PCP, caused by Pneumocystis jiroveci, formerly classified as P. carinii) (alveolar - arterial oxygen tension difference [(A-a) DO2] < 45 mmHg (6 kPa) and oxygen tension in arterial blood (PaO2)
4.2 Posology And Method Of Administration
The importance of taking the full prescribed dose of Wellvone with food should be stressed to patients. The presence of food, particularly high fat food, increases bioavailability two to three fold.
Dosage in adults
Pneumocystis pneumonia:
The recommended oral dose is 750 mg twice a day (1 x 5 ml morning and evening) administered with food each day for 21 days.
Higher doses may be more effective in some patients (see section 5.2).
Dosage in Children
Clinical efficacy has not been studied.
Dosage in the Elderly
There have been no studies of Wellvone in the elderly (see section 4.4).
Renal or hepatic impairment
Wellvone has not been specifically studied in