GENERIC NAME OF THE MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Composition:
Each 5ml contains:
Sodium Valproate BP…………………200mg
Excipients……………………...q.s.
Flavored Syrup Base
Colour: Ponceau 4R
THERAPEUTIC INDICATIONS:
DIRECTION OF USE:
CAUTION & WARNING:
Weight gain: Taking Wallbrurate may make you put on weight. Talk to your doctor about how this will affect you.
WARNING:
WARNING FOR WOMEN & GIRLS: Wallbrurate, sodium valproate, can seriously harm an unborn baby when taken during pregnancy. If you are a female able to have a baby, you must use an effective method of birth control (contraception) at all times during your entire treatment with Wallbrurate.
Warning and precaution: A small number of people being treated with anti-epileptics such as sodium valproate have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.
STORAGE & DOSAGE:
KEEP OUT OF REACH AND SIGHT OF CHILDREN.
DOSAGE: As directed by physician.
Sodium Valproate Oral Solution BP 200mg/5ml Technical Specification:
| Product Name: | Sodium Valproate Oral Solution BP 200mg/5ml |
| Brand Name: | Wallbrurate |
| Strength: | 200mg/5ml |
| Dosage Form: | Syrup |
| Packing: | 100ml |
| Route of Administration: | For Oral Syrup. |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Antiepileptic, Anticonvulsant, Bipolar disorder |
| Indication: | Sodium Valproate is used for the treatment of Generalized & Partial Epilepsy. |
| Storage: | Store in a dry place at a temperature below 30°C. |
GENERIC NAME OF MEDICINAL PRODUCT:
- Sodium Valproate Oral Solution BP 200mg/5ml
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Sodium Valproate Oral Solution BP 200mg/5ml
Composition:
Each 5ml contains:
Sodium Valproate BP…………………200mg
Excipients………………………q.s.
Flavored Syrup Base
Colour: Ponceau 4R
THERAPEUTIC INDICATION:
Sodium Valproate is used for the treatment of Generalized & Partial Epilepsy.
DIRECTION OF USE:
Shake well before using. Use a medicine spoon or syringe to measure your medicine. Do not use household spoons as they may not be accurate. Do not take with carbonated drinks as it may cause throat and gastric irritation.
CAUTION & WARNING:
CAUTION: Not to be sold by retail without the prescription of a Registered Medical Practitioner only.
Weight gain: Taking Wallbrurate may make you put on weight. Talk to your doctor about how this will affect you.
WARNING:
WARNING FOR WOMEN & GIRLS: Wallbrurate, sodium valproate, can seriously harm an unborn baby when taken during pregnancy. If you are a female able to have a baby, you must use an effective method of birth control (contraception) at all times during your entire treatment with Wallbrurate.
Warning and precaution: A small number of people being treated with anti-epileptics such as sodium valproate have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.
STORAGE AND DOSAGE:
STORAGE: Store in a dry place at a temperature below 30°C.
KEEP OUT OF REACH AND SIGHT OF CHILDREN.
DOSAGE: As directed by physician.
