Sodium Valproate + Valproic acid Controlled Release Tablets 500mg Technical Specification:
Product Name: | Sodium Valproate + Valproic acid Controlled Release Tablets |
Brand Name: | Generics |
Strength: | 500mg |
Dosage Form: | Tablets (Film-coated) |
Route of Administration: | Via oral Route |
Packing: | 30s, 90s, 100s, 500s, 1000s |
Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
Therapeutic use: | Anti-Epileptic, Anticonvulsant, Central Nervous System |
Indication: | SODIUM VALPROATE+VALPROIC ACID is used to treat epilepsy/seizures/fits, mood disorder and prevent migraine headaches |
Storage: | Store below 25°C in a dry place. Do not freeze. Keep the container tightly closed in order to protect from moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Sodium Valproate + Valproic acid Controlled Release Tablets 500mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Sodium Valproate + Valproic acid Controlled Release Tablets 500mg
Each Film Coated Controlled Release Tablet contains:
Sodium Valproate BP……………………….333 mg
Valproic Acid USP……………………………145 mg
Excipients………………………………………q.s.
Colours: Allura Red
THERAPEUTIC INDICATIONS:
- The controlled release preparation is indicated as monotherapy or adjunctive therapy in the treatment of generalized, partial or other epilepsy. also indicated in bipolar affective disorder.
CAUTION & WARNING:
- CAUTION:
Read enclosed leaflet before use.
Keep medicine out of reach of children. - Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
- Storage: Store below 25°C in a dry place. Do not freeze. Keep the container tightly closed in order to protect from moisture.
- Dosage: As directed by the Physician.
Attach dispensing label as per end county. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Sodium Valproate + Valproic acid Controlled Release Tablets 500mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Sodium Valproate + Valproic acid Controlled Release Tablets 500mg
Each Film Coated Controlled Release Tablet contains:
Sodium Valproate BP……………………….333 mg
Valproic Acid USP…………………………...145 mg
Excipients……………………………………...q.s.
Colours: Allura Red
Each Film Coated Controlled Release Tablet contains:
Sodium Valproate BP……………………….333 mg
Valproic Acid USP…………………………...145 mg
Excipients……………………………………...q.s.
Colours: Allura Red
THERAPEUTIC INDICATIONS:
The controlled release preparation is indicated as monotherapy or adjunctive therapy in the treatment of generalized, partial or other epilepsy. also indicated in bipolar affective disorder.
CAUTION & WARNING:
CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store below 25°C in a dry place. Do not freeze. Keep the container tightly closed in order to protect from moisture.
Dosage: As directed by the Physician.
Attach dispensing label as per end county.
Dosage: As directed by the Physician.
Attach dispensing label as per end county.