| Product Name: | Valproate Sodium Injection USP |
| Brand Name: | WALLBRURATE |
| Strength: | 100mg/1ml |
| Dosage Form: | Liquid Dosage form Injection |
| Packing: | Single dose Vial |
| Route of Administration: | For I.V. Infusion only |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Anticonvulsants, Anti-Epileptic |
| Indication: | Valproate sodium injection is indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures. |
| Storage: | Store at a Temperature not exceeding 30ºC. Do not freeze. |
GENERIC NAME OF MEDICINAL PRODUCT:
Valproate Sodium Injection USP 100mg/ml
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Valproate Sodium Injection USP 100mg/ml
Each ml contains:
Valproate Sodium Eq. to
Valproic Acid…………………100mg
Disodium Edetate BP…………0.4mg
Water for Injections USP………….q.s.
THERAPEUTIC INDICATION:
Valproate sodium injection is indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures.
DIRECTION OF USE:
As directed by the Neurologist.
For dosage and administration please see the enclosed leaflet.
CAUTION & Warning:
CAUTION:
Do not use the injection if the contents are not clear, contain visible particulate, or if any discoloration is observed.
Do not accept if the ampoule is broken.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
FLIP-OFF SEAL IS PROVIDED FOR TEMPER EVIDENCE.
Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner/ Cancer Hospital only.
It is dangerous to take this preparation except under Medical Supervision.
STORAGE & DOSAGE:
Storage:
Store at a temperature not exceeding 30ºC
Protect from light.
Do not freeze.
Dosage:
As directed by the Neurologist.