| Product Name: | Levetiracetam Injection USP |
| Brand Name: | Generic |
| Strength: | 500mg/5ml |
| Dosage Form: | Liquid Injection (Sterile) |
| Packing: | 5ml vial |
| Route of Administration: | For IV Infusion. |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Documents: | COA, MOA, Product Permission, Stability Studies, GMP |
| Therapeutic use: | Anticonvulsants, Anti- epileptic, CNS |
| Indication: | Levetiracetam belongs to the group of medicines called Anticonvulsants. It is used to treat epilepsy |
| Storage: | Store at controlled room temperature (20°C to 25°C). Protect from light & moisture. Do not freeze. |
GENERIC NAME OF MEDICINAL PRODUCT:
Levetiracetam Injection USP 500mg/5ml
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Levetiracetam Injection USP 500mg/5ml
Each ml contains:
Levetiracetam I.P…………………. 500 mg
Water for Injections I.P…………. q.s.
Excipients………………………………q.s.
DIRECTION OF USE:
For IV Infusion. To be diluted prior to Intravenous Infusion
THERAPEUTIC INDICATION:
Levetiracetam belongs to the group of medicines called Anticonvulsants. It is used to treat epilepsy (when oral administration is temporarily not feasible). Epilepsy is a disorder in the central nervous system in which the brain activity becomes abnormal, causing seizures (fits) or unusual sensations, behaviors, and sometimes loss of consciousness.
CAUTION AND SCHEDULE:
CAUTION:
- Use immediately after dilution.
- Do not use it if the solution is not clear or has suspended matter.
- DO NOT ACCEPT IF THE VIAL SEAL IS BROKEN.
- Discard any unused solution.
- KEEP OUT OF REACH AND SIGHT OF CHILDREN.
SCHEDULE H PRESCRIPTION: WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE AND DOSAGE:
STORAGE: Store at controlled room temperature (20°C to 25°C). Protect from light & moisture. Do not freeze.
DOSAGE: As directed by the Physician/Neurologist.