| Product Name: | Telbivudine Tablet |
| Brand Name: | Generics |
| Strength: | 600mg |
| Dosage Form: | Tablets (Film-coated) |
| Route of Administration: | Via oral route |
| Packing: | 30s, 90s, 500s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Hepatology, hepatitis B virus (HBV) |
| Indication: | Telbivudine is used to treat chronic hepatitis B infection. Telbivudine is not a cure for hepatitis B infection, but it may lower the amount of virus in your body and may decrease the ability of the virus to multiply. This medicine is available only with your doctor’s prescription. |
| Storage: | Controlled room temperature medications must be stored between 68°F and 77°F (20°C and 25°C), with some allowances for temporary excursions. Keep the container tightly closed in order to protect from moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Telbivudine Tablet USP 600mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Telbivudine Tablet USP 600mg
Each Filmed coated tablet contains:
Telbivudine USP……………….600mg
Excipients…………………. q.s.
Color: Indigo Carmine
THERAPEUTIC INDICATIONS:
Telbivudine is used to treat chronic hepatitis B infection. Telbivudine is not a cure for hepatitis B infection, but it may lower the amount of virus in your body and may decrease the ability of the virus to multiply. This medicine is available only with your doctor’s prescription.
CAUTION & WARNING:
CAUTION:
Read the enclosed leaflet before use.
Keep the medicine out of reach of CHILDREN.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
Any unused product or waste material should be disposed of in accordance with local requirements.
STORAGE & DOSAGE:
Storage:Controlled room temperature medications must be stored between 68°F and 77°F (20°C and 25°C), with some allowances for temporary excursions.
Keep the container tightly closed in order to protect it from moisture.
Dosage:
As directed by the Physician.