Tenofovir Alafenamide Tablets Technical Specification:
| Product Name: | Tenofovir Alafenamide Tablets 25mg |
| Brand Name: | Generic |
| Strength: | 25 mg |
| Dosage Form: | Tablets (film-coated tablet) |
| Route of Administration: | Via Oral Route |
| Packing: | 30s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Chronic hepatitis B virus infection, Antiviral |
| Indication: | Tenofovir Alafenamide is used in the treatment of chronic hepatitis B virus (HBV) infection, also has property as novel nucleotide reverse transcriptase inhibitor option for initial HIV treatment. |
| Storage: | Store at a temperature not exceeding 30°C. Protect from light & Moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Tenofovir Alafenamide Tablets 25mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each film-coated tablet contains:
Tenofovir Alafenamide fumarate IP
equivalent to Tenofovir Alafenamide …………….25mg
Excipients………………………………. q. s.
Color: Titanium Dioxide IP, Brilliant blue FCF USP
THERAPEUTIC INDICATIONS:
Tenofovir Alafenamide is used in the treatment of chronic hepatitis B virus (HBV) infection, also has property as novel nucleotide reverse transcriptase inhibitor option for initial HIV treatment.
CAUTION & SCHEDULE:
Read the enclosed leaflet before use.
Do not use it if the seal over the bottle opening is broken or missing.
Dispense in a tight, light-resistance, container.
Keep stored in a tightly closed container.
Dispense in original container.
Keep the medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
To report adverse events.
SCHEDULE: SCHEDULE H PRESCRIPTION: WARNING: To be sold by retail on the prescription of a HEPATOLOGIST/Gastroenterologist only.
STORAGE & DOSAGE:
Storage: Store below 30°C. Protect from Light and moisture.
Dosage: As directed by the Physician.