Sofosbuvir + Velpatasvir Tablets Technical Specification:
| Product Name: | Sofosbuvir 400mg + Velpatasvir 100mg Tablets |
| Brand Name: | Generic |
| Strength: | 400mg+100mg |
| Dosage Form: | Tablets (film-coated tablet) |
| Route of Administration: | Via Oral Route |
| Packing: | 28s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Hepatitis C Treatment, Antiviral |
| Indication: | Sofosbuvir and Velpatasvir combination is used with or without ribavirin to treat chronic hepatitis C genotype 1, 2, 3, 4, 5, or 6 infections (including with or without cirrhosis). |
| Storage: | Store at a temperature not exceeding 30°C. Protect from light & Moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Sofosbuvir 400mg + Velpatasvir 100mg Tablets
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each film-coated tablet contains:
Sofosbuvir IP ………….400mg
Velpatasvir………….100mg
Excipients…….…. q. s
Color: Red Oxide of Iron & Titanium Dioxide USP
THERAPEUTIC INDICATIONS:
Sofosbuvir and Velpatasvir combination is used with or without ribavirin to treat chronic hepatitis C genotype 1, 2, 3, 4, 5, or 6 infections (including with or without cirrhosis).
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 Gastroenterologist.
STORAGE & DOSAGE:
Storage: Store below 30°C. Protect from Light and moisture.
Dosage: As directed by the Physician.