Sofosbuvir Tablets Technical Specification:
| Product Name: | Sofosbuvir Tablets 400mg |
| Brand Name: | Generic |
| Strength: | 400mg |
| Dosage Form: | Tablets (film-coated tablet) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 30s, 100s, 500s |
| 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 is used along with ribavirin (Copegus, Rebetol, Ribasphere, others) and sometimes another medication (peginterferon alfa [Pegasys]) to treat certain types of chronic hepatitis C (an ongoing viral infection that damages the liver) in adults. |
| Storage: | Store at a temperature not exceeding 30°C. Protect from light & Moisture. |
Sofosbuvir Tablets 400mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Sofosbuvir Tablets 400mg
Each film-coated tablet contains:
Sofosbuvir IP ………….400mg
Excipients…….…. q. s.
Color: Red Oxide of Iron & Titanium Dioxide USP
THERAPEUTIC INDICATIONS:
Sofosbuvir is used along with ribavirin (Copegus, Rebetol, Ribasphere, others) and sometimes another medication (peginterferon alfa [Pegasys]) to treat certain types of chronic hepatitis C (an ongoing viral infection that damages the liver) in adults.
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 Only”.
STORAGE & DOSAGE:
Storage: Store below 30°C. Protect from Light and moisture.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.