Daclatasvir and Sofosbuvir Tablets Technical Specification:
| Product Name: | Daclatasvir and Sofosbuvir Tablets 60mg/400mg |
| Brand Name: | Generic |
| Strength: | 60mg+400mg |
| Dosage Form: | Tablets (film-coated tablet) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 28s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Hepatitis C Treatment, Antiviral |
| Indication: | Daclatasvir is used with sofosbuvir to treat chronic (long-lasting) hepatitis C, a viral infection of the liver. The combination of both is an effective and safe treatment for patients infected with all genotypes of hepatitis C who have severe renal impairment, including patients on hemodialysis. |
| Storage: | Store at a temperature not exceeding 30°C. Protect from light & Moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Daclatasvir and Sofosbuvir Tablets 60mg/400mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each film-coated tablet contains:
Daclatasvir Dihydrochloride IP equivalent to
Daclatasvir ………….60mg
Velpatasvir ………….400mg
Excipients…….…. q. s.
Color: Titanium Dioxide IP, Red Oxide of Iron
THERAPEUTIC INDICATIONS:
Daclatasvir is used with sofosbuvir to treat chronic (long-lasting) hepatitis C, a viral infection of the liver. The combination of both is an effective and safe treatment for patients infected with all genotypes of hepatitis C who have severe renal impairment, including patients on hemodialysis.
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.
SCHEDULE: SCHEDULE H PRESCRIPTION: WARNING: To be sold by retail on the prescription of a Gastroenterologist/Hepatologist.
STORAGE & DOSAGE:
Storage: Store below 30°C. Protect from Light and moisture.
Dosage: As directed by the Physician.