Ledipasvir & Sofosbuvir tablets technical specification:
| Product Name: | Ledipasvir 90mg & Sofosbuvir 400mg Tablets |
| Brand Name: | Generic |
| Strength: | 90mg+400mg |
| Dosage Form: | Tablet (film coated) |
| Route of Administration: | Via Oral Route |
| Packing: | 28s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Hepatitis C |
| Indication: | Ledipasvir and sofosbuvir combination is a used to treat chronic (long-lasting) hepatitis C, a viral infection of the liver with or without ribavirin in adults and children 3 years of age and older (including liver transplant patients, with or without cirrhosis). |
| Storage: | Store at a temperature not exceeding 30°C. Protect from light & Moisture. |
Ledipasvir 90mg & Sofosbuvir 400mg Tablets
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each film coated tablet contains:
Ledipasvir ………….90mg
Sofosbuvir IP………….400mg
Excipients…….…. q. s.
Color: Ferric oxide Red USP-NF, Ferric oxide yellow USP-NF, Titanium Dioxide IP
THERAPEUTIC INDICATIONS:
Ledipasvir and sofosbuvir combination is a used to treat chronic (long-lasting) hepatitis C, a viral infection of the liver with or without ribavirin in adults and children 3 years of age and older (including liver transplant patients, 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 effect
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.