| Product Name: | Ledipasvir 90mg & Sofosbuvir 400mg Tablets |
| Brand Name: | (HEPCITAJ-LP) |
| Strength: | 90mg+400mg |
| Dosage Form: | Film-coated Oral Tablets |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 30s, 100s, 500s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | HEPATITIS C TREATMENT |
| Indication: | Ledipasvir and sofosbuvir combination is used with or without ribavirin to treat chronic hepatitis C infection in adults and children 3 years of age and older (including liver transplant patients, with or without cirrhosis). |
| Storage: | Protect from Light & moisture at temperature not exceeding 30°C. Keep in cool & Dry place. |
Ledipasvir 90mg & Sofosbuvir 400mg Tablets Technical Specification:
GENERIC NAME OF THE MEDICINAL PRODUCT:
Ledipasvir 90mg & Sofosbuvir 400mg Tablets
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Ledipasvir 90mg & Sofosbuvir 400mg Tablets
Each film-coated tablet contains:
Ledipasvir…………..90mg
Sofosbuvir ……………400mg
Excipients…………………………q.s.
Color: Ferric Oxide USP-NF and Titanium Dioxide IP
THERAPEUTIC INDICATIONS:
Ledipasvir and sofosbuvir combination is used with or without ribavirin to treat chronic hepatitis C infection in adults and children 3 years of age and older (including liver transplant patients, with or without cirrhosis).
CAUTION & SHEDULE:
CAUTION: Do not use if seal over bottle opening is broken or missing.
Dispense in a tight, light-resistance, container.
Keep store in tightly closed container.
DO NOT BREAK OR CRUSH TABLET.
Find out about the medicine that should not be taken with Ledipasvir & Sofosbuvir Tablets
SCHEDULE: SCHEDULE H PRESCRIPTION: WARNING: To be sold by retail on the prescription of a “Hepatologist Only”.
STORAGE & DOSAGE:
STORAGE: Protect from Light & moisture at temperature not exceeding 30°C. Keep in cool & Dry place.
Keep medicine out of reach of children.
Read enclosed leaflet before use.
Dosage: AS DIRECTED BY THE HEPATOLOGIST.