Daclatasvir Tablets Technical Specification:
| Product Name: | Daclatasvir Tablets 60mg |
| Brand Name: | Generic |
| Strength: | 60 mg |
| 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: | Chronic hepatitis C virus (HCV)/Antiviral |
| Indication: | Daclatasvir is used along with sofosbuvir to treat a certain type of chronic hepatitis C (an ongoing viral infection that damage the liver). It is a class of antiviral medications as hepatitis C Virus (HCV) NS5A inhibitors. |
| Storage: | Store at a temperature not exceeding 30°C in dry place. Protect from light & Moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Daclatasvir Tablets 60mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Daclatasvir Tablets 60mg
Each film-coated tablet contains:
Daclatasvir Dihydrochloride IP
equivalent to Daclatasvir ………….60mg
Excipients…….…. q. s.
Color: Sunset yellow FCF USP and Titanium dioxide IP
THERAPEUTIC INDICATIONS:
Daclatasvir is used along with sofosbuvir to treat a certain type of chronic hepatitis C (an ongoing viral infection that damage the liver). It is a class of antiviral medications as hepatitis C Virus (HCV) NS5A inhibitors.
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.
Keep the medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Report adverse events.
SCHEDULE: SCHEDULE H PRESCRIPTION: WARNING: To be sold by retail on the prescription of a “Hepatologist” only.
STORAGE & DOSAGE:
Storage: Store at a temperature not exceeding 30°C in dry place. Protect from light & Moisture.
Dosage: As directed by the Physician.