| Product Name: | Ribavirin Tablet |
| Brand Name: | Generics |
| Strength: | 100mg, 200mg |
| Dosage Form: | Tablets (Film-Coated-Extended Release) |
| Route of Administration: | Via oral Route |
| Packing: | 90s, 100s, 500s, 1000s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Antiviral |
| Indication: | Ribavirin is used in combination with other antiviral medications (such as interferon, and sofosbuvir) to treat chronic (long-lasting) hepatitis C, a viral infection of the liver. Chronic hepatitis C infection can cause serious liver problems such as scarring (cirrhosis), or liver cancer. |
| Storage: | Store below 25°C in a dry place. Do not freeze. Keep the container tightly closed in order to protect it from moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Ribavirin Tablet 100mg
- Ribavirin Tablet 200mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Ribavirin Tablet 100mg
Each Film-Coated tablet contains:
Ribavirin Tablet USP…………………100mg
Excipients……………………………. q.s.
Color: Yellow Iron Oxide - Ribavirin Tablet 200mg
Each Film-Coated tablet contains:
Ribavirin Tablet USP …………………200mg
Excipients……………………………. q.s.
Colures: Quinoline Yellow Lake
THERAPEUTIC INDICATIONS:
Ribavirin is used to treat infections caused by certain types of viruses. It treats shingles caused by herpes zoster. It also treats outbreaks of herpes simplex that cause cold sores around the mouth, sores around the anus, and genital herpes.
CAUTION & WARNING:
CAUTION:
Read the enclosed leaflet before use.
Keep the medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage:
Store below 25°C in a dry place. Do not freeze.
Keep the container tightly closed in order to protect it from moisture.
Dosage:
As directed by the Physician.