| Product Name: | Ribavirin Capsule USP |
| Brand Name: | Generics |
| Strength: | 100mg, 200mg |
| Dosage Form: | Capsule (Hard-Gelatine) |
| 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 agents |
| Indication: | Ribavirin is used with an interferon medication such as peginterferon alfa-2a [Pegasys] or peginterferon alpha-2b [PEG-Intron]) to treat hepatitis C in people who have not been treated with an interferon before. Ribavirin is in a class of antiviral medications called nucleoside analogues. |
| Storage: | Store below 25°C in a dry place. Do not freeze. Keep the container tightly closed in order to protect from moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Ribavirin Capsule USP 100mg
- Ribavirin Capsule USP 200mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Ribavirin Capsule USP 100mg
Each Hard-gelatin capsules contains:
Ribavirin USP…………………100mg
Excipients……………………………. q.s.
Approved Colours used in empty capsule shell. - Ribavirin Capsule USP 200mg
Each Hard-gelatin capsules contains:
Ribavirin USP…………………200mg
Excipients……………………………. q.s.
Approved Colours used in empty capsule shell.
THERAPEUTIC INDICATIONS:
Ribavirin is used with an interferon medication such as peginterferon alfa-2a [Pegasys] or peginterferon alpha-2b [PEG-Intron]) to treat hepatitis C in people who have not been treated with an interferon before. Ribavirin is in a class of antiviral medications called nucleoside analogues.
CAUTION & WARNING:
CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH
Not suitable for children under 3 years.
Read enclosed leaflet before use.
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
Keep medicine out of reach of children.
STORAGE & DOSAGE:
Storage: Store below 25°C in a dry place. Do not freeze. Keep the container tightly closed in order to protect from moisture.
Dosage: Ribavirin capsule are to be administered orally each day in two divided doses (morning & evening) with food. In the cases in which no specific dose recommendation is made, the following dose should be used. Patient weight: <75 kg = 1000mg and >75 kg = 1200mg.