Ribavirin Capsule USP 200mg Technical Specification:

Product Name:                                                             Ribavirin Capsule USP
Brand Name:Generics
Strength: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 200mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • 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.

Attach dispensing label as per end country.

GENERIC NAME OF THE MEDICINAL PRODUCT:

Ribavirin Capsule USP 200mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

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.
Attach dispensing label as per end country.