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Ribavirin Capsule USP 200mg Ribavirin Capsule USP 200mg Ribavirin Capsule USP 200mg Ribavirin Capsule USP 200mg Ribavirin Capsule USP 200mg Ribavirin Capsule USP 200mg Ribavirin Capsule USP 200mg Ribavirin Capsule USP 200mg Ribavirin Capsule USP 200mg Ribavirin Capsule USP 200mg Ribavirin Capsule USP 200mg Ribavirin Capsule USP 200mg Ribavirin Capsule USP 200mg

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.

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.