Favipiravir Tablets 400mg Technical Specification:
Product Name: | Favipiravir Tablets 400mg |
Brand Name: | Fabitaj |
Strength: | 200mg, 400mg, 800mg |
Dosage Form: | Film-coated Tablet |
Packing: | 10s, 17s, 34s |
Route of Administration: | For Oral Use only. |
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: | Favipiravir is uses in the treatment of influenza, Ebola and other pathogenic viral infections. It is also being studied to treat a number of other viral infections, including SARS-CoV-2 |
Storage: | Store at a temperature not exceeding 25°C. Protect from moisture |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Favipiravir Tablets 400mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Favipiravir Tablets 400mg
Each film-coated tablet contains:
Favipiravir……………………….400mg
Excipients………………………. q.s.
Colours: Red oxide of Iron
THERAPEUTIC INDICATIONS:
Favipiravir is uses in the treatment of influenza, Ebola and other pathogenic viral infections. It is also being studied to treat a number of other viral infections, including SARS-CoV-2.
Favipiravir tablets used for the treatment of mild to moderate COVID-19 disease in adults under restricted emergency use.
CAUTION & WARNING:
CAUTION: Swallow complete tablet, do not crush or chew.
Read enclosed leaflet before use.
Keep medicine out of reach of children.
Warning: Do not administer the drug to women known or suspected to be pregnant
Warning: Male patient should use most effective contraceptive methods in sexual intercourse during and for 7 days after the end of treatment.
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].
Dosage: As directed by the Physician.
Attach dispensing label as per end country.
NOTE: 14-day oral administration of favipiravir at a dose of 30 mg/kg/day.
GENERIC NAME OF THE MEDICINAL PRODUCT:
A. Favipiravir Tablets 200mg
B. Favipiravir Tablets 400mg
C. Favipiravir Tablets 800mg
B. Favipiravir Tablets 400mg
C. Favipiravir Tablets 800mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Favipiravir Tablets 200mg
Each film-coated tablet contains:
Favipiravir………………...…….200mg
Excipients………………………. q.s.
Colours: Titanium Dioxide USP
B. Favipiravir Tablets 400mg
Each film-coated tablet contains:
Favipiravir……………….…….400mg
Excipients………………………. q.s.
Colours: Red oxide of Iron
C. Favipiravir Tablets 800mg
Each film-coated tablet contains:
Favipiravir……………….…….800mg
Excipients………………………. q.s.
Colours: Yellow oxide of Iron
Each film-coated tablet contains:
Favipiravir………………...…….200mg
Excipients………………………. q.s.
Colours: Titanium Dioxide USP
B. Favipiravir Tablets 400mg
Each film-coated tablet contains:
Favipiravir……………….…….400mg
Excipients………………………. q.s.
Colours: Red oxide of Iron
C. Favipiravir Tablets 800mg
Each film-coated tablet contains:
Favipiravir……………….…….800mg
Excipients………………………. q.s.
Colours: Yellow oxide of Iron
THERAPEUTIC INDICATIONS:
Favipiravir is uses in the treatment of influenza, Ebola and other pathogenic viral infections. It is also being studied to treat a number of other viral infections, including SARS-CoV-2.
Favipiravir tablets used for the treatment of mild to moderate COVID-19 disease in adults under restricted emergency use.
Favipiravir tablets used for the treatment of mild to moderate COVID-19 disease in adults under restricted emergency use.
CAUTION & WARNING:
CAUTION: Swallow complete tablet, do not crush or chew.
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
WARNING: Do not administer the drug to women known or suspected to be pregnant.
WARNING: Male patient should use most effective contraceptive methods in sexual intercourse during and for 7 days after the end of treatment.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
WARNING: Do not administer the drug to women known or suspected to be pregnant.
WARNING: Male patient should use most effective contraceptive methods in sexual intercourse during and for 7 days after the end of treatment.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].
Dosage: As directed by the Physician.
Attach dispensing label as per end country.
NOTE: 14-day oral administration of favipiravir at a dose of 30 mg/kg/day.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.
NOTE: 14-day oral administration of favipiravir at a dose of 30 mg/kg/day.