AVIGAN Tablets
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Περιεχόμενα
1. Name of the medicinal product
AVIGAN Tablets 200mg.
2. Qualitative and quantitative composition
Ingredient/content: Favipiravir 200mg. Nonproprietary name: Favipiravir Chemical name: 6-Fluoro-3-hydroxypyrazine-2-carboxamide Structure formula: Molecular formula: C<sub>5</sub>H<sub>4</sub>FN<sub> ...
3. Pharmaceutical form
Color/dosage form: Light-yellow, film-coated tablet. Appearance: Size (mm): Diameter: apprrox. 8.7 Thickness: apprrox. 4.3
4.1. Therapeutic indications
Novel or re-emerging influenza virus infections (limited to cases in which other anti-influenza virus agents are not effective or insufficiently effective). Precautions: AVIGAN is a drug the use of which ...
4.2. Posology and method of administration
The usual dosage of favipiravir for adults is 1600 mg orally twice daily for 1 day followed by 600 mg orally twice daily for 4 days. The total administration period should be 5 days. Precautions: The administration ...
4.3. Contraindications
AVIGAN is contraindicated in the following patients. Women known or suspected to be pregnant (Early embryonic deaths and teratogenicity have been observed in n animal studies) Patients with a history of ...
4.4. Special warnings and precautions for use
Warnings Since early embryonic deaths and teratogenicity have been observed in animal studies for AVIGAN, do not administer the drug to women known or suspected to be pregnant. When administering AVIGAN ...
4.5. Interaction with other medicinal products and other forms of interaction
AVIGAN is not metabolized by cytochrome P-450 (CYP), mostly metabolized by aldehyde oxidase (AO), and partly metabolized by xanthine oxidase (XO). The drug inhibits AO and CYP2C8, but does not induce CYP. ...
4.6. Pregnancy and lactation
Pregnancy Do not administer favipiravir to women known or suspected to be pregnant. Early embryonic deaths (rats) and teratogenicity (monkeys, mice, rats and rabbits) have been observed in animal studies ...
4.8. Undesirable effects
AVIGAN has never been administered with the approved dosage. In Japanese clinical studies and the global phase III study (studies conducted with dose levels lower than the approved dosage), adverse reactions ...
5.1. Pharmacodynamic properties
Mechanism of action Favipiravir (originally known as T-705) is an orally administered novel anti-viral compound with a unique mechanism of action that is active against a wide range of RNA-based viruses ...
5.2. Pharmacokinetic properties
Blood Concentrations The following table shows pharmacokinetic parameters of favipiravir after an oral administration in 8 healthy adults at 1600 mg twice daily for 1 day, then 600 mg twice daily for 4 ...
6.5. Nature and contents of container
AVIGAN Tablets 200mg: boxes of 100 tablets in press-through packages.
6.6. Special precautions for disposal and other handling
Precautions concerning Use Precautions regarding dispensing For drugs that are dispensed in a press-through package (PTP), patients should be instructed to remove the drug from the package prior to use. ...
7. Marketing authorization holder
Manufactured and Marketed by: TOYAMA CHEMICAL CO., LTD. 2-5, Nishishinjuku 3-chome, Shinjuku-ku, Tokyo, 160-0023, Japan
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