AVIGAN Film-Coated Tablets 200mg (Favipiravir)

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

Favipiravir

Boleh didapati daripada:

LUEN WAH MEDICAL CO. SDN. BHD.

INN (Nama Antarabangsa):

Favipiravir

Unit dalam pakej:

100 Tablets

Dikeluarkan oleh:

TOYAMA FACTORY, FUJIFILM TOYAMA CHEMICAL CO.,LTD

Risalah maklumat

Consumer Medication Information Leaflet (RiMUP)
AVIGAN Film-coated Tablets 200mg
Favipiravir (200 mg)
1
What is in this leaflet
1. What AVIGAN is used for
2. How AVIGAN works
3. Before you use AVIGAN
4. How to use AVIGAN
5. While you are using it
6. Side effects
7. Storage and Disposal of AVIGAN
8. Product Description
9. Manufacturer and Product
Registration Holder
10. Date of revision
11. Serial Number
What AVIGAN is used for
AVIGAN is used for treatment of
novel or re-emerging pandemic
influenza virus infections (limited to
cases in which other influenza
antiviral drugs are ineffective or not
sufficiently effective).
The use of AVIGAN is considered
only when there is an outbreak of
novel or re-emerging influenza virus
infections in which other anti-
influenza virus agents are ineffective
or insufficiently effective, and the
government decides to use AVIGAN
as a countermeasure against such
influenza viruses.
How AVIGAN works
AVIGAN contains favipiravir, which
belongs to a group of medicines
named influenza antiviral agents.
Favipiravir prevents the growth of
influenza viruses and eases the
symptoms of influenza virus
infection.
Before you use AVIGAN
- When you must not use it
Taking AVIGAN during pregnancy
can cause fetal malformation or
abortion/stillbirth.
Do not take AVIGAN if:
• you are pregnant or may possibly be
pregnant.
• you are allergic (hypersensitive) to
any ingredient of AVIGAN.
Pregnancy, lactation and sexual
intercourse
AVIGAN transfers to breast milk or
semen.
If you have childbearing potential,
confirm a negative pregnancy test
result before taking AVIGAN.
Stop breastfeeding if you are
breastfeeding.
Avoid sexual intercourse with
pregnant women while taking
AVIGAN and for 7 days after
withdrawal of the drug because of
possible effects on the fetus.
If you are to have sexual intercourse
while taking AVIGAN and within 7
days after withdrawal of the drug,
conduct effective contraceptive
methods with your partner.
If you or your partner turns out to be
pregnant due to the sexual intercourse
that

Ciri produk

-1-
- INFLUENZA ANTIVIRAL AGENT -
Prescription drug
Note
AVIGAN FILM-COATED TABLETS 200MG
Favipiravir
AVIGAN
WARNINGS
1.
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 (See
“CONTRAINDICATIONS” and “6. Use during Pregnancy,
Delivery or Lactation”).
2.
When administering AVIGAN to women of child-bearing
potential, confirm a negative pregnancy test result before
starting the treatment. Explain fully the risks and instruct
thoroughly to use most effective contraceptive methods
with her partner during and for 7 days after the end of the
treatment (See “6. Use during Pregnancy, Delivery or
Lactation”).
If
pregnancy
is
suspected
during
the
treatment,
instruct
to
discontinue
the
treatment
immediately and to consult a doctor.
3.
AVIGAN is distributed in sperm
1
. When administering the
drug to male patients, explain fully the risks and instruct
thoroughly to use most effective contraceptive methods in
sexual intercourse during and for 7 days after the end of
the treatment (men must wear a condom). In addition,
instruct not to have sexual intercourse (See “6. Use during
Pregnancy,
Delivery
or
Lactation”
and
“PHARMACOKINETICS, 2. Distribution”).
4.
Prior to the treatment, explain thoroughly the efficacy and
risks (including the risk of exposure to fetus) in writing to
patients or their family members and obtain their written
consent (See “CONTRAINDICATIONS”, “2. Important
Precautions” and “6. Use during Pregnancy, Delivery or
Lactation”).
5.
Examine carefully the necessity of AVIGAN before use.
CONTRAINDICATIONS (AVIGAN IS CONTRAINDICATED IN THE FOLLOWING PATIENTS.)
1.
Women known or suspected to be pregnant
(Early
embryonic
deaths
and
teratogenicity
have
been
observed in animal studies [See “6. Use during Pregnancy,
Delivery or Lactation”].)
2.
Patients
with
a
history
of
hypersensitivity
to
any
ingredient of the drug
DESCRIPTION
BRAND NAME
AVIGAN Film-coated Tablets
200