Tavin tablets film-coated

国家: 亚美尼亚

语言: 英文

来源: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

有效成分:

tenofovir (tenofovir disoproxil fumarate)

可用日期:

Emcure Pharmaceuticals Ltd.

ATC代码:

J05AF07

INN（国际名称）:

tenofovir (tenofovir disoproxil fumarate)

剂量:

300mg

药物剂型:

tablets film-coated

每包单位数:

(30) in plastic container

处方类型:

Prescription

授权状态:

Registered

授权日期:

2022-12-06

资料单张

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TAVIN 300 MG FILM-COATED TABLETS
Tenofovir disoproxil fumarate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Tavin is and what it is used for
2.
What you need to know before you take Tavin
3.
How to use Tavin
4.
Possible side effects
5.
How to store Tavin
6.
Contents of the pack and other information
IF TAVIN HAS BEEN PRESCRIBED FOR YOUR CHILD, PLEASE NOTE THAT ALL THE
INFORMATION IN THIS LEAFLET IS
ADDRESSED TO YOUR CHILD (IN THIS CASE PLEASE READ “YOUR CHILD”
INSTEAD OF “YOU”).
1.
WHAT TAVIN IS AND WHAT IT IS USED FOR
Tavin contains the active substance tenofovir disoproxil fumarate.
This active substance is an antiretroviral
or antiviral medicine which is used to treat HIV or HBV infection or
both. Tenofovir is a nucleotide reverse
transcriptase inhibitor, generally known as an NRTI and works by
interfering with the normal working of
enzymes (in HIV reverse transcriptase; in hepatitis B DNA polymerase)
that are essential for the viruses to
reproduce themselves. In HIV Tavin should always be used combined with
other medicines to treat HIV
infection.
TAVIN 300 MG TABLETS ARE A TREATMENT FOR HIV (Human Immunodeficiency
Virus) infection. The tablets are
suitable for:ADULTS
-
ADOLESCENTS AGED 12 TO LESS THAN 18 YEARS WHO HAVE ALREADY BEEN
TREATED with other HIV
medicines which are no longer fully effective due to development of
resistance, or have caused side effects.
TAVIN 300 MG TABLETS ARE ALSO A TREATMENT FOR CHRONIC HEPATITIS B, AN
I

产品特点

1
SUMMARY OF PRODUCT CHARACTERISTICS
TAVIN
(Tenofovir Disoproxil Fumarate tablets)
2
1.
NAME OF THE MEDICINAL PRODUCT
Tavin 300mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains:
Tenofovir Disoproxil Fumarate ..................... 300 mg
Excipient with known effect
Each tablet contains 153.66 mg lactose (as monohydrate). For the full
list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
White coloured, modified capsule shaped, film-coated tablets debossed
with “EM” on one side and “143” on
other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
HIV-1 INFECTION
Tavin 300 mg film-coated tablets are indicated in combination with
other antiretroviral medicinal products for
the treatment of HIV-1 infected adults.
Tavin 300 mg film-coated tablets are also indicated for the treatment
of HIV-1 infected adolescents, with NRTI
resistance or toxicities precluding the use of first line agents, aged
12 to < 18 years.
The choice of Tavin to treat antiretroviral-experienced patients with
HIV-1 infection should be based on
individual viral resistance testing and/or treatment history of
patients.
HEPATITIS B INFECTION:
Tavin 300 mg film-coated tablets are indicated for the treatment of
chronic hepatitis B in adults with:
•
compensated liver disease, with evidence of active viral replication,
persistently elevated serum alanine
aminotransferase (ALT) levels and histological evidence of active
inflammation and/or fibrosis (see section 5.1).
•
evidence of lamivudine-resistant hepatitis B virus (see sections 4.8
and 5.1).
•
decompensated liver disease (see sections 4.4, 4.8 and 5.1).
Tavin 300 mg film-coated tablets are indicated for the treatment of
chronic hepatitis B in adolescents 12 to < 18
years of age with:
•
compensated liver disease and evidence of immune active disease, i.e.
active viral replication, persistently
elevated serum ALT levels and histological evidence of active
inflammation and/or fibrosis (see sections 4