Tavin-EM Oral tablet 300/200

Country: Tanzania

Language: English

Source: Tanzania Medicinces & Medical Devices Authority

Active ingredient:

Emtricitabine , Tenofovir Disoproxil Fumarate

Available from:

Emcure pharmaceuticals Limited, INDIA

ATC code:

Agents affecting the virus directly

INN (International Name):

Emtricitabine and Tenofovir Disoproxil Fumarate

Dosage:

300/200

Pharmaceutical form:

Oral tablet

Manufactured by:

Emcure Pharmaceuticals limited, INDIA

Product summary:

Physical description: White to off white, modified capsule shaped, film - coated tablets, debossed with 'EM' on one side and '144' on other side of the tablet; Local technical representative: Phillips Pharmaceuticals (Tanzania) Limited

Authorization status:

Registered/Compliant

Authorization date:

2021-08-20

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
TAVIN – EM
2.
QUALITATIVE AND QUANTITATIVE
Each film coated Tablet contains:
Tenofovir Disoproxil Fumarate 300 mg
Emtricitabine 200 mg
Excipients q.s.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
White to off white, modified capsule shaped, film-coated tablets,
debossed with ‘EM’ on one
side and ‘144’ on other side of the tablet.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Treatment of HIV-1 Infection _
Tavin-EM is indicated in antiretroviral combination therapy for the
treatment of HIV-1 infected
adults (see section 5.1).
Tavin-EM is also indicated for the treatment of HIV-1 infected
adolescents, with NRTI resistance
or toxicities precluding the use of first line agents (see sections
4.2, 4.4 and 5.1).
_Pre-exposure prophylaxis (PrEP): _
Tavin-EM is indicated in combination with safer sex practices for
pre-exposure prophylaxis to
reduce the risk of sexually acquired HIV-1 infection in adults and
adolescents at high risk (see
sections 4.2, 4.4 and 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Tavin-EM should be initiated by a physician experienced in the
management of HIV infection.
Posology
Treatment of HIV in adults and adolescents aged 12 years and older,
weighing at least 35 kg:
One tablet, once daily.
Prevention of HIV in adults and adolescents aged 12 years and older,
weighing at least 35 kg:
One tablet, once daily.
Separate preparations of emtricitabine and tenofovir disoproxil are
available for treatment of
HIV-1 infection if it becomes necessary to discontinue or modify the
dose of one of the
components of Tavin-EM. Please refer to the Summary of Product
Characteristics for these
medicinal products.
If a dose of Tavin-EM is missed within 12 hours of the time it is
usually taken, Tavin-EM should
be taken as soon as possible and the normal dosing schedule should be
resumed. If a dose of
Tavin-EM is missed by more than 12 hours and it is almost time for the
next dose, the missed
dose should n