Dolutegravir 50 mg, Lamivudine 300 mg and Tenofovir disoproxil fumarate 300 mg Tablet Oral tablet Dolutegravir 50mg, Lamivudine 300mg and Tenofovir disoproxil fumerate 300mg

Country: Танзанија

Језик: Енглески

Извор: Tanzania Medicinces & Medical Devices Authority

Активни састојак:

Dolutegravir Sodium, Lamivudine , Tenofovovir Disoproxil Fumarate

Доступно од:

Macleods Pharmaceuticals Limited, INDIA

АТЦ код:

Antivirals for systemic use, antivirals for treatm

INN (Међународно име):

Dolutegravir Sodium+ Lamivudine + Tenofovovir Disoproxil Fumarate

Дозирање:

Dolutegravir 50mg, Lamivudine 300mg and Tenofovir disoproxil fumerate 300mg

Фармацеутски облик:

Oral tablet

Произведен од:

Macleods Pharmaceuticals Limited, INDIA

Резиме производа:

Physical description: White to off white, capsule shaped, film coated tablets, debossed with F67 on one side and plain on other side; Local technical representative: RK Pharmaceuticals (TZ) LIMITED (2050)

Статус ауторизације:

Registered/Compliant

Датум одобрења:

2022-08-04

Карактеристике производа

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Dolutegravir/Lamivudine/Tenofovir Disoproxil Fumarate 50/300mg/300mg
Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film - coated tablet contains:
50 mg of Dolutegravir equivalent to 52.6 mg of Dolutegravir sodium
300 mg of Lamivudine USP
300 mg of Tenofovir disoproxil fumarate equivalent to 245 mg of
Tenofovir disoproxil.
2.6 mg per tablet of Sodium
120 mg of Mannitol (USP-NF/ Ph.Eur)
21 mg of Sodium Starch Glycolate (USP-NF/ Ph.Eur)
9 mg of Sodium Stearyl Fumarate (USP-NF/ Ph.Eur) FOR EXCIPIENTS SEE POINT 6.1
3.
PHARMACEUTICAL FORM
Tablet
White to off white, capsule shaped, film coated tablets, debossed with
'F67' on one side and
plain on other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Dolutegravir 50mg + Lamivudine 300mg + Tenofovir disoproxil fumarate
300mg Tablet is
indicated for the treatment of HIV- infection in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For the treatment of HIV that is resistant to other medicines similar
to Dolutegravir, Tenofovir
Disoproxil Fumarate and Lamivudine Tablets 50mg/300mg/300mg , the
usual dose of
Dolutegravir, Tenofovir Disoproxil Fumarate and Lamivudine Tablets
50mg/300mg/300mg is
one tablet, once a day.
Swallow
the
tablet
with
some
liquid.
Dolutegravir, Tenofovir
Disoproxil
Fumarate
and
Lamivudine Tablets 50mg/300mg/300mg can be taken with or without food.
3.
CONTRAINDICATIONS
•
Hypersensitivity to the active substances or to any of the excipients.
•
Co-administration with dofetilide
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
DOLUTEGRAVIR
While effective viral suppression with antiretroviral therapy has been
proven to substantially
reduce the risk of sexual transmission, a residual risk cannot be
excluded. Precautions to
prevent transmission should be taken in accordance with national
guidelines.
_INTEGRASE CLASS RESISTANCE OF PARTICULAR CONCERN _
The decision to use dolutegravir in the presence of integrase class
resistance should take into
account
that
the
activity