DOLUTEGRAVIR SODIUM, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE Tablets 50/200/25 mg

País: Tanzania

Idioma: inglés

Fuente: Tanzania Medicinces & Medical Devices Authority

Ingredientes activos:

Dolutegragravir, Emtricitabine , Tenofovir Alafenamide Tablets

Disponible desde:

Hetero Laboratories Limited, INDIA

Código ATC:

Agents affecting the virus directly

Designación común internacional (DCI):

Dolutegragravir, Emtricitabine and Tenofovir Alafenamide Tablets

Dosis:

50/200/25 mg

formulario farmacéutico:

Tablets

Fabricado por:

Hetero Labs Limited (Unit-III), INDIA

Resumen del producto:

Physical description: White to off white, capsule shaped film coated tablets, debossed with "T-47" on one side and "H" on other side; Local technical representative: SURYA PHARMA LIMITED (29253)

Estado de Autorización:

Registered/Compliant

Fecha de autorización:

2022-01-10

Ficha técnica

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE FINISHED PHARMACEUTICAL PRODUCT
INN NAME: Dolutegravir Sodium, Emtricitabine and Tenofovir alafenamide
hemifumarate
TRADE NAME: Not Applicable
STRENGTH: 50 mg / 200 mg / 25 mg
PHARMACEUTICAL FORM: Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains Dolutegravir 50 mg equivalent to
52.60 mg of Dolutegravir
sodium, Emtricitabine 200 mg and Tenofovir alafenamide 25 mg
equivalent to 28.043 mg of
Tenofovir alafenamide hemifumarate.
_For full list of excipients, see section 6.1 _
3. PHARMACEUTICAL FORM DOSAGE FORM: Film coated tablets
DESCRIPTION: White to off white, capsule shaped film coated tablets,
debossed with "T47" on
one side and "H" on other side.
4. CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Dolutegravir, Emtricitabine and Tenofovir alafenamide is indicated, in
combination with:
•
Other antiretroviral agents, for the treatment of HIV-1 infection in
adults and pediatric patients
weighing at least 35 Kg.
•
Other antiretroviral agents other than protease inhibitors that
require a CYP3A inhibitor, for
the treatment of HIV-1 infection in pediatric patients weighing at
least 25 Kg and less than 35 Kg.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION TESTING PRIOR TO INITIATION OF
TREATMENT
•
Perform pregnancy testing before initiation of treatment
in
adolescents and adults of
childbearing potential.
•
Prior to initiation of treatment, patients should be tested for
hepatitis B virus infection.
•
Estimated
creatinine
clearance,
urine
glucose,
and
urine
protein
should
be
assessed
before initiating therapy and should be monitored during therapy in
all patients
DOSAGE RECOMMENDATION
The recommended dosage is one tablet taken orally once daily with or
without food in adults and
pediatric patients with body weight at least 35 Kg and creatinine
clearance greater than or equal
to 30 mL per minute.
For specific dosing recommendations for coadministered third agents,
refer to their respective
prescribing information. The safety and e