KOCITAF Tablets 50/200/25 mg

Maa: Tansania

Kieli: englanti

Lähde: Tanzania Medicinces & Medical Devices Authority

Aktiivinen ainesosa:

Dolutegravir Sodium

Saatavilla:

Mylan Laboratories Limited, INDIA

ATC-koodi:

DIRECT ACTING ANTIVIRALS

INN (Kansainvälinen yleisnimi):

Dolutegravir Sodium

Annos:

50/200/25 mg

Lääkemuoto:

Tablets

Valmistaja:

Mylan Laboratories Limited, INDIA

Tuoteyhteenveto:

Physical description: A white to off white, film coated, oval shaped, biconvex beveled edge tablet debossed with M on one side of the tablet and TD1 on the other side; Local technical representative: Synermed Pharmaceuticals (T) Limited (5197)

Valtuutuksen tilan:

Registered/Compliant

Valtuutus päivämäärä:

2022-05-04

Valmisteyhteenveto

SUMMARY OF PRODUCT CHARACTERISTICS SMPC
KOCITAF
Dolutegravir/ Emtricitabine/ Tenofovir Alafenamide Tablets 50 mg/ 200
mg/
25 mg
1. NAME OF THE MEDICINAL PRODUCT
Dolutegravir, Emtricitabine and Tenofovir Alafenamide Tablets 50 mg/
200 mg/ 25 mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains:
Dolutegravir Sodium equivalent to Dolutegravir 50
mg Emtricitabine 200 mg
Tenofovir Alafenamide Fumarate equivalent to Tenofovir Alafenamide 25
mg
Excipient with known effect
Each tablet contains 120 mg lactose (as
monohydrate). For the full list of excipients, see
section 6.1.
3. PHARMACEUTICAL FORM
Film coated tablet.
A white to off white, film coated, oval shaped, biconvex beveled edge
tablet debossed with M on
one side of the tablet and TD1 on the other side.
4. CLINICAL PARTICULARS
4.1.Therapeutic indications
Dolutegravir, Emtricitabine and Tenofovir alafenamide 50 mg/ 200 mg/
25 mg is indicated in
combination with other antiretroviral agents for the treatment of
adults and adolescents (aged 12
years and older with body weight at least 40 kg) infected with human
immunodeficiency virus type
1 (HIV
-
1) (see sections 4.2 and 5.1).
Combination of Dolutegravir, Emtricitabine and Tenofovir alafenamide
has not been studied so far.
4.2.Posology and method of administration
Therapy should be initiated by a physician experienced in the
management of HIV infection.
_Posology _
Adults and adolescents aged 12 years and older, weighing at least 40
kg
1.
Patients infected with HIV
-
1 without documented or clinically supected resistance to the
integrase class
a.
Fixed dose combination of Dolutegravir, Emtricitabine and Tenofovir
alafenamide
50 mg/ 200 mg/ 25 mg should be administered orally once daily.
2.
Patients infected with HIV
-
1 with documented or clinically supected resistance to the
integrase class
a.
The recommended dose of dolutegravir is 50 mg (one tablet) twice
daily.
b.
Separate preparations of Dolutegravir, Emtricitabine and Tenofovir
alafenamide
are available in cases where discontinuation