ACRIPTEGA

Land: Indonesien

Sprog: indonesisk

Kilde: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Aktiv bestanddel:

DOLUTEGRAVIR SODIUM, LAMIVUDINE, TENOFOVIR DISOPROXIL FUMARATE

Tilgængelig fra:

KIMIA FARMA Tbk. - Indonesia

INN (International Name):

DOLUTEGRAVIR SODIUM, LAMIVUDINE, TENOFOVIR DISOPROXIL FUMARATE

Dosering:

52.600 MG /300.000 Mg /300.000 Mg

Lægemiddelform:

TABLET SALUT SELAPUT

Enheder i pakken:

DUS, BOTOL PLASTIK @ 30 TABLET SALUT SELAPUT

Fremstillet af:

MYLAN LABORATORIES LIMITED - India

Autorisation dato:

2020-09-03

Produktets egenskaber

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.
SUMMARY OF PRODUCT CHARACTERISTIC
ACRIPTEGA
Dolutegravir/Lamivudine/Tenofovir Disoproxil Fumarate Tablets
50mg/300mg/300mg
1. NAME OF THE MEDICINAL PRODUCT
ACRIPTEGA
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains:
Dolutegravir sodium 52,6 mg equivalent to Dolutegravir 50 mg
Lamivudine 300 mg
Tenofovir Disoproxil Fumarate 300 mg equivalent to
245 mg
Excipient(s) with known effect
Each film coated tablet contains 136.0 mg of Lactose Monohydrate.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film coated Tablets
A white to off-white, film coated, capsule shaped, biconvex beveled
edge tablet debossed with M on
one side and LTD on the other side of the tablet.
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 and adolescents over 12 years
of age. Consideration should be
given to official treatment guideline for HIV-1 infection.
4.2 Posology and method of administration
DISETUJUI OLEH BPOM : 02/09/2020
EREG10030312000019
DISETUJUI OLEH BPOM : 02/09/2020
EREG10030312000019
In patients receiving tenofovir disoproxil fumarate renal function
should be re-evaluated within one
week, including measurements of blood glucose, blood potassium and
urine glucose concentrations, if
serum phosphate is < 1.5 mg/dl (0.48 mmol/l) or creatinine clearance
decreases below 50 ml/min.
Consideration should also be given to interrupting treatment with
Lamivudine/Tenofovir Disoproxil
Fumarate 300mg/300mg Tablets in