Negara: Indonesia
Bahasa: Bahasa Indonesia
Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
DOLUTEGRAVIR SODIUM, LAMIVUDINE, TENOFOVIR DISOPROXIL FUMARATE
KIMIA FARMA Tbk. - Indonesia
DOLUTEGRAVIR SODIUM, LAMIVUDINE, TENOFOVIR DISOPROXIL FUMARATE
52.600 MG /300.000 Mg /300.000 Mg
TABLET SALUT SELAPUT
DUS, BOTOL PLASTIK @ 30 TABLET SALUT SELAPUT
MYLAN LABORATORIES LIMITED - India
2020-09-03
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 Baca dokumen lengkapnya