Land: Indonesia
Språk: indonesisk
Kilde: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
LAMIVUDINE, TENOFOVIR DISOPROXIL FUMARATE, DOLUTEGRAVIR SODIUM
SAMPHARINDO RETROVIRAL INDONESIA - Indonesia
LAMIVUDINE, TENOFOVIR DISOPROXIL FUMARATE, DOLUTEGRAVIR SODIUM
300 Mg /300 Mg /52,6 Mg
TABLET SALUT SELAPUT
DUS, 1 BOTOL PLASTIK @ 30 TABLET SALUT SELAPUT
MACLEODS PHARMACEUTICALS LIMITED - India
2020-02-25
SUMMARY OF PRODUCT CHARACTERISTIC 1. NAME OF THE MEDICINAL PRODUCT TELADO 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film - coated tablet contains: 50 mg of Dolutegravir equvivalent 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. FOR EXCIPIENTS SEE POINT 6.1 3. PHARMACEUTICAL FORM Tablet 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Dolutegravir 50mg + Lamivudine 300mg + Tenofovir disoproxil fumarate 300mg Tablet is indicated for thetreatment of HIV infection in adults and adolescents over 12 years of age. 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. 4.3. 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 of dolutegravir is considerably compromised for viral strains harbouring Q148+ ≥ 2 secondary mutations from G140A/C/S, E138A/K/T, L74I. To what extent dolutegravir provides added efficacy in the presence of such integrase class resistance is uncertain. HYPERSENSITIVITY REACTIONS Hypersensitivity reactions have been Les hele dokumentet