Land: Nederland
Språk: nederlandsk
Kilde: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
EFAVIRENZ ; EMTRICITABINE ; TENOFOVIRDISOPROXILSUCCINAAT SAMENSTELLING overeenkomend met ; TENOFOVIRDISOPROXIL
Sandoz B.V. Veluwezoom 22 1327 AH ALMERE
J05AR06
EFAVIRENZ ; EMTRICITABINE ; TENOFOVIRDISOPROXILSUCCINAAT COMPOSITION corresponding to ; TENOFOVIRDISOPROXIL
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROLOSE (E 463) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; POLOXAMEER 407 ; POLYVINYLALCOHOL (E1203) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Emtricitabine, Tenofovir Disoproxil And Efavirenz
Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); HYPROLOSE (E 463); IJZEROXIDE ROOD (E 172); IJZEROXIDE ZWART (E 172); MACROGOL 3350; MAGNESIUMSTEARAAT (E 470b); NATRIUMLAURILSULFAAT (E 487); POLOXAMEER 407; POLYVINYLALCOHOL (E1203); TALK (E 553 B); TITAANDIOXIDE (E 171);
2017-09-07
Sandoz B.V. Page 1/12 Efavirenz/Emtricitabine/Tenofovirdisoproxil Sandoz 600 mg/200 mg/245 mg, filmomhulde tabletten RVG 120143 1313-v5 1.3.1.3 Bijsluiter Maart 2022 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT EFAVIRENZ/EMTRICITABINE/TENOFOVIRDISOPROXIL SANDOZ 600 MG/200 MG/245 MG, FILMOMHULDE TABLETTEN efavirenz/emtricitabine/tenofovir disoproxil READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What [Nationally completed name] is and what it is used for 2. What you need to know before you take [Nationally completed name] 3. How to take [Nationally completed name] 4. Possible side effects 5. How to store [Nationally completed name] 6. Contents of the pack and other information 1. WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR [NATIONALLY COMPLETED NAME] CONTAINS THREE ACTIVE SUBSTANCES that are used to treat human immunodeficiency virus (HIV) infection: - efavirenz is a non-nucleoside reverse transcriptase inhibitor (NNRTI) - emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI) - tenofovir is a nucleotide reverse transcriptase inhibitor (NtRTI) Each of these active substances, also known as antiretroviral medicines, work by interfering with an enzyme (reverse transcriptase) that is essential for the virus to multiply. [NATIONALLY COMPLETED NAME] IS A TREATMENT FOR HUMAN IMMUNODEFICIENCY VIRUS (HIV) infection in adults aged 18 years and over who have previously been treated with other antiretroviral medicines and have their HIV-1 infection under control for at least three Les hele dokumentet
Sandoz B.V. Efavirenz/Emtricitabine/Tenofovirdisoproxil Sandoz 600 mg/200 mg/245 mg, filmomhulde tabletten Page 1/57 RVG 120143 1311-v9 1.3.1.1 Samenvatting van de Productkenmerken December 2022 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Efavirenz/Emtricitabine/Tenofovirdisoproxil Sandoz 600 mg/200 mg/245 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 600 mg of efavirenz, 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (equivalent to 300.6 mg tenofovir disoproxilsuccinate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Pink, capsule-shaped film-coated tablets, plain on both sides, with dimensions 11 mm x 22 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONSis a fixed-dose combination of efavirenz, emtricitabine and tenofovir disoproxil. It is indicated for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults aged 18 years and over with virologic suppression to HIV-1 RNA levels of < 50 copies/ml on their current combination antiretroviral therapy for more than three months. Patients must not have experienced virological failure on any prior antiretroviral therapy and must be known not to have harboured virus strains with mutations conferring significant resistance to any of the three components contained in Les hele dokumentetprior to initiation of their first antiretroviral treatment regimen (see sections 4.4 and 5.1). The demonstration of the benefit of the fixed-dose combination of efavirenz/emtricitabine/tenofovir disoproxil is primarily based on 48-week data from a clinical study in which patients with stable virologic suppression on a combination antiretroviral therapy changed to the fixed-dose combination of efavirenz/emtricitabine/tenofovir disoproxil (see section 5.1). No data are currently available from clinical studies with the fixed-dose combination of efavirenz/emtricitabine/tenofovir disoproxil in treatment-naïve