देश: माल्टा
भाषा: अंग्रेज़ी
स्रोत: Medicines Authority
TENOFOVIR DISOPROXIL, EFAVIRENZ, EMTRICITABINE
Teva B.V. Swensweg 5, 2031 GA Haarlem, Netherlands
J05AR06
TENOFOVIR DISOPROXIL 245 mg EFAVIRENZ 600 mg EMTRICITABINE 200 mg
FILM-COATED TABLET
TENOFOVIR DISOPROXIL 245 mg EFAVIRENZ 600 mg EMTRICITABINE 200 mg
POM
ANTIVIRALS FOR SYSTEMIC USE
Withdrawn
2017-02-02
1 PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE USER EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL TEVA 600 MG/200 MG/245 MG FILM-COATED TABLETS 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 Efavirenz/Emtricitabine/Tenofovir disoproxil Teva is and what it is used for 2. What you need to know before you take Efavirenz/Emtricitabine/Tenofovir disoproxil Teva 3. How to take use Efavirenz/Emtricitabine/Tenofovir disoproxil Teva 4. Possible side effects 5. How to store Efavirenz/Emtricitabine/Tenofovir disoproxil Teva 6. Contents of the pack and other information 1. WHAT EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL TEVA IS AND WHAT IT IS USED FOR EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL TEVA 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. EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL TEVA 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 t पूरा दस्तावेज़ पढ़ें
Page 1 of 45 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Efavirenz/Emtricitabine/Tenofovir disoproxil Teva 600 mg/200 mg/245 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 600mg of efavirenz, 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (equivalent to 291.22 mg of tenofovir disoproxil phosphate or 136 mg of tenofovir). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Pink, oval shaped film coated tablet, approximately 23mm x 11mm x 8mm, debossed with “TEE” on one side of the tablet and plainon the other side of the tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Efavirenz/Emtricitabine/Tenofovir disoproxil Teva is a fixed-dose combination of efavirenz, emtricitabine and tenofovir disoproxil phosphate. 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 Efavirenz/Emtricitabine/Tenofovir disoproxil Teva prior 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 or in heavily pretreate पूरा दस्तावेज़ पढ़ें