Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
efavirenz, emtricitabine, tenofovir disoproxil, phosphate
Zentiva k.s.
J05AR06
efavirenz / emtricitabine / tenofovir disoproxil
Antivirals for systemic use,
HIV Infections
Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva is 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 Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva prior to initiation of their first antiretroviral treatment regimen., The demonstration of the benefit of the combination 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 efavir
Revision: 2
Authorised
2017-07-17
51 B. PACKAGE LEAFLET 52 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL ZENTIVA 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 Zentiva is and what it is used for 2. What you need to know before you take Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva 3. How to take Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva 4. Possible side effects 5. How to store Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva 6. Contents of the pack and other information 1. WHAT EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL ZENTIVA IS AND WHAT IT IS USED FOR EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL ZENTIVA 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 ZENTIVA 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 H Прочетете целия документ
1 _ _ ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva 600 mg/200 mg/245 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 600 mg of efavirenz, 200 mg of emtricitabine and tenofovir disoproxil phosphate equivalent to 245 mg of tenofovir disoproxil. Excipient with known effect: each tablet contains a maximum of 10.96 mg sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Pink, oval biconvex film coated tablet of dimensions approx. 20.0 x 10.7 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva is a f ixed-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 resist ance to any of the t hree components contained in Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva prior to initiation of their first antiretroviral treatment regimen (see sections 4.4 and 5.1). The demonstration o f the benefit of the combination 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 efavirenz/emtricitabine/tenofovir disoproxil (see section 5.1). No data are currently available from clinical studies with combination efavirenz/emtricitabine/tenofovir disoproxil in treatment-naïve or in heavily pretreated patients. No data are available to support the combination of efavirenz/emtricitabin Прочетете целия документ