Nazione: Unione Europea
Lingua: inglese
Fonte: EMA (European Medicines Agency)
efavirenz, emtricitabine, tenofovir disoproxil maleate
Mylan Pharmaceuticals Limited
J05AR06
efavirenz, emtricitabine, tenofovir disoproxil
Antivirals for systemic use
HIV Infections
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan 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 Mylan prior to initiation of their first antiretroviral treatment regimen.The demonstration of the benefit 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 efavirenz/emtricitabine/tenofovir disoproxil (see section 5.1). No data are currently available from clinical studies with efavirenz/emtricitabine/tenofovir disoproxil in treatment-naïve or in heavily pretreated patients.No data are available to support the combination of efavirenz/emtricitabine/tenofovir disoproxil and other antiretroviral agents.
Revision: 16
Authorised
2017-09-05
69 B. PACKAGE LEAFLET 70 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL MYLAN 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 Mylan is and what it is used for 2. What you need to know before you take Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan 3. How to take Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan 4. Possible side effects 5. How to store Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan 6. Contents of the pack and other information 1. WHAT EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL MYLAN IS AND WHAT IT IS USED FOR EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL MYLAN 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 disoproxil 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 MYLAN 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 Leggi il documento completo
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan 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 245 mg of tenofovir disoproxil (as maleate). Excipient with known effect Each film-coated tablet contains 7.5 mg of sodium metabisulfite and 105.5 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Pink capsule-shaped, biconvex, beveled-edge film-coated tablet, approximately 21 mm x 11 mm and debossed with ‘M’ on one side and ‘TME’ on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan 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 Mylan prior to initiation of their first antiretroviral treatment regimen (see sections 4.4 and 5.1). The demonstration of the benefit 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 efavirenz/emtricitabine/tenofovir disoproxil (see section 5.1). No data are currently available from clinical studies with efavirenz/emtricitabine/tenofovir disoproxil in treatment-naïve or in heavily pretreated patients. No data are available Leggi il documento completo