Χώρα: Ευρωπαϊκή Ένωση
Γλώσσα: Αγγλικά
Πηγή: EMA (European Medicines Agency)
emtricitabine, tenofovir disoproxil maleate
Mylan Pharmaceuticals Limited
J05AR03
emtricitabine, tenofovir disoproxil
Antivirals for systemic use
HIV Infections
Treatment of HIV-1 infection:Emtricitabine/Tenofovir disoproxil Mylan is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults (see section 5.1).Emtricitabine/Tenofovir disoproxil Mylan is also indicated for the treatment of HIV-1 infected adolescents, with NRTI resistance or toxicities precluding the use of first line agents, (see sections 4.2, 4.4 and 5.1).Pre-exposure prophylaxis (PrEP):Emtricitabine/Tenofovir disoproxil Mylan is indicated in combination with safer sex practices for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents at high risk (see sections 4.2, 4.4 and 5.1).
Revision: 14
Authorised
2016-12-16
55 B. PACKAGE LEAFLET 56 Package leaflet: Information for the user Emtricitabine/Tenofovir disoproxil Mylan 200 mg/245 mg film-coated tablets 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 Emtricitabine/Tenofovir disoproxil Mylan is and what it is used for 2. What you need to know before you take Emtricitabine/Tenofovir disoproxil Mylan 3. How to take Emtricitabine/Tenofovir disoproxil Mylan 4. Possible side effects 5. How to store Emtricitabine/Tenofovir disoproxil Mylan 6. Contents of the pack and other information 1. What Emtricitabine/Tenofovir disoproxil Mylan is and what it is used for Emtricitabine/Tenofovir disoproxil Mylan contains two active substances, emtricitabine and tenofovir disoproxil. Both of these active substances are antiretroviral medicines which are used to treat HIV infection. Emtricitabine is a nucleoside reverse transcriptase inhibitor and tenofovir is a nucleotide reverse transcriptase inhibitor. However, both are generally known as NRTIs and they work by interfering with the normal working of an enzyme (reverse transcriptase) that is essential for the virus to reproduce itself. Emtricitabine/Tenofovir disoproxil Mylan is used to treat Human Immunodeficiency Virus 1 (HIV-1) infection in adults. It is also used to treat HIV in adolescents aged 12 to less than 18 years who weigh at least 35 kg, and who have already been treated with other HIV medicines that are no longer effective or have caused side effects. - Emtricitabine/Te Διαβάστε το πλήρες έγγραφο
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Emtricitabine/Tenofovir disoproxil Mylan 200 mg/245 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (as maleate). Excipient with known effect Each tablet contains 93.6 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. A light green, film-coated, capsule shaped, biconvex tablet, of dimensions 19.80 mm x 9.00 mm, debossed with ‘M’ on one side of the tablet and ‘ETD’ on the other side 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Treatment of HIV-1 infection: Emtricitabine/Tenofovir disoproxil Mylan is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults (see section 5.1). Emtricitabine/Tenofovir disoproxil Mylan is also indicated for the treatment of HIV-1 infected adolescents, with NRTI resistance or toxicities precluding the use of first line agents, (see sections 4.2, 4.4 and 5.1). Pre-exposure prophylaxis (PrEP): Emtricitabine/Tenofovir disoproxil Mylan is indicated in combination with safer sex practices for pre- exposure prophylaxis to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents at high risk (see sections 4.2, 4.4 and 5.1). 4.2 Posology and method of administration Emtricitabine/Tenofovir disoproxil Mylan should be initiated by a physician experienced in the management of HIV infection. Posology Treatment of HIV in adults and adolescents aged 12 years and older, weighing at least 35 kg: One tablet, once daily. Prevention of HIV in adults and adolescents aged 12 years and older, weighing at least35 kg: One tablet, once daily. Separate preparations of emtricitabine and tenofovir disoproxil are available for treatment of HIV-1 infection if it becomes necessary to discontinue or modify the dose of one of the components of 3 Emtricitabine/Tenofovir disoproxil Mylan. Plea Διαβάστε το πλήρες έγγραφο