Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate
Gilead Sciences Ireland UC
J05AR09
elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil
Antivirals for treatment of HIV infections, combinations, Antivirals for systemic use
HIV Infections
Treatment of human immunodeficiency virus 1 (HIV 1) infection in adults aged 18 years and over who are antiretroviral treatment-naïve or are infected with HIV 1 without known mutations associated with resistance to any of the three antiretroviral agents in Stribild.
Revision: 25
Authorised
2013-05-24
44 B. PACKAGE LEAFLET 45 PACKAGE LEAFLET: INFORMATION FOR THE USER STRIBILD 150 MG/150 MG/200 MG/245 MG FILM-COATED TABLETS elvitegravir/cobicistat/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 Stribild is and what it is used for 2. What you need to know before you take Stribild 3. How to take Stribild 4. Possible side effects 5. How to store Stribild 6. Contents of the pack and other information 1. WHAT STRIBILD IS AND WHAT IT IS USED FOR STRIBILD CONTAINS FOUR ACTIVE SUBSTANCES: • ELVITEGRAVIR, an antiretroviral medicine known as an integrase inhibitor • COBICISTAT, a booster ( _pharmacokinetic enhancer_ ) of the effects of elvitegravir • EMTRICITABINE, an antiretroviral medicine known as a nucleoside reverse transcriptase inhibitor (NRTI) • TENOFOVIR DISOPROXIL, an antiretroviral medicine known as a nucleotide reverse transcriptase inhibitor (NtRTI) Stribild is a single tablet regimen for the treatment of human immunodeficiency virus (HIV) infection in adults. Stribild is also used to treat HIV-1 infected 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 have caused side effects. STRIBILD REDUCES THE AMOUNT OF HIV IN YOUR BODY. THIS WILL IMPROVE YOUR IMMUNE SYSTEM AND REDUCE the risk of developing illnesses linked to HIV infection. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE STRIBILD DO NOT TAKE STRIBILD • IF YOU ARE ALLERGIC TO ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Stribild 150 mg/150 mg/200 mg/245 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (equivalent to 300 mg of tenofovir disoproxil fumarate or 136 mg of tenofovir). Excipients with known effect Each tablet contains 10.4 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Green, capsule-shaped, film-coated tablet of dimensions 20 mm x 10 mm, debossed on one side with “GSI” and the number “1” surrounded by a square box on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Stribild is indicated for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults aged 18 years and over who are antiretroviral treatment-naïve or are infected with HIV-1 without known mutations associated with resistance to any of the three antiretroviral agents in Stribild (see sections 4.2, 4.4 and 5.1). Stribild is also indicated for the treatment of HIV-1 infection in adolescents aged 12 to < 18 years weighing ≥ 35 kg who are infected with HIV-1 without known mutations associated with resistance to any of the three antiretroviral agents in Stribild and who have experienced toxicities which preclude the use of other regimens that do not contain tenofovir disoproxil (see sections 4.2, 4.4 and 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Therapy should be initiated by a physician experienced in the management of HIV infection. Posology _Adults and adolescents aged 12 years and older weighing at least 35 kg_ : One tablet, once daily with food. If the patient misses a dose of Stribild within 18 hours of the time it is usually taken, the patient should take Stribild with food as soon as possible and resume the normal dosing schedule. If a patient misses a dose of Stribild by more than 18 hou Pročitajte cijeli dokument