País: Unió Europea
Idioma: anglès
Font: EMA (European Medicines Agency)
cobicistat, atazanavir
Bristol-Myers Squibb Pharma EEIG
J05AR15
atazanavir, cobicistat
Antivirals for systemic use
HIV Infections
EVOTAZ is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected adults and adolescents (aged 12 years and older weighing at least 35 kg) without known mutations associated with resistance to atazanavir (see sections 4.4 and 5.1).
Revision: 14
Authorised
2015-07-13
52 B. PACKAGE LEAFLET 53 PACKAGE LEAFLET: INFORMATION FOR THE USER EVOTAZ 300 MG/150 MG FILM-COATED TABLETS atazanavir/cobicistat 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 EVOTAZ is and what it is used for 2. What you need to know before you take EVOTAZ 3. How to take EVOTAZ 4. Possible side effects 5. How to store EVOTAZ 6. Contents of the pack and other information 1. WHAT EVOTAZ IS AND WHAT IT IS USED FOR EVOTAZ contains two active substances: ATAZANAVIR, AN ANTIVIRAL (OR ANTIRETROVIRAL) MEDICINE. It is one of a group called _protease _ _inhibitors_ . These medicines control human immunodeficiency virus (HIV) infection by stopping production of a protein that HIV needs for its multiplication. They work by reducing the amount of HIV in your body and this in turn, strengthens your immune system. In this way atazanavir reduces the risk of developing illnesses linked to HIV infection. COBICISTAT, A BOOSTER (PHARMACOKINETIC ENHANCER) TO HELP IMPROVE THE EFFECTS OF ATAZANAVIR . Cobicistat, does not directly treat your HIV, but boosts the levels of atazanavir in the blood. It does this by slowing down the breakdown of atazanavir which will make it stay in the body for longer. EVOTAZ may be used by adults and adolescents (aged 12 years and older weighing at least 35 kg), who are infected with HIV, the virus that causes acquired immunodeficiency syndrome (AIDS). It is used in combination with other anti-HIV medicines to help control your HIV infection. Your doctor will discuss wi Llegiu el document complet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT EVOTAZ 300 mg/150 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains atazanavir sulphate corresponding to 300 mg atazanavir and 150 mg of cobicistat. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Pink, oval, biconvex, film-coated tablet of approximate dimensions of 19 mm x 10.4 mm, debossed with "3641" on one side and plain on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS EVOTAZ is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected adults and adolescents (aged 12 years and older weighing at least 35 kg) without known mutations associated with resistance to atazanavir (see sections 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 _ _ The recommended dose of EVOTAZ for adults and adolescents (aged 12 years and older weighing at least 35 kg) is one tablet once daily taken orally with food (see section 5.2). _Advice on missed doses_ If EVOTAZ is missed within 12 hours of the time it is usually taken, patients should be instructed to take the prescribed dose of EVOTAZ with food as soon as possible. If this is noticed later than 12 hours of the time it is usually taken, the missed dose should not be taken and the patient should resume the usual dosing schedule. Special populations _ _ _Renal impairment _ Based on the very limited renal elimination of cobicistat and atazanavir, no special precautions or dose adjustments of EVOTAZ are required for patients with renal impairment. EVOTAZ is not recommended for patients undergoing haemodialysis (see sections 4.4 and 5.2). Cobicistat has been shown to decrease estimated creatinine clearance due to inhibition of tubular secretion of creatinine without affecting actual renal glomerular function. EVOTAZ should not be initiate Llegiu el document complet