国家: 欧盟
语言: 英文
来源: EMA (European Medicines Agency)
darunavir, cobicistat
Janssen-Cilag International N.V.
J05
darunavir, cobicistat
Antivirals for systemic use, Antivirals for treatment of HIV infections, combinations
HIV Infections
Rezolsta, is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus 1 (HIV 1) infection in adults aged 18 years or older.Genotypic testing should guide the use of Rezolsta.
Revision: 16
Authorised
2014-11-19
42 B. PACKAGE LEAFLET 43 PACKAGE LEAFLET: INFORMATION FOR THE USER REZOLSTA 800 MG/150 MG - FILM-COATED TABLETS darunavir/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, pharmacist or nurse. - 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What REZOLSTA is and what it is used for 2. What you need to know before you take REZOLSTA 3. How to take REZOLSTA 4. Possible side effects 5. How to store REZOLSTA 6. Contents of the pack and other information 1. WHAT REZOLSTA IS AND WHAT IT IS USED FOR WHAT IS REZOLSTA? REZOLSTA contains the active substances darunavir and cobicistat. Darunavir belongs to a group of HIV medicines called ‘protease inhibitors’ which work by reducing the amount of HIV in your body to a very low level. It is given with cobicistat, which increases the amount of darunavir in your blood. Treatment with REZOLSTA will improve your immune system (your body’s natural defences) and reduce the risk of developing illnesses linked to HIV infection, but REZOLSTA is not a cure for HIV infection. WHAT IT IS USED FOR? REZOLSTA is used to treat adults and adolescents aged 12 years and older who weigh at least 40 kilograms and who are infected by HIV (see How to take REZOLSTA). REZOLSTA must be taken in combination with other HIV medicines. Your doctor will discuss with you which combination of medicines is best for you. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE REZOLSTA DO NOT TAKE REZOLSTA - if you are ALLERGIC to darunavir, cobicistat or any of the other ingredients of this medicine (listed in section 6). - if you have SEVERE LIVER PROB 阅读完整的文件
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT REZOLSTA 800 mg/150 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 800 mg of darunavir (as ethanolate) and 150 mg of cobicistat. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Pink oval shaped tablet of 23 mm x 11.5 mm, debossed with “800” on one side and “TG” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS REZOLSTA is indicated, in combination with other antiretroviral medicinal products, for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg). Genotypic testing should guide the use of REZOLSTA (see sections 4.2, 4.4 and 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Therapy should be initiated by a healthcare provider experienced in the management of HIV infection. Posology The recommended dose regimen in adults and adolescents aged 12 years and older, weighing at least 40 kg, is one tablet taken once daily with food. _ART-naïve patients_ The recommended dose regimen is one film-coated tablet of REZOLSTA once daily taken with food. _ART-experienced patients_ One film-coated tablet of REZOLSTA once daily taken with food may be used in patients with prior exposure to antiretroviral medicinal products, but without darunavir resistance associated mutations (DRV-RAMs)* and who have plasma HIV-1 RNA < 100,000 copies/mL and CD4+ cell count ≥ 100 cells x 10 6 /L (see section 4.1). * DRV-RAMs: V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V, L89V. In all other ART-experienced patients or if HIV-1 genotype testing is not available, the use of REZOLSTA is not appropriate and another antiretroviral regimen should be used. Refer to the Summary of Product Characteristics of other antiretroviral medicinal products for dosing information. _Advice on missed doses_ If REZOLSTA is missed within 12 hours of the 阅读完整的文件