Country: Холандија
Језик: Холандски
Извор: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
DARUNAVIR 800 mg/stuk
Alvogen Malta Operations (ROW) Ltd. Malta Life Sciences Park, Building 1, Level 4, Sir Temi Zammit Buildings SGN 3000 SAN GW
J05AE10
DARUNAVIR 800 mg/stuk
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSPOVIDON (E 1202) ; IJZEROXIDE ROOD (E 172) ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; IJZEROXIDE ROOD (E 172) ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Darunavir
Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSPOVIDON (E 1202); IJZEROXIDE ROOD (E 172); MACROGOL 3350; MAGNESIUMSTEARAAT (E 470b); POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);
2017-04-12
Darunavir_400 mg_800 mg_fct_EN_NL-H-3607-001_003_ EPAR 082022-122022 + name change 2023_02 1 PACKAGE LEAFLET: INFORMATION FOR THE USER DARUNAVIR ZENTIVA 400 MG, FILMOMHULDE TABLETTEN DARUNAVIR ZENTIVA 800 MG, FILMOMHULDE TABLETTEN darunavir 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 Darunavir Zentiva is and what it is used for 2. What you need to know before you take Darunavir Zentiva 3. How to take Darunavir Zentiva 4. Possible side effects 5. How to store Darunavir Zentiva 6. Contents of the pack and other information 1. WHAT DARUNAVIR ZENTIVA IS AND WHAT IT IS USED FOR WHAT IS DARUNAVIR ZENTIVA? Darunavir Zentiva contains the active substance darunavir. Darunavir Zentiva is an antiretroviral medicine used in the treatment of Human Immunodeficiency Virus (HIV) infection. It belongs to a group of medicines called protease inhibitors. Darunavir Zentiva works by reducing the amount of HIV in your body. This will improve your immune system and reduces the risk of developing illnesses linked to HIV infection. WHAT IT IS USED FOR? The Darunavir Zentiva 400 mg/800 mg tablet is used to treat adults and children (3 years of age and above, at least 40 kilogram (kg) body weight) who are infected by HIV and - who have not used antiretroviral medicines before. - in certain patients who have used antiretroviral medicines before (your doctor will determine this). Darunavir Zentiva must be taken in combination with a low dose of cobicistat or ritonavir and other anti-HIV medicines. Your doc Прочитајте комплетан документ
Darunavir_400 mg_800 mg_fct_EN_NL-H-3607-001_003_ EPAR 082022-122022 + name change 2023_02 1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAAM VAN HET GENEESMIDDELNAME OF THE MEDICINAL PRODUCT Darunavir Zentiva 400 mg, filmomhulde tabletten Darunavir Zentiva 800 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Darunavir Zentiva 400 mg film-coated tablets: Each film-coated tablet contains 400 mg of darunavir. Excipient with known effect: Each tablet contains 0.258 mg sunset yellow FCF (E110). Darunavir Zentiva 800 mg film-coated tablets: Each film-coated tablet contains 800 mg of darunavir. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Darunavir Zentiva 400 mg film-coated tablets: Light orange oval shaped film-coated tablet, debossed with ‘400’ on one side and plain on the other side, with dimensions of approximately 17.1 mm x 8.6 mm. Darunavir Zentiva 800 mg film-coated tablets: Dark red oval shaped film-coated tablets, debossed with ‘800’ on one side and plain on the other side, with dimensions of approximately 20.2 mm x 10.1 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Darunavir Zentiva, co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV-1) infection. Darunavir Zentiva, co-administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg) (see section 4.2). Darunavir Zentiva 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of HIV-1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are: - antiretroviral therapy (ART)-naïve (see section 4.2). - ART-experienced with no darunavir resistance associated mutations (DRV-RAMs) and who have plas Прочитајте комплетан документ