País: Unió Europea
Idioma: anglès
Font: EMA (European Medicines Agency)
darunavir, cobicistat, emtricitabine, tenofovir alafenamide
Janssen-Cilag International NV
J05
darunavir, cobicistat, emtricitabine, tenofovir alafenamide
Antivirals for systemic use, Antivirals for treatment of HIV infections, combinations
HIV Infections
Symtuza is indicated for the treatment of human immunodeficiency virus type 1 (HIV‑1) infection in adults and adolescents (aged 12 years and older with body weight at least 40 kg).Genotypic testing should guide the use of Symtuza.
Revision: 17
Authorised
2017-09-21
42 B. PACKAGE LEAFLET 43 PACKAGE LEAFLET: INFORMATION FOR THE USER SYMTUZA 800 MG/150 MG/200 MG/10 MG - FILM-COATED TABLETS darunavir/cobicistat/emtricitabine/tenofovir alafenamide 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 Symtuza is and what it is used for 2. What you need to know before you take Symtuza 3. How to take Symtuza 4. Possible side effects 5. How to store Symtuza 6. Contents of the pack and other information 1. WHAT SYMTUZA IS AND WHAT IT IS USED FOR Symtuza is an antiretroviral medicine used to treat infection with human immunodeficiency virus 1 (HIV-1). It is used in adults and adolescents aged 12 years and older who weigh at least 40 kg. Symtuza contains four active substances: darunavir, an anti-HIV medicine known as a protease inhibitor cobicistat, a booster (enhancer) of darunavir emtricitabine, an anti-HIV medicine known as a nucleoside reverse transcriptase inhibitor tenofovir alafenamide, an anti-HIV medicine known as a nucleotide reverse transcriptase inhibitor Symtuza reduces HIV-1 in your body and this will improve your immune system (your body’s natural defences) and reduce the risk of developing illnesses linked to HIV infection but Symtuza is not a cure for HIV infection. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SYMTUZA DO NOT TAKE SYMTUZA - if you are ALLERGIC (hypersensitive) to darunavir, cobicistat, emtricitabine, tenofovir alafenamide, or any of the other ingredients of Symtuza (listed in section 6). - if you have SEVERE LIVE Llegiu el document complet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Symtuza 800 mg/150 mg/200 mg/10 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 800 mg of darunavir (as ethanolate), 150 mg of cobicistat, 200 mg of emtricitabine, and 10 mg of tenofovir alafenamide (as fumarate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Yellow to yellowish-brown capsule shaped tablet of 22 mm x 11 mm, debossed with “8121” on one side and “JG” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symtuza is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents (aged 12 years and older with body weight at least 40 kg). Genotypic testing should guide the use of Symtuza (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-1 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. _Antiretroviral Therapy (ART)-naïve patients_ The recommended dose regimen is one film-coated tablet of Symtuza once daily taken with food. _ART-experienced patients_ One film-coated tablet of Symtuza 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 5.1). * DRV-RAMs: V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V, L89V. _Advice on missed doses_ If a dose of Symtuza is missed within 12 hours of the time it is usually taken, patients should be instructed to take the prescribed dose of Symtuza with food as soon as possible. If a missed dose is noticed later than 12 hours of the time it is usually taken, it s Llegiu el document complet