Pajjiż: Olanda
Lingwa: Olandiż
Sors: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
DARUNAVIR
Sandoz B.V. Veluwezoom 22 1327 AH ALMERE
J05AE10
DARUNAVIR
Filmomhulde tablet
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);
2017-05-18
Sandoz B.V. Page 1/12 Darunavir Sandoz ® 800 mg, filmomhulde tabletten RVG 118533 1313-V9 1.3.1.3 Bijsluiter Februari 2023 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT DARUNAVIR SANDOZ 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 [Nationally completed name] is and what it is used for 2. What you need to know before you take [Nationally completed name] 3. How to take [Nationally completed name] 4. Possible side effects 5. How to store [Nationally completed name] 6. Contents of the pack and other information 1. WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR WHAT IS [NATIONALLY COMPLETED NAME]? [Nationally completed name] contains the active substance darunavir. [Nationally completed name] is an antiretroviral medicine used in the treatment of Human Immunodeficiency Virus (HIV) infection. It belongs to a group of medicines called protease inhibitors. [Nationally completed name] 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? [Nationally completed name] is used to treat adults and children (3 years of age and above, at least 40 kilograms 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) [Nationally completed name] must be taken in combination with a low dose o Aqra d-dokument sħiħ
Sandoz B.V. Page 1/56 Darunavir Sandoz 800 mg, filmomhulde tabletten RVG 118533 1311-V9 1.3.1.1 Samenvatting van de Productkenmerken Februari 2023 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Darunavir Sandoz 800 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 400 mg of darunavir. Excipient with known effect Each film-coated tablet contains 0.258 mg of sunset yellow FCF (E 110). 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. _400 mg film-coated tablets _ Light orange oval shaped film-coated tablet, debossed with ‘400’ on one side and plain on the other side. Dimensions: approximately 17.1 x 8.6 mm _800 mg film-coated tablets _ Dark red oval shaped film-coated tablet, debossed with ‘800’ on one side and plain on the other side. Dimensions: approximately 20.2 x 10.1 mm 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS [Nationally completed name], 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. [Nationally completed name], co-administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in adult patients and adolescents (aged 12 years and older, weighing at least 40 kg) (see section 4.2). [Nationally completed name] 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 plasma HIV-1 RNA < 100,000 copies/ml and CD4+ cell count ≥ 100 Sandoz B.V. Page 2/56 Darunavir Sandoz 800 mg, filmomhulde tabl Aqra d-dokument sħiħ