国: オランダ
言語: オランダ語
ソース: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
DARUNAVIR 600 mg/stuk
Centrafarm B.V. Nieuwe Donk 3 4879 AC ETTEN LEUR
J05AE10
DARUNAVIR 600 mg/stuk
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSPOVIDON (E 1202) ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; ZONNEGEEL FCF ALUMINIUMLAK (E 110), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; ZONNEGEEL FCF ALUMINIUMLAK (E 110),
Oraal gebruik
Darunavir
Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSPOVIDON (E 1202); MACROGOL 3350; MAGNESIUMSTEARAAT (E 470b); POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171); ZONNEGEEL FCF ALUMINIUMLAK (E 110);
2017-04-11
PACKAGE LEAFLET: INFORMATION FOR THE USER DARUNAVIR STADA 75 MG, FILMOMHULDE TABLETTEN DARUNAVIR STADA 150 MG, FILMOMHULDE TABLETTEN DARUNAVIR STADA 300 MG, FILMOMHULDE TABLETTEN DARUNAVIR STADA 600 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 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 Darunavir STADA is and what it is used for 2. What you need to know before you take Darunavir STADA 3. How to take Darunavir STADA 4. Possible side effects 5. How to store Darunavir STADA 6. Contents of the pack and other information 1. WHAT DARUNAVIR STADA IS AND WHAT IT IS USED FOR WHAT IS DARUNAVIR STADA? Darunavir STADA contains the active substance darunavir. Darunavir STADA 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 STADA 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? Darunavir STADA is used to treat adults and children of 3 years of age and above, and at least 15 kg body weight who are infected by HIV and who have already used other antiretroviral medicines. Darunavir STADA must be taken in combination with a low dose of ritonavir and other anti-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 DARUNAVIR STADA DO NOT TAKE DARUNAVIR STADA • if you are ALLERGIC to dar 完全なドキュメントを読む
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Darunavir STADA 75 mg, filmomhulde tabletten Darunavir STADA 150 mg, filmomhulde tabletten Darunavir STADA 300 mg, filmomhulde tabletten Darunavir STADA 600 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Darunavir STADA 75 mg: Each film-coated tablet contains 75 mg of darunavir. Darunavir STADA 150 mg: Each film-coated tablet contains 150 mg of darunavir. Darunavir STADA 300 mg: Each film-coated tablet contains 300 mg of darunavir. Darunavir STADA 600 mg: Each film-coated tablet contains 600 mg of darunavir. Excipient with known effect Darunavir STADA 300 mg: Each tablet contains 1.296 mg sunset yellow FCF (E110). Darunavir STADA 600 mg: Each tablet contains 2.592 mg sunset yellow FCF (E110). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Darunavir STADA 75 mg: White, caplet shaped film-coated tablet, debossed with ‘75’ on one side and plain on the other side, with dimensions of approximately 8.6 mm x 4.6 mm. Darunavir STADA 150 mg: White, oval shaped film-coated tablet, debossed with ‘150’ on one side and plain on the other side, with dimensions of approximately 11.1 mm x 5.6 mm. Darunavir STADA 300 mg: Orange, oval shaped film-coated tablet, debossed with ‘300’ on one side and plain on the other side, with dimensions of approximately 15.1 mm x 7.6 mm. Darunavir STADA 600 mg: Orange oval shaped film coated tablet, debossed with ‘600’ on one side and plain on the other side, with dimensions of approximately 20.1 mm x 10.1 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Darunavir STADA, 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 (see section 4.2). Darunavir STADA 75 mg/150 mg/300 mg/600 mg tablets may be used to provide suitable dose regimens (see section 4.2): • For the treatment of HIV-1 infection in an 完全なドキュメントを読む