Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
darunavir
KRKA, d.d., Novo mesto
J05AE10
darunavir
Antivirals for systemic use
HIV Infections
400 and 800 mgDarunavir Krka, 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 Krka 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 plasma HIV-1 RNA < 100,000 copies/ml and CD4+ cell count ≥ 100 cells x 106/l. In deciding to initiate treatment with darunavir in such ART-experienced patients, genotypic testing should guide the use of darunavir (see sections 4.2, 4.3, 4.4 and 5.1).600 mg Darunavir Krka, 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 Krka 600 mg tablets may be used to provide suitable dose regimens (see section 4.2):For the treatment of HIV-1 infection in antiretroviral treatment (ART)-experienced adult patients, including those that have been highly pre-treated.For the treatment of HIV-1 infection in paediatric patients from the age of 3 years and at least 15 kg body weight.In deciding to initiate treatment with darunavir co-administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. Genotypic or phenotypic testing (when available) and treatment history should guide the use of darunavir.
Revision: 10
Authorised
2018-01-26
90 B. PACKAGE LEAFLET 91 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT DARUNAVIR KRKA 400 MG FILM-COATED TABLETS DARUNAVIR KRKA 800 MG FILM-COATED TABLETS 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 Krka is and what it is used for 2. What you need to know before you take Darunavir Krka 3. How to take Darunavir Krka 4. Possible side effects 5. How to store Darunavir Krka 6. Contents of the pack and other information 1. WHAT DARUNAVIR KRKA IS AND WHAT IT IS USED FOR WHAT IS DARUNAVIR KRKA? Darunavir Krka contains the active substance darunavir. Darunavir Krka 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 Krka 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 Krka 400 and 800 milligram tablets are 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). Darunavir Krka 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 KRK Przeczytaj cały dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Darunavir Krka 400 mg film-coated tablets Darunavir Krka 800 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Darunavir Krka 400 mg film-coated tablets Each film-coated tablet contains 400 mg darunavir. Darunavir Krka 800 mg film-coated tablets Each film-coated tablet contains 800 mg darunavir. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet) Darunavir Krka 400 mg film-coated tablets Yellowish brown, oval, biconvex film-coated tablets, engraved with a mark S1 on one side. Tablet dimension: 17 x 8.5 mm. Darunavir Krka 800 mg film-coated tablets Brownish red, oval, biconvex film-coated tablets, engraved with a mark S3 on one side. Tablet dimension: 20 x 10 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Darunavir Krka, 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 Krka 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 plasma HIV-1 RNA < 100 000 copies/ml and CD4+ cell count ≥ 100 cells x 10 6 /l. In deciding to initiate treatment with darunavir in such ART-experienced patients, genotypic testing should guide the use of darunavir (see sections 4.2, 4.3, 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. After therapy with darunavir has been initiated, patients should be advised not to alter the dose, dose form or discontinue therapy without discussing with their healthcare provider. 3 The interactio Przeczytaj cały dokument