Country: Եվրոպական Միություն
language: անգլերեն
source: EMA (European Medicines Agency)
darunavir
Janssen-Cilag International NV
J05AE10
darunavir
Antivirals for systemic use
HIV Infections
PREZISTA, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV 1) infection in adult and paediatric patients from the age of 3 years and at least 15 kg body weight.PREZISTA, 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).In deciding to initiate treatment with PREZISTA co administered with cobicistat or 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 PREZISTA.PREZISTA, 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.PREZISTA 75 mg, 150 mg, and 600 mg tablets may be used to provide suitable dose regimens: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 PREZISTA 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 PREZISTA.PREZISTA, 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.PREZISTA, 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).PREZISTA 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.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 PREZISTA in such ART experienced patients, genotypic testing should guide the use of PREZISTA.
Revision: 54
Authorised
2007-02-11
144 B. PACKAGE LEAFLET 145 PACKAGE LEAFLET: INFORMATION FOR THE USER PREZISTA 100 MG/ML ORAL SUSPENSION 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 PREZISTA is and what it is used for 2. What you need to know before you take PREZISTA 3. How to take PREZISTA 4. Possible side effects 5. How to store PREZISTA 6. Contents of the pack and other information 1. WHAT PREZISTA IS AND WHAT IT IS USED FOR WHAT IS PREZISTA? PREZISTA contains the active substance darunavir. PREZISTA is an antiretroviral medicine used in the treatment of Human Immunodeficiency Virus (HIV) infection. It belongs to a group of medicines called protease inhibitors. PREZISTA 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? PREZISTA is used to treat HIV infected adults as well as HIV infected children of 3 years of age and above, and at least 15 kilogram body weight (see HOW TO TAKE PREZISTA). PREZISTA must be taken in combination with a low dose of cobicistat or 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 PREZISTA DO NOT TAKE PREZISTA - if you are ALLERGIC to darunavir or any of the other ingredients of this medicine (listed in section 6) or to cobicistat or ritonavir. - if you have SEVERE LIVER PROBLEMS. Ask your doctor if you are unsure about the severity of read_full_document
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT PREZISTA 100 mg/ml oral suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of oral suspension contains 100 mg of darunavir (as ethanolate). Excipient with known effect: sodium methyl parahydroxybenzoate (E219) 3.43 mg/ml. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral suspension White to off-white opaque suspension 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS PREZISTA, co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in adult and paediatric patients from the age of 3 years and at least 15 kg body weight (see section 4.2). PREZISTA, 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). In deciding to initiate treatment with PREZISTA co-administered with cobicistat or 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 PREZISTA (see sections 4.2, 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 PREZISTA has been initiated, patients should be advised not to alter the dosage, dose form or discontinue therapy without discussing with their healthcare provider. The interaction profile of darunavir depends on whether ritonavir or cobicistat is used as pharmacokinetic enhancer. Darunavir may therefore have different contraindications and recommendations for concomitant medications depending on whether the compound is read_full_document