Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DARUNAVIR ETHANOLATE; Cobicistat on silicon dioxide
JOHNSON & JOHNSON SDN BHD
DARUNAVIR ETHANOLATE; Cobicistat on silicon dioxide
30 Tablets
Janssen Ortho LLC
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ PREZCOBIX ® (DARUNAVIR/COBICISTAT) 800MG/150MG FILM-COATED TABLETS Darunavir/Cobicistat (800mg/150mg) 1 WHAT IS IN THIS LEAFLET 1. What PREZCOBIX ® is used for 2. How PREZCOBIX ® works 3. Before you use PREZCOBIX ® 4. How to use PREZCOBIX ® 5. While you are using it 6. Side effects 7. Storage and disposal of PREZCOBIX ® 8. Product description 9. Manufacturer and product registration holder 10. Date of revision WHAT PREZCOBIX ® IS USED FOR PREZCOBIX ® is used to treat adults infected by HIV-1 (Human Immunodeficiency Virus-1), who may or may not have received prior treatment. PREZCOBIX ® should be taken with other anti-HIV medicines. Your doctor will discuss with you which combination of medicines will work best with PREZCOBIX ® . HOW PREZCOBIX ® WORKS PREZCOBIX ® contains two active ingredients which work in combination for the treatment of HIV. These active ingredients are darunavir and cobicistat. Darunavir is an antiretroviral medicine. It belongs to a group of medicines called protease inhibitors. Darunavir works by reducing the amount of HIV in your body. Reducing the amount of HIV in your blood improves your immune system, and reduces the risk of developing illnesses as a result of HIV infection. Cobicistat is a type of medicine called a pharmacokinetic enhancer (or "booster"). Cobicistat helps increase the levels of darunavir, the HIV medicine in your body. BEFORE YOU USE PREZCOBIX ® It is important to tell your doctor if you are taking corticosteroids such as betamethasone, budesonide, fluticasone, mometasone, prednisone and triamcinolone. These medicines are used to treat allergies, asthma, inflammatory bowel diseases, inflammatory conditions of the eyes, joints and muscles and other inflammatory conditions. If alternatives cannot be used, its use should only take place after medical evaluation and under close monitoring by your doctor for corticosteroid side effects. - _When you must not use it _ Do not take PREZCOBIX ® • if you are aller Baca dokumen lengkap
1 1. NAME OF THE MEDICINE PREZCOBIX ® (darunavir/cobicistat) 800 mg/150 mg Film-Coated Tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION PREZCOBIX 800/150 mg tablets contain 800 mg of darunavir (as 867.28 mg darunavir ethanolate) and 150 mg of cobicistat. For a full list of excipients, see SECTION 6.1 List of excipients. 3. PHARMACEUTICAL FORM PREZCOBIX 800/150 mg film-coated tablet: Pink oval-shaped tablet, debossed with “800” on one side and “TG” on the opposite side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS PREZCOBIX, a fixed dose combination of darunavir and cobicistat, is indicated in combination with other antiretroviral agents for the treatment of adult patients with human immunodeficiency virus-1 (HIV-1) infection in: - Antiretroviral treatment-naïve patients - Antiretroviral treatment-experienced patients with no darunavir resistance associated mutations and who have plasma HIV-1 RNA <100,000 copies/mL and CD4+ cell count ≥ 100 cells x 10 6 /L - Antiretroviral treatment-experienced but HIV protease inhibitor-naive patients for whom HIV- 1 genotype testing is unavailable and who have plasma HIV-1 RNA < 100,000 copies/mL and CD4+ cell count ≥ 100 cells x 10 6 /L (see SECTION 4.2 Dose and method of administration) 4.2 DOSE AND METHOD OF ADMINISTRATION DOSE IN ADULTS The recommended dose regimen is PREZCOBIX one tablet taken once daily with food. The type of food does not affect the exposure to PREZCOBIX. For antiretroviral treatment-experienced patients* HIV-1 genotype testing is recommended. *Darunavir resistance associated mutations: V11l, V32l, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V, L89V. When HIV genotypic testing is not feasible: • PREZISTA (darunavir) should be used for protease inhibitor-experienced patients. Refer to PREZISTA Product Information for dosing recommendations. • PREZCOBIX can be used in protease inhibitor naïve patients DOSE IN PAEDIATRIC PATIENTS (17 YEARS OF AGE AND YOUNGER) The safety and efficacy of PREZCOBIX have not been established in paedi Baca dokumen lengkap