Țară: Australia
Limbă: engleză
Sursă: Department of Health (Therapeutic Goods Administration)
darunavir, Quantity: 800 mg; cobicistat, Quantity: 150 mg
Janssen-Cilag Pty Ltd
Cobicistat,Darunavir
Tablet, film coated
Excipient Ingredients: microcrystalline cellulose; crospovidone; silicon dioxide; magnesium stearate; hypromellose; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black
Oral
30
(S4) Prescription Only Medicine
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-naive patients,- Antiretroviral treatment-experienced patients with no darunavir resistance associated mutations and who have plasma HIV-1 RNA <100,000 copies/mL,- Antiretroviral treatment-experienced but HIV protease inhibitor-naive patients for whom HIV-1 genotype testing is unavailable (see section 4.2 Dose and method of administration)
Visual Identification: Pink oval-shaped tablet, debossed with "800" on one side and "TG" on the opposite side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2015-09-24
PREZCOBIX (211103) ACMI 1 PREZCOBIX ® TABLETS _Darunavir/cobicistat _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE This leaflet answers some common questions about PREZCOBIX tablets. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you being given PREZCOBIX against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN PREZCOBIX ASK YOUR DOCTOR. KEEP THIS LEAFLET WHILE YOU ARE TAKING PREZCOBIX. You may need to read it again. WHAT PREZCOBIX IS USED FOR PREZCOBIX is used to treat adults, who are infected by HIV (Human Immunodeficiency Virus). 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. PREZCOBIX can be taken with other anti-HIV medicines. Your doctor will discuss with you which combination of medicines will work best with PREZCOBIX. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY PREZCOBIX HAS BEEN PRESCRIBED FOR YOU. THIS MEDICINE IS AVAILABLE ONLY WITH A DOCTOR'S PRESCRIPTION. BEFORE YOU TAKE PREZCOBIX _WHEN YOU MUST NOT USE IT: _ DO NOT TAKE PREZCOBIX: • if you are allergic (hypersensitive) to darunavir, cobicistat or any of the other ingredients of PREZCOBIX. Symptoms of an allergic reaction may include rash, itching or hives on the skin, shortness of breath, wheezing o Citiți documentul complet
CCDS210601 1 PREZCOBIX (211021) API AUSTRALIAN PRODUCT INFORMATION PREZCOBIX ® DARUNAVIR/COBICISTAT FILM-COATED TABLETS 1. NAME OF THE MEDICINE Darunavir/cobicistat 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-naive patients - Antiretroviral treatment-experienced patients with no darunavir resistance associated mutations and who have plasma HIV-1 RNA <100,000 copies/mL - Antiretroviral treatment-experienced but HIV protease inhibitor-naive patients for whom HIV-1 genotype testing is unavailable (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. Product Information - Australia CCDS210601 2 PREZCOBIX (211021) API 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 paedia Citiți documentul complet