Land: Australien
Sprache: Englisch
Quelle: Department of Health (Therapeutic Goods Administration)
darunavir, Quantity: 600 mg
Janssen-Cilag Pty Ltd
Darunavir
Tablet, film coated
Excipient Ingredients: magnesium stearate; purified talc; polyvinyl alcohol; macrogol 3350; crospovidone; colloidal anhydrous silica; microcrystalline cellulose; sunset yellow FCF aluminium lake; titanium dioxide
Oral
60 tablets
(S4) Prescription Only Medicine
Adult Patients,PREZISTA ( with low dose ritonavir as a pharmacokinetic enhancer) is indicated in combination with other antiretroviral agents, for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adult patients.,Paediatric Patients,PREZISTA (with low dose ritonavir as a pharmacokinetic enhancer) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV) infection in treatment-experienced paediatric patients aged 6 years and older, weighing at least 20 kg.
Visual Identification: Orange, oval-shaped, film-coated tablet debossed with '600MG' on one side and 'TMC' on the other; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
2009-07-30
PREZISTA (211105) ACMI 1 PREZISTA ® TABLETS _darunavir (da-ROO-nuh-veer) _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about PREZISTA (pre- ZIS-ta) 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 PREZISTA against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN PREZISTA ASK YOUR DOCTOR. KEEP THIS LEAFLET WHILE YOU ARE TAKING PREZISTA. You may need to read it again. WHAT PREZISTA IS USED FOR PREZISTA is an antiretroviral medicine. It belongs to a group of medicines called protease (PRO-tee- ase) inhibitors. PREZISTA 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. PREZISTA is used to treat adults, and children 6 years of age or above weighing more than 20 kg, who are infected by HIV (Human Immunodeficiency Virus). In adults, PREZISTA must be taken in combination with cobicistat or with a low dose of ritonavir, and with other anti-HIV medicines. In children, PREZISTA must be taken in combination with a low dose of ritonavir, and with other anti-HIV medicines. Your doctor will discuss with you which combination of medicines will work best with PREZISTA. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY PREZISTA HAS BEEN PRESCRIBED FOR YOU. THIS MEDICINE IS AVAILABLE ONLY WITH A DOCTOR'S PRESCRIPTION. BEFORE YOU TAKE PREZISTA _WHEN YOU MUST NOT USE IT: _ DO NOT TAKE PREZISTA: • if you are allergic (hypersensitive) to darunavir, other ingredients of PREZISTA or to ritonavir or to cobicistat. Symptoms of an allergic reaction may include rash, itching or hives on the skin, shortness of breath, wheezing or difficulty breathing, swelling of the face, lips, tongue or other parts of the body. DO NOT TAKE P Lesen Sie das vollständige Dokument
_ _ CCDS210601 Page 1 PREZISTA (211102) API AUSTRALIAN PRODUCT INFORMATION PREZISTA ® DARUNAVIR FILM-COATED TABLET 1. NAME OF THE MEDICINE Darunavir 2. QUALITATIVE AND QUANTITATIVE COMPOSITION PREZISTA darunavir is available as 75 mg, 400 mg, 600 mg and 800 mg film-coated tablets (the 75 mg and 400 mg tablets are not currently marketed). Each film-coated tablet contains 75 mg, 400 mg, 600 mg or 800 mg of darunavir, as 81.31 mg, 433.64 mg, 650.46 mg or 867.28 mg of darunavir ethanolate, respectively. For a full list of excipients, see section 6.1 List of Excipients. 3. PHARMACEUTICAL FORM PREZISTA 75 mg film-coated tablets are white caplet-shaped tablets, debossed with 75 on one side and TMC on the other side (currently not marketed). PREZISTA 400 mg film-coated tablets are light orange oval shaped tablets, debossed with 400MG on one side and TMC on the other side (currently not marketed). PREZISTA 600 mg film-coated tablets are orange oval shaped tablets, debossed with 600MG on one side and TMC on the other side. PREZISTA 800 mg film-coated tablets are dark red oval-shaped tablets, debossed with 800 on one side and T on the other side. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS ADULT PATIENTS PREZISTA (with low dose ritonavir as a pharmacokinetic enhancer) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adult patients. _ _ CCDS210601 Page 2 PREZISTA (211102) API PAEDIATRIC PATIENTS PREZISTA (with low dose ritonavir as a pharmacokinetic enhancer) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV) infection in treatment-experienced paediatric patients aged 6 years and older, weighing at least 20 kg. 4.2. DOSE AND METHOD OF ADMINISTRATION DOSAGE (DOSE AND INTERVAL) _Adults: _ For antiretroviral treatment-experienced patients, HIV-1 genotype testing is recommended_. _ _Once Daily Dose _ The recommended dose of PREZISTA is 800 mg once daily with ritonavir 10 Lesen Sie das vollständige Dokument