Land: Neuseeland
Sprache: Englisch
Quelle: Medsafe (Medicines Safety Authority)
Darunavir ethanolate 81.31mg equivalent to darunavir 75 mg
Janssen-Cilag (New Zealand) Ltd
Darunavir ethanolate 81.31 mg (equivalent to darunavir 75 mg)
75 mg
Film coated tablet
Active: Darunavir ethanolate 81.31mg equivalent to darunavir 75 mg Excipient: Colloidal silicon dioxide Crospovidone Magnesium stearate Opadry white 85F18422 Purified water Silicified microcrystalline cellulose
Bottle, plastic, HDPE bottle with PP child resistant closure, 480 tablets, 480 tablets
Prescription
Prescription
Janssen Pharmaceutical Sciences Unlimited Company (JPSUC)
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.
Package - Contents - Shelf Life: Bottle, plastic, HDPE bottle with PP child resistant closure - 480 tablets - 36 months from date of manufacture stored at or below 30°C
2008-12-22
PREZISTA (230831) NZ CMI 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). 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 (listed in ingredients section below) or to ritonavir. 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 PREZISTA: • if the packaging is torn or shows signs of tampering. • if the expiry date (month and year) printed on the p Lesen Sie das vollständige Dokument
36.220704 1 PREZISTA (230831) ADS PREZISTA ® DARUNAVIR DATA SHEET 1. PRODUCT NAME PREZISTA 75 mg film-coated tablets PREZISTA 150 mg film-coated tablets PREZISTA 300 mg film-coated tablets PREZISTA 400 mg film-coated tablets PREZISTA 600 mg film-coated tablets PREZISTA 800 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 75 mg, 150 mg, 300 mg, 400 mg, 600 mg or 800 mg darunavir, as 81.31 mg, 162.62 mg, 325.23 mg, 433.64 mg, 650.46 or 867.28 mg darunavir ethanolate, respectively. Excipient(s) with known effect: The 300 mg, 400 mg and 600 mg tablets contains 1.375 mg, 0.834 mg and 2.750 mg sunset yellow FCF (E110), respectively. For the full list of excipients, see SECTION 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. PREZISTA 75 mg film-coated tablet: White caplet-shaped tablet, debossed with 75 on one side and TMC on the other side. PREZISTA 150 mg film-coated tablet: White oval-shaped tablet, debossed with 150 on one side and TMC on the other side. PREZISTA 300 mg film-coated tablet: Orange oval shaped tablet, debossed with 300MG on one side and TMC114 on the other side. PREZISTA 400 mg film-coated tablet: Light orange oval shaped tablet, debossed with 400MG on one side and TMC on the other side. PREZISTA 600 mg film-coated tablet: Orange oval shaped tablet, debossed with 600MG on one side and TMC on the other side. PREZISTA 800 mg film-coated tablet: Dark red oval-shaped tablet, debossed with 800 on one side and T on the other side. 36.220704 2 PREZISTA (230831) ADS 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. 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 trea Lesen Sie das vollständige Dokument