Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
darunavir, Quantity: 400 mg
Janssen-Cilag Pty Ltd
Darunavir
Tablet, film coated
Excipient Ingredients: colloidal anhydrous silica; purified talc; microcrystalline cellulose; crospovidone; macrogol 3350; sunset yellow FCF aluminium lake; polyvinyl alcohol; magnesium stearate; 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: Light orange, oval-shaped, film-coated tablet debossed with '400MG' 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
_ _ 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 Read the complete document