Země: Austrálie
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
darunavir, Quantity: 600 mg
Juno Pharmaceuticals Pty Ltd
Tablet, film coated
Excipient Ingredients: crospovidone; magnesium stearate; purified talc; polyvinyl alcohol; hyprolose; polacrilin potassium; macrogol 4000; sodium chloride; titanium dioxide; iron oxide red; silicified microcrystalline cellulose; colloidal anhydrous silica; iron oxide yellow
Oral
60 tablets
(S4) Prescription Only Medicine
Adult patients,DARUNAVIR JUNO (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,DARUNAVIR JUNO (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: DARUNAVIR JUNO 600 mg film-coated tablets are beige-coloured, oval shaped, biconvex, debossed with D on one side and 600 on the other.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 30 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Registered
2020-04-22
1 DARUNAVIR JUNO _Darunavir (da-ROO-nuh-veer) _ _ _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Darunavir Juno 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 Darunavir Juno against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WHILE YOU ARE TAKING DARUNAVIR JUNO. You may need to read it again. WHAT DARUNAVIR JUNO IS USED FOR Darunavir Juno is an antiretroviral medicine. It belongs to a group of medicines called protease (PRO- tee-ase) inhibitors. Darunavir Juno 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. Darunavir Juno 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, Darunavir Juno must be taken in combination with cobicistat or with a low dose of ritonavir, and with other anti-HIV medicines. In children, Darunavir Juno 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 Darunavir Juno. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY DARUNAVIR JUNO HAS BEEN PRESCRIBED FOR YOU. THIS MEDICINE IS AVAILABLE ONLY WITH A DOCTOR'S PRESCRIPTION. BEFORE YOU TAKE DARUNAVIR JUNO _WHEN YOU MUST NOT USE IT: _ DO NOT TAKE DARUNAVIR JUNO: • if you are allergic (hypersensitive) to darunavir, other ingredients of DARUNAVIR JUNO 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, swell Přečtěte si celý dokument
DARUNAVIR JUNO PI Ver 4.0 1 AUSTRALIAN PRODUCT INFORMATION – DARUNAVIR JUNO (DARUNAVIR) 1. NAME OF THE MEDICINE Darunavir 2. QUALITIATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 600 mg or 800 mg of darunavir. For a full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3. PHARMACEUTICAL FORM DARUNAVIR JUNO 600 mg film-coated tablets are beige-coloured, oval shaped, biconvex, film coated tablets, debossed with “D” on one side and “600” on the other side. DARUNAVIR JUNO 800 mg film-coated tablets are brown colored, oval shaped, biconvex, film-coated tablets, debossed with “D” on one side and “800” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ADULT PATIENTS DARUNAVIR JUNO (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 DARUNAVIR JUNO (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 _DARUNAVIR Juno is unavailable in tablet strengths below 600 mg. For paediatric patients _ _requiring treatment with lower strengths of darunavir, other brands are available. _ DOSAGE (DOSE AND INTERVAL) _Adults: _ For antiretroviral treatment-experienced patients, HIV-1 genotype testing is recommended. _Once Daily Dose _ The recommended dose of DARUNAVIR JUNO is 800 mg once daily with ritonavir 100 mg once daily taken with food. The once daily dose regimen is recommended for the following patients: • Antiretroviral treatment-naive patients DARUNAVIR JUNO PI Ver 4.0 2 • Antiretroviral treatment-experienced patients with no darunavir resistance associated mutations* and who have plasma HIV-1 RNA <100,000 copies/ml • Antiretrovi Přečtěte si celý dokument