Maa: Uusi-Seelanti
Kieli: englanti
Lähde: Medsafe (Medicines Safety Authority)
Darunavir 400mg; Darunavir 400mg
Viatris Limited
Darunavir 400 mg
400 mg
Film coated tablet
Active: Darunavir 400mg Excipient: Colloidal silicon dioxide Crospovidone Hypromellose Magnesium stearate Microcrystalline cellulose Opadry Orange 85F530014 Sodium starch glycolate Active: Darunavir 400mg Excipient: Colloidal silicon dioxide Crospovidone Hypromellose Magnesium stearate Microcrystalline cellulose Opadry white 85F18422 Purified water Sodium starch glycolate
Prescription
Mylan Laboratories Limited
Darunavir Viatris (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. Darunavir Viatris (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 greater than or equal to 6 years old and weighing at least 40 kg.
Package - Contents - Shelf Life: Blister pack, PVC/PE/PVdC - Alu - 60 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PE/PVdC - Alu - 100 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, HDPE 100cc, Closure: White PP screw CRC cap with induction sealing liner - 60 tablets - 24 months from date of manufacture stored at or below 25°C - Bottle, HDPE 150cc, Closure: Blue PP screw cap with induction sealing liner - 100 tablets - 24 months from date of manufacture stored at or below 25°C
2016-01-06
Page 1 of 6 NEW ZEALAND CONSUMER MEDICINE INFORMATION DARUNAVIR VIATRIS _DARUNAVIR FILM COATED TABLET 400 & 600 MG_ WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start taking Darunavir Viatris. This leaflet answers some common questions about Darunavir Viatris. 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 taking Darunavir Viatris against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT DARUNAVIR VIATRIS IS USED FOR Darunavir Viatris is used to treat • Human immunodeficiency virus- 1 (HIV-1) infection in adult patients. • Human immunodeficiency virus (HIV) infection in treatment- experienced paediatric patients aged ≥ 6 years old and weighing at least 40 kg. Darunavir Viatris must be taken in combination with a low dose ritonavir, and with other anti-HIV medicines. Darunavir Viatris contains the active ingredient darunavir_._ It belongs to a group of medicines called protease inhibitors. It 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 illness as a result of HIV infection. Your doctor may have prescribed this medicine for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. This medicine is available only with a doctor’s prescription. BEFORE YOU TAKE DARUNAVIR VIATRIS _WHEN YOU MUST NOT TAKE _ _IT_ DO NOT TAKE DARUNAVIR VIATRIS IF YOU HAVE AN ALLERGY TO: • any medicine containing darunavir. • any of the ingredients listed at the end of this leaflet. • Some of the symptoms of an allergic reaction may include: shortness of breath; wheezing or difficulty breathing; swelling of the face, lips, tongue or other part Lue koko asiakirja
Page 1 of 52 NEW ZEALAND DATA SHEET DARUNAVIR VIATRIS 1. PRODUCT NAME Darunavir Viatris, 300 mg, 400 mg & 600 mg, film coated tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film coated tablet contains 300 mg, 400 mg or 600 mg of darunavir. Excipients with known effect: Sodium starch glycolate Allergen Declaration: Contains phenylalanine For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Darunavir Viatris 300 mg – White to Off white, oval shaped, biconvex film coated tablets debossed with 'M' on one side of the tablet and 'DV3' on other side. Dimensions: (16.50 x 8.20) + 0.3 mm approximately. Darunavir Viatris 400 mg – White to Off white, oval shaped, biconvex film coated tablets debossed with 'M' on one side of the tablet and 'DV4' on other side. Dimensions: (19.15 x 9.60) + 0.3 mm approximately. Darunavir Viatris 600 mg – White to Off white, oval shaped, biconvex film coated tablets debossed with 'M' on one side of the tablet and 'DV5' on other side. Dimensions: (21.20 x 10.60) + 0.3 mm approximately. 4. CLINICAL PARTICULARS _4.1 _ _THERAPEUTIC INDICATIONS_ _ADULT PATIENTS_ Darunavir Viatris (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 Viatris (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 old and weighing at least 40 kg. Page 2 of 52 _4.2_ _DOSE AND METHOD OF ADMINISTRATION_ DOSE _ANTIRETROVIRAL TREATMENT-NAÏVE PATIENTS_ The recommended dosage of darunavir is 800 mg once daily (q.d.) taken with ritonavir 100 mg q.d. and with food. _ANTIRETROVIRAL TREATMENT-EXPERIENCED PATIENTS_ For antiretroviral treatment experienced patients, genotypic testing is recommended. However, when genotypic tes Lue koko asiakirja