Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
atazanavir (as sulfate)
Mylan Pharmaceuticals Limited
J05AE08
atazanavir
Antivirals for systemic use
HIV Infections
Atazanavir Mylan, co-administered with low dose ritonavir, is indicated for the treatment of HIV 1 infected adults and paediatric patients 6 years of age and older in combination with other antiretroviral medicinal products.Based on available virological and clinical data from adult patients, no benefit is expected in patients with strains resistant to multiple protease inhibitors (≥ 4 PI mutations). There are very limited data available from children aged 6 to less than 18 years.The choice of Atazanavir Mylan in treatment experienced adult and paediatric patients should be based on individual viral resistance testing and the patient’s treatment history.
Revision: 14
Authorised
2016-08-22
69 B. PACKAGE LEAFLET 70 PACKAGE LEAFLET: INFORMATION FOR THE USER ATAZANAVIR MYLAN 150 MG HARD CAPSULES ATAZANAVIR MYLAN 200 MG HARD CAPSULES ATAZANAVIR MYLAN 300 MG HARD CAPSULES atazanavir READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Atazanavir Mylan is and what it is used for 2. What you need to know before you take Atazanavir Mylan 3. How to take Atazanavir Mylan 4. Possible side effects 5. How to store Atazanavir Mylan 6. Contents of the pack and other information 1. WHAT ATAZANAVIR MYLAN IS AND WHAT IT IS USED FOR ATAZANAVIR MYLAN IS AN ANTIVIRAL (OR ANTIRETROVIRAL) MEDICINE . It is one of a group called protease inhibitors. These medicines control Human Immunodeficiency Virus (HIV) infection by stopping a protein that the HIV needs for its multiplication. They work by reducing the amount of HIV in your body and this in turn, strengthens your immune system. In this way Atazanavir Mylan reduces the risk of developing illnesses linked to HIV infection. Atazanavir Mylan capsules may be used by adults and children 6 years of age and older. Your doctor has prescribed Atazanavir Mylan for you because you are infected by the HIV that causes Acquired Immunodeficiency Syndrome (AIDS). It is normally used in combination with other anti-HIV medicines. Your doctor will discuss with you which combination of these medicines with Atazanavir Mylan is best for you. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ATAZANAVIR MYLAN _ _ DO NOT TAKE ATAZANAVIR MYLAN • IF YOU ARE ALLERGIC to atazanavir or any of Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Atazanavir Mylan 150 mg hard capsules Atazanavir Mylan 200 mg hard capsules Atazanavir Mylan 300 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 150 mg capsules Each capsule contains 150 mg atazanavir (as sulphate) 200 mg capsules Each capsule contains 200 mg atazanavir (as sulphate) 300 mg capsules Each capsule contains 300 mg atazanavir (as sulphate) Excipient(s) with known effect 150 mg capsules Each capsule contains 84 mg lactose monohydrate 200 mg capsules Each capsule contains 112 mg lactose monohydrate 300 mg capsules Each capsule contains 168 mg lactose monohydrate For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule 150 mg capsules Atazanavir Mylan 150 mg capsules are greenish-blue and blue opaque hard shell gelatin capsules filled with white to pale yellow powder and approximately 19.3 mm in length. The capsules are axially printed with ‘MYLAN’ over ‘AR150’ in black ink on cap and body. 200 mg capsules Atazanavir Mylan 200 mg capsules are blue and greenish-blue opaque hard shell gelatin capsules filled with white to pale yellow powder and approximately 21.4 mm in length. The capsules are axially printed with ‘MYLAN’ over ‘AR200’ in black ink on cap and body. 3 300 mg capsules Atazanavir Mylan 300 mg capsules are red and greenish-blue opaque hard shell gelatine capsules filled with white to pale yellow powder and approximately 23.5 mm in length. The capsules are axially printed with ‘MYLAN’ over ‘AR300’ in black ink on cap and body. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Atazanavir Mylan, co-administered with low dose ritonavir, is indicated for the treatment of HIV-1-infected adults and paediatric patients 6 years of age and older in combination with other antiretroviral medicinal products (see section 4.2). Based on available virological and clinical data from adult patients, no benefit is expected in patients with strains resistant to multip Aqra d-dokument sħiħ