Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
atazanavir (as sulfate)
Krka, d.d., Novo mesto
J05AE08
atazanavir
Antivirals for systemic use
HIV Infections
Atazanavir Krka capsules, co-administered with low dose ritonavir, are 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).The choice of Atazanavir Krka in treatment experienced adult and paediatric patients should be based on individual viral resistance testing and the patient’s treatment history.
Revision: 2
Authorised
2019-03-25
53 B. PACKAGE LEAFLET 54 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ATAZANAVIR KRKA 150 MG HARD CAPSULES ATAZANAVIR KRKA 200 MG HARD CAPSULES ATAZANAVIR KRKA 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 Krka is and what it is used for 2. What you need to know before you take Atazanavir Krka 3. How to take Atazanavir Krka 4. Possible side effects 5. How to store Atazanavir Krka 6. Contents of the pack and other information 1. WHAT ATAZANAVIR KRKA IS AND WHAT IT IS USED FOR ATAZANAVIR KRKA 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 Krka reduces the risk of developing illnesses linked to HIV infection. Atazanavir Krka capsules may be used by adults and children 6 years of age and older. Your doctor has prescribed Atazanavir Krka 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 Krka is best for you. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ATAZANAVIR KRKA DO NOT TAKE ATAZANAVIR KRKA - IF YOU ARE ALLERGIC to atazanavir or any of the other ingr Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Atazanavir Krka 150 mg hard capsules Atazanavir Krka 200 mg hard capsules Atazanavir Krka 300 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _Atazanavir Krka 150 mg hard capsules_ Each hard capsule contains 150 mg atazanavir (as sulphate). Excipient with known effect Each hard capsule contains 79.43 mg lactose monohydrate. _Atazanavir Krka 200 mg hard capsules_ Each hard capsule contains 200 mg atazanavir (as sulphate). Excipient with known effect Each hard capsule contains 105.91 mg lactose monohydrate. _Atazanavir Krka 300 mg hard capsules_ Each hard capsule contains 300 mg atazanavir (as sulphate). Excipient with known effect Each hard capsule contains 158.86 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule (capsule) _Atazanavir Krka 150 mg hard capsules_ Hard gelatine capsule, size no. 1. The body of the capsule is white or almost white colour, the cap of the capsule is brownish-orange colour. The capsule cap is imprinted with black mark A150. The content of the capsule is yellowish-white to yellow-white powder. _Atazanavir Krka 200 mg hard capsules_ Hard gelatine capsule, size no. 0. The body and the cap of the capsule are brownish-orange colour. The capsule cap is imprinted with black mark A200. The content of the capsule is yellowish-white to yellow-white powder. _Atazanavir Krka 300 mg hard capsules_ Hard gelatine capsule, size no. 00. The body of the capsule is white or almost white colour, the cap of the capsule is dark brown colour. The capsule cap is imprinted with white mark A300. The content of the capsule is yellowish-white to yellow-white powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Atazanavir Krka capsules, co-administered with low dose ritonavir, are 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). Aqra d-dokument sħiħ