Country: Malta
Lingwa: Ingliż
Sors: Medicines Authority
ATAZANAVIR SULFATE
Teva B.V. Swensweg 5, 2031 GA Haarlem, Netherlands
J05AE08
ATAZANAVIR SULFATE 150 mg
HARD CAPSULE
ATAZANAVIR SULFATE 150 mg
POM
ANTIVIRALS FOR SYSTEMIC USE
Withdrawn
2015-12-21
1 PACKAGE LEAFLET: INFORMATION FOR THE USER ATAZANAVIR TEVA 150 MG CAPSULES, HARD ATAZANAVIR TEVA 200 MG CAPSULES, HARD ATAZANAVIR TEVA 300 MG CAPSULES, HARD 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 Teva is and what it is used for 2. What you need to know before you take Atazanavir Teva 3. How to take Atazanavir Teva 4. Possible side effects 5. How to store Atazanavir Teva 6. Contents of the pack and other information 1. WHAT ATAZANAVIR TEVA IS AND WHAT IT IS USED FOR Atazanavir Teva 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 Teva reduces the risk of developing illnesses linked to HIV infection. Atazanavir Teva capsules may be used by adults and children 6 years of age and older. Your doctor has prescribed Atazanavir Teva 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 Teva is best for you. Atazanavir Teva is not a cure for HIV infection. You may continue to develop infections or other illnesses linked to HIV infection. You can still pass on HIV when taki Aqra d-dokument sħiħ
Page 1 of 37 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Atazanavir Teva 150 mg Capsules, hard Atazanavir Teva 200 mg Capsules, hard Atazanavir Teva 300 mg Capsules, hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains atazanavir sulfate corresponding to 150 mg, 200 mg and 300 mg of atazanavir. Excipient with known effect: Each 150 mg capsule contains 67.2 mg of lactose monohydrate. Each 200 mg capsule contains 89.6 mg of lactose monohydrate. Each 300 mg capsule contains 134.4 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard Atazanavir Teva 150 mg hard capsules are non transparent size 1 capsules with overall closed length 19.4 ± 0.3 mm, with dark blue cap, and black mark 150 on light blue body. The content of the capsule is light yellow powder. Atazanavir Teva 200 mg hard capsules are non transparent size 0 capsules with overall closed length 21.7 ± 0.3 mm with blue cap, and black mark 200 on blue body. The content of the capsule is light yellow powder. Atazanavir Teva 300 mg hard capsules are non transparent size 00 capsules with overall closed length 23.3 ± 0.3 mm with red cap, and black mark 300 on blue body. The content of the capsule is light yellow powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Atazanavir Teva 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). There are very limited data available from children aged 6 to less than 18 years (see sections 4.4 and 5.1). 2 The choice of Atazanavir Teva in treatment experienced adult and paediatric patients should be based on individual viral resistance testing and the patient’s treatment history (se Aqra d-dokument sħiħ