Nazione: Unione Europea
Lingua: inglese
Fonte: EMA (European Medicines Agency)
atazanavir (as sulfate)
Bristol-Myers Squibb Pharma EEIG
J05AE08
atazanavir sulfate
Antivirals for systemic use
HIV Infections
Reyataz 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).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 Reyataz in treatment experienced adult and paediatric patients should be based on individual viral resistance testing and the patient’s treatment history (see sections 4.4 and 5.1).Reyataz oral powder, co-administered with low dose ritonavir, is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected paediatric patients at least 3 months of age and weighing at least 5 kg (see section 4.2).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 Reyataz in treatment experienced adult and paediatric patients should be based on individual viral resistance testing and the patient’s treatment history (see sections 4.4 and 5.1).
Revision: 54
Authorised
2004-03-01
100 B. PACKAGE LEAFLET 101 PACKAGE LEAFLET: INFORMATION FOR THE USER REYATAZ 100 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 REYATAZ is and what it is used for 2. What you need to know before you take REYATAZ 3. How to take REYATAZ 4. Possible side effects 5. How to store REYATAZ 6. Contents of the pack and other information 1. WHAT REYATAZ IS AND WHAT IT IS USED FOR REYATAZ 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 REYATAZ reduces the risk of developing illnesses linked to HIV infection. REYATAZ capsules may be used by adults and children 6 years of age and older. Your doctor has prescribed REYATAZ 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 REYATAZ is best for you. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE REYATAZ DO NOT TAKE REYATAZ IF YOU ARE ALLERGIC to atazanavir or any of the other ingredients of this medicine (listed in section 6) IF YOU HAVE MODERATE TO SEVERE LIVER PROBLEMS. Your doctor will evaluate how severe your liver disease is before Leggi il documento completo
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT REYATAZ 100 mg hard capsules REYATAZ 150 mg hard capsules REYATAZ 200 mg hard capsules REYATAZ 300 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION REYATAZ 100 mg hard capsules Each capsule contains 100 mg of atazanavir (as sulphate). Excipient with known effect: 54.79 mg of lactose per capsule. REYATAZ 150 mg hard capsules Each capsule contains 150 mg of atazanavir (as sulphate). Excipient with known effect: 82.18 mg of lactose per capsule. REYATAZ 200 mg hard capsules Each capsule contains 200 mg of atazanavir (as sulphate). Excipient with known effect: 109.57 mg of lactose per capsule. REYATAZ 300 mg hard capsules Each capsule contains 300 mg of atazanavir (as sulphate). Excipient with known effect: 164.36 mg of lactose per capsule. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule REYATAZ 100 mg hard capsules Opaque blue and white capsule printed with white and blue inks, with "BMS 100 mg" on one half and with "3623" on the other half. REYATAZ 150 mg hard capsules Opaque blue and powder blue capsule printed with white and blue inks, with "BMS 150 mg" on one half and with "3624" on the other half. REYATAZ 200 mg hard capsules Opaque blue capsule printed with white ink, with "BMS 200 mg" on one half and with "3631" on the other half. 3 REYATAZ 300 mg hard capsules Opaque red and blue capsule printed with white ink, with "BMS 300 mg" on one half and with "3622" on the other half. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS REYATAZ 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). 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 REYATAZ in treatment-exp Leggi il documento completo