Țară: Țările de Jos
Limbă: olandeză
Sursă: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
ATAZANAVIRSULFAAT SAMENSTELLING overeenkomend met ; ATAZANAVIR
Hetero Europe S.L.
J05AE08
ATAZANAVIRSULFAAT COMPOSITION corresponding to ; ATAZANAVIR
Capsule, hard
AMMONIA (E 527) ; BRILJANTBLAUW FCF (E 133) ; CROSPOVIDON (E 1202) ; GELATINE (E 441) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ZWART (E 172) ; KALIUMHYDROXIDE (E 525) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; TITAANDIOXIDE (E 171) ; ZWARTE INKT
Oraal gebruik
Atazanavir
2019-07-11
1 PACKAGE LEAFLET: INFORMATION FOR THE USER ATAZANAVIR HETERO 150 MG, HARDE CAPSULES ATAZANAVIR HETERO 200 MG, HARDE CAPSULES ATAZANAVIR HETERO 300 MG, HARDE 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 Hetero is and what it is used for 2. What you need to know before you take Atazanavir Hetero 3. How to take Atazanavir Hetero 4. Possible side effects 5. How to store Atazanavir Hetero 6. Contents of the pack and other information 1. WHAT ATAZANAVIR HETERO IS AND WHAT IT IS USED FOR ATAZANAVIR HETERO 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 Hetero reduces the risk of developing illnesses linked to HIV infection. Atazanavir Hetero capsules may be used by adults and children 6 years of age and older. Your doctor has prescribed Atazanavir Hetero 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 Hetero is best for you. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ATAZANAVIR HETERO DO NOT TAKE ATAZANAVIR HETERO: IF YOU ARE ALLERGIC to atazanavir or any of the ot Citiți documentul complet
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Atazanavir Hetero 150 mg, harde capsules Atazanavir Hetero 200 mg, harde capsules Atazanavir Hetero 300 mg, harde capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Atazanavir Hetero 150 mg hard capsules Each capsule contains atazanavir sulphate corresponding to 150 mg of atazanavir. Excipient(s) with known effect: 81.45 mg of lactose per capsule Atazanavir Hetero 200 mg hard capsules Each capsule contains atazanavir sulphate corresponding to 200 mg of atazanavir. Excipient(s) with known effect: 109 mg of lactose per capsule 0.0007 mg of sunset yellow FCF (E110) per capsule Atazanavir Hetero 300 mg hard capsules Each capsule contains atazanavir sulphate corresponding to 300 mg of atazanavir. Excipient(s) with known effect: 163 mg of lactose per capsule 0.41 mg of sunset yellow FCF (E110) per capsule For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule. Atazanavir Hetero 150 mg hard capsules Off white to pale yellow coloured granular powder filled in hard gelatin capsules of approx. 19.3 mm in length with green opaque cap imprinted with “H” in black colour and light green opaque body imprinted with “A6” in black colour. Atazanavir Hetero 200 mg hard capsules Off white to pale yellow coloured granular powder filled in hard gelatin capsules of approx. 21.4 mm in length with green opaque cap imprinted with “H” in black colour and light green opaque body imprinted with “A7” in black colour. Atazanavir Hetero 300 mg hard capsules Off white to pale yellow coloured granular powder filled in hard gelatin capsules of approx. 23.5 mm in length with orange opaque cap imprinted with “H” in black colour and green opaque body imprinted with “A8” in black colour. _ _ 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Atazanavir Hetero 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 combinati Citiți documentul complet