国家: 荷兰
语言: 荷兰文
来源: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
ATAZANAVIRSULFAAT 341,7 mg/stuk SAMENSTELLING overeenkomend met ; ATAZANAVIR 300 mg/stuk
Medicopharm AG Stangenreiterstraße 4 83131 NUßDORF AM INN (DUITSLAND)
J05AE08
ATAZANAVIRSULFAAT 341,7 mg/stuk SAMENSTELLING overeenkomend met ; ATAZANAVIR 300 mg/stuk
Capsule, hard
AMMONIA (E 527) ; BRILJANTBLAUW FCF (E 133) ; CROSPOVIDON (E 1202) ; ERYTHROSINE (E 127) ; 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) ; ZONNEGEEL FCF (E 110) ; ZWARTE INKT
Oraal gebruik
Atazanavir
1900-01-01
1 PACKAGE LEAFLET: INFORMATION FOR THE USER ATAZANAVIR MEDICOPHARM 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 [Invented name] is and what it is used for 2. What you need to know before you take [Invented name] 3. How to take [Invented name] 4. Possible side effects 5. How to store [Invented name] 6. Contents of the pack and other information 1. WHAT [INVENTED NAME] IS AND WHAT IT IS USED FOR [INVENTED NAME] 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 [Invented name] reduces the risk of developing illnesses linked to HIV infection. [Invented name] capsules may be used by adults and children 6 years of age and older. Your doctor has prescribed [Invented name] 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 [Invented name] is best for you. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE [INVENTED NAME] DO NOT TAKE [INVENTED NAME]: ▪ 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 PROB 阅读完整的文件
1 1. NAME OF THE MEDICINAL PRODUCT Atazanavir Medicopharm 300 mg, harde capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Atazanavir Medicopharm 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 Medicopharm 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 Medicopharm 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 Atazanavir Medicopharm 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). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Therapy should be initiated by a physician experienced in the management of HIV infection. Posology _Adults_ The recommended dose of Atazanavir Medicopharm capsules is 300 mg once daily taken with ritonavir 100 mg once daily and with food. Ritonavir is used as a booster of atazanavir pharmacokinetics (see sections 4.5 and 5.1). (See also section 4.4 Withdrawal of ritonavir only under restrictive conditions). _Paediatric population (6 years to less than 18 years of age and weighing at least 15 kg)_ The dose of atazanavir capsules for paediatric patients is based on bo 阅读完整的文件