Land: Europeiska unionen
Språk: engelska
Källa: EMA (European Medicines Agency)
fosamprenavir calcium
ViiV Healthcare BV
J05AE07
fosamprenavir
Antivirals for systemic use
HIV Infections
Telzir in combination with low-dose ritonavir is indicated for the treatment of human-immunodeficiency-virus-type-1-infected adults, adolescents and children of six years and above in combination with other antiretroviral medicinal products. In moderately antiretroviral-experienced adults, Telzir in combination with low-dose ritonavir has not been shown to be as effective as lopinavir / ritonavir. No comparative studies have been undertaken in children or adolescents. In heavily pretreated patients, the use of Telzir in combination with low-dose ritonavir has not been sufficiently studied. In protease-inhibitor-experienced patients, the choice of Telzir should be based on individual viral resistance testing and treatment history.,
Revision: 48
Authorised
2004-07-12
77 B. PACKAGE LEAFLET 78 PACKAGE LEAFLET: INFORMATION FOR THE USER TELZIR 700 MG FILM-COATED TABLETS Fosamprenavir 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 TELZIR IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TELZIR 3. HOW TO TAKE TELZIR 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE TELZIR 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT TELZIR IS AND WHAT IT IS USED FOR TELZIR IS USED TO TREAT HIV (HUMAN IMMUNODEFICIENCY VIRUS) INFECTION. Telzir is a type of medicine known as an anti-retroviral. It is taken with low doses of another medicine, ritonavir, which boosts the level of Telzir in the blood. Telzir belongs to a group of anti-retroviral medicines called _protease inhibitors_ . Protease is an enzyme produced by HIV which enables the virus to multiply in white blood cells _(CD4 cells)_ in your blood. By stopping protease from working, Telzir stops HIV multiplying and infecting more CD4 cells. Telzir with low doses of ritonavir is used in combination with other anti-retroviral medicines (‘combination therapy’) to treat adults, adolescents and children aged over 6 years infected with HIV. HIV can become resistant to anti-HIV medicines. To avoid this happening, and to stop your illness getting worse, it is very important that you keep taking all your medicines exactly as prescribed. Telzir will not stop you passing on HIV. HIV infection is spread by sexual contact with someone who’s got the infection, or by transfer of infected blood (for example by Läs hela dokumentet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Telzir 700 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ Each film-coated tablet contains 700 mg of fosamprenavir as fosamprenavir calcium (equivalent to approximately 600 mg of amprenavir). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Pink film coated, capsule shaped, biconvex tablets, marked with GXLL7 on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Telzir in combination with low dose ritonavir is indicated for the treatment of Human Immunodeficiency Virus Type 1 (HIV-1) infected adults, adolescents and children of 6 years and above in combination with other antiretroviral medicinal products. In moderately antiretroviral experienced adults, Telzir in combination with low dose ritonavir has not been shown to be as effective as lopinavir / ritonavir. No comparative studies have been undertaken in children or adolescents. In heavily pretreated patients the use of Telzir in combination with low dose ritonavir has not been sufficiently studied. In protease inhibitor (PI) experienced patients the choice of Telzir should be based on individual viral resistance testing and treatment history (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Telzir must only be given with low dose ritonavir as a pharmacokinetic enhancer of amprenavir and in combination with other antiretroviral medicinal products. The Summary of Product Characteristics of ritonavir must therefore be consulted prior to initiation of therapy with Telzir. Therapy should be initiated by a physician experienced in the management of HIV infection. Fosamprenavir is a pro-drug of amprenavir and must not be administered concomitantly with other medicinal products containing amprenavir. The importance of complying with the full recommended dosing regimen should be stressed to all patients. Caution is advised if the recommended doses of Telzir with ritonavir detailed below are exceeded (s Läs hela dokumentet