Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
tipranavir
Boehringer Ingelheim International GmbH
J05AE09
tipranavir
Antivirals for systemic use
HIV Infections
Aptivus, co-administered with low-dose ritonavir, is indicated for combination antiretroviral treatment of HIV-1 infection in highly pretreated adults and adolescents 12 years of age or older with virus resistant to multiple protease inhibitors.Aptivus should only be used as part of an active combination antiretroviral regimen in patients with no other therapeutic options.This indication is based on the results of two phase-III studies, performed in highly pretreated adult patients (median number of 12 prior antiretroviral agents) with virus resistant to protease inhibitors and of one phase-II study investigating pharmacokinetics, safety and efficacy of Aptivus in mostly treatment-experienced adolescent patients aged 12 to 18 years.In deciding to initiate treatment with Aptivus, co-administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. Genotypic or phenotypic testing (when available) and treatment history should guide the use of Aptivus. Initiation of treatment should take into account the combinations of mutations which may negatively impact the virological response to Aptivus, co-administered with low-dose ritonavir.
Revision: 42
Authorised
2005-10-25
45 B. PACKAGE LEAFLET 46 PACKAGE LEAFLET: INFORMATION FOR THE USER APTIVUS 250 MG SOFT CAPSULES tipranavir 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, please ask your doctor or your 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 Aptivus is and what it is used for 2. What you need to know before you take Aptivus 3. How to take Aptivus 4. Possible side effects 5. How to store Aptivus 6. Contents of the pack and other information IF APTIVUS HAS BEEN PRESCRIBED FOR YOUR CHILD, PLEASE NOTE THAT ALL INFORMATION IN THIS LEAFLET IS ADDRESSED TO YOUR CHILD (IN THIS CASE PLEASE READ “YOUR CHILD” INSTEAD OF “YOU”). 1. WHAT APTIVUS IS AND WHAT IT IS USED FOR Aptivus contains the active substance tipranavir. It belongs to a group of medicines called protease inhibitors and is used in the treatment of Human Immunodeficiency Virus (HIV) infection. It blocks an enzyme called protease that is involved in the reproduction of HIV. When the enzyme is blocked, the virus does not reproduce normally, slowing down the infection. You must take Aptivus together with: low dose ritonavir (this helps Aptivus to reach a high enough level in your blood) other HIV medicines. Your doctor, together with you, will decide which other medicines you should take. This will depend on, for example: which other medicines you have already taken for HIV which medicines your HIV is resistant to. If your HIV is resistant to some HIV medicines, this means that the medicine will not work so well, or will not work at all. Aptivus is specifically used for the treatment of HIV which Lestu allt skjalið
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Aptivus 250 mg soft capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each soft capsule contains 250 mg tipranavir. Excipients with known effect: Each soft capsule contains 100.0 mg ethanol, 455.0 mg macrogolglycerol ricinoleate and 12.6 mg sorbitol For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Soft capsule. Pink, oblong soft gelatin capsules imprinted with “TPV 250” in black. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Aptivus, co-administered with low dose ritonavir, is indicated for combination antiretroviral treatment of HIV-1 infection in highly pre-treated adults and adolescents 12 years of age or older who have a Body Surface Area (BSA) of ≥1.3 m 2 or weight ≥36 kg and with virus resistant to multiple protease inhibitors. Aptivus should only be used as part of an active combination antiretroviral regimen in patients with no other therapeutic options. In deciding to initiate treatment with Aptivus, co-administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. Genotypic or phenotypic testing (when available) and treatment history should guide the use of Aptivus. Initiation of treatment should take into account the combinations of mutations which may negatively impact the virological response to Aptivus, co- administered with low dose ritonavir (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Aptivus must always be given with low dose ritonavir as a pharmacokinetic enhancer, 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 Aptivus (especially as regards the contraindications, warnings and undesirable effects sections). Aptivus should be prescribed by physicians who are experienced in the treatment of HIV-1 infectio Lestu allt skjalið