Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
enfuvirtide
Roche Registration GmbH
J05AX07
enfuvirtide
Antivirals for systemic use
HIV Infections
Fuzeon is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1-infected patients who have received treatment with and failed on regimens containing at least one medicinal product from each of the following antiretroviral classes: protease inhibitors, non-nucleoside reverse-transcriptase inhibitors and nucleoside reverse-transcriptase inhibitors, or who have intolerance to previous antiretroviral regimens.In deciding on a new regimen for patients who have failed an antiretroviral regimen, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different medicinal products. Where available, resistance testing may be appropriate.
Revision: 24
Authorised
2003-05-27
29 B. PACKAGE LEAFLET 30 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT FUZEON 90 MG/ML POWDER AND SOLVENT FOR SOLUTION FOR INJECTION Enfuvirtide READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, pharmacist or nurse. • 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Fuzeon is and what it is used for 2. What you need to know before you use Fuzeon 3. How to use Fuzeon 4. Possible side effects 5. How to store Fuzeon 6. Contents of the pack and other information 7. STEP-BY-STEP GUIDE TO INJECTING FUZEON 1. WHAT FUZEON IS AND WHAT IS IT USED FOR WHAT FUZEON IS Fuzeon contains the active substance enfuvirtide and belongs to a group of medicines called ‘antiretrovirals’. WHAT FUZEON IS USED FOR Fuzeon is used for the treatment of Human Immune deficiency Virus (HIV) - in combination with other antiretroviral medicines in patients infected with HIV. • Your doctor has prescribed Fuzeon to help control your HIV infection. • Fuzeon is not a cure for HIV infection. HOW FUZEON WORKS HIV attacks cells in your blood called CD4 or T-cells. The virus needs to make contact with, and get inside these cells in order for the virus to multiply. Fuzeon helps by preventing this. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE FUZEON DO NOT USE FUZEON IF • you are allergic to enfuvirtide or any of the other ingredients of this medicine (listed in section 6). If you are not sure, talk to your doctor, pharmacist or nurse before using Fuzeon. 31 WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before using Fuzeon if: • you have ever had any lung problems Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS _ _ 2 1. NAME OF THE MEDICINAL PRODUCT Fuzeon 90 mg/ml powder and solvent for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 108 mg enfuvirtide. Each ml of reconstituted solution contains 90 mg enfuvirtide. Excipient with known effect: sodium. Contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection. White to off-white lyophilised powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fuzeon is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected patients who have received treatment with and failed on regimens containing at least one medicinal product from each of the following antiretroviral classes: protease inhibitors, non- nucleoside reverse transcriptase inhibitors and nucleoside reverse transcriptase inhibitors, or who have intolerance to previous antiretroviral regimens (see section 5.1). _ _ _ _ In deciding on a new regimen for patients who have failed an antiretroviral regimen, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different medicinal products. Where available, resistance testing may be appropriate _ _ (see sections 4.4 and 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Fuzeon should be prescribed by physicians who are experienced in the treatment of HIV infection. Posology _Adults and adolescents _ ≥ _ 16 years:_ The recommended dose of Fuzeon is 90 mg twice daily injected subcutaneously into the upper arm, anterior thigh or abdomen. In case a Fuzeon dose is missed, patients should be instructed to administer the dose as soon as possible. However, if it is less than 6 hours before the next regular dose, the missed dose should be skipped. _Elderly_ : There is no experience in patients > 65 years old. 3 _Childre Aqra d-dokument sħiħ