Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
lamivudine, zidovudine
Teva Pharma B.V.
J05AR01
lamivudine, zidovudine
Antivirals for systemic use
HIV Infections
Lamivudine/Zidovudine Teva is indicated in antiretroviral combination therapy for the treatment of human-immunodeficiency-virus (HIV) infection.
Revision: 16
Withdrawn
2011-02-28
32 B. PACKAGE LEAFLET Medicinal product no longer authorised 33 PACKAGE LEAFLET: INFORMATION FOR THE USER LAMIVUDINE/ZIDOVUDINE TEVA 150 MG/300 MG FILM-COATED TABLETS lamivudine/zidovudine 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 Lamivudine/Zidovudine Teva is and what it is used for 2. What you need to know before you take Lamivudine/Zidovudine Teva 3. How to take Lamivudine/Zidovudine Teva 4. Possible side effects 5. How to store Lamivudine/Zidovudine Teva 6. Contents of the pack and other information 1. WHAT LAMIVUDINE/ZIDOVUDINE TEVA IS AND WHAT IT IS USED FOR LAMIVUDINE/ZIDOVUDINE TEVA IS USED TO TREAT HIV (HUMAN IMMUNODEFICIENCY VIRUS) INFECTION IN ADULTS AND CHILDREN. Lamivudine/Zidovudine Teva contains two active ingredients that are used to treat HIV infection: lamivudine and zidovudine. Both of these belong to a group of anti-retroviral medicines called _nucleoside analogue reverse transcriptase inhibitors_ ( _NRTIs_ ) _. _ _ _ Lamivudine/Zidovudine Teva does not completely cure HIV infection; it reduces the amount of virus in your body, and keeps it at a low level. It also increases the CD4 cell count in your blood. CD4 cells are a type of white blood cells that are important in helping your body to fight infection. Not everyone responds to treatment with Lamivudine/Zidovudine Teva in the same way. Your doctor will monitor the effectiveness of your treatment. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LAMIVUDINE/ZIDOVUDINE TEVA DO NOT TAKE LAMIVUDINE/ZIDOVUDINE TEVA • if you ar Lestu allt skjalið
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Lamivudine/Zidovudine Teva 150 mg/300 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 150 mg lamivudine and 300 mg zidovudine. For the full list of excipients see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet White, capsule shaped, biconvex, film-coated scored tablet – engraved with “L/Z” on one side and “150/300” on the other side. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Lamivudine/Zidovudine Teva is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection (see section 4.2). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Therapy should be initiated by a physician experienced in the management of HIV infection. Lamivudine/Zidovudine Teva may be administered with or without food. To ensure administration of the entire dose, the tablet(s) should ideally be swallowed without crushing. For patients who are unable to swallow tablets, tablets may be crushed and added to a small amount of semi-solid food or liquid, all of which should be consumed immediately (see section 5.2). Adults and adolescents weighing at least 30 kg The recommended oral dose of Lamivudine/Zidovudine Teva is one tablet twice daily. Children weighing between 21 kg and 30 kg The recommended oral dose of Lamivudine/Zidovudine Teva is one-half tablet taken in the morning and one whole tablet taken in the evening. Children weighing from 14 kg to 21 kg The recommended oral dose of Lamivudine/Zidovudine Teva is one-half tablet taken twice daily. The dosing regimen for paediatric patients weighing 14-30 kg is based primarily on pharmacokinetic modelling and supported by data from clinical studies using the individual components lamivudine and zidovudine. A pharmacokinetic overexposure of zidovudine can occur, therefore close safety monitoring is warranted in thes Lestu allt skjalið