Land: Europese Unie
Taal: Engels
Bron: EMA (European Medicines Agency)
lamivudine, zidovudine
ViiV Healthcare BV
J05AR01
lamivudine, zidovudine
Antivirals for systemic use
HIV Infections
Combivir is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection.,
Revision: 37
Authorised
1998-03-18
31 B. PACKAGE LEAFLET 32 PACKAGE LEAFLET: INFORMATION FOR THE USER COMBIVIR 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 of the 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 Combivir is and what it is used for 2. What you need to know before you take Combivir 3. How to take Combivir 4. Possible side effects 5. How to store Combivir 6. Contents of the pack and other information 1. WHAT COMBIVIR IS AND WHAT IT IS USED FOR COMBIVIR IS USED TO TREAT HIV (HUMAN IMMUNODEFICIENCY VIRUS) INFECTION IN ADULTS AND CHILDREN. Combivir contains two active ingredients that are used to treat HIV infection: lamivudine and zidovudine. Both of these belong to a group of antiretroviral medicines called _nucleoside analogue _ _reverse transcriptase inhibitors_ ( _NRTIs_ ) _. _ _ _ Combivir 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 Combivir in the same way. Your doctor will monitor the effectiveness of your treatment. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE COMBIVIR DO NOT TAKE COMBIVIR: • if you are ALLERGIC to lamivudine or zidovudine, or any of the other ingredients of this medicine _ _ (listed in section 6) • if you have A VERY LOW RED BLOOD CELL COUNT ( _anaemia_ ) _ _ or A VERY LOW WHITE BLOOD CELL COUNT ( _neutrop Lees het volledige document
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Combivir 150 mg/300 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 150 mg lamivudine and 300 mg zidovudine. Excipient(s) with known effect: Each 150/300 mg tablet contains 0.945 mg sodium. For the full list of excipients see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet White to off-white, capsule-shaped film-coated scored tablets engraved with “GXFC3” on both sides. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Combivir 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. Combivir 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 dose of Combivir is one tablet twice daily. Children weighing between 21 kg and 30 kg The recommended oral dose of Combivir 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 Combivir 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 these patients. If gastrointestinal intolerance occurs in patients weighing 3 21-30 kg, an alternative dosing schedule with one-half tablet taken th Lees het volledige document