Страна: Европейский союз
Язык: английский
Источник: EMA (European Medicines Agency)
lamivudine
Teva B.V.
J05AF05
lamivudine
Antivirals for systemic use
HIV Infections
Lamivudine Teva Pharma B.V. is indicated as part of antiretroviral combination therapy for the treatment of human-immunodeficiency-virus (HIV)-infected adults and children.
Revision: 19
Authorised
2009-12-10
33 B. PACKAGE LEAFLET 34 PACKAGE LEAFLET: INFORMATION FOR THE USER LAMIVUDINE TEVA PHARMA B.V. 150 MG FILM-COATED TABLETS lamivudine 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 Teva Pharma B.V. is and what it is used for 2. What you need to know before you take Lamivudine Teva Pharma B.V. 3. How to take Lamivudine Teva Pharma B.V. 4. Possible side effects 5. How to store Lamivudine Teva Pharma B.V. 6. Contents of the pack and other information 1. WHAT LAMIVUDINE TEVA PHARMA B.V. IS AND WHAT IT IS USED FOR LAMIVUDINE TEVA PHARMA B.V. IS USED TO TREAT HIV (HUMAN IMMUNODEFICIENCY VIRUS) INFECTION IN ADULTS AND CHILDREN. The active ingredient in Lamivudine Teva Pharma B.V. is lamivudine. Lamivudine Teva Pharma B.V. is a type of medicine known as an antiretroviral. It belongs to a group of medicines called _nucleoside _ _analogue reverse transcriptase inhibitors (NRTIs)_ . Lamivudine Teva Pharma B.V. 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 Teva Pharma B.V. in the same way. Your doctor will monitor the effectiveness of your treatment. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LAMIVUDINE TEVA PHARMA B.V. DO NOT TAKE LAMIVUDINE TEVA PHARMA B.V. • if you are ALLERGIC to lamivudine or any of the other ingredients of Прочитать полный документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Lamivudine Teva Pharma B.V. 150 mg film-coated tablets Lamivudine Teva Pharma B.V. 300 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Lamivudine Teva Pharma B.V. 150 mg film-coated tablets Each film-coated tablet contains 150 mg lamivudine. Lamivudine Teva Pharma B.V. 300 mg film-coated tablets Each film-coated tablet contains 300 mg lamivudine. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Lamivudine Teva Pharma B.V. 150 mg film-coated tablets Light grey, diamond shaped, biconvex film-coated tablet with approx. 14.5 mm length and 7.0 mm width – engraved with “L 150” and breakline on one side and breakline on the other. The tablet can be divided into equal doses. Lamivudine Teva Pharma B.V. 300 mg film-coated tablets Grey, diamond shaped, biconvex film-coated tablet with approx. 18.0 mm length and 8.0 mm width – engraved with “L 300” on one side and plain on the other 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Lamivudine Teva Pharma B.V. is indicated as part of antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infected adults and children. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The therapy should be initiated by a physician experienced in the management of HIV infection. Lamivudine is also available as an oral solution for children over three months of age and who weigh less than 14 kg or for patients who are unable to swallow tablets (see section 4.4). Patients changing between lamivudine oral solution and lamivudine tablets should follow the dosing recommendations that are specific for the formulation (see section 5.2) Posology _Adults, adolescents and children (weighing at least 25 kg) _ The recommended dose of lamivudine is 300 mg daily. This may be administered as either 150 mg twice daily or 300 mg once daily (see section 4.4). The 300 mg tablet is only suitable for the once a day regimen. _Children Прочитать полный документ