Country: Եվրոպական Միություն
language: անգլերեն
source: EMA (European Medicines Agency)
lopinavir/ritonavir
Mylan S.A.S.
J05AR10
lopinavir/ritonavir
Antivirals for systemic use,
HIV Infections
Lopinavir/ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infected adults, adolescents and children above the age of 2 years.The choice of lopinavir/ritonavir to treat protease inhibitor experienced HIV-1 infected patients should be based on individual viral resistance testing and treatment history of patients.
Revision: 9
Authorised
2016-01-14
67 B. PACKAGE LEAFLET 68 PACKAGE LEAFLET: INFORMATION FOR THE USER LOPINAVIR/RITONAVIR MYLAN 200 MG/50 MG FILM-COATED TABLETS lopinavir/ritonavir READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU OR YOUR CHILD. - 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 or your child 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 Lopinavir/Ritonavir Mylan is and what it is used for 2. What you need to know before you or your child takes Lopinavir/Ritonavir Mylan 3. How to take Lopinavir/Ritonavir Mylan 4. Possible side effects 5. How to store Lopinavir/Ritonavir Mylan 6. Contents of the pack and other information 1. WHAT LOPINAVIR/RITONAVIR MYLAN IS AND WHAT IT IS USED FOR - Your doctor has prescribed lopinavir/ritonavir to help to control your Human Immunodeficiency Virus (HIV) infection. Lopinavir/ritonavir does this by slowing down the spread of the infection in your body. - Lopinavir/Ritonavir Mylan is not a cure for HIV infection or AIDS - Lopinavir/ritonavir is used by children 2 years of age or older, adolescents and adults who are infected with HIV, the virus which causes AIDS. - Lopinavir/Ritonavir Mylan contains the active substances lopinavir and ritonavir. Lopinavir/ritonavir is an antiretroviral medicine. It belongs to a group of medicines called protease inhibitors. - Lopinavir/ritonavir is prescribed for use in combination with other antiviral medicines. Your doctor will discuss with you and determine which medicines are best for you. 2. WHAT YOU NEED TO KNOW BEFORE YOU OR YOUR CHILD TAKES LOPINAVIR/RITONAVIR MYLAN _ _ DO NOT TAKE LOPINAVIR/RITONAVIR MYLAN IF: - you are allergic to lopina read_full_document
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Lopinavir/Ritonavir Mylan 100 mg/25 mg film-coated tablets. Lopinavir/Ritonavir Mylan 200 mg/50 mg film-coated tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Lopinavir/Ritonavir Mylan 100 mg/25 mg film-coated tablets Each film-coated tablet contains 100 mg of lopinavir co-formulated with 25 mg of ritonavir as a pharmacokinetic enhancer. Lopinavir/Ritonavir Mylan 200 mg/50 mg film-coated tablets Each film-coated tablet contains 200 mg of lopinavir co-formulated with 50 mg of ritonavir as a pharmacokinetic enhancer. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Lopinavir/Ritonavir Mylan 100 mg/25 mg film-coated tablets Approx 15.0 mm x 8.0 mm, white, film coated, ovaloid, biconvex beveled edge tablet debossed with 'MLR4' on one side of the tablet and plain on the other side. Lopinavir/Ritonavir Mylan 200 mg/50 mg film-coated tablets Approx 18.8 mm x 10.0 mm, white, film coated, ovaloid, biconvex beveled edge tablet debossed with 'MLR3' on one side of the tablet and plain on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Lopinavir/ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infected adults, adolescents and children above the age of 2 years. The choice of lopinavir/ritonavir to treat protease inhibitor experienced HIV-1 infected patients should be based on individual viral resistance testing and treatment history of patients (see sections 4.4 and 5.1). _ _ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Lopinavir/ritonavir should be prescribed by physicians who are experienced in the treatment of HIV infection. Lopinavir/ritonavir tablets must be swallowed whole and not chewed, broken or crushed. Posology _Adults and adolescents _ The standard recommended dosage of lopinavir/ritonavir tablets is 400/100 mg (two 200/50 mg) tablets twice daily taken with or without food. In adul read_full_document