País: Australia
Idioma: inglés
Fuente: Department of Health (Therapeutic Goods Administration)
Lamivudine
Sun Pharma ANZ Pty Ltd
Lamivudine
1 LAMIVUDINE RBX CMI V3 Jan 2012 LAMIVUDINE RBX _LAMIVUDINE TABLETS _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about LAMIVUDINE RBX. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. This leaflet was last updated on the date at the end of this leaflet. More recent information may be available. The latest Consumer Medicine Information is available from https://www.ebs.tga.gov.au/ and may contain important information about the medicine and its use of which you should be aware. All medicines have benefits and risks. Your doctor has weighed the risks of you taking LAMIVUDINE RBX against the benefits it is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT LAMIVUDINE RBX IS USED FOR LAMIVUDINE RBX contains the medicine lamivudine which belongs to a group of medicines called antivirals. LAMIVUDINE RBX is used together with other antivirals to slow down the progression of human immunodeficiency virus (HIV) infection, which can lead to Acquired Immune Deficiency Syndrome (AIDS) and other related illnesses (eg AIDS-related Complex or ARC). LAMIVUDINE RBX does not cure AIDS or kill the HIV virus, but prevents further damage to the immune system by stopping production of new viruses. LAMIVUDINE RBX does not reduce the risk of passing the infection to others. You will still be able to pass on the HIV virus by sexual activity or by contamination with infected blood. You should still use proper precautions. While taking LAMIVUDINE RBX and/or any other therapy for HIV disease, you may continue to develop other infections and other complications of HIV infection. You should keep in regular contact with the doctor who is looking after you. LAMIVUDINE RBX tablets are not addictive. Your doctor may have prescribed LAMIVUDINE RBX for another reason. ASK YOUR DOCTOR IF YOU HAVE Leer el documento completo
LAMIVUDINE RBX PI V5 Sept 2013 Page 1 of 24 LAMIVUDINE RBX LAMIVUDINE 150 MG & 300 MG TABLETS NAME OF THE MEDICINE Lamivudine Structural formula: HO N N O NH 2 O S Molecular formula: C 8 H 11 N 3 O 3 S Chemical name: (2R-cis)-4-amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(1H)-pyrimidin- 2-one Molecular weight: 229.26 CAS Number: 134678-17-4 DESCRIPTION Lamivudine is a white or almost white powder which is soluble in water. Each film-coated tablet of LAMIVUDINE RBX contains 150 mg or 300 mg of lamivudine, and the inactive ingredients microcrystalline cellulose, sodium starch glycollate type A and magnesium stearate. Lamivudine tablets also contain Opadry 13B28444 White (Proprietary Ingredient # 107104) for 150 mg strength, and Opadry 16B57534 Grey (Proprietary Ingredient # 107103) for 300 mg strength. PHARMACOLOGY MODE OF ACTION: Lamivudine is a potent, selective inhibitor of HIV-1 and HIV-2 replication _in vitro_ . It is also active against zidovudine-resistant clinical isolates of HIV. _In vitro_ , lamivudine demonstrates low cytotoxicity to peripheral blood lymphocytes, to established lymphocyte and monocyte-macrophage cell lines and to a variety of bone marrow progenitor cells. Lamivudine therefore has, _in vitro_ , a high therapeutic index. Lamivudine is metabolised intracellularly to the 5’-triphosphate which has an intracellular half-life of 10.5 - 15.5 hours. Lamivudine 5’-triphosphate is a weak inhibitor of the RNA and DNA-dependent activities of HIV reverse transcriptase; its main mode of action is as a chain terminator of HIV reverse transcription. LAMIVUDINE RBX PI V5 Sept 2013 Page 2 of 24 Lamivudine does not interfere with cellular deoxynucleotide metabolism and has little effect on mammalian cell and mitochondrial DNA content. The relationships between _in vitro_ susceptibility of HIV to lamivudine and the clinical response to therapy remain under investigation. _In vitro_ sensitivity testing has not been standardised and results may vary according to methodological factors. Reduced _in vitro_ Leer el documento completo