Nchi: Australia
Lugha: Kiingereza
Chanzo: Department of Health (Therapeutic Goods Administration)
Liraglutide
Novo Nordisk Pharmaceuticals Pty Ltd
Medicine Registered
Victoza ® Page 1 of 9 Victoza_cmi6.docx VICTOZA ® _Liraglutide (rys) _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET WHAT VICTOZA ® IS USED FOR ........ 1 BEFORE YOU USE VICTOZA ® ........... 1 HOW TO USE VICTOZA ® ................. 2 WHILE YOU ARE USING VICTOZA ® .. 3 THINGS TO BE CAREFUL OF .............. 3 SIDE EFFECTS ................................. 3 AFTER USING VICTOZA ® ................. 4 PRODUCT DESCRIPTION ................. 4 FURTHER INFORMATION ................. 4 INSTRUCTIONS FOR USE ................. 5 This leaflet answers some common questions about Victoza ® . It does not contain all the available information. It does not take the place of talking to your doctor, diabetes educator/nurse or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using Victoza ® against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT VICTOZA ® IS USED FOR Victoza ® contains the active ingredient liraglutide. Victoza ® is an injection that is used once a day. Victoza ® is used to treat type 2 diabetes mellitus. Diabetes mellitus is a condition where your pancreas does not produce enough insulin to control your blood sugar (glucose) level. If you have type 2 diabetes mellitus your body is also not able to use insulin properly. Victoza ® helps your body to produce more insulin when your blood sugar level is high. Victoza ® is used when previous medicines have not been enough to control your blood sugar levels. Your doctor may want you to use one or more other medicines in addition to Victoza ® , such as metformin or a sulfonylurea. It is also i Soma hati kamili
Product Information Victoza_pi5a.docx Page 1 of 20 PRODUCT INFORMATION LIRAGLUTIDE VICTOZA ® NAME OF THE MEDICINE Liraglutide (rys) Liraglutide (rys) has the molecular formula C 172 H 265 N 43 O 51 and a molecular weight of 3751.20 daltons. CAS No.: 204656-20-2 DESCRIPTION Liraglutide is a human Glucagon-Like Peptide-1 (GLP-1) analogue that binds to and activates the GLP- 1 receptor. The GLP-1 receptor is the target for native GLP-1, an endogenous incretin hormone that potentiates glucose-dependent insulin secretion from the pancreatic beta cells. Liraglutide exhibits 97% homology to human GLP-1. In liraglutide, the lysine at position 34 has been replaced with arginine, and a palmitic acid has been attached via a glutamoyl spacer to lysine at position 26. Liraglutide is produced by recombinant DNA technology using _Saccharomyces cerevisiae_. One mL contains 6 mg salt-free anhydrous liraglutide. Victoza ® is a sterile, clear, colourless, isotonic solution of liraglutide 6 mg/mL (pH=8.15). Victoza is a solution for injection. Each mL of Victoza also contains the following inactive ingredients: 1.42 mg dibasic sodium phosphate dihydrate, 14.0 mg propylene glycol, 5.5 mg phenol, hydrochloric acid q.s., sodium hydroxide q.s. and water for injections to 1 mL. PHARMACOLOGY _MECHANISM OF ACTION _ Unlike native GLP-1, liraglutide has a pharmacokinetic and pharmacodynamic profile in humans suitable for once daily administration. Following subcutaneous administration, the protracted action profile is based on three mechanisms: self-association (which results in slow absorption), binding to albumin and enzymatic stability towards the dipeptidyl peptidase (DPP-IV) and neutral endopeptidase (NEP) enzymes, resulting in a long plasma half life. Liraglutide action is mediated via a specific interaction with GLP-1 receptors, leading to an increase in cyclic adenosine monophosphate (cAM Soma hati kamili