Χώρα: Αυστραλία
Γλώσσα: Αγγλικά
Πηγή: Department of Health (Therapeutic Goods Administration)
alirocumab, Quantity: 75 mg
Sanofi-Aventis Australia Pty Ltd
alirocumab
Injection, solution
Excipient Ingredients: histidine; sucrose; polysorbate 20; water for injections
Subcutaneous
1 (starter pack), 1, 2, 6
(S4) Prescription Only Medicine
Primary hypercholesterolaemia Praluent is indicated as an adjunct to diet and exercise to reduce LDL-C in adults with primary (heterozygous familial or non-familial) hypercholesterolaemia in patients with moderate to very high cardiovascular risk: - In combination with a statin, or statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with maximum tolerated dose of a statin, - alone or in combination with other lipid lowering therapies in patients who are statin intolerant or for whom a statin is contraindicated who are unable to reach LDL-C goals.,Prevention of cardiovascular events Praluent is indicated to reduce the risk of cardiovascular events (myocardial infarction, stroke, unstable angina requiring hospitalisation) in adults with established cardiovascular disease, in combination with optimally dosed statins and/or other lipid-lowering therapies (see section 5.1 Pharmacodynamic Properties, Clinical Trials).
Visual Identification: Clear, colourless to pale yellow; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 30 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2016-05-17
PRALUENT ® _Alirocumab (rch)_ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Praluent. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using Praluent against the benefits this medicine is expected to 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 PRALUENT IS USED FOR Praluent contains the active substance alirocumab, a protein produced in Chinese hamster ovary cells. Praluent is used with other cholesterol lowering medicines to treat high levels of cholesterol in the blood. Cholesterol is one of several fatty substances found in the bloodstream. Your total cholesterol is made up of mainly of Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) cholesterol. Praluent reduces LDL cholesterol. LDL cholesterol can build up in the walls of your arteries forming plaque. Eventually this plaque build-up can lead to a narrowing of the arteries. This narrowing can slow or block blood flow to vital organs such as the heart and brain. This blocking of blood flow can result in a heart attack or stroke and can cause other health problems. Praluent reduces the risk of heart attack, stroke, and chest pain that may be caused by too little blood and oxygen getting to the heart (angina), in adults with cardiovascular disease and high cholesterol levels in their blood. Praluent is used in adults who cannot reduce their cholesterol levels by cholesterol lowering diet and exercise. Praluent should be used with other lipid lowering medicines such as statins to treat high cholesterol and lipid disorders. When a statin cannot be used or does not work well, Praluent can be used alone or together with other cholesterol lowering medicines. Praluent should be used along with cholesterol lowering diet Διαβάστε το πλήρες έγγραφο
praluent-ccdsv7-piv7-10jan20 Page 1 of 34 AUSTRALIAN PRODUCT INFORMATION - PRALUENT ® (ALIROCUMAB) 1 NAME OF THE MEDICINE Praluent 75mg/mL and 150mg/mL solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Alirocumab (rch) 75mg/mL and 150mg/mL Alirocumab is a fully human monoclonal antibody (IgG1 isotype) that targets PCSK9. Alirocumab is produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture. For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection Praluent is a sterile, clear, colourless to pale yellow solution for subcutaneous injection with pH of about 6.0, containing no antimicrobial preservatives. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS PRIMARY HYPERCHOLESTEROLAEMIA Praluent is indicated as an adjunct to diet and exercise to reduce LDL-C in adults with primary (heterozygous familial or non-familial) hypercholesterolaemia in patients with moderate to very high cardiovascular risk: - In combination with a statin, or statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with maximum tolerated dose of a statin, - alone or in combination with other lipid lowering therapies in patients who are statin intolerant or for whom a statin is contraindicated who are unable to reach LDL-C goals. PREVENTION OF CARDIOVASCULAR EVENTS praluent-ccdsv7-piv7-10jan20 Page 2 of 34 Praluent is indicated to reduce the risk of cardiovascular events (myocardial infarction, stroke, unstable angina requiring hospitalisation) in adults with established cardiovascular disease, in combination with optimally dosed statins and/or other lipid-lowering therapies (see section 5.1 Pharmacodynamic properties, CLINICAL TRIALS). 4.2 DOSE AND METHOD OF ADMINISTRATION The recommended starting dose of Praluent is 75 mg once every 2 weeks or 300 mg once every 4 weeks (monthly), administered subcutaneously. The dose of Praluent can be individualised based on patient characteristics such as baseline LDL- C level, goal of therapy and res Διαβάστε το πλήρες έγγραφο