Χώρα: Μαλαισία
Γλώσσα: Αγγλικά
Πηγή: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Alirocumab
SANOFI-AVENTIS (MALAYSIA) SDN. BHD.
Alirocumab
2units Units; 1units Units; 6units Units
Genzyme Ireland Limited
PRALUENT ® Alirocumab 75mg/mL or 150 mg/mL Solution for injection in pre-filled pen _Consumer Medication Information Leaflet (RiMUP)_ _ _ _Page 1_ WHAT IS IN THIS LEAFLET 1. What Praluent is used for 2. How Praluent works 3. Before you use Praluent 4. How to use Praluent 5. While you are using it 6. Side effects 7. Storage and Disposal of Praluent 8. Product Description 9. Manufacturer and Product Registration Holder 10.Date of revision WHAT PRALUENT IS USED FOR Praluent is used along with diet and maximally tolerated statin therapy in adults with heterozygous familial hypercholesterolemia (an inherited condition that causes high levels of LDL) or atherosclerotic heart problems, who need additional lowering of LDL cholesterol. Praluent is used for adults with high cholesterol levels in their blood and with cardiovascular disease to reduce cardiovascular risk. HOW PRALUENT WORKS Praluent helps lower your levels of “bad” cholesterol (also called “LDL cholesterol”). Praluent blocks a protein called PCSK9. • PCSK9 is a protein secreted by liver cells. • “Bad” cholesterol is normally removed from your blood by binding to specific “receptors” (docking stations) in your liver. • PCSK9 lowers the number of these receptors in the liver – this causes your “bad” cholesterol to be higher than it should. • By blocking PCSK9, Praluent increases the number of receptors available to help remove the “bad” cholesterol – this lowers your “bad” cholesterol levels. BEFORE YOU USE PRALUENT _When you must not use it _ If you are allergic to alirocumab or any of the other ingredients of this medicine. _Before you start to use it _ Warnings and precautions Talk to your doctor, pharmacist or nurse about all your medical conditions, including allergies, before using Praluent. If you develop a serious allergic reaction, stop using Praluent, talk to your doctor right away. Sometimes serious allergic reactions such as hypersensitivity, including angioedema (difficulties breathing, or swelling of the fa Διαβάστε το πλήρες έγγραφο
MY/PRA/0423/ USPI0417 & SmPC0622 1. NAME OF THE MEDICINAL PRODUCT Praluent 75 mg solution for injection in pre-filled pen Praluent 150 mg solution for injection in pre-filled pen Praluent 75 mg solution for injection in pre-filled syringe Praluent 150 mg solution for injection in pre-filled syringe 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 75 mg/ml solution for injection Each single-use pre-filled pen contains 75 mg alirocumab in 1 ml solution. Each single-use pre-filled syringe contains 75 mg alirocumab in 1 ml solution. 150 mg/ml solution for injection Each single-use pre-filled pen contains 150 mg alirocumab in 1 ml solution. Each single-use pre-filled syringe contains 150 mg alirocumab in 1 ml solution. Alirocumab is a human IgG1 monoclonal antibody produced in Chinese Hamster Ovary cells by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection (injection) Clear, colourless to pale yellow solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Primary Hyperlipidemia Praluent is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease, who require additional lowering of LDL-C. Established atherosclerotic cardiovascular disease Praluent is indicated in adults with established atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors: - in combination with the maximum tolerated dose of a statin with or without other lipid-lowering therapies or, - alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated. For study results with respect to effects on LDL-C, cardiovascular events and populations studied see section 5.1. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended starting dose of Praluent is 75 mg once every 2 we Διαβάστε το πλήρες έγγραφο