Country: ইউরোপীয় ইউনিয়ন
ভাষা: ইংরেজি
সূত্র: EMA (European Medicines Agency)
Alirocumab
Sanofi Winthrop Industrie
C10AX14
alirocumab
Lipid modifying agents
Dyslipidemias
Primary hypercholesterolaemia and mixed dyslipidaemiaPraluent is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:in combination with a statin or statin with other lipid lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin or,alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.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.
Revision: 21
Authorised
2015-09-23
53 B. PACKAGE LEAFLET 54 PACKAGE LEAFLET: INFORMATION FOR THE USER PRALUENT 75 MG SOLUTION FOR INJECTION IN A PRE-FILLED PEN PRALUENT 150 MG SOLUTION FOR INJECTION IN A PRE-FILLED PEN PRALUENT 300 MG SOLUTION FOR INJECTION IN A PRE-FILLED PEN alirocumab READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - This medicine has been prescribed for you 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Praluent is and what it is used for 2. What you need to know before you use Praluent 3. How to use Praluent 4. Possible side effects 5. How to store Praluent 6. Contents of the pack and other information 1. WHAT PRALUENT IS AND WHAT IT IS USED FOR WHAT PRALUENT IS • Praluent contains the active substance alirocumab. • Praluent is a monoclonal antibody (a type of specialised protein designed to attach to a target substance in the body). Monoclonal antibodies are proteins that recognise and bind to other unique proteins. Alirocumab binds to PCSK9. 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. WHAT PRALUEN সম্পূর্ণ নথি পড়ুন
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 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 Praluent 300 mg solution for injection in pre-filled pen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Praluent 75 mg solution for injection in pre-filled pen Each single-use pre-filled pen contains 75 mg alirocumab in 1 ml solution. Praluent 75 mg solution for injection in pre-filled syringe Each single-use pre-filled syringe contains 75 mg alirocumab in 1 ml solution. Praluent 150 mg solution for injection in pre-filled pen Each single-use pre-filled pen contains 150 mg alirocumab in 1 ml solution. Praluent 150 mg solution for injection in pre-filled syringe Each single-use pre-filled syringe contains 150 mg alirocumab in 1 ml solution. Praluent 300 mg solution for injection in pre-filled pen Each single-use pre-filled pen contains 300 mg alirocumab in 2 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. pH: 5.7 – 6.3 Osmolality: Praluent 75 mg solution for injection 293 - 439 mOsm/kg Praluent 150 mg solution for injection 383 - 434 mOsm/kg Praluent 300 mg solution for injection 383 – 434 mOsm/kg 3 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Primary hypercholesterolaemia and mixed dyslipidaemia Praluent is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, and in paediatric patients 8 years of age and older with heterozygous familial hypercholesterolaemia (HeFH) as an adjunct to diet: - in combination with a statin or statin with other lipid lowering therapies in patients unable to reach LDL-C goals সম্পূর্ণ নথি পড়ুন