Šalis: Izraelis
kalba: anglų
Šaltinis: Ministry of Health
EVOLOCUMAB
AMGEN EUROPE B.V.
C10AX13
SOLUTION FOR INJECTION
EVOLOCUMAB 140 MG/ML
S.C
Required
AMGEN EUROPE B.V., NETHERLANDS
EVOLOCUMAB
Hypercholesterolaemia and mixed dyslipidaemiaRepatha is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, and in paediatric patients aged 10 years and over with heterozygous familial hypercholesterolaemia, 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. Homozygous familial hypercholesterolaemia Repatha is indicated in adults and paediatric patients aged 10 years and over with homozygous familial hypercholesterolaemia in combination with other lipid-lowering therapies.Established atherosclerotic cardiovascular disease Repatha is indicated in adults with established atherosclerotic cardiovascular disease (myocardial infarction, stroke or peripheral arterial 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.
2021-02-28
1 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only. REPATHA 140 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 140 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN ACTIVE INGREDIENT The active substance is evolocumab. • Each pre-filled syringe contains 140 mg of evolocumab in 1 mL of solution. • Each pre-filled pen contains 140 mg of evolocumab in 1 mL of solution. FOR INACTIVE INGREDIENTS AND ALLERGENS IN THE MEDICINE – SEE SECTION 6 ‘‘ADDITIONAL INFORMATION’’ READ THIS LEAFLET CAREFULLY AND UNTIL THE END BEFORE USING THIS MEDICINE. This leaflet contains essential information about the medicine. If you have additional questions, contact your doctor or pharmacist. This medicine is prescribed for treating your illness. Do not pass it on to others. It may cause them harm even if it appears to you that their medical condition is similar. 1. WHAT IS THIS MEDICINE INTENDED FOR? Hypercholesterolemia and mixed dyslipidemia Repatha is indicated in adults with primary hypercholesterolemia (heterozygous familial and non- familial; condition of high cholesterol level in the blood) or mixed dyslipidemia (disorder in various lipids level in the blood), and in pediatric patients aged 10 years and over with heterozygous familial hypercholesterolemia, as an adjunct to diet: o in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach the goals set for cholesterol levels with the maximum tolerated dose of a statin or, o alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated. Homozygous familial hypercholesterolemia (condition of high cholesterol level in the blood) Repatha is indicated in adults and pediatric patients aged 10 years and over with homozygous familial hypercholesterolemia in combination with other lipid-lowering therapies. Established atherosclerotic cardiovascular disease Repatha Perskaitykite visą dokumentą
1 _Revised in May 2023 according to MoHs guidelines. _ 1. NAME OF THE MEDICINAL PRODUCT Repatha 140 mg solution for injection in pre-filled syringe Repatha 140 mg solution for injection in pre-filled pen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Repatha 140 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 140 mg of evolocumab in 1 mL of solution. Repatha 140 mg solution for injection in pre-filled pen Each pre-filled pen contains 140 mg of evolocumab in 1 mL of solution. Repatha is a human IgG2 monoclonal antibody produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection (injection). Solution for injection (injection) in pre-filled pen (SureClick). The solution is clear to opalescent, colorless to yellowish, and practically free from particles. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypercholesterolemia and mixed dyslipidemia Repatha is indicated in adults with primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia, and in pediatric patients aged 10 years and over with heterozygous familial hypercholesterolemia, 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. Homozygous familial hypercholesterolemia Repatha is indicated in adults and pediatric patients aged 10 years and over with homozygous familial hypercholesterolemia in combination with other lipid-lowering therapies. 2 Established atherosclerotic cardiovascular disease Repatha is indicated in adults with established atherosclerotic cardiovascular disease (myocardial infarction, stroke or peripheral arterial disease) to reduce cardiovascular risk by lowering LDL-C levels, as an adjunc Perskaitykite visą dokumentą