REPATHA

Land: Israel

Språk: engelska

Källa: Ministry of Health

Aktiva substanser:

EVOLOCUMAB

Tillgänglig från:

AMGEN EUROPE B.V.

ATC-kod:

C10AX13

Läkemedelsform:

SOLUTION FOR INJECTION

Sammansättning:

EVOLOCUMAB 140 MG/ML

Administreringssätt:

S.C

Receptbelagda typ:

Required

Tillverkad av:

AMGEN EUROPE B.V., NETHERLANDS

Terapiområde:

EVOLOCUMAB

Terapeutiska indikationer:

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.

Tillstånd datum:

2021-02-28

Bipacksedel

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

Produktens egenskaper

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