REPATHA SOLUTION FOR INJECTION IN PRE-FILLED AUTOINJECTOR 140MGML

Ország: Szingapúr

Nyelv: angol

Forrás: HSA (Health Sciences Authority)

Aktív összetevők:

Evolocumab

Beszerezhető a:

AMGEN BIOTECHNOLOGY SINGAPORE PTE LTD

ATC-kód:

C10AX13

Gyógyszerészeti forma:

INJECTION, SOLUTION

Összetétel:

Evolocumab 140mg/ml

Az alkalmazás módja:

SUBCUTANEOUS

Recept típusa:

Prescription Only

Gyártó:

AMGEN MANUFACTURING LIMITED

Engedélyezési státusz:

ACTIVE

Engedély dátuma:

2017-04-24

Termékjellemzők

1
1.
NAME OF THE MEDICINAL PRODUCT
Repatha
®
solution for injection in pre-filled syringe 140 mg
Repatha
®
solution for injection in pre-filled autoinjector 140 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Repatha solution for injection in pre-filled syringe 140 mg
Each pre-filled syringe contains 140 mg of evolocumab in 1 mL of
solution.
Repatha solution for injection in pre-filled autoinjector 140 mg
Each pre-filled autoinjector 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.
The solution is sterile and preservative-free, clear to opalescent,
colourless to yellowish, and
practically free from particles.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prevention of Cardiovascular Events
In adults with established cardiovascular disease, Repatha in
combination with an optimally dosed
statin and/or other lipid-lowering therapies is indicated to reduce
the risk of myocardial infarction,
stroke, and coronary revascularisation (see section 5.1
Pharmacodynamic properties).
Primary Hypercholesterolaemia and Mixed Dyslipidaemia
Repatha is indicated as an adjunct to diet, for the treatment of
adults with primary
hypercholesterolaemia (heterozygous familial and non-familial) or
mixed dyslipidaemia, and
paediatric patients aged 10 years and over with heterozygous familial
hypercholesterolaemia to reduce
low density lipoprotein cholesterol (LDL-C):
•
In combination with a statin or statin with other lipid-lowering
therapies in patients who are
unable to reach LDL-C goals with 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