REPATHA evolocumab (rch) 140 mg/mL injection solution syringe within a pen injector

Страна: Австралія

мова: англійська

Джерело: Department of Health (Therapeutic Goods Administration)

Активний інгредієнт:

evolocumab, Quantity: 140 mg

Доступна з:

Amgen Australia Pty Ltd

ІПН (Міжнародна Ім'я):

evolocumab

Фармацевтична форма:

Injection, solution

Склад:

Excipient Ingredients: proline; glacial acetic acid; polysorbate 80; sodium hydroxide; water for injections

Адміністрація маршрут:

Subcutaneous

Одиниць в упаковці:

3, 2, 1

Тип рецепту:

(S4) Prescription Only Medicine

Терапевтичні свідчення:

Repatha is indicated as an adjunct to diet and exercise in:,Prevention of Cardiovascular Events,REPATHA is indicated to reduce the risk of cardiovascular events (myocardial infarction, stroke and coronary revascularisation) in adults with established cardiovascular disease in combination with an optimally dosed statin and/or other lipid-lowering therapies (see CLINICAL TRIALS).,Primary hypercholesterolaemia,REPATHA is indicated in adults with primary hypercholesterolaemia (including heterozygous familial hypercholesterolaemia and non-familial hypercholesterolaemia) to reduce low-density lipoprotein cholesterol (LDL-C): - in combination with a statin or statin with other lipid lowering therapies, or - alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant.,Homozygous familial hypercholesterolaemia,Repatha is indicated in adults and adolescents aged 12 years and over with homozygous familial hypercholesterolaemia in combination with other lipid lowering therapies.

Огляд продуктів:

Visual Identification: Clear to opalescent, colourless to yellowish solution; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Статус Авторизація:

Registered

Дата Авторизація:

2015-12-09

інформаційний буклет

REPATHA
®
_Evolocumab (rch) - e” voe lok’ ue mab_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Repatha.
It does not contain all the available
information. It does not take the
place of talking to your doctor, nurse
or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using Repatha
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR, PHARMACIST OR NURSE.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT REPATHA IS USED
FOR
Repatha is used with other
cholesterol lowering medicines in
adults with heart disease to reduce
the risk of heart attack, stroke, and
certain heart procedures to restore
blood flow to the heart. Risk factors
of heart disease include a history of
heart attack, stroke or blood vessel
disease.
Repatha is used in adults who cannot
control their cholesterol levels by
cholesterol lowering diet and
exercise. You should stay on your
cholesterol lowering diet and
exercise as directed by your doctor
while taking this medicine.
Repatha contains the active substance
evolocumab, which is a protein
(human monoclonal antibody) that
lowers cholesterol.
Cholesterol is one of several fatty
substances found in the bloodstream.
Your total cholesterol is made up
mainly of Low Density Lipoprotein
(LDL) and High Density Lipoprotein
(HDL) cholesterol.
Repatha lowers LDL cholesterol and
triglycerides. It can raise your HDL
cholesterol as well.
LDL cholesterol can build up in the
walls of your arteries forming plaque.
Eventually this plaque build-up can
lead to a narrowing of the arteries.
This narrowing can slow or block
blood flow to vital organs such as the
heart and brain. This blocking of
blood flow can result in a heart attack
or stroke and can cause other health
problems.
HDL cholesterol helps to keep LDL
cholesterol from building up in the
arteries and protects against heart
disease.
Triglycerides are another form of

Характеристики продукта

REPATHA

(EVOLOCUMAB) SOLUTION FOR INJECTION
PAGE 1 OF 31
AUSTRALIAN PRODUCT INFORMATION – REPATHA

(EVOLOCUMAB) SOLUTION FOR INJECTION
1.
NAME OF THE MEDICINE
Evolocumab
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Repatha is a sterile, preservative-free solution for injection
containing 140 mg/mL
evolocumab in a pre-filled syringe or pre-filled pen or a 420 mg/3.5
mL solution delivering
120 mg/mL evolocumab in a pre-filled cartridge co-packaged with an
automated mini-
doser (AMD).
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Solution for Injection.
Repatha is a sterile, preservative-free solution, clear to opalescent;
colourless to
yellowish solution for injection, practically free from particles.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Repatha is indicated as an adjunct to diet and exercise in:
Prevention of Cardiovascular Events
Repatha is indicated to reduce the risk of cardiovascular events
(myocardial infarction,
stroke and coronary revascularisation) in adults with established
cardiovascular disease
in combination with an optimally dosed statin and/or other
lipid-lowering therapies (see
section 5.1 Pharmacodynamic properties, Clinical trials).
Primary Hypercholesterolaemia
Repatha is indicated in adults with primary hypercholesterolaemia
(including
heterozygous familial hypercholesterolaemia and non-familial
hypercholesterolaemia) to
reduce low-density lipoprotein cholesterol (LDL-C):
•
in combination with a statin or statin with other lipid lowering
therapies, or
•
alone or in combination with other lipid-lowering therapies in
patients who are
statin-intolerant.
REPATHA

(EVOLOCUMAB) SOLUTION FOR INJECTION
PAGE 2 OF 31
Homozygous Familial Hypercholesterolaemia
Repatha is indicated in adults and adolescents aged 12 years and over
with
homozygous familial hypercholesterolaemia in combination with other
lipid lowering
therapies.
4.2
DOSE AND METHOD OF ADMINISTRATION
Dosage (dose and interval)
_Primary Hypercholesterolaemia and Preventi