REPATHA evolocumab (rch) 420 mg /3.5 mL injection solution automated mini-doser AMD

Država: Australija

Jezik: engleski

Izvor: Department of Health (Therapeutic Goods Administration)

Aktivni sastojci:

evolocumab, Quantity: 420 mg

Dostupno od:

Amgen Australia Pty Ltd

Farmaceutski oblik:

Injection, solution

Sastav:

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

Administracija rute:

Subcutaneous

Jedinice u paketu:

1

Tip recepta:

(S4) Prescription Only Medicine

Terapijske indikacije:

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.

Proizvod sažetak:

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

Status autorizacije:

Registered

Datum autorizacije:

2020-12-03

Uputa o lijeku

REPATHA
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1
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING REPATHA?
Repatha contains the active ingredient evolocumab. Repatha is used to
treat high cholesterol. Repatha is also used to treat high
cholesterol in adults and people 12 years and older who have high
cholesterol because of a condition that runs in their family.
Repatha can be 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.
For more information, see Section 1. Why am I using Repatha? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE REPATHA?
Do not use if you have ever had an allergic reaction to evolocumab or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Repatha? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Repatha and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE REPATHA?
•
Repatha is injected under the skin (subcutaneous)
•
Repatha can be self-administered by injection under the skin after
training from your doctor or nurse.
More instructions can be found in Section 4. How do I use Repatha? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING REPATHA?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist, pharmacist or nurse you visit that you are
using Repatha.
•
Keep all of your doctor's appointments so that your progress can be
monitored.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine or lower your dose without checking
with your doctor.
•
Do not give your medi

Svojstava lijeka

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