LEQVIO inclisiran 284 mg /1.5 mL solution for injection in pre-filled syringe

Country: অস্ট্রেলিয়া

ভাষা: ইংরেজি

সূত্র: Department of Health (Therapeutic Goods Administration)

সক্রিয় উপাদান:

inclisiran, Quantity: 284 mg

থেকে পাওয়া:

Novartis Pharmaceuticals Australia Pty Ltd

ফার্মাসিউটিকাল ফর্ম:

Injection, solution

রচনা:

Excipient Ingredients: sodium hydroxide; phosphoric acid; water for injections

প্রশাসন রুট:

Subcutaneous

প্যাকেজ ইউনিট:

1 unit pack contains 1 pre-filled syringe

প্রেসক্রিপশন টাইপ:

(S4) Prescription Only Medicine

থেরাপিউটিক ইঙ্গিত:

Leqvio is indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with heterozygous familial hypercholesterolaemia, atherosclerotic cardiovascular disease, or at high risk of a cardiovascular event:,? 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.

পণ্য সারাংশ:

Visual Identification: Leqvio is supplied as a solution for injection. The solution is clear, colorless to pale yellow and essentially free of particulates.; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

অনুমোদন অবস্থা:

Registered

অনুমোদন তারিখ:

2021-09-14

তথ্য লিফলেট

LEQVIO
®
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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.
▼
This medicine is new or being used differently. Please report side
effects. See the full CMI for further details.
1.
WHY AM I USING LEQVIO?
Leqvio contains the active ingredient inclisiran. Leqvio is used to
lower LDL-cholesterol ('bad' cholesterol) in addition to a
cholesterol-lowering diet and exercise if you are an adult with a high
cholesterol level in your blood.
For more information, see Section 1. Why am I using Leqvio in the full
CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE LEQVIO?
Do not use if you have ever had an allergic reaction to Leqvio 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
Leqvio? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Leqvio is not expected to interact with other medicines even though it
has not been tested.
For more information, see Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW IS LEQVIO GIVEN?
•
Leqvio is given as an injection under the skin in your abdomen,
alternatively the upper arm or thigh. It will be given to you by a
doctor or healthcare provider.
•
The recommended dose is one injection initially, again at 3 months,
followed by every 6 months.
More instructions can be found in Section 4. How is Leqvio given? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING LEQVIO?
THINGS YOU SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Leqvio.
THINGS YOU SHOULD NOT DO
•
Do not use this medicine if you are allergic to inclisiran, or any of
the ingredients listed at the
end of this leaflet.
DRIVING OR USING MACHINES
•
Leqvio is not expected to affect your ability to drive or use
machin

পণ্য বৈশিষ্ট্য

1
This medicinal product is subject to additional monitoring in
Australia. This will allow quick
identification of new safety information. Healthcare professionals are
asked to report any
suspected adverse events at www.tga.gov.au/reporting-problems.
AUSTRALIAN PRODUCT INFORMATION - LEQVIO
® (INCLISIRAN)
SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Inclisiran
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe contains 1.5 mL of solution containing 284 mg
inclisiran (equivalent to 300 mg
inclisiran sodium).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Leqvio is supplied as a solution for injection. The solution is clear,
colourless to pale yellow and
essentially free of particulates.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Leqvio is indicated as an adjunct to diet and exercise to reduce
low-density lipoprotein cholesterol
(LDL-C) in adults with heterozygous familial hypercholesterolaemia,
atherosclerotic cardiovascular
disease, or at high risk of a cardiovascular event:
•
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.
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
The recommended dose of Leqvio is 284 mg administered as a single
subcutaneous injection: initially,
again at 3 months, followed by every 6 months.
_Missed dose _
If a planned dose of Leqvio is missed by less than 3 months, Leqvio
should be administered and dosing
maintained according to the patient’s original schedule.
▼

2
If a planned dose of Leqvio is missed by more than 3 months, a new
dosing schedule should be started
– Leqvio should be administered initially, again at 3 months,
followed by every 6 months.
_Treatment Transition from PCSK9 Inhibitor Monoclonal Antibody _
When transitioning from a PCSK9 monoclonal antibody to Leqvio,
administ