Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - leqvio

Document Subject

Generated Narrative: MedicinalProductDefinition mp7a35b3e3ae23ba7c3c63288dcbee5ac6

identifier: http://ema.europa.eu/identifier/EU/1/20/1494/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Leqvio 284 mg solution for injection in pre-filled syringe

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-7a35b3e3ae23ba7c3c63288dcbee5ac6

identifier: http://ema.europa.eu/identifier/EU/1/20/1494/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - leqvio

Attesters

What is in this leaflet

1. What Leqvio is and what it is used for
2. What you need to know before you are given Leqvio
3. How Leqvio is given
4. Possible side effects
5. How to store Leqvio
6. Contents of the pack and other information

What Leqvio is and how it works Leqvio contains the active substance inclisiran. Inclisiran lowers levels of LDL-cholesterol ( bad
cholesterol), which can cause heart and blood circulation problems when levels are raised.

Inclisiran works by interfering with RNA (genetic material in body cells) to limit the production of a protein called PCSK9. This protein can increase LDL-cholesterol levels and preventing its production helps to lower your LDL-cholesterol levels.

What Leqvio is used for Leqvio is used in addition to your cholesterol-lowering diet if you are an adult with a high cholesterol level in your blood (primary hypercholesterolaemia, including heterozygous familial and non-familial, or mixed dyslipidaemia).

Leqvio is given:

• together with a statin (a type of medicine that treats high cholesterol), sometimes combined with another cholesterol-lowering treatment if the maximum dose of the statin does not work well enough, or
• alone or together with other cholesterol-lowering medicines when statins do not work well or cannot be used.

You must not be given Leqvio

• if you are allergic to inclisiran or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions Talk to your doctor, pharmacist or nurse before you are given Leqvio:

• if you are receiving dialysis
• if you have severe liver disease
• if you have severe kidney disease

Children and adolescents Do not give this medicine to children and adolescents under 18 years of age, because there is no experience of using the medicine in this age group.

Other medicines and Leqvio Tell your doctor, pharmacist or nurse if you are using, have recently used or might use any other medicines.

Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before you are given this medicine.

The use of Leqvio should be avoided during pregnancy.

It is not yet known whether Leqvio passes into human breast milk. Your doctor will help you to decide whether to continue breast-feeding or to start treatment with Leqvio. Your doctor will consider the potential benefits of treatment for you, compared with the health benefits and risks of breast-feeding for your baby.

Driving and using machines Leqvio is not expected to affect your ability to drive or use machines.

Leqvio contains sodium This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially sodium-free .

The recommended dose of Leqvio is 284 mg given by injection under the skin (subcutaneous injection). The next dose is given after 3 months, followed by further doses every 6 months.

Before starting Leqvio you should be on a diet to lower your cholesterol and it is likely that you will be taking a statin. You should stay on this cholesterol-lowering diet and keep taking the statin all the time you receive Leqvio.

Leqvio is for injection under the skin of the abdomen; alternative injection sites include the upper arm or thigh. Leqvio will be given to you by a doctor, pharmacist or nurse (healthcare professional).

If you receive more Leqvio than you should This medicine will be given to you by your doctor, pharmacist or nurse (healthcare professional). In the highly unlikely event that you are given too much (an overdose) the doctor or other healthcare professional will check you for side effects.

If you miss your dose of Leqvio If you miss your appointment for your Leqvio injection, contact your doctor, pharmacist or nurse as soon as you can to arrange your next injection.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common (may affect up to 1 in 10 people)

• Injection site reactions, such as pain, redness or rash.

Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions. Do not freeze.

The doctor, pharmacist or nurse will check this medicine and will discard it if it contains particles.

Medicines should not be disposed of via wastewater or household waste. Your doctor, pharmacist or nurse will throw away medicines no longer being used. These measures will help protect the environment.

What Leqvio contains

• The active substance is inclisiran. Each pre-filled syringe contains inclisiran sodium equivalent to 284 mg inclisiran in 1.5 ml solution. Each ml contains inclisiran sodium equivalent to 189 mg inclisiran.
• The other ingredients are water for injections, sodium hydroxide (see section 2 Leqvio contains sodium ) and concentrated phosphoric acid.

What Leqvio looks like and contents of the pack Leqvio is a clear, colourless to pale yellow solution, essentially free of particulates.

Each pack contains one single-use pre-filled syringe.

Marketing Authorisation Holder Novartis Europharm Limited Vista Building Elm Park, Merrion Road Dublin 4 Ireland

Manufacturer Sandoz GmbH Biochemiestrasse 6336 Langkampfen Austria

Novartis Pharmaceutical Manufacturing GmbH Biochemiestrasse 6336 Langkampfen Austria

Novartis Pharma GmbH Roonstrasse 90429 Nuremberg Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien Novartis Pharma N.V. T l/Tel: +32 2 246 16 Lietuva SIA Novartis Baltics Lietuvos filialas Tel: +370 5 269 16
Novartis Bulgaria EOOD .: +359 2 489 98 Luxembourg/Luxemburg Novartis Pharma N.V. T l/Tel: +32 2 246 16 esk republika Novartis s.r.o. Tel: +420 225 775 Magyarorsz g Novartis Hung ria Kft. Tel.: +36 1 457 65 Danmark Novartis Healthcare A/S Tlf: +45 39 16 84 Malta Novartis Pharma Services Inc. Tel: +356 2122 2Deutschland Novartis Pharma GmbH Tel: +49 911 273 0

Nederland Novartis Pharma B.V. Tel: +31 88 04 52 Eesti SIA Novartis Baltics Eesti filiaal Tel: +372 66 30 Norge Novartis Norge AS Tlf: +47 23 05 20
Novartis (Hellas) A.E.B.E. : +30 210 281 17 sterreich Novartis Pharma GmbH Tel: +43 1 86 6Espa a Novartis Farmac utica, S.A. Tel: +34 93 306 42 Polska Novartis Poland Sp. z o.o. Tel.: +48 22 375 4France Novartis Pharma S.A.S. T l: +33 1 55 47 66 Portugal Novartis Farma - Produtos Farmac uticos, S.A. Tel: +351 21 000 8Hrvatska Novartis Hrvatska d.o.o. Tel. +385 1 6274 Rom nia Novartis Pharma Services Romania SRL Tel: +40 21 31299 Ireland Novartis Ireland Limited Tel: +353 1 260 12 Slovenija Novartis Pharma Services Inc. Tel: +386 1 300 75 sland Vistor hf. S mi: +354 535 7Slovensk republika Novartis Slovakia s.r.o. Tel: +421 2 5542 5Italia Novartis Farma S.p.A. Tel: +39 02 96 54 1 Suomi/Finland Novartis Finland Oy Puh/Tel: +358 (0)10 6133
Novartis Pharma Services Inc. : +357 22 690 Sverige Novartis Sverige AB Tel: +46 8 732 32 Latvija SIA Novartis Baltics Tel: +371 67 887 United Kingdom (Northern Ireland) Novartis Ireland Limited Tel: +44 1276 698This leaflet was last revised in

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: