Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - lysakare

Document Subject

Generated Narrative: MedicinalProductDefinition mp73814721e492c5f1086b1c5537e49b46

identifier: http://ema.europa.eu/identifier/EU/1/19/1381/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: LysaKare 25 g/25 g solution for infusion

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-73814721e492c5f1086b1c5537e49b46

identifier: http://ema.europa.eu/identifier/EU/1/19/1381/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - lysakare

Attesters

What is in this leaflet

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

What LysaKare is LysaKare contains the active substances arginine and lysine, two different amino acids. It belongs to a group of medicines which are used to reduce the side effects of anti-cancer medicine.

What LysaKare is used for LysaKare is used in adult patients to protect kidneys from unnecessary radiation during treatment with Lutathera (lutetium (177Lu) oxodotreotide), a radioactive medicine used to treat certain tumours.

Follow all of your doctor s instructions carefully. As you will receive another treatment, Lutathera, with LysaKare, read the Lutathera leaflet carefully as well as this leaflet. If you have any further questions on the use of this medicine, ask your doctor, nurse or pharmacist.

You should not be given LysaKare

• if you are allergic to arginine and lysine or any of the other ingredients of this medicine (listed in section 6).
• If you have high blood levels of potassium (hyperkalaemia).

Warnings and precautions Talk to your doctor before taking LysaKare if your kidneys, heart or liver are severely impaired or if you have a history of high blood levels of potassium (hyperkalaemia). Because feeling sick (nausea) and vomiting are commonly seen with amino acid infusions, you will be given medicines to prevent nausea and vomitting 30 minutes before the LysaKare infusion.

The doctor will check your blood potassium levels, and will correct them if they are too high before starting the infusion. The doctor will also check your kidney and liver function before starting the infusion. For other tests which need to be performed before your treatment, please read the Lutathera leaflet. Follow your doctor s advice on how much fluid to drink on the day of your treatment so you stay well hydrated. Children and adolescents This medicine should not be given to children and adolescents under 18 years old because it is not known whether it is safe and effective in this age group.

Other medicines and LysaKare Tell your doctor if you are taking, have recently taken, or might take any other medicines.

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

Driving and using machines It is considered unlikely that LysaKare will affect your ability to drive or to use machines.

The recommended dose of LysaKare solution is 1 L (1,000 mL). You should receive the full LysaKare dose, regardless of any Lutathera dose adjustments. LysaKare is given as an infusion (drip) into a vein. The infusion of LysaKare will start 30 minutes before you are given Lutathera, and will last over a 4 hour period.

If you receive more LysaKare than you should LysaKare will be given in a controlled clinical setting and is provided as a single dose bag. It is therefore unlikely that you will receive more of the infusion than you should as your doctor will monitor you during the treatment. However, in the case of an overdose, you will receive the appropriate treatment.

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

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

Very common (may affect more than 1 in 10 people):

• nausea (feeling sick) and vomiting

Not known (frequency cannot be estimated from the available data):

• high potassium levels seen in blood tests, abdominal (belly) pain, headache, dizziness and flushing.

Reporting of side effects If you get any side effects, talk to your doctor. 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 after EXP. The expiry date refers to the last day of that month. LysaKare should be stored below 25 C. You will not have to store this medicine. The correct storage, use and disposal of this medicine are under the responsibility of the specialist in appropriate premises. You will receive LysaKare in a controlled clinical setting. The following information is intended for the healthcare specialist charged with your care. Do not use this medicine:

• if you notice the solution is cloudy or has deposits.
• if overwrap has been previously opened or damaged.
• if the infusion bag is damaged or leaking

What LysaKare contains

• The active substances are arginine and lysine. Each infusion bag contains 25 g of L-arginine hydrochloride and 25 g of L-lysine hydrochloride.
• The other ingredient is water for injections.

What LysaKare looks like and contents of the pack LysaKare is a clear and colourless solution for infusion, supplied in a single use flexible plastic bag. Each infusion bag contains 1 L LysaKare of solution.

Marketing Authorisation Holder Advanced Accelerator Applications 8-10 Rue Henri Sainte-Claire Deville 92500 Rueil-Malmaison France

Manufacturer Laboratoire Bioluz Zone Industrielle de Jalday 64500 Saint Jean de Luz France

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 SAM Nordic vedija Tel: +46 8 720 58
Novartis Bulgaria EOOD : +359 2 489 98 Luxembourg/Luxemburg Novartis Pharma N.V. T l/Tel: +32 2 246 16 esk republika M.G.P. spol. s r.o. Tel: +420 602 303 Magyarorsz g Novartis Hung ria Kft. Tel.: +36 1 457 65 Danmark SAM Nordic Sverige Tel: +46 8 720 58 Malta Novartis Pharma Services Inc. Tel: +356 2122 2Deutschland Novartis Radiopharmaceuticals GmbH Tel: +49 911 2Nederland Novartis Pharma B.V. Tel: +31 88 04 52 Eesti SAM Nordic Rootsi Tel: +46 8 720 58 Norge SAM Nordic Sverige Tlf: +46 8 720 58

: +30 22920 63 sterreich Novartis Pharma GmbH Tel: +43 1 86 6Espa a Advanced Accelerator Applications Ib rica, S.L.U. Tel: +34 97 6600 Polska Advanced Accelerator Applications Polska Sp. z o.o. Tel.: +48 22 275 56 France Advanced Accelerator Applications T l: +33 1 55 47 63 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 Advanced Accelerator Applications Francija Tel: +33 1 55 47 63 sland SAM Nordic Sv j
S mi: +46 8 720 58 Slovensk republika MGP, spol. s r.o. Tel: +421 254 654 Italia Advanced Accelerator Applications (Italy) S.r.l. Tel: +39 0125 561Suomi/Finland SAM Nordic Ruotsi/Sverige Puh/Tel: +46 8 720 58

: +30 22920 63Sverige SAM Nordic Tel: +46 8 720 58 Latvija SAM Nordic Zviedrija Tel: +46 8 720 58 United Kingdom (Northern Ireland) Novartis Ireland Limited Tel: +44 1276 698This leaflet was last revised in {month YYYY}.

Other sources of information

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