Yttriga radiopharmaceutical precursor solution

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Yttriga radiopharmaceutical precursor solution.

Yttrium (90Y) chloride

Read all of this leaflet carefully before you start using this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• If you notice any adverse reactions not mentioned in this leaflet, or if you experience any of the described side effects severely, inform your doctor or pharmacist.

In this leaflet:

1. What Yttriga is and what it is used for
2. Before you use Yttriga
3. How to use Yttriga
4. Possible side effects
5. How to store Yttriga
6. Further information

1. What YTTRIGA is and what it is used for

YTTRIGA is a radioactive medicine used in combination with another medicine that targets specific cells in the body.

When the target is reached, YTTRIGA delivers tiny doses of radiation to these specific sites.

For further information regarding the treatment and possible effects caused by the radiolabelled medicine, please consult the package leaflet of the medicine used in combination.

2. BEFORE USING YTTRIGA

Do not use Yttriga:

• if you are allergic (hypersensitive) to yttrium (90Y) chloride or to any of the other components of Yttriga.
• if you are pregnant or if there is any possibility that you might be pregnant (see below).

Take special care with Yttriga:

Yttriga is a radioactive medicine and is only used in combination with another medicine.

Its intended use is not for direct administration to patients.

Due to strict regulations regarding the use, handling, and disposal of radiopharmaceuticals, this product must be used exclusively in a hospital or similar facility. It must be handled and administered solely by qualified and trained personnel experienced in the safe management of radioactive materials.

Special caution must be taken when administering radioactive medicines to children and adolescents (aged 2 to 16 years).

Use of other medicines

Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

Interaction of yttrium (90Y) chloride with other medicines is unknown, as clinical studies are not available.

Pregnancy

Yttriga is contraindicated during pregnancy.

Inform your doctor if there is any possibility that you might be pregnant. If you experience a delayed menstrual period, you should consider yourself pregnant until proven otherwise.

Your doctor will consider using alternative techniques that do not involve ionizing radiation.

Women of childbearing potential must use effective contraceptive methods during and after treatment.

Breastfeeding

Your doctor will instruct you to discontinue breastfeeding.

Consult your doctor or pharmacist before using any medicine.

3. How to USE YTTRIGA

Your doctor will not administer Yttriga directly.

Dosage

Your doctor will decide the amount of Yttriga you will receive for treatment.

Method of administration

YTTRIGA is a radioactive medicinal product used in combination with another medicine that targets specific cells in the body and is administered by your doctor.

If Yttriga is inadvertently administered

Yttriga is administered by your doctor after being combined with another medicine under strictly controlled conditions. The risk of receiving a potential overdose is small. However, if this were to occur, you would receive appropriate treatment from your doctor.

4. Possible adverse effects

Like all medicines, Yttriga may cause adverse effects, although not everyone experiences them.

For further information, please refer to the package leaflet of the specific medicinal product to be radiolabelled.

If you notice any adverse effect not mentioned in this leaflet, or if you experience any of the described adverse effects severely, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system detailed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of YTTRIGA

Keep out of the reach and sight of children.

Do not use Yttriga after the expiry date stated on the label after EXP.

Storage must comply with local regulations for radioactive substances.

Disposal of unused medication and all materials that have come into contact with it must be carried out in accordance with local regulations.

6. ADDITIONAL INFORMATION

What Yttriga contains

• The active substance is (90Y) yttrium chloride.
• 1 ml of sterile solution contains 0.1–300 GBq of (90Y) yttrium at the reference date and time (equivalent to 0.005–15 micrograms of (90Y) yttrium) (as (90Y) yttrium chloride).
• The other component is hydrochloric acid (0.04 M).

What Yttriga looks like and contents of the pack

A colourless type I glass vial of 3 ml with a V-shaped bottom or a colourless type I glass vial with a flat bottom of 10 ml, with a silicone stopper and sealed with an aluminium cap.

Radiopharmaceutical precursor in solution.

Sterile, clear, colourless solution.

Marketing Authorisation Holder

Eckert & Ziegler Radiopharma GmbH

Robert-Rössle-Str. 10

D-13125 Berlin

Germany

Tel +49-30-941084-280

Fax +49-30-941084-470

e-mail: [email protected]

Manufacturer responsible

Eckert & Ziegler Radiopharma GmbH

Branch Braunschweig

Gieselweg 1

D-38110 Braunschweig

Germany

Further information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorisation Holder:

Date of the most recent review of this leaflet: {MM/YYYY}.

Other sources of information

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.

This leaflet can be found on the European Medicines Agency website in all languages of the European Union/European Economic Area.