YTTRIGA PRECURSOR RADIOFARMACEUTICO EN SOLUCION - Radiopharmaceutical precursor in solution

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Yttriga radiopharmaceutical precursor in solution.

Chloride of (90Y) yttrium

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 further questions, ask your doctor or pharmacist.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

In this leaflet:

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

1. What is YTTRIGA and what is it used for

Yttriga is a radioactive medicinal product used in combination with another medicinal product that targets specific cells in the body.

When the target is reached, Yttriga provides tiny doses of radiation to these specific sites.

For more information about the treatment and possible effects caused by the radiolabelled medicinal product, see the package leaflet of the medicinal product used in combination.

2. Before you use YTTRIGA

Do not use Yttriga:

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

Take special care with Yttriga:

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

Its intended use is not direct administration to patients.

Due to strict laws 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 exclusively by qualified and trained personnel for the safe treatment of radioactive materials.

Special care should be taken when administering radioactive medicinal products to children and adolescents (from 2 to 16 years of age).

Use of other medicinal products

Tell your doctor or pharmacist if you are using or have recently used any other medicinal products, including those obtained without a prescription.

The interaction of chloride of (90Y) yttrium with other medicinal products is unknown, as no clinical studies are available.

Pregnancy

Yttriga is contraindicated in pregnancy.

Tell your doctor if there is any possibility that you may be pregnant. If you experience a delay in your menstrual period, you should assume you are pregnant until proven otherwise.

Your doctor will consider the possibility of using alternative techniques that do not involve the use of ionizing radiation.

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

Breast-feeding

Your doctor will ask you to interrupt breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicinal product.

3. How to use YTTRIGA

Your doctor will not administer Yttriga directly.

Dose.

Your doctor will decide what quantity of Yttriga you will receive for treatment.

Method of administration

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

If Yttriga is administered inadvertently

Yttriga is administered by your doctor after combining it with another medicinal product under strictly controlled conditions. The risk of receiving a possible overdose is small. However, if this occurs, you will receive appropriate treatment from your doctor.

4. Possible side effects

Like all medicinal products, Yttriga can cause side effects, although not everybody gets them.

For more information, see the package leaflet of the specific medicinal product that will be radiolabelled.

If you experience any side effect not mentioned in this leaflet or if you experience any of the side effects described as severe, tell your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. 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 medicinal product.

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 be carried out in accordance with local regulations for radioactive substances.

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

6. FURTHER INFORMATION

What contains Yttriga?

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

Appearance and packaging of Yttriga

Colourless glass type I vial of 3 ml with a V-shaped bottom or a colourless glass type I vial with a flat bottom of 10 ml with a silicone plug, sealed with an aluminium seal.

Radiopharmaceutical precursor in solution.

Transparent and colourless sterile 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: radiopharma@ezag.de

Manufacturer

Eckert & Ziegler Radiopharma GmbH

Branch Braunschweig

Gieselweg 1

D-38110 Braunschweig

Germany

You can obtain further information on this medicinal product from the representative of the marketing authorisation holder in your country:

Date of last revision 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.

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

.