Yttriga
yttrium [90Y] chloride
Yttrium (90Y) chloride
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
What Yttriga is and what it is used for
Before you use Yttriga
How to use Yttriga.
Possible side effects
How to store Yttriga
Further information
Yttriga is a radioactive medicine used in combination with another medicine which targets specific body cells.
When the target is reached, Yttriga gives tiny radiation doses to these specific sites.
For further information regarding the treatment and possible effects caused by the radiolabelled medicinal product, please refer to the package leaflet of the medicinal product used as combination partner.
if you are allergic (hypersensitive) to Yttrium (90Y) chloride or any of the other ingredients of Yttriga.
if you are pregnant or if there is a possibility that you may be pregnant (see below).
Yttriga is a radioactive medicine and is only used in combination with another medicinal product. It is not intended for direct use in patients.
Because there are strict laws covering the use, handling and disposal of radiopharmaceuticals, Yttriga will always be used in a hospital or a similar setting. It will only be handled and administered by people who are trained and qualified in the safe handling of radioactive material.
Particular care should be taken when administering radioactive medicinal products to children and adolescents (from 2 to 16 years old).
Please tell your doctor or pharmacist, if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
No interactions of Yttrium (90Y) chloride with other medicines are known as no clinical studies are
available.
Yttriga is contraindicated in Pregnancy.
Please tell your doctor if there is any possibility that you are pregnant. If you have missed a period, you should assume to be pregnant until a pregnancy test conducted is negative.
Your doctor will consider alternative techniques which do not involve ionising radiation. Women of childbearing potential should use effective contraception during and after treatment.
Your doctor will ask you to stop breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Your doctor will not administer Yttriga directly.
Your physician will decide on the amount of Yttriga, which you will receive for the treatment.
Yttriga is intended for radiolabelling of medicinal products to treat specific diseases, which are subsequently administered by approved route.
Yttriga is administered after being combined with another medicine by your doctor under strictly controlled conditions. The risk to receive a possible overdose is small. However, should this occur, you will receive appropriate treatment from your doctor.
Like all medicines, Yttriga can cause side effects, although not everybody gets them.
For more information, refer to the package leaflet of the particular medicinal product to be radiolabelled.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
If you get 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 medicine.
Keep out of the reach and sight of children.
Do not use Yttriga after the expiry date and time which is stated on the label after EXP. Store in accordance with local regulations for radioactive substances.
Any unused product or waste material should be disposed of in accordance with local requirements.
The active substance is Yttrium (90Y) chloride.
1 ml sterile solution contains 0.1-300 GBq Yttrium (90Y) on the reference date and time (corresponding to 0.005-15 micrograms of Yttrium [90Y]) (as Yttrium [90Y] chloride).
The other ingredient is hydrochloric acid (0.04 M).
Colourless type I glass vial of 3 ml with a V-shapped bottom or a colourless type I glass vial of 10 ml with a flat bottom with a silicon stopper, closed with an aluminium seal.
Radiopharmaceutical precursor, solution. Colourless clear sterile solution.
Eckert & Ziegler Radiopharma GmbH Robert-Rössle-Str. 10
D-13125 Berlin
Germany
Tel +49-30-941084-280
Fax +49- 30-941084-470
Eckert & Ziegler Radiopharma GmbH Branch Braunschweig
Gieselweg 1
D-38110 Braunschweig Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Eckert & Ziegler Radiopharma GmbH Robert-Rössle-Straße 10
D-13125 Berlin
Tél/Tel: +49-30-941084-280
Eckert & Ziegler Radiopharma GmbH Robert-Rössle-Straße 10
D-13125 Berlin
Tel: +49-30-941084-280
Eckert & Ziegler Radiopharma GmbH Robert-Rössle-Straße 10
D-13125 Berlin
Teл.: +49-30-941084-280
Eckert & Ziegler Radiopharma GmbH Robert-Rössle-Straße 10
D-13125 Berlin
Tél/Tel: +49-30-941084-280
Eckert & Ziegler Radiopharma GmbH Robert-Rössle-Straße 10
D-13125 Berlin
Tel: +49-30-941084-280
Eckert & Ziegler Radiopharma GmbH Robert-Rössle-Straße 10
D-13125 Berlin
Tel: +49-30-941084-280
Eckert & Ziegler Radiopharma GmbH Robert-Rössle-Straße 10
D-13125 Berlin
Tlf: +49-30-941084-280
Eckert & Ziegler Radiopharma GmbH Robert-Rössle-Straße 10
D-13125 Berlin
Tel: +49-30-941084-280
Eckert & Ziegler Radiopharma GmbH Robert-Rössle-Straße 10
D-13125 Berlin
Tel: +49-30-941084-280
Eckert & Ziegler Radiopharma GmbH Robert-Rössle-Straße 10
D-13125 Berlin
Tel: +49-30-941084-280
Eckert & Ziegler Radiopharma GmbH Robert-Rössle-Straße 10
D-13125 Berlin
Tel: +49-30-941084-280
Eckert & Ziegler Radiopharma GmbH Robert-Rössle-Straße 10
D-13125 Berlin
Tlf: +49-30-941084-280
Eckert & Ziegler Radiopharma GmbH Robert-Rössle-Straße 10
D-13125 Berlin
Τηλ: +49-30-941084-280
Eckert & Ziegler Radiopharma GmbH Robert-Rössle-Straße 10
D-13125 Berlin
Tel: +49-30-941084-280
NUCLIBER, S.A.
C/ Hierro, 33
E-28045 Madrid
Tel: +34 915 062 940
Eckert & Ziegler Radiopharma GmbH Robert-Rössle-Straße 10
D-13125 Berlin
Tel: +49-30-941084-280
Eckert & Ziegler Radiopharma GmbH Robert-Rössle-Straße 10
D-13125 Berlin
Tél: +49-30-941084-280
Eckert & Ziegler Radiopharma GmbH Robert-Rössle-Straße 10
D-13125 Berlin
Tel: +49-30-941084-280
Eckert & Ziegler Radiopharma GmbH Robert-Rössle-Straße 10
D-13125 Berlin
Tel: +49-30-941084-280
Eckert & Ziegler Radiopharma GmbH Robert-Rössle-Straße 10
D-13125 Berlin
Tel: +49-30-941084-280
Advanced Accelerator Applications (UK & Ireland) Ltd.
Edison House, 223-231 Old Marylebone Road, London, NW1 5QT – UK
Tel: +44 (0)2072585252
customerservices.UK@adacap.com
Eckert & Ziegler Radiopharma GmbH Robert-Rössle-Straße 10
D-13125 Berlin
Tel: +49-30-941084-280
Eckert & Ziegler Radiopharma GmbH Robert-Rössle-Straße 10
D-13125 Berlin
Sími: +49-30-941084-280
Eckert & Ziegler Radiopharma GmbH Robert-Rössle-Straße 10
D-13125 Berlin
Tel: +49-30-941084-280
Campoverde srl Via Quintiliano, 30
I-20138 Milano
Tel: +39-02-58039045
Eckert & Ziegler Radiopharma GmbH Robert-Rössle-Straße 10
D-13125 Berlin
Puh/Tel: +49-30-941084-280
Eckert & Ziegler Radiopharma GmbH Robert-Rössle-Straße 10
D-13125 Berlin
Τηλ: +49-30-941084-280
Eckert & Ziegler Radiopharma GmbH Robert-Rössle-Straße 10
D-13125 Berlin
Tel: +49-30-941084-280
Eckert & Ziegler Radiopharma GmbH Robert-Rössle-Straße 10
D-13125 Berlin
Tel: +49-30-941084-280
Advanced Accelerator Applications (UK & Ireland) Ltd.
Edison House, 223-231 Old Marylebone Road, London, NW1 5QT – UK
Tel: +44 (0)2072585252
customerservices.UK@adacap.com
This leaflet is available in all EU/EEA languages on the European Medicines Agency website.