Ytracis
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 your 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. See section 4.
In this leaflet:
What YTRACIS is and what it is used for
Before you use YTRACIS
How to use YTRACIS
Possible side effects
5 How to store YTRACIS
6. Further information
Medicinal product no longer authorised
YTRACIS is a radioactive medicine used in combination with another medicine product which targets specific body cells. When the target is reached, Ytracis gives tiny radiation doses to these specific sites.
For further information regarding the treatment and possible effects caused by the medicinal product to be radiolabelled please refer to the package leaflet of the medicinal product to be radiolabelled.
if you are hypersensitive (allergic) to Yttrium (90Y) chloride or any of the other ingredients of YTRACIS.
if you are pregnant or if there is a possibility that you might be pregnant (see below).
YTRACIS is not to be administered directly to the patient.
Because there are strict laws covering the use, handling and disposal of radioactivity, YTRACIS 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.
Ask your doctor or pharmacist for advice before taking any medicine.
It is important to tell your doctor if there is any possibility that you are pregnant. Any woman who has missed a period should be assumed to be pregnant until proven otherwise. Alternative techniques which do not involve radioactive medicines should always be considered.
Ask your doctor or pharmacist for advice before taking any medicine. You will be asked to stop breast-feeding.
No studies on the effects on the ability to drive and use machines have been performed.
No interactions of Yttrium (90Y) chloride with other medicinal products are known because no studies have investigated this issue.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Medicinal product no longer authorised
YTRACIS is not to be administered directly to the patient.
Your physician will decide on the amount of YTRACIS to be used in your case.
YTRACIS is intended for radiolabelling of medicinal products to treat specific diseases, which are subsequently administered by approved route.
Since YTRACIS is administered by a doctor under strictly controlled conditions there is little chance of possible overdose. However, should this occur, you will receive appropriate treatment from your doctor.
Like all medicines, YTRACIS 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 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 after the expiry date and time stated on the label. Store in the original package.
Store in accordance with local regulations for radioactive substances.
The product label includes the appropriate storage conditions and the expiry date for the batch of product. Hospital personnel will ensure that the product is stored correctly and not administered to you after the stated expiry date.
The active substance is Yttrium (90Y) chloride.
Each millilitre of solution contains 1.850 GBq of Yttrium (90Y) chloride at the date of calibration.(GBq : GigaBecquerel, Becquerel is the unit in which radioactivity is measured).
The other ingredients are hydrochloric acid and water for injections.
YTRACIS is a radiopharmaceutical precursor.
Medicinal product no longer authorised
This medicine is a clear and colourless solution which is packed in a colourless Type I glass 2-ml vial closed with Teflon-coated bromobutyl rubber stopper and aluminium overseal.
A vial contains 0.5 ml (0.925 GBq at calibration) to 2 ml (3.700 GBq at calibration).
CIS bio international Boîte Postale 32
F-91192 Gif-sur-Yvette Cedex FRANCE
For detailed information refer to the Summary of Product Characteristics of YTRACIS.