Yttriga precursor radiofarmaceutico en solucion

PATIENT INFORMATION LEAFLET

Radioactive precursor Yttriga in solution.

Yttrium-90 chloride

Read this leaflet carefully before you start using the 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 of the side effects listed below or any other side effects not listed in this leaflet, or if they become serious, or if you want information or advice, inform your doctor or pharmacist.

In this leaflet:

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

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

When the target is reached, YTTRIGA provides small doses of radiation to these specific areas.

For further information regarding treatment and possible effects caused by the radioactive medication, consult the prospectus of the medication used in combination.

Do not use Yttriga:

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

Be especially careful with Yttriga:

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

Its intended use is not direct use in patients.

Due to strict laws regarding the use, handling, and disposal of radioactive pharmaceuticals, this product must be used exclusively in a hospital or a similar facility. It must be handled and administered exclusively by qualified and trained individuals for the safe treatment of radioactive materials.

Special care must be taken when administering radioactive medications to children and adolescents (2 to 16 years of age).

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those obtained without a prescription.

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

Pregnancy

Yttriga is contraindicated in pregnancy.

Inform your doctor if there is any possibility that you may be pregnant. If you experience menstrual delay, consider yourself 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.

Breastfeeding

Your doctor will ask you to stop breastfeeding.

Consult your doctor or pharmacist before using any medication.

Your doctor will not administer Yttriga directly.

Dose.

Your doctor will decide how much Yttriga you will receive for treatment.

Administration form

YTTRIGA is a radioactive medication used in combination with another medication 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 medication 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.

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

For more information, consult the specific medication's prospectus.

If you notice any adverse effect not mentioned in this prospectus or suffer from a severe adverse effect described, inform your doctor or pharmacist.

Reporting 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 prospectus. You can also report them directly through the national notification system included in theAppendix V. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep out of reach and sight of children.

Do not use Yttriga after the expiration date appearing on the label after CAD.

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

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

What Yttriga contains?

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

Appearance of Yttriga and packaging size

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

Radioactive precursor in solution.

Transparent and colourless sterile solution.

Marketing authorisation holder

Eckert & Ziegler Radiopharma GmbH

Robert-Rössle-Str. 10

D-13125 Berlin

Germany

Phone +49- 30-941084-280

Fax +49- 30-941084-470

e-mail: radiopharma@ezag.de

Responsible person

Eckert & Ziegler Radiopharma GmbH

Branch Braunschweig

Gieselweg 1

D-38110 Braunschweig

Germany

You can request more information about this medicine by contacting the local representative of the marketing authorisation holder:

Last update of the summary of product characteristics:{MM/AAAA}.

Other sources of information

The detailed information on this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu.

The summary of product characteristics of this medicine is available on the website of the European Medicines Agency in all languages of the European Union/European Economic Area.

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