Yttriga

PACKAGE LEAFLET: INFORMATION FOR THE USER

Yttriga, precursor radiopharmaceutical, solution.

Yttrium (Y) chloride
Please read all of this leaflet carefully before using this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• If any of the side effects worsens, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist. Contents of 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 medicinal product used in combination with another medicinal product that acts on specific cells in the body.
Once it reaches its target, Yttriga releases minimal doses of radiation to those specific sites.
For further information on the treatment and possible effects caused by the radiolabelled medicinal product, please refer to the package leaflet of the medicinal product used in combination with Yttriga.

2. BEFORE USING YTTRIGA

Do not use Yttriga

• if you are allergic (hypersensitive) to yttrium (Y) chloride or to any of the excipients of Yttriga.
• during pregnancy or if pregnancy is suspected (see below). Exercise particular caution with Yttriga especially

Yttriga is a radioactive medicinal product and is used only in combination with another
medicinal product. It is not intended for direct administration to patients.
Due to strict regulations concerning the use, handling, and disposal of radiopharmaceuticals,
Yttriga must always be used in hospitals or similar healthcare facilities. The medicinal product must
be handled and administered only by authorized personnel qualified in the safe handling of radioactive
material.
Special care must be taken when administering radiopharmaceuticals to children and
adolescents (aged between 2 and 16 years).
Use of Yttriga with other medicinal products
Inform your doctor or pharmacist if you are taking or have recently taken any other
medicinal products, including those obtained without a prescription.
No interactions of yttrium (Y) chloride with other medicinal products are known, 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. In case of a delayed
menstrual cycle, pregnancy should be assumed until a negative pregnancy test result is confirmed.
Your doctor will consider alternative techniques that do not involve ionizing radiation.
Women of childbearing potential must use effective contraceptive measures during and after treatment.
Breast-feeding
Your doctor will ask you to discontinue 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 to you.
Dose
Your doctor will determine the amount of Yttriga to be administered to you for treatment.
Method of administration
YTTRIGA is intended for radiolabelling of medicinal products used in the treatment of specific diseases, which will subsequently be administered via the approved route.
If Yttriga is administered accidentally
Yttriga is administered by the doctor after being bound to another medicinal product, under strictly controlled conditions. The risk of receiving a potential overdose is low. However, if this should occur, you will receive appropriate treatment from your doctor.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Yttriga can cause side effects, although not everybody will experience them.
For further information, please refer to the package leaflet of the medicinal product that must be
radiolabelled.
If any of the side effects worsen, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist <,>. You can also report side effects directly via the national reporting system detailed in Annex V.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE YTTRIGA

Keep out of the reach and sight of children.
Do not use Yttriga after the expiry date and time stated on the label after EXP.
Storage conditions must comply with national regulations for radioactive materials.
Unused medicine and waste materials derived from this medicine must be disposed of in accordance with local regulations.

6. OTHER INFORMATION

What Yttriga contains

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

Description of the appearance of Yttriga and contents of the pack

Clear, colourless glass vial of type I, 3 ml with V-bottom or 10 ml colourless glass vial of type I with flat base, with silicone stopper and sealed with an aluminium seal.
Radiopharmaceutical precursor, 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

Eckert & Ziegler Radiopharma GmbH
Braunschweig facility
Gieselweg 1
D-38110 Braunschweig
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Luxembourg/Luxemburg
Eckert & Ziegler Radiopharma GmbH Eckert & Ziegler Radiopharma GmbH
Robert-Rössle-Straße 10 Robert-Rössle-Straße 10
D-13125 Berlin D-13125 Berlin
+49-30-941084-280 +49-30-941084-280
[email protected] [email protected]

България Magyarország
Eckert & Ziegler Radiopharma GmbH Eckert & Ziegler Radiopharma GmbH
Robert-Rössle-Straße 10 Robert-Rössle-Straße 10
D-13125 Berlin D-13125 Berlin
+49-30-941084-280 +49-30-941084-280
[email protected] [email protected]

Česká republika Malta
Eckert & Ziegler Radiopharma GmbH Eckert & Ziegler Radiopharma GmbH
Robert-Rössle-Straße 10 Robert-Rössle-Straße 10
D-13125 Berlin D-13125 Berlin
+49-30-941084-280 +49-30-941084-280
[email protected] [email protected]

Danmark Nederland
Eckert & Ziegler Radiopharma GmbH Eckert & Ziegler Radiopharma GmbH
Robert-Rössle-Straße 10 Robert-Rössle-Straße 10
D-13125 Berlin D-13125 Berlin
+49-30-941084-280 +49-30-941084-280
[email protected] [email protected]

Deutschland Norge
Eckert & Ziegler Radiopharma GmbH Eckert & Ziegler Radiopharma GmbH
Robert-Rössle-Straße 10 Robert-Rössle-Straße 10
D-13125 Berlin D-13125 Berlin
+49-30-941084-280 +49-30-941084-280
[email protected] [email protected]

Eesti Österreich
Eckert & Ziegler Radiopharma GmbH Eckert & Ziegler Radiopharma GmbH
Robert-Rössle-Straße 10 Robert-Rössle-Straße 10
D-13125 Berlin D-13125 Berlin
+49-30-941084-280 +49-30-941084-280
[email protected] [email protected]

Ελλάδα Polska
Eckert & Ziegler Radiopharma GmbH Eckert & Ziegler Radiopharma GmbH
Robert-Rössle-Straße 10 Robert-Rössle-Straße 10
D-13125 Berlin D-13125 Berlin
+49-30-941084-280 +49-30-941084-280
[email protected] [email protected]

España Portugal
NUCLIBER, S.A. Eckert & Ziegler Radiopharma GmbH
C/ Hierro, 33 Robert-Rössle-Straße 10
E-28045 Madrid D-13125 Berlin
Tel: +34 915 062 940 +49-30-941084-280
[email protected] [email protected]

France România
Eckert & Ziegler Radiopharma GmbH Eckert & Ziegler Radiopharma GmbH
Robert-Rössle-Straße 10 Robert-Rössle-Straße 10
D-13125 Berlin D-13125 Berlin
+49-30-941084-280 +49-30-941084-280
[email protected] [email protected]

Ireland Slovenija
Imaging Equipment Limited Eckert & Ziegler Radiopharma GmbH
The Barn, Manor Farm, Church Lane Robert-Rössle-Straße 10
Chilcompton, Somerset BA3 4 HP D-13125 Berlin
+44-1761-417402 +49-30-941084-280
[email protected] [email protected]

Ísland Slovenská republika
Eckert & Ziegler Radiopharma GmbH Eckert & Ziegler Radiopharma GmbH
Robert-Rössle-Straße 10 Robert-Rössle-Straße 10
D-13125 Berlin D-13125 Berlin
+49-30-941084-280 +49-30-941084-280
[email protected] [email protected]

Italia Suomi/Finland
Campoverde srl Eckert & Ziegler Radiopharma GmbH
Via Quintiliano, 30 Robert-Rössle-Straße 10
I-20138 Milano D-13125 Berlin
Tel: +39-02-58039045 +49-30-941084-280
[email protected] [email protected]

Κύπρος Sverige
Eckert & Ziegler Radiopharma GmbH Eckert & Ziegler Radiopharma GmbH
Robert-Rössle-Straße 10 Robert-Rössle-Straße 10
D-13125 Berlin D-13125 Berlin
+49-30-941084-280 +49-30-941084-280
[email protected] [email protected]

Latvija United Kingdom
Eckert & Ziegler Radiopharma GmbH Imaging Equipment Limited
Robert-Rössle-Straße 10 The Barn, Manor Farm, Church Lane
D-13125 Berlin Chilcompton, Somerset BA3 4 HP
+49-30-941084-280 Tel: +44-1761-417402
[email protected] [email protected]

Lietuva
Eckert & Ziegler Radiopharma GmbH
Robert-Rössle-Straße 10
D-13125 Berlin
+49-30-941084-280
[email protected]

Other sources of information

More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.
This leaflet is available in all languages of the European Union/European Economic Area on the website of the European Medicines Agency.