YTRACIS radiopharmaceutical precursor, solution

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.

Do not use YTRACIS:

- 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).

Take special care with YTRACIS:

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.

Pregnancy:
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.

Breast-feeding:
Ask your doctor or pharmacist for advice before taking any medicine.

You will be asked to stop breast-feeding.

Driving and using machines:

No studies on the effects on the ability to drive and use machines have been performed.

Taking other medicines:

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.

YTRACIS is not to be administered directly to the patient.

Dosage

Your physician will decide on the amount of YTRACIS to be used in your case.

Method of Administration

YTRACIS is intended for radiolabelling of medicinal products to treat specific diseases, which are subsequently administered by approved route.

If you use more YTRACIS than you should

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 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.

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.

What YTRACIS contains

- 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.

What YTRACIS looks like and contents of the pack

YTRACIS is a radiopharmaceutical precursor.

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).

Marketing Authorisation Holder and Manufacturer

CIS bio international
Boîte Postale 32
F-91192 Gif-sur-Yvette Cedex
FRANCE

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

BelgiëBelgiqueBelgien IBA-Pharma S.A. TélTel 32 0 10 47 58 13 LuxembourgLuxemburg IBA-Pharma S.A. TélTel 32 0 10 47 58 13

CIS bio international Tel 33 01 69 85 70 70 Magyarország Bayer Hungária Kft. Telefon 36 1-487 4100

eská republika Bayer Schering Pharma Tel 420 271 730 661 Malta Alfred Gera Sons Ltd. Tel. 35 621 44 62 05

Danmark Bayer AS Tlf 45 45 23 50 00 Nederland IBA-Pharma S.A. Tel 32 0 10 47 58 13

Deutschland CIS bio GmbH Tel. 49 0 30 800 93 05-0 Norge Bayer AS Tlf 47 24 11 18 00

Eesti UAB Bayer Eesti filiaal Tel. 372 06-55 85 65 Österreich Bayer Austria Ges.m.b.H Tel 43- 0 1-711 46-0

SS . . 30 210 61 36 332 Polska Bayer Sp z.o.o. Tel. 48 22 57 23 500

España IBA MOLECULAR SPAIN SA Tel 34 91 484 1721 Portugal FARDIOTOP Tel 351 217 923 778

France CIS bio international Tél 33 01 69 85 70 70 România CIS bio international Tel 33 01 69 85 70 70

Ireland ELECTRAMED Ltd. Tel 353 01 897 00 30 Slovenija Bayer d.o.o. Tel.38 61 -58 14 400

Ísland Icepharma Tel. 354 540 8000 Slovenská republika Bayer, spol. s r.o. Tel. 42 12 59 21 31 11

Italia CIS bio SpA Tel 39 0236263200 SuomiFinland ELECTRABOX PHARMA OY PuhTel 358 19 312 373

BIOTRONICS . 357 22 467880-90 Sverige Bayer AB Tel. 46 0 8 580 223 00

Latvija UAB Bayer Latvijas filile Tel. 371-784 55 63 United Kingdom QADOS Division of CROSS TECHNOLOGIES plc Tel 44 0 1252 749 500

Lietuva

UAB Bayer, Bayer Schering Pharma
Tel.: +370 5 2336868

This leaflet was last approved on ().

The following information is intended for medical or healthcare professionals only: For detailed information refer to the Summary of Product Characteristics of YTRACIS.