Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
yttrium (90Y) chloride
CIS bio international
V09
yttrium [90Y] chloride
Diagnostic radiopharmaceuticals
Radionuclide Imaging
To be used only for the radiolabelling of carrier molecules which have been specifically developed and authorised for radiolabelling with this radionuclide.Radiopharmaceutical precursor - Not intended for direct application to patients.
Revision: 7
Withdrawn
2003-03-24
17 B.PACKAGE LEAFLET Medicinal product no longer authorised 18 PACKAGE LEAFLET: INFORMATION FOR THE USER YTRACIS RADIOPHARMACEUTICAL PRECURSOR, SOLUTION. Yttrium ( 90 Y) chloride. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. - 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: 1. What YTRACIS is and what it is used for 2. Before you use YTRACIS 3. How to use YTRACIS 4. Possible side effects 5 How to store YTRACIS 6. Further information 1. WHAT YTRACIS IS AND WHAT IT IS USED FOR 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. 2. BEFORE YOU USE YTRACIS DO NOT USE YTRACIS: - if you are hypersensitive (allergic) to Yttrium ( 90 Y) 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. Medicinal product no longer authorised 19 PREGNANCY: Ask your doctor or pharmacist for advice before taking any medicine. It is important to tell you Lue koko asiakirja
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT YTRACIS radiopharmaceutical precursor, solution. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of sterile solution contains 1.850 GBq Yttrium ( 90 Y) chloride, at the date of calibration, corresponding to 92 ng of Yttrium. One vial contains 0.925 to 3.700 GBq (see section 6.5). For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Radiopharmaceutical precursor, solution. Clear, colourless solution, free of particulate matter. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS To be used only for the radiolabelling of carrier molecules which have been specifically developed and authorised for radiolabelling with this radionuclide. Radiopharmaceutical precursor - Not intended for direct application to patients. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION YTRACIS is only to be used by specialists with the appropriate experience. The quantity of YTRACIS required for radiolabelling and the quantity of Yttrium ( 90 Y)-labelled medicinal product that is subsequently administered will depend on the medicinal product radiolabelled and its intended use. Refer to the Summary of Product Characteristics/package leaflet of the particular medicinal product to be radiolabelled. YTRACIS is intended for _ in vitro _ radiolabelling of medicinal products, which are subsequently administered by approved route. 4.3 CONTRAINDICATIONS Do not administer YTRACIS directly to the patient. YTRACIS is contraindicated in the following cases: - Hypersensitivity to the active substance or to any of the excipients. - Established or suspected pregnancy or when pregnancy has not been excluded (see section 4.6). For information on contraindications to particular Yttrium ( 90 Y)-labelled medicinal products prepared by radiolabelling with YTRACIS, refer to the Summary of Product Characteristics/package leaflet of the particular medicinal product to be radiolabelled. Medicinal product no longer authorised 3 4.4 SPECI Lue koko asiakirja