Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
yttrium (90Y) chloride
Eckert Ziegler Radiopharma GmbH
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 use in patients.
Revision: 10
Authorised
2006-01-19
21 B. PACKAGE LEAFLET 22 PACKAGE LEAFLET: INFORMATION FOR THE USER YTTRIGA RADIOPHARMACEUTICAL PRECURSOR, SOLUTION. Yttrium ( 90 Y) chloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or 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. IN 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 medicine used in combination with another medicine which targets specific body cells. When the target is reached, Yttriga gives tiny radiation doses to these specific sites. For further information regarding the treatment and possible effects caused by the radiolabelled medicinal product, please refer to the package leaflet of the medicinal product used as combination partner. 2. BEFORE YOU USE YTTRIGA DO NOT USE YTTRIGA: - if you are allergic (hypersensitive) to Yttrium ( 90 Y) chloride or any of the other ingredients of Yttriga. - if you are pregnant or if there is a possibility that you may be pregnant (see below). TAKE SPECIAL CARE WITH YTTRIGA - Yttriga is a radioactive medicine and is only used in combination with another medicinal product. It is not intended for direct use in patients. - Because there are strict laws covering the use, handling and disposal of radiopharmaceuticals, Yttriga 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 (from 2 to 16 years old). TAKING OTHER MEDICINES Please tell your doctor or pharmacist, if you are taking or have recen Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Yttriga radiopharmaceutical precursor, solution. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml sterile solution contains 0.1-300 GBq Yttrium ( 90 Y) on the reference date and time (corresponding to 0.005-15 micrograms of Yttrium [ 90 Y]) (as Yttrium [ 90 Y] chloride). Each 3ml vial contains 0.1-300 GBq, corresponding to 0.005-15 micrograms of Yttrium ( 90 Y), at reference date and time. The volume is 0.02-3 ml. Each 10ml vial contains 0.1-300 GBq, corresponding to 0.005-15 micrograms of Yttrium ( 90 Y), at reference date and time. The volume is 0.02-5 ml. The theoretical specific activity is 20 GBq/microgram of Yttrium ( 90 Y) (see section 6.5). Yttrium ( 90 Y) chloride is produced by decay of its radioactive precursor Strontium ( 90 Sr). It decays by emission of beta radiation of 2.281 MeV (99.98 %) of maximal energy to stable Zirconium ( 90 Zr). Yttrium ( 90 Y) has a half-life of 2.67 days (64.1 hours). 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 use in patients. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Yttriga is only to be used by specialists experienced with _in vitro_ radiolabelling. Posology The quantity of Yttriga 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. Method of administration Yttriga is intended for _in vitro_ labelling of medicinal products which are subsequently a Aqra d-dokument sħiħ