Yttriga
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
29-01-2021
Fachinformation
(SPC)
29-01-2021
Öffentlichen Beurteilungsberichts
(PAR)
12-09-2011
Wirkstoff:
yttrium (90Y) chloride
Verfügbar ab:
Eckert Ziegler Radiopharma GmbH
ATC-Code:
V09
INN (Internationale Bezeichnung):
yttrium [90Y] chloride
Therapiegruppe:
Diagnostic radiopharmaceuticals
Therapiebereich:
Radionuclide Imaging
Anwendungsgebiete:
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.
Produktbesonderheiten:
Revision: 10
Berechtigungsstatus:
Authorised
Berechtigungsdatum:
2006-01-19
Gebrauchsinformation
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
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Fachinformation
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
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