Ytracis
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
17-01-2022
Charakterystyka produktu
(SPC)
17-01-2022
Sprawozdanie z oceny publicznego
(PAR)
17-01-2022
Składnik aktywny:
yttrium (90Y) chloride
Dostępny od:
CIS bio international
Kod ATC:
V09
INN (International Nazwa):
yttrium [90Y] chloride
Grupa terapeutyczna:
Diagnostic radiopharmaceuticals
Dziedzina terapeutyczna:
Radionuclide Imaging
Wskazania:
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.
Podsumowanie produktu:
Revision: 7
Status autoryzacji:
Withdrawn
Data autoryzacji:
2003-03-24
Ulotka dla pacjenta
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
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Charakterystyka produktu
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
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