YTRACIS

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

YTTRIUM (90Y) CHLORIDE

Available from:

ISOTOPIA MOLECULAR IMAGING, ISRAEL

ATC code:

V10AA

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

YTTRIUM (90Y) CHLORIDE 1850 MBQ

Administration route:

I.V

Prescription type:

Required

Manufactured by:

CIS BIO INTERNATIONAL, FRANCE

Therapeutic group:

YTTRIUM (90-Y) COMPOUNDS

Therapeutic indications:

Ytracis is indicated to be used only for the radiolabelling of carrier molecules which have been specifically developed and authorized for radiolabelling with this radionuclide. Radiopharmaceutical precursor - Not intended for direct application to patients.

Authorization date:

2010-06-30

Summary of Product characteristics

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YTRACIS - SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
YTRACIS radiopharmaceutical precursor, solution.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Yttrium (90Y) chloride: 1ml of sterile solution contains 1.850 GBq,
corresponding to 92 ng of Yttrium
at 12h00 Central European Time (CET) on the date of calibration.
One vial contains 0.925 to 3.700 GBq (see section 6.5).
For 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.
METHOD OF ADMINISTRATION:
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 Yttrium (
90
Y) chloride or to any of the excipients.
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-
Established or suspected pregnancy or when pregnancy has not been
excluded (see 4.6
Pregnancy and lactation).