GALLIUM (GA 67) CITRATE

País: Israel

Idioma: anglès

Font: Ministry of Health

Compra'l ara

Fitxa tècnica Fitxa tècnica (SPC)
18-08-2016

ingredients actius:

GALLIUM (67GA) CITRATE; SODIUM CITRATE

Disponible des:

ISORAD LTD, ISRAEL

Codi ATC:

V09HX01

formulario farmacéutico:

SOLUTION FOR INJECTION

Composición:

GALLIUM (67GA) CITRATE 1.5 - 2 MCI; SODIUM CITRATE 1.5 - 2 MG

Vía de administración:

I.V

tipo de receta:

Required

Fabricat per:

ISORAD LTD., ISRAEL

Grupo terapéutico:

GALLIUM (67GA) CITRATE

Área terapéutica:

GALLIUM (67GA) CITRATE

indicaciones terapéuticas:

Inflammatory lesions and abscesses. Primary and metastatic tumors Hodgkin's disease. Lymphomas and brochogenic carcinoma.

Data d'autorització:

2015-12-31

Fitxa tècnica

                                1
SOREQ
RADIOPHARMACEUTICALS
NUCLEAR RESEARCH CENTER (NRC)
YAVNE 81800, ISRAEL
To
Be
Used
In
Diagnostic
Institutes
Only
DESCRIPTION:
Gallium
Citrate
Ga67
Injection is supplied in isotonic solution as a
sterile,
non-pyrogenic
diagnostic
radiopharmaceutical
for
intravenous
administration. Each milliliter of the isotonic
solution contains Gallium Citrate Ga67 1.5-2
mCi, at the time of calibration, Sodium Citrate
1.5-2 mg and Sodium Chloride 0.9% sol. The
pH
is
adjusted
to
between
5-8
with
hydrochloric
acid
and/or
sodium
hydroxide
solution. Gallium Ga67, with a half-life of 78.3
hours,
is
cyclotron
produced
by
the
proton
irradiation of enriched zinc oxide, is essentially
carrier-free
and
contains
negligible
concentrations of other radioactive isotopes.
The radionuclidic composition at calibration
time is not less than 99.89% Gallium Ga67,
less than 0.01% Gallium Ga66 and less than
0.1% due to other radio contaminants, each
expressed as a percentage of total activity. The
radionuclidic composition at calibration time is
not less than 99.89% Gallium Ga67, essentially
zero (0.0002%) Gallium Ga66 and essentially
zero
of
other
radio
contaminants
each
expressed as a percentage of total activity.
The chemical structure for Gallium Citrate is
shown below:
CH
2
COO
HO C COO Ga
CH
2
COO
PHYSICAL CHARACTERISTICS
Gallium Ga67 decays to stable Zinc Zn67 by
electron capture with a physical half-life of
78.3 hours.
1
TABLE 1.
PRINCIPAL RADIATION EMISSION DATA
RADIATION MEAN %/DISINTEGRATION MEAN ENERGY (KEV)
Gamma-3
35.7
93.3
Gamma-4
19.7
184.6
Gamma-6
16.0
300.2 ___
1
Kocher, David C., “Radioactive Decay Data Tables”,
DOE/TIC-11026 (1981).
EXTERNAL RADIATION
The specific gamma ray constant for Gallium
Ga67
is
5.58
microcoulombs/Kg-hr-MBq
(0.80R/hr-mCi) at 1cm. The first half value
thickness
of
lead
is
0.066cm.
A
range
of
values
for
the
relative
attenuation
of
the
radiation
emitted
by
this
radionuclide
that
results
from
the
interposition
of
various
thicknesses of Pb is shown in Table 2. For
example, the use 0.41cm of Pb will de
                                
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