Gallium Citrate
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Summary of Product characteristics
(SPC)
12-05-2024
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Active ingredient:
Gallium(67Ga) citrate
Summary of Product characteristics
DRN 3103
GALLIUM (GA67) CITRATE INJECTION AUSTRALIA
PAGE 1 OF 3
03103800BYS01f.doc / 05 GGK 3103 Australia SPC 17032010 /
02 GGK 3103 Australia CMI 17032010
PRODUCT INFORMATION
NAME OF MEDICINE
Trade name: Gallium (Ga67) Citrate Injection
(Mallinckrodt Medical catalogue number: DRN 3103)
DESCRIPTION
QUALITATIVE AND QUANTITATIVE COMPOSITION
Composition per ml at activity reference date and time
67
Ga as gallium citrate 37 MBq.
The qualitative composition is in conformity with the monograph 555
of
the European Pharmacopoeia. Gallium (
67
Ga) is a radionuclide (Atomic
number 31; atomic weight 67) and has a physical half-life of 3.3
days
(78.3 hours). It decays to stable zinc by electron capture
emitting
gamma energies of 93 keV (38%), 185 keV (21%) and 300 keV
(16.8%). A small, but clinically insignificant amount of
66
Ga is present as
a natural contaminant (see dosimetry).
For excipients, see List of excipients.
CAS #: 41183-64-6
STRUCTURE
PHARMACEUTICAL FORM
Solution for injections.
LIST OF EXCIPIENTS
Sodium citrate, benzyl alcohol, sodium chloride and water for
injection.
The pH of the product is 6-8.
INCOMPATIBILITIES
Incompatibilities are not known to exist.
PHARMACOLOGY
PHARMACODYNAMIC PROPERTIES
Pharmacotherapeutic group: Other radiopharmaceuticals for
inflammation and infection detection. ATC code: V09H X01.
The accumulation of gallium in tumour tissue and in sites of
inflammation is thought to be due to its behavioural similarity to
iron.
Incorporation of gallium in transferrin, ferritin and lactoferrin has
been
demonstrated in-vivo and, with respect to transferrin, also in-vitro.
In the chemical dosages administered in man for imaging procedures
(< 10
-7
mg/kg) it is not envisaged that gallium would have clinically
important pharmacodynamic effects. High doses of gallium are known
to interac
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