Gallium(67Ga) citrate 82MBq/2.2mL injection

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

gallium (67Ga) citrate

Available from:

Landauer Radiopharmaceuticals Pty Ltd

Class:

Medicine Registered

Authorization status:

Registered

Patient Information leaflet

Australian CMI 201511-01
1
GALLIUM (GA 67) CITRATE INJECTION
_Gallium (Ga 67) Citrate Injection
_______________________________________________________
CONSUMER MEDICINE INFORMATION
_______________ _________________________________
_WHAT IS IN THIS _
_LEAFLET _
This leaflet answers some of
the common questions about
Gallium (Ga 67) Citrate
Injection. It does not contain
all of the available information
about Gallium (Ga 67) Citrate
Injection. It does not replace
talking to your doctor.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you or
your child receiving Gallium
(Ga 67) Citrate Injection
against the benefits he or she
expects it will have.
IF YOU HAVE ANY CONCERNS
ABOUT HAVING THIS MEDICINE,
ASK YOUR DOCTOR.
KEEP THIS LEAFLET. You may
need to read it again.
_WHAT IS GALLIUM _
_(GA 67) CITRATE _
_INJECTION_
_ _
Gallium (Ga 67) Citrate
Injection contains the active
ingredient called Gallium Ga
67 and belongs to a group of
medicines called
radiopharmaceutical agents,
which are all radioactive.
Gallium (Ga 67) Citrate
Injection comes in a 10 mL
vial and is available in three
different radioactivities. It is
ready for intravenous
injection as packaged.
_WHAT GALLIUM (GA _
_67) CITRATE _
_INJECTION IS USED _
_FOR_
_ _
Gallium (Ga 67) Citrate
Injection is used to diagnose,
stage and/or manage
malignant lymphomas such
as Hodgkin’s and non-
Hodgkin’s lymphoma.
Gallium (Ga 67) Citrate
Injection may also help in the
diagnosis of lung cancer.
Gallium (Ga 67) Citrate
Injection can also be used to
diagnose specific lung
inflammatory lesions.
Your doctor may have
prescribed Gallium (Ga 67)
Citrate Injection for another
purpose. Ask your doctor if
you have any questions about
why Gallium (Ga 67) Citrate
Injection has been prescribed
for you. If you have any
concerns, you should discuss
these with your doctor.
This medicine is only
available with a doctor's
prescription.
_BEFORE YOU ARE _
_GIVEN GALLIUM (GA _
_67) CITRATE _
_INJECTION_
_ _
Before you are given Gallium
(Ga 67) Citrate Injectio

Summary of Product characteristics

Australian PI_201511-01
DRN 3103 GALLIUM (GA67) CITRATE INJECTION
PRODUCT INFORMATION
NAME OF THE MEDICINE
Gallium (Ga67) Citrate Injection
(Mallinckrodt Medical catalogue number: DRN 3103)
CAS number: 41183-64-6
STRUCTURE
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
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 interact with body tissues and
the effects of its decay product zinc
(> 2 g) are described in man as toxic.
PHARMACOKINETIC PROPERTIES
During the first 24 hours after administration 15 to 25% of the
administered dose is excreted via the kidneys. The remaining
activity is slowly excreted via the intestinal tract (t½ of