ANSTO Health GALLIUM(Ga-67) CITRATE 100MBq/mL injection multidose vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

gallium (67Ga) citrate, Quantity: 100 MBq/mL

Available from:

Australian Nuclear Science and Technology Organisation T/A ANSTO

INN (International Name):

gallium (67Ga) citrate

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: benzyl alcohol; sodium hydroxide; sodium citrate dihydrate; water for injections

Administration route:

Intravenous

Units in package:

400MBq/4mL x 1 vial, 100MBq/1mL x 1 vial, 800MBq/8mLx1 vial, 200MBq/2mL x 1 vial, 300MBq/3mLx1 vial

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

(As per R46108) Gallium (67Ga) Citrate Injection BP may be useful in demonstrating the presence and extent of Hodgkin's Disease, lymphomas and bronchogenic carcinoma. Positive intake in the absence of prior symptoms may indicate a potential disease state. New indications as specified in the letter of 18 October 1993 from Dr Alex Proudfoot: Gallium (67Ga) Citrate Injection BP may be useful in demonstrating the presence and extent of Hodgkin's Disease, lymphomas and bronchogenic carcinoma. Positive uptake in the absence of prior symptoms may indicate a potential disease state. Gallium (67Ga) may also be useful as an aid in detecting some acute inflammatory lesions. Gallium (67Ga) Citrate Injection BP may also be useful as an aid in detecting some acute inflammatory lesions. (As per R46110) Gallium (67Ga) Citrate Injection BP may be useful in demonstrating the presence and extent of Hodgkin's Disease, lymphomas and bronchogenic carcinoma. Positive uptake in the absence of prior symptoms may indicate a potential disease state. New indications as specified in the letter of 18 October 1993 from Dr Alex Proudfoot: Gallium (67Ga) Citrate Injection BP may be useful in demonstrating the presence and extent of Hodgkin's Disease, lymphomas and bronchogenic carcinoma. Positive uptake in the absence of prior symptoms may indicate a potential disease state. Gallium (67Ga) may also be useful as an aid in detecting some acute inflammatory lesions. Gallium 67Ga) Citrate Injection BP may be useful in demonstrating the presence and extent of Hodgkin's Disease, lymphomas and bronchogenic carcinoma. Positive uptake in the absence of prior symptoms may indicate a potential disease state. Gallium (67Ga) may also be useful as an aid in detecting some acute inflammatory lesions.

Product summary:

Visual Identification: Clear colourless solution.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 5 Days; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1993-11-16

Patient Information leaflet

1
GALLIUM [
67
GA] CITRATE INJECTION BP
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Gallium (
67
Ga) injection. It does not
contain all the available information.
It does not take the place of you talking to your nuclear medicine
physician or specialist.
All medicines have potential risks and benefits associated with their
use. Your nuclear
medicine physician or specialist has weighed the small risks of you
being treated with
Gallium (
67
Ga) against the benefits it is expected you will receive from it.
If you have any concerns about being given this injection, discuss
them with your
nuclear medicine physician or specialist.
KEEP THIS LEAFLET. You may need to read it again.
WHAT IS GALLIUM (
67
GA) INJECTION USED FOR
Gallium (
67
Ga) Citrate BP is a diagnostic radiopharmaceutical, which emits small
amount
of energy similar to the X -ray, which can be detected with a special
camera, called a
“gamma camera”.
There are many reasons for having a Gallium scan. The most common
reasons are to
investigate whether there is an area of localised infection in the
body or to detect the
location of certain types of tumours.
Ask your nuclear medicine physician or specialist to explain why you
have been referred
for a Gallium scan.
For more information ask for a copy of the booklet “Nuclear Medicine
– Answering your
Questions” available from the hospital, clinic or the supplier.
HOW IS GALLIUM (
67
GA) INJECTION GIVEN
It is given as an injection into a vein in your arm. You may feel a
slight sting from the
needle but the injection itself is painless. GALLIUM [
67
GA] CITRATE INJECTION BP
••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••
2
TEST PROCEDURE
Gallium (
67
Ga) Citrate Injection BP like all other radiopharmaceuticals can only
be

Summary of Product characteristics

DESCRIPTION
The product is an injection containing
radioactive Gallium [
67
Ga] at an activity
concentration of 100 MBq/mL at the
calibration time and date. The product
conforms to the British Pharmacopoeia for
Gallium [
67
Ga] Citrate Injection.
4 mL and 8 mL.
As supplied the product is sterile and contains
1% benzyl alcohol as a preservative. The
product is designed for diagnostic use. Use by
intravenous administration
PHYSICAL CHARACTERISTICS OF
67
GA
Gallium-67 with a physical half life of 78.3
hours, decays by electron capture to stable
zinc-67. Photons associated with this transition
that are useful for detection and imaging studies
are listed in Table 1.
TABLE 1: PRINCIPAL RADIATION EMISSION DATA
Reference: Weber D A, Eckerman K F, Dillman
L T and Ryman J C.MIRD. Radionuclide
Data and Decay Schemes (1989)
TABLE 2: PHYSICAL DECAY CHART
EXTERNAL RADIATION
The specific gamma ray constant for
67
Ga
is 0.21 mGy per MBq-h at 1 cm. The first
half value thickness of lead (Pb) for
67
Ga is
0.066 cm. Attenuation by lead is given in the
following table.
TABLE 3: RADIATION ATTENUATION BY LEAD
SHIELDING
GALLIUM [
67
GA] CITRATE INJECTION BP
PRINCIPAL
ENERGY (KEV)*
ABUNDANCE
RADIATION
Gamma-2
37.0
93.3
Gamma-3
20.4
184.6
Gamma-5
16.0
300.2
TIME
FACTOR
TIME FACTOR
(HR)*
(HR)*
0
1.00
72
0.53
6
0.95
78
0.50
12
0.90
84
0.48
18
0.85
90
0.45
24
0.81
96
0.43
30
0.77
108
0.38
36
0.73
120
0.35
42
0.69
132
0.31
48
0.65
144
0.28
54
0.62
156
0.25
60
0.59
168
0.23
66
0.563
SHIELD THICKNESS
COEFFICIENT OF ATTENUATION
MM PB
0.066
0.5
0.41
0.1
1.2
0.01
2.5
0.001
4.8
0.0001
The dose sizes are made of 1mL, 2 mL ,
_PI_
P
RODUCT
I
NFORMATION
PHARMACOLOGY
Upon intravenous injection, Gallium [
67
Ga]
Citrate concentrates in certain viable primary
and metastatic tumours as well as focal sites of
infection. The mechanism of concentration is
unknown but investigations have shown that
Gallium [
67
Ga] accumulates in lysosomes and
is bound to a soluble intracellular protein. It
has been reported in scientific literature that
following intravenous