GENTECH molybdenum (99Mo) / technetium (99mTc) sterile generator for production of sodium pertechneta

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sodium pertechnetate(99mTc), Quantity: 370 GBq

Available from:

Australian Nuclear Science and Technology Organisation T/A ANSTO

INN (International Name):

sodium pertechnetate(99mTc)

Pharmaceutical form:

Injection

Composition:

Excipient Ingredients: water for injections; sodium chloride

Administration route:

Intravenous

Units in package:

2 kits each 5 x 20mL (370GBq), plus, 2 kits each 5 x 10mL (370GBq), sterile generator, evacuated vials, sterile, needles, mediswabs + vial shield.

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

Sodium pertechnetate [99mTc] is used for scintigraphy, principally of the brain and thyroid. It can also be used to prepare various technetium-99m labelled injections for selective organ imaging especially of the liver, lung, bone and kidney.

Product summary:

Visual Identification: Clear colourless solution.; Container Type: Vial; Container Material: Glass; Container Life Time: 14 Days; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2000-10-03

Patient Information leaflet

10000-GENTECH-ANSTO-cmi – July 2021.
1
CONSUMER MEDICINE INFORMATION
GENTECH (SODIUM PERTECHNETATE [
99M
TC]) INJECTION
1
MEDICINE NAME
MOLYBDENUM [
99
MO]/TECHNETIUM [
99M
TC] STERILE GENERATOR
For Production of Sodium Pertechnetate [
99m
Tc] Injection Multidose Vial.
2
SPECIAL ADVISORY
Radiopharmaceuticals should be used only by physicians who are
qualified by specific training in the safe
use and handling of radionuclides produced by a nuclear reactor or
particle accelerator, and whose
experience and training have been approved by the appropriate
government agency authorised to license
the use of radionuclides.
Care should be taken to minimise radiation exposure to patients,
consistent with proper patient
management. As with other radioactive drugs, sodium pertechnetate [
99m
Tc] must be handled with care
and appropriate safety measures should be used to minimise radiation
exposure to clinical personnel.
3
WHY AM I BEING GIVEN THE GENTECH (SODIUM PERTECHNETATE [
99M
TC] INJECTION)?
You are being given the Sodium Pertechnetate [
99m
Tc] Injection for imaging of your body organs.
When injected, the radioactive pertechnetate will temporarily collect
in certain organ areas of your body.
Using special cameras your doctor will then detect this radioactivity
to produce an image (scan) of the
concerned organ. These images can provide your doctor valuable
information about the structure and
function of your body organ.
Sodium Pertechnetate (
99m
Tc) injection is used for a variety of diagnostic procedures, such as
brain and
thyroid imaging.
Sodium Pertechnetate (
99m
Tc) injection can also be mixed with other reagents to help your
doctor see
images of your liver, lung, bone and kidney.
Ask your nuclear medicine specialist why you have been referred for a
Sodium Pertechnetate (
99m
Tc)
scan.
4
WHAT
SHOULD
I
KNOW
BEFORE
I
USE
GENTECH
(SODIUM
PERTECHNETATE
[
99M
TC])
INJECTION?
All medicines and diagnostic agents have risks and benefits associated
with their usage. Your nuclear
medicine specialist has weighed the risks

Summary of Product characteristics

10000-GENTECH-ANSTO-pi
1
AUSTRALIAN PRODUCT INFORMATION
GENTECH (SODIUM PERTECHNETATE [
99m
Tc]) INJECTION
1
NAME OF THE MEDICINE
Molybdenum [
99
Mo]/Technetium [
99m
Tc] Sterile Generator
For Production of sodium pertechnetate [
99m
Tc] Injection Multidose Vial.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Description
ANSTO’s Gentech
®
Generator provides a means of obtaining a sterile, isotonic, additive
and pyrogen free
solution of sodium pertechnetate [
99m
Tc] Injection (fission) BP. The generator contains fission-product
molybdenum-99 [
99
Mo] from which
99m
Tc is separated by elution into evacuated vials.
The generator consists of a sealed glass vessel containing aluminium
oxide. The
99
Mo is firmly bound to
the alumina and as a result, the eluted
99m
Tc contains negligible amounts of
99
Mo. Over the life of the
generator, an elution will provide a yield of approximately 90% of the
theoretical amount of
99m
Tc available
from the
99
Mo contained within the generator vessel.
Active Ingredient:
Each vial of eluted solution contains active
99m
Tc in 0.9% sodium chloride solution for injections BP.
Quantity: 10 to 370 GBq at calibration
Physical Characteristics
Technetium-99m [
99m
Tc], with a physical half-life of 6.02 hours, decays by isometric
transition to
99
Tc.
Photons associated with this transition which are useful for detection
and imaging studies are listed in
Table 1.
Table-1
Principal Radiation
Mean % per Disintegration
Mean Energy (keV)
Gamma-2
89.1
140.5
Reference: “D A Weber, K F Eckerman, LT Dillman and JC Ryman.MIRD:
Radionuclide and Decay Schemes.” The Society of Nuclear
Medicine Inc., New York, 1989.
External Radiation
The specific gamma ray constant for
99m
Tc is 0.19mGy per MBq
-h-1
at 1cm. The first half value thickness
of lead for
99m
Tc is 0.2mm. Attenuation by lead is given in the following table.
Table-2
Shield Thicknesses mm Pb
Coefficient of Attenuation (approx.)
0.2
0.5
0.95
10
-1
1.8
10
-2
2.7
10
-3
3.6
10
-4
10000-GENTECH-ANSTO-pi
2
Elution Behaviour
Molybdenum-99, with a half