TECHNELITE Molybdenum(99Mo)/Technetium(99mTc) sterile Generator for production of Sodium pertechnetate(99mTc) injection multidose vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sodium pertechnetate(99mTc), Quantity: 18.5 GBq

Available from:

Global Medical Solutions Australia Pty Limited

INN (International Name):

sodium pertechnetate(99mTc)

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: water for injections; sodium chloride

Administration route:

Intravenous

Units in package:

555 GBq, 46.3 GBq, 37.0 GBq, 148 GBq, 129.5 GBq, 55.5 GBq, 222 GBq, 185 GBq, 462.5 GBq, 277.5 GBq, 27.8 GBq, 74.0 GBq, 370 GBq, 111 GBq, 18.5 GBq, 64.8 GBq, 92.5 GBq, 166.5 GBq

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

Technetium [99mTc] generator is used for the preparation of Sodium Pertechnetate 99m Tc injection. Sodium Pertechnetate 99mTc is used as an agent for: Brain Imaging, Thyroid Imaging, Salivary Gland Imaging, Blood Pool Imaging.

Product summary:

Visual Identification: Clear, colourless solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 14 Days; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2007-08-14

Patient Information leaflet

TECHNELITE

Technetium Tc-99m Generator
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the common questions about Technelite. It
does not
contain all of the available information about Technelite. 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 Technelite 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 TECHNELITE
Technelite contains the active ingredient called _Sodium Pertechnetate
Tc-99m_ and
belongs to a group of medicines called radiopharmaceutical agents,
which are all
radioactive.
Technelite comes as a generator, that supplies a radioactive solution,
which can be
given to you as an injection, oral solution, eye drop or by a catheter
into the bladder.
WHAT TECHNELITE IS USED FOR
Technelite is used to show how certain organs of your body are
functioning, such as
the brain, thyroid gland. salivary gland, bladder and blood flow.
Your doctor may have prescribed Technelite for another purpose. Ask
your doctor if
you have any questions about why Technelite 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 TECHNELITE
Before you or your child are given Technelite your doctor will explain
to you the
procedure you are about to undergo, and the radioactive medicine you
will be given.
You must discuss any concerns you have with your doctor.
2
You must tell your doctor if you have allergies to:

any other medicines

any other substances such as foods, preservatives or dyes
TELL YOUR DOCTOR IF YOU ARE OR PLAN TO BECOME PREGNANT.
Like most medicines Technelite is not recommended for use during
pregnancy. If
there is a need to consider Technelite during your pregnancy, your
doctor will discuss
the benefits and risks of g

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – TECHNELITE
®
MOLYBDENUM (99MO)/TECHNETIUM (99MTC) STERILE GENERATOR
FOR PRODUCTION OF SODIUM PERTECHNETATE (99MTC) INJECTION
1
NAME OF THE MEDICINE
Sodium Pertechnetate [
99m
Tc]
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium Pertechnetate [
99m
Tc] Injection, as eluted according to the elution instructions with
Lantheus Medical Imaging. Inc. TECHNELITE® Technetium [
99m
Tc] Generator, is in Sodium
Chloride 0.9% as a sterile, non-pyrogenic, diagnostic
radiopharmaceutical suitable for
intravenous injection, oral administration, and direct instillation.
The pH is 4.5-7.5.
Lantheus Medical Imaging, Inc. TECHNELITE® Technetium [
99m
Tc] Generator consists of a
column containing fission produced Molybdenum [
99
Mo] adsorbed on alumina. The
terminally sterilised and sealed column is enclosed in a lead shield,
the shield and other
components are sealed in a cylindrical plastic container with an
attached handle. Built into
the top surface are two recessed wells marked SALINE CHARGE and
COLLECT. Needles
protruding from these two wells accommodate supplied sterile eluant
charge vials and
sterile eluate collection vials. The eluting solvent consists of
Sodium Chloride 0.9%,
prepacked into septum-sealed vials.
The eluate collection vial is evacuated, sterile and non-pyrogenic. A
sterile 0.22 micrometre
bacteriological filter is incorporated between the column outlet and
the collection vials.
During and subsequent to elution, the eluate collection vial should be
kept in a radiation
shield. The Generator is shipped with a silicone needle seal over the
charge needle and a
vented needle cover over the collect needle. A sterile vial containing
bacteriostat is
supplied for the customer to aseptically reseal the collect needle
after each elution.
For the full list of excipients, see Section 6.1 List of excipients
3
PHARMACEUTICAL FORM
Sodium Pertechnetate [
99m
Tc] Injection is a clear and colourless solution usually
administered by intravenous injection..
4
CLINICAL PARTICULARS
4.1
T
HERA