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.

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 giving it to you.

Tell your doctor if you are breastfeeding or plan to breastfeed. Like most medicines Technelite is not recommended while you are breastfeeding. However if you are breastfeeding, formula feedings should be substituted for breastfeeding following the administration of Technelite.

Tell your doctor if you have any other medical conditions, especially if you suffer from kidney disease.

Taking other medicines

Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from pharmacy, supermarket or health food shop.

How Technelite is given

How much is given

Your doctor will decide how much you will be given. This depends on your condition and other factors, such as weight.

How it is given

Technelite is given as an injection into a vein, an oral solution, an eye drop or by a catheter into the bladder. Technelite should only be given by a doctor or nurse that are trained in using radiopharmaceutical agents.

When you are given Technelite

Things you must do

If you are given Technelite orally, you must not eat for at least 6 hours before and 2 hours after the procedure.

If Technelite is given to you as an eye drop, then blowing the nose and washing the eyes with sterile distilled water or isotonic sodium chloride solution will help to reduce the radioactivity in your body.

Things you must not do

Do not take any other medicines until advised by your doctor.

Things to be careful of

Do not drive or operate machinery until you know how Technelite affects you. Technelite may cause dizziness and headache in some people. Make sure you know how you react to Technelite before you drive a car, operate machinery or do anything else that could be dangerous if you are dizzy.

Side effects

Tell your doctor or a nurse as soon as possible if you do not feel well after being given Technelite. All medicines have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some side effects.

Tell your doctor or a nurse immediately if you notice any of the following:

• allergic reaction - shortness of breath, wheezing or difficulty breathing, swelling of the face, lips, tongue or other parts of the body, rash, itching or hives on the skin.

These are serious side effects for which you may need urgent medical treatment.

Do not be alarmed by this list of side effects. You may not experience any of them.

Product description

What it looks like

Technelite is supplied as a generator containing:

• 1 collect needle seal vial
• 6 eluant charge vials
• 6 eluate collection vials
• 1 package insert
• 6 radiation labels (collecting vial)
• 6 radiation labels (eluting shield)
• 1 molybdenum Mo99 activity record

Ingredients

Active ingredients: Sodium Pertechnetate Tc-99m

Sponsor

Lantheus MI Australia Pty Ltd
Unit 8/24-26 Carrick Drive
Tullamarine
Victoria 3043

Registration Number

AUST R 130301

Date of Preparation

Updated: April 2012

Technelite(cmi)-2.doc

Published by MIMS January 2015

1 Name of Medicine

Sodium Pertechnetate [^99mTc].

2 Qualitative and Quantitative Composition

Sodium Pertechnetate [^99mTc] Injection, as eluted according to the elution instructions with Lantheus Medical Imaging. Inc. TechneLite Technetium [^99mTc] 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 [^99mTc] generator consists of a column containing fission produced molybdenum [⁹⁹Mo] 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 nonpyrogenic. A sterile 0.22 micrometer 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 [^99mTc] Injection is a clear and colourless solution usually administered by intravenous injection.

4 Clinical Particulars

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. No data available.
Carcinogenicity. Adequate reproduction studies have not been performed in animals to determine whether this drug affects has teratogenic potential.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Physical characteristics. Technetium [^99mTc] decays by isometric transition with a physical half-life of 6.02 hours⁴. Photons that are useful for imaging studies are listed in Table 4.
⁴ Kocher, David C. "Radioactive Decay Data Tables," DOE/TIC-11026, 108 (1981).
https://stagingapi.mims.com/au/public/v2/images/fulltablegif/TECHNE04.gif External radiation. The specific gamma ray constant for Technetium [^99mTc] is 5.4 micro-coulombs/Kg-MBq-hr at 1 cm. The first half-value thickness is 0.017 cm of lead (Pb). To facilitate control of radiation exposure of Technetium [^99mTc], for example, the use of 0.25 cm thick standard radiation elution lead shield will attenuate the radiation emitted by a factor of about 1000.
A range of values for the relative attenuation of the radiation is shown in Table 5.
Note. Because the generator is well contained and essentially dry, there is little likelihood of contamination due to damage in transit.
https://stagingapi.mims.com/au/public/v2/images/fulltablegif/TECHNE05.gif Molybdenum [⁹⁹Mo] decays to Technetium [^99mTc] with a Molybdenum [⁹⁹Mo] half-life of 66 hours. This means that only 78% of the activity remains after 24 hours; 60% remains after 48 hours, etc. (see Table 6). All units have a minimum of 38 mm, 1.5 inches (~ 6 half-value layers [for ⁹⁹Mo]) of lead surrounding the activity.
https://stagingapi.mims.com/au/public/v2/images/fulltablegif/TECHNE06.gif The physical decay characteristics of Molybdenum [⁹⁹Mo] are such that only 88.6% of the decaying Molybdenum [⁹⁹Mo] atoms form Technetium [^99mTc]. Since the Molybdenum [⁹⁹Mo] is constantly decaying to fresh Technetium [^99mTc], it is possible to elute the generator at any time. However, the total amount of Technetium [^99mTc] available at a given elution time will depend on the remaining Molybdenum [⁹⁹Mo] activity and the time interval from the previous elution. For example, the maximum Technetium [^99mTc] activity available for an elution performed 6 hours from the previous elution time will be approximately equal to 45% of the remaining Molybdenum [⁹⁹Mo] while the maximum Technetium [^99mTc] activity available for an elution performed 24 hours from the previous elution time will be approximately equal to 88% of the remaining Molybdenum [⁹⁹Mo].
The elution vial shield has a wall thickness of 7.9 mm, 0.31 inches, and reduces transmitted Technetium [^99mTc] radiation essentially to zero. To correct for physical decay of [^99mTc], the fractions that remain at selected intervals of time are shown in Table 7.
https://stagingapi.mims.com/au/public/v2/images/fulltablegif/TECHNE07.gif Chemical structure. ^99mTc.
CAS number. CAS number not available.

7 Medicine Schedule (Poisons Standard)

Unscheduled.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/TECHNEST.gif