Consumer medicine information

TECHNELITE

Sodium pertechnetate (99mTc)

BRAND INFORMATION

Brand name

TechneLite

Active ingredient

Sodium pertechnetate (99mTc)

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using TECHNELITE.

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

BRAND INFORMATION

Brand name

TechneLite

Active ingredient

Sodium pertechnetate (99mTc)

Schedule

Unscheduled

 

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

4.1 Therapeutic Indications

Technetium [99mTc] generator is used for the preparation of sodium pertechnetate [99mTc] injection. Sodium pertechnetate [99mTc] is used as an agent for: brain imaging; thyroid imaging; salivary gland imaging; and blood pool imaging.

4.2 Dose and Method of Administration

This medical product is for diagnostic use only. Sodium Pertechnetate [99mTc] Injection is usually administered by intravascular injection but can be given orally. Sodium Pertechnetate [99mTc] Injection eluted from TechneLite (Technetium [99mTc] Generator) should not contain more than 0.15 kBq of Molybdenum [99Mo] per MBq of Technetium [99mTc] per administered dose at the time of administration. The Molybdenum [99Mo] content of the Technetium [99mTc] must be determined by the user before administration. The Sodium Pertechnetate [Tc] Injection should not contain more than 5 micrograms of aluminium per millilitre. Since the eluate does not contain an antimicrobial agent, it should not be used later than one (1) working day after elution (12 hours).
For imaging the urinary bladder and ureters (direct isotopic cystography), the sodium pertechnetate [99mTc] injection is administered by direct instillation aseptically into the bladder via a urethral catheter, following which the catheter is flushed with approximately 200 mL of sterile saline directly into the bladder. The dosage employed varies with each diagnostic procedure. If the oral route is elected, the patient should fast for at least six (6) hours before and two (2) hours after administration. When imaging the nasolacrimal drainage system, instil the sodium pertechnetate [99mTc] injection by use of a device such as a micropipette or similar method, which will ensure the accuracy of the dose.
The suggested dose range employed for various diagnostic indications in the average adult patient (70 kg) is:
Vesicoureteral imaging: 18.5 to 37 MBq.
Brain imaging: 370 to 740 MBq.
Thyroid gland imaging: 37 to 370 MBq.
Salivary gland imaging: 37 to 185 MBq.
Placenta localisation: 37 to 111 MBq.
Blood pool imaging: 370 to 1110 MBq.
Nasolacrimal drainage system: Max. 3.7 MBq.
The recommended dosage range in paediatric patients is:
Vesicoureteral imaging: 18.5 to 37 MBq.
Brain imaging: 5.18 to 10.36 MBq/kg bodyweight.
Thyroid gland imaging: 2.22 to 2.96 MBq/kg bodyweight.
Blood pool imaging: 5.18 to 10.36 MBq/kg bodyweight.
A minimum dose of 111 to 185 MBq should be employed if radionuclide angiography is performed as part of the blood pool or brain imaging procedure.

Note.

Up to one (1) gram of pharmaceutical grade potassium perchlorate in a suitable base or capsule may be given prior to administration of sodium pertechnetate [99mTc] injection. When sodium pertechnetate [99mTc] injection is used in children for brain or blood pool imaging, the administration of potassium perchlorate is especially important in order to minimise the absorbed radiation dose to the thyroid gland.
The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration of the dose.
Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration whenever solution and container permit. The solution to be administered as the patient dose should be clear and contain no particulate matter. Do not use an eluate of the TechneLite, technetium [99mTc] generator later than one (1) working day after elution (12 hours).

Elution instructions - total elution method.

1. Waterproof gloves should be worn during elution.
2. Remove dust (clear plastic) cover of generator.
3. Perform all subsequent operations aseptically.
4. Remove silicone needle seal from eluant charge well. Discard as radioactive waste.
5. Remove flip off seal and swab septum of eluant charge vial with a bactericide (such as 70% isopropyl alcohol), allow to dry, and insert the vial into charge well. Vial should be firmly inserted to assure puncture of septum.
6. Open elution shield base and insert an eluate collection vial from which the flip off seal has been removed. Screw base back on securely. Swab the exposed vial septum with a bactericide.
7. Remove vented needle cover from collect well. Discard as radioactive waste.
8. Insert shielded eluate collection vial in collect well. Elution should commence within 30 seconds and can be visually checked by the appearance of bubbles in the eluant charge vial*.

* Note.

If bubbles do not appear in the eluant charge vial within 30 seconds, either one of the vials has not been properly placed on its needle or the eluate vial has no vacuum. Remove the eluate collection vial to prevent vacuum loss; then remove and reinsert the charge vial. Reinsert the eluate collection vial and if elution does not commence, use a second shielded collection vial.

Caution.

Tampering with the internal components could compromise sterility and present a radiation hazard. This generator should not be dismantled.
9. To assure proper yield and functioning, elution must proceed to completion as evidenced by emptying of the charge vial. Allow generator to elute for at least 3 minutes after the charge has been drained, or for a total of 6 minutes.
10. After elution has been completed, remove shield containing the collection vial. Obtain the collect needle seal vial, and using a bactericide, swab the septum of the collect needle seal vial and insert over the collect needle. The eluant vial is sterile and should stay in place until the next elution, functioning as a seal for the needles within the charge well. Upon initiating the next elution, discard the empty eluant vial as radioactive waste.
11. Fill out and attach the appropriate supplied pressure sensitive radioactivity labels to the elution shield containing the filled eluate collection vial. Do not use an eluate of the technetium [99mTc] generator later than 1 working day after the time of elution (12 hours).
12. Use a shielded syringe when introducing the sodium pertechnetate [99mTc] solution into mixing vials.
13. Maintain adequate shielding during the life of the radioactive preparation by using a lead vial shield and cover, and use a shielded syringe for withdrawing and injecting the preparation.

Assay instructions for the TechneLite, technetium [99mTc] generator eluate.

The TechneLite, technetium [99mTc] generator eluate may be assayed using an ionisation chamber dose calibrator. The manufacturer's instruction for operation of the dose calibrator should be followed for measurement of technetium [99mTc] and molybdenum [99Mo] activity in the generator eluate. The molybdenum [99Mo]/ technetium [99mTc] ratio should be determined at the time of elution prior to administration, and from that ratio, the expiration time (up to 12 hours) of the eluate mathematically determined. Each eluate should meet or exceed the purity requirements of the current United States Pharmacopeia; that is, not more than 0.15 kBq of molybdenum [99Mo] per MBq of technetium [99mTc] per administered dose at the time of administration.

Radiometric molybdenum test procedure.

This method is based on the fact that most technetium [99mTc] radiation can be readily shielded and only the more energetic gamma rays from molybdenum [99Mo] (739 keV and 778 keV) are counted in the 550-850 keV energy range. The entire eluate may be assayed for molybdenum [99Mo] activity as follows.
1. A caesium [137Cs] reference source which has the same geometry as the generator eluate must be used to standardise the well counter.
2. Determine the background after setting the window to the 550-850 keV energy range.
3. Count the technetium [99mTc] eluate in its lead shield (thereby shielding out technetium [99mTc] by placing over the well or probe.
4. Count the caesium [137Cs] reference source in the same shield geometry for the same time period.
5. Compute molybdenum [99Mo] activity in the eluate as follows (see Equation 1).
Divide the number by the MBq of technetium [99mTc].
The U.S. Pharmacopoeia specifies a limit of 0.15 kBq molybdenum [99Mo] per MBq of technetium [99mTc] at the time of administration to each patient.

4.3 Contraindications

None known.

4.4 Special Warnings and Precautions for Use

Identified precautions.

Radiation risks associated with the use of sodium pertechnetate [99mTc] injection are greater in children than in adults and, in general, the younger the child, the greater the risk owing to greater absorbed radiation doses and longer life expectancy. These greater risks should be taken firmly into account in all benefit/ risk assessments involving children.
As in the use of any radioactive material, care should be taken to minimise radiation exposure to the patient consistent with proper patient management and to ensure minimum radiation exposure to occupational workers.
Since the eluate does not contain an antimicrobial agent, it should not be used after 12 hours from the time of TechneLite, molybdenum [99Mo]/ technetium [99mTc] generator elution.
After the termination of the nasolacrimal imaging procedure, blowing the nose and washing the eyes with sterile distilled water or an isotonic sodium chloride solution will further minimise the radiation dose.
Radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the safe handling of radionuclides and whose experience and training have been approved by the appropriate government agency authorised to license the use of radionuclides.
Adequate hydration of the patient is recommended before and after examination to promote urinary flow. Also, urination is recommended as often as possible for 4 to 6 hours after the examination to reduce bladder exposure to radiation.
The appropriate literature should be consulted for optimal times when imaging should be performed.
Improper handling of this radiopharmaceutical may cause radioactive contamination.
Risk/ benefit should be considered when a sodium pertechnetate [99mTc] scan is performed on the following patient populations:

Use in gastrointestinal tract obstructions.

Patients with gastrointestinal track obstructions may give rise to higher level of radiation exposure.

Use in hepatic impairment.

No data available.

Use in renal impairment.

Patients with renal impairment or suffering from renal obstructions may give rise to higher level of radiation exposure.

Use in the elderly.

Clinical studies of TechneLite did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience had not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Paediatric use.

Safety and effectiveness in children have not been established.

Children.

Radiation risks associated with the use of Sodium Pertechnetate [99mTc] scan are greater in children than in adults and, in general, the younger the child, the greater the risk owing to greater absorbed radiation doses and longer life-expectancy. These greater risks should be taken firmly into account in all benefit-risk assessments involving children.

Other.

Patients who have a scan performed on them in the previous 6 weeks with agents containing tin (stannous) may show distribution artefacts and/or poor quality images in a subsequent Sodium Pertechnetate [99mTc] brain scan as a result of uptake of pertechnetate by the red cells. The physician should give special consideration in such cases to an alternative agent that may be more appropriate.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No data available.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Adequate reproduction studies have not been performed in animals to determine whether this drug affects fertility in males or females, or has other adverse effects on the foetus.
(Category C)
Radiopharmaceuticals should not be administered to pregnant women unless the benefits to be gained outweigh the potential hazards.
Ideally examinations using radiopharmaceuticals, especially those elective in nature, of a woman of childbearing capability should be performed during the first few (approximately 10) days following the onset of menses.
 Sodium pertechnetate [99mTc] is excreted in human milk during lactation; therefore formula feedings should be substituted for breastfeeding.
This radiopharmaceutical preparation should not be administered to pregnant or lactating women unless expected benefits to be gained outweigh the potential risks.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Allergic reactions including anaphylaxis have been reported infrequently following the administration of sodium pertechnetate [99mTc] injection.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

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

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

No data available.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

The estimated absorbed radiation doses to an average adult patient (70 kg) and paediatric patients from an intravenous injection of a maximum dose of 1100 MBq of Sodium Pertechnetate [99mTc] Injection distributed uniformly in the total body of subjects not pretreated with blocking agents such as pharmaceutical grade potassium perchlorate are shown in Table 1 For patients pre-treated with a blocking agent, the estimated doses are shown in Table 2.
In paediatric patients, an average 30 minute exposure to 37 MBq of Sodium Pertechnetate [99mTc] Injection following instillation for direct cystography, results in an estimated absorbed radiation dose of approximately 0.30 mGy to the bladder wall and 0.04 to 0.05 mGy to the gonads2. See Table 3.

Distribution/excretion.

The pertechnetate ion distributes in the body similarly to the iodide ion but is not organified when trapped in the thyroid gland. Pertechnetate tends to accumulate in intracranial lesions with excessive neovascularity or an altered blood brain barrier. It also concentrates in the choroid plexus, thyroid gland, salivary glands, and stomach. However, in contrast to the iodide ion, the pertechnetate ion is released unchanged from the thyroid gland.
After intravascular administration it remains in the circulatory system for sufficient time to permit blood pool, organ perfusion, and major vessel studies. It gradually equilibrates with the extracellular space. A fraction is promptly excreted via the kidneys.
Following the administration of sodium pertechnetate [99mTc] injection as an eye drop, the drug mixes with tears within the conjunctival space. Within seconds to minutes it leaves the conjunctival space and escapes into the inferior meatus of the nose through the nasolacrimal drainage system. During this process the pertechnetate ion passes through the canaliculi, the lacrimal sac and the nasolacrimal duct. In the event of any anatomical or functional blockage of the drainage system there will be a backflow resulting in tearing (epiphora). Thus the pertechnetate escapes the conjunctival space in the tears.
While the major part of the pertechnetate escapes within a few minutes of normal drainage and tearing, it has been documented that there is some degree of transconjunctival absorption with a fractional turnover rate of 0.015/min in normal individuals, 0.021/min in patients without any sac and 0.027/min in patients with inflamed conjunctiva due to chronic dacryocystitis. Individual values may vary but these rates are probably representative and indicate that the maximum possible pertechnetate absorbed will remain below on thousandth of that used in other routine diagnostic procedures.

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

6.1 List of Excipients

Sodium chloride, water for injections.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

The expiration time of the Sodium Pertechnetate [99mTc] Injection is not later than 12 hours after elution. (If the eluate is to be used to reconstitute a kit for the preparation of a Technetium [99mTc] radiopharmaceutical, the kit should not be used after 12 hours from time of Generator elution or after six hours from the time of reconstitution of the kit). The expiration date of the TechneLite, Technetium [99mTc] Generator is fourteen days postmanufacture.

6.4 Special Precautions for Storage

Store in controlled room temperature 20°C to 25°C.
Storage of radiopharmaceuticals should be in accordance with national regulations on radioactive materials (Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) website (www.arpansa.gov.au).

6.5 Nature and Contents of Container

TechneLite, Technetium [99mTc] Generator is available in the following quantities of radioactivity: 37.0, 55.5, 74.0, 92.5, 111.0, 148.0, 166.5, 185.0, 222.0, 277.5, 370.0, 462.5, and 555.0 GBq, of Molybdenum [99mMo] on the calibration date (date of manufacture) as specified on the product lot identification label affixed to the generator. Each generator is supplied with the following standard components:
Collect Needle Seal Vial;
Eluant Charge Vials (may be supplied separately);
Eluate Collection Vials (may be supplied separately);
1 Package Insert;
6 Radiation Labels (Collection Vial);
6 Radiation Labels (Eluting Shield).
First order generators are shipped with the following accessory components:
2 Eluting Shields.
Extra quantities of these components may be obtained at the customer's request.

6.6 Special Precautions for Disposal

All components shipped with the TechneLite, Technetium [99mTc] Generator should be monitored for contamination prior to disposing into routine trash systems. The Technetium [99mTc] should not be disposed of into routine trash systems.
In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements and the Code for Disposal of Radioactive Waste by the User (RPS C-6).

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).

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.
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.
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.

Chemical structure.

99mTc.

CAS number.

CAS number not available.

7 Medicine Schedule (Poisons Standard)

Unscheduled.

Summary Table of Changes