Consumer medicine information

Technescan HDP

Technetium Tc-99m oxidronate

BRAND INFORMATION

Brand name

Technescan HDP

Active ingredient

Technetium Tc-99m oxidronate

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Technescan HDP.

What is in this leaflet

This leaflet answers some of the common questions about Technescan HDP. It does not contain all of the available information about Technescan HDP. 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 Technescan HDP 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 Technescan HDP

Technescan HDP contains two active ingredients – sodium oxidronate and stannous chloride. Technescan HDP belongs to a group of medicines called radiopharmaceutical agents, which are all radioactive.

Technescan HDP comes as a kit. A vial containing the sodium oxidronate and stannous chloride is to be reconstituted with additive-free sodium pertechnetate (99mTc). The kits are packaged as a 5 vial multi-dose kit.

What Technescan HDP is used for

Technescan HDP is an imaging agent that is used to detect areas in the skeletal system that may be altered in adults.

Your doctor may have prescribed Technescan HDP for another purpose. Ask your doctor if you have any questions about why Technescan HDP 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 Technescan HDP

Before you are given Technescan HDP, 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.

Technescan HDP is recommended for adult patients. If your doctor believes it is necessary to give Technescan HDP to a patient under 18, he or she will discuss the benefits and risks with you.

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, Technescan HDP is not recommended for use during pregnancy. If there is a need to consider Technescan HDP during your pregnancy, your doctor will discuss the benefits and risks of giving it to you.

Tell your doctor if you are predisposed to hypocalcemia.

Tell your doctor if you are breast feeding or plan to breast feed. Like most medicines, Technescan HDP is not recommended while you are breast feeding. However, if you are breast feeding, formula feedings should be substituted for breast feeding for 24 hours following the administration of Technescan HDP. Breast milk produced within that time should be discarded.

Tell your doctor if you have any other medical conditions.

Taking other medicines

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

How Technescan HDP 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

Technescan HDP is given as an injection into a vein. Technescan HDP should only be given by a doctor or a nurse.

When you are given Technescan HDP

Things you must do

There is nothing in particular you must do once given Technescan HDP.

Things you must not do

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

Things to be careful of

To minimise the radiation dose to the bladder, drink fluids and void immediately before the examination and as often thereafter as possible for the next 4 to 6 hours.

Side effects

Tell your doctor as soon as possible if you do not feel well after being given Technescan HDP.

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 if you experience any of the following and they worry you:

  • nausea
  • vomiting
  • urticaria (hives)
  • erythema (redness)
  • injection site inflammation
  • injection site reaction.

These side effects are usually mild.

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

Product description

What it looks like

Technescan HDP is supplied in a glass vial. An injection is prepared from the vial and is reconstituted with additive-free sodium pertechnetate (99mTc) immediately before it is injected.

Ingredients

Active ingredient:

  • 3.15 mg sodium oxidronate

Inactive ingredients:

  • gentisic acid
  • sodium chloride
  • stannous chloride dihydrate

This medicine does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.

Sponsor

Landauer Radiopharmaceuticals Pty Ltd
Level 3/69 Phillip Street
Parramatta NSW 2150
Australia

Manufactured by Curium US LLC.
Made in USA


Registration Number:
AUST R 75500

This leaflet was last prepared in April 2020.

Published by MIMS June 2020

BRAND INFORMATION

Brand name

Technescan HDP

Active ingredient

Technetium Tc-99m oxidronate

Schedule

Unscheduled

 

1 Name of Medicine

Sodium oxidronate.

6.7 Physicochemical Properties

Chemical structure.

The chemical structural formula of oxidronate sodium is:

CAS number.

CAS number for oxidronate sodium: 14255-61-9.
The radiopharmaceutical diagnostic agent, when reconstituted with additive-free sodium pertechnetate (99mTc) forms a complex of unknown structure.

2 Qualitative and Quantitative Composition

Technescan HDP is a kit for the preparation of technetium (99mTc) oxidronate, a diagnostic radiopharmaceutical agent.
Technescan HDP is supplied as a sterile, non-pyrogenic, lyophilised powder, packaged under nitrogen, in vials for intravenous administration after reconstitution with additive-free sodium pertechnetate (99mTc). Each vial contains 3.15 mg oxidronate sodium.
For the full list of excipients, see Section 6.1 List of Excipients.

Physical characteristics.

Technetium (99mTc) decays by isomeric transition with a physical half-life of 6.02 hours.1 The principal photon that is useful for detection and imaging is listed in Table 1.
1 Kocher, David C., "Radioactive Decay Data Tables," DOE/TIC-11026, 108 (1981).

External radiation.

The specific gamma ray constant for technetium (99mTc) is 0.2108 mGy at 1 cm. The first half-value thickness of lead (Pb) for technetium (99mTc) is 0.017 cm. A range of values for the relative attenuation of the radiation emitted by this radionuclide that results from interposition of various thicknesses of Pb is shown in Table 2.
To correct for physical decay of the radionuclide, the fractions that remain at selected time intervals after the time of calibration are shown in Table 3.

3 Pharmaceutical Form

Powder for Injection.
Technescan HDP is a white lyophilised powder in a glass vial intended for intravenous injection.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

This information is not available.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

This information is not available.

Distribution.

Blood levels are about 10% of the injected dose at one hour post-injection and continue to fall to about 6%, 4% and 3% at 2, 3 and 4 hours respectively. When measured at 24 hours following its administration, skeletal retention is approximately 50% of the injected dose. Technetium (99mTc) oxidronate exhibits its greatest affinity for areas of altered osteogenesis and actively metabolising bone.

Metabolism.

This information is not available.

Excretion.

During the 24 hours following injection, technetium Tc 99m oxidronate is rapidly cleared from blood and other non-osseous tissues and accumulates in the skeleton and urine in humans.

5.3 Preclinical Safety Data

No long term animal studies have been performed to evaluate carcinogenic or mutagenic potential, or whether (99mTc)-labeled Technescan HDP (technetium [99mTc] oxidronate) affects fertility in males and females.

4 Clinical Particulars

4.1 Therapeutic Indications

Technescan HDP is a diagnostic skeletal imaging agent used to demonstrate areas of altered osteogenesis in adult patients.

4.3 Contraindications

None known.

4.4 Special Warnings and Precautions for Use

This class of compounds is known to complex cations such as calcium. Particular caution should be used with patients who have or who may be predisposed to hypocalcemia (i.e. alkalosis).
The contents of the Technescan HDP kit are intended only for use in the preparation of technetium (99mTc) oxidronate and are not to be directly administered to the patient.
The contents of the kit are not radioactive. However, after the sodium pertechnetate (99mTc) is added, adequate shielding of the final preparation must be maintained to minimise radiation exposure to occupational workers and patients.
Examinations using radiopharmaceuticals, especially those elective in nature, of women of childbearing capability, should be performed during the first 10 days following the onset of menses.
The components of the kit are sterile and non-pyrogenic. It is essential that the user follow the directions carefully and adhere to strict aseptic procedures during preparation. Sodium pertechnetate (99mTc) solutions which contain an oxidizing agent or saline solutions containing preservatives are not suitable for use in the preparation of technetium (99mTc) oxidronate.
Technetium (99mTc) oxidronate should be formulated within eight (8) hours prior to clinical use. Optimal imaging results are obtained one to four hours after administration.
Technetium (99mTc) oxidronate as well as other radioactive agents, must be handled with care and appropriate safety measures should be used to minimise radiation exposure to the patients consistent with proper patient management and to ensure minimum radiation exposure the occupational workers.
Radiopharmaceuticals should be used only by medical practitioners who are qualified by specific training in the safe use and handling of radionuclides and whose experience and training have been approved by the appropriate government agency authorised to license the use of radionuclides.
To minimise radiation dose to the bladder, the patients should be encouraged to drink fluids and to void immediately before the examination and as often thereafter as possible for the next four to six hours.
Since adequate reproduction studies have not been performed in animals to determine whether technetium (99mTc) oxidronate affects fertility in males or females, has teratogenic potential, or has other adverse effects on the foetus, this radiopharmaceutical preparation should not be administered to pregnant women. Any woman who has missed a period should be assumed to be pregnant unless proven otherwise.

Use in the elderly.

There is no special safety or dosing information available for use in the elderly.

Paediatric use.

This information is not available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

This information is not available.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
No data available.
Technetium (99mTc) is excreted in human milk during lactation, therefore formula feedings should be substituted for breast feedings.

4.8 Adverse Effects (Undesirable Effects)

The incidence of total adverse events reported to the FDA over a one year period was less than 0.004%.

Body as a whole.

Hypersensitivity reactions, including life-threatening reaction.

Gastrointestinal.

Nausea, vomiting.

Skin and appendages.

Allergic dermatological manifestations (erythema), urticaria.

General disorders and administration site.

Injection site reaction, injection site inflammation.

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.

4.2 Dose and Method of Administration

Dosage.

The recommended adult dose of technetium (99mTc)-labeled Technescan HDP is 555 megabecquerel (MBq) with a range of 370 to 740 MBq. The maximum total dose to be injected is 740 MBq. The radioactivity of each dose should be measured by a suitable radiation calibration system just prior to administration. The dose should be given intravenously by slow injection. For optimal results imaging should be performed 1 to 4 hours post-injection.

Radiation dosimetry.

The estimated absorbed radiation doses in an average patient (70 kg) from an intravenous injection of 740 MBq technetium (99mTc)-labeled Technescan HDP are shown in Table 4.

Preparation of technetium (99mTc) oxidronate.

Technescan HDP contains no antimicrobial agent. Use aseptic technique and wear waterproof gloves throughout the entire preparation procedure.
Make all transfers of radioactive solutions with an adequately shielded syringe and maintain adequate shielding around the vial during the useful life of the radioactive product.
Parenteral products should be inspected visually for particulate matter and discolouration prior to administration whenever solution and container permit.

Procedure for the preparation of technetium (99mTc) oxidronate.

1. Remove plastic disc from Technescan HDP vial and cleanse top by swabbing with alcohol.

Note.

If dose is for a single-adult patient, see unit dose preparation method below.
2. Place vial in lead vial shield. Add 3 to 6 mL of sodium pertechnetate (99mTc) solution and secure with a fitted lead cover. In choosing the amount of (99mTc) radioactivity to be used, the number of doses desired, the activity of each dose (recommended adult dose is 555 MBq [15 mCi] with a range of 370 to 740 MBq) and radioactive decay must be taken into account. The recommended range of 1.11 GBq to 11.1 GBq of (99mTc) radioactivity should be used to reconstitute the vial of Technescan HDP.

Note.

The contents of the vial are now radioactive. Maintain adequate shielding using the lead vial shield and fitted lead cover during the life of the radioactive preparation.
3. Shake the vial gently, for approximately 30 seconds to assure complete dissolution. Parenteral products should be inspected visually for particulate matter and discolouration prior to administration whenever solution and container permit.
4. Record the time, date of preparation and the activity of the technetium (99mTc)-labeled oxidronate injection on the radioassay information label and affix to the vial.
5. Use within eight (8) hours of preparation. To reduce microbiological hazard, use as soon as practicable after reconstitution/preparation. The preparation should be stored between 15 to 25°C. The disposal of all radioactive wastes should be carried out in accordance with the NHMRC 9 Code of Practice for the Disposal of Radioactive Wastes by the User (1985).

Unit dose preparation.

To minimise volume injected and to ensure optimum solution concentration, reconstitute the vial contents in 3 to 6 mL of sterile, non-pyrogenic normal saline containing no preservatives. Shake the vial gently for approximately 30 seconds to assure complete dissolution, withdraw and discard all but approximately 1 mL of the solution. Add appropriate amount of sodium pertechnetate (99mTc) for a single adult dose and shake gently. Proceed with steps 4 and 5.
The radiochemical purity of reconstituted technetium (99mTc) oxidronate Injection can be checked prior to administration to the patient by use of the method set out below. This method includes the directions for performing the tests and the limits for acceptable radiochemical purity.

Instructions for determining radiochemical purity.

Required materials.

ITLC-SG (silica gel strips), 0.9% sodium chloride injection, methanol, acetone.

Procedure.

1. On each of two ITLC strips, place approximately 20 to 30 microlitre of the technetium (99mTc) oxidronate injection approximately 2 to 3 cm from the end of the strip.
2. Develop one strip by ascending chromatography using a solvent system consisting of 0.9% sodium chloride injection. Allow the solvent front to move about 8 cm from the origin.
3. Develop the second strip by ascending chromatography using a mixture of 1:1 methanol and acetone. Allow the solvent front to move about 8 cm from the origin.
4. Determine the radioactivity distribution on each strip by cutting the strips as described below and counting the sections in a suitable ionization chamber. Saline system: cut the strip at a point one third (1/3) of the distance from the origin to the solvent front. Methanol + acetone system: cut the strip at a point two thirds (2/3) of the distance from the origin to the solvent front.
5. In the saline system hydrolyzed-reduced technetium remains at the origin (Rf 0 to 0.1) while the complex (99mTc) oxidronate and any free (99mTc) pertechnetate move to the solvent front (Rf 0.85 to 1.0). The percentage of hydrolyzed-reduced technetium is calculated by dividing the activity on the bottom one third (1/3) (origin section) of the strip by the total activity of both sections of the strip and multiplying by 100%.
6. In the 1:1 methanol + acetone system, the complex plus any hydrolyzed-reduced technetium remain at the origin (Rf 0 to 0.1), while the free pertechnetate moves to the solvent front (RF 0 to 1.0). The percentage of free technetium is calculated by dividing the activity on the top one third (1/3) (solvent front section) of the strip by the total activity of both sections of the strip and multiplying by 100%.
7. The sum of the percentage of radioactivity at the origin in the saline system (the hydrolyzed-reduced technetium) plus the percentage of radioactivity at the solvent front in the methanol + acetone system (free pertechnetate) must not be greater than 10%.

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.

4.9 Overdose

In the event of the administration of a radiation overdose with technetium (99mTc) oxidronate the absorbed dose to the patient should be reduced where possible by increasing the elimination of the radionuclide from the body by forced diuresis and bladder voiding.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

7 Medicine Schedule (Poisons Standard)

Not scheduled. Not considered by committee.

6 Pharmaceutical Particulars

6.1 List of Excipients

Gentisic acid, sodium chloride, stannous chloride dihydrate.

6.2 Incompatibilities

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

6.3 Shelf Life

Before reconstitution: 12 months.
After reconstitution: The reconstituted vial must be used within eight (8) hours of preparation.

6.4 Special Precautions for Storage

Before and after reconstitution: Technescan HDP should be stored between 15 to 25°C with additive-free sodium pertechnetate (99mTc).

6.5 Nature and Contents of Container

Glass vial.
Kits contain 5 vials or 30 vials.
Not all presentations may be available.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

Summary Table of Changes