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.

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.
https://stagingapi.mims.com/au/public/v2/images/fulltablegif/TECHDP01.gif 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.
https://stagingapi.mims.com/au/public/v2/images/fulltablegif/TECHDP02.gif 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.
https://stagingapi.mims.com/au/public/v2/images/fulltablegif/TECHDP03.gif

3 Pharmaceutical Form

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

4 Clinical Particulars

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).

5 Pharmacological Properties

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.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. The chemical structural formula of oxidronate sodium is:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSSODOXI.gif 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.

7 Medicine Schedule (Poisons Standard)

Not scheduled. Not considered by committee.

Summary Table of Changes

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