Summary for ARTG Entry:
RADPHARM DMSA kit for the production of Technetium (99mTc) succimer powder for injection multidose
ARTG entry for
Global Medical Solutions Australia Pty Limited T/A Radpharm Scientific
PO Box 3334 BMDC,BELCONNEN, ACT, 2617
ARTG Start Date
Drug Safety Evaluation Branch
Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Conditions Applying to Therapeutic Goods
Accepted for Registration or Listing as Goods Currently Supplied at the Commencement of the Therapeutic Goods Act 1989"
Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods
Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.
Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered
or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.
1. RADPHARM DMSA powder for injection
Single Medicine Product
See Product Information and Consumer Medicine Information for this product
INDICATIONS AS AT 25 SEPTEMBER 1996: Technetium (99mTc) succimer may be used as a static renal imaging pharmaceutical and is particularly
suited for evaluation of renal cortex, deliniation of renal space occupying lesions, determination of intrarenal function, distribution and identification of
ectopic renal sites.
Additional Product information
Glass Type I Coloured 1 Years
Store at 2 to 8
Do not Freeze
Pack Size/Poison information
Not scheduled. Not considered by committee
1. Medicine Component
Injection, powder for
Route of Administration
Lyophilised white powder
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Kit for the Preparation of Technetium[
Tc] Succimer Injection for Renal
AUST R 14326
This Kit consists of sterile, pyrogen free lyophilised ingredients which need
reconstitution with sodium pertechnetate[
Tc] injection to produce a
Tc] succimer complex suitable for renal imaging.
The precise structure of the technetium[
Tc] succimer complex is
not known at this time.
Tc] succimer is a diagnostic pharmaceutical administered
by intravenous injection.
CONTENTS AND PRESENTATION
DMSA Radpharm is supplied as a carton of 5 sterile, pyrogen free, vacuum
sealed multidose 8 mL vials.
Each vial contains 1 mg succimer (meso-2,3-dimercaptosuccinic acid),
0.4 mg stannous chloride anhydrous, 0.7 mg ascorbic acid and 50.0 mg
inositol as a lyophilised powder.
The product contains no preservatives.
PHYSICAL CHARACTERISTICS OF TECHNETIUM-99m
Technetium-99m with a physical half life of 6 hours decays by isomeric
transition to technetium-99. Photons associated with this transition that are
useful for detection and imaging studies are listed in Table 1.
Table 1. Principal Radiation Emission Data
Mean Energy (keV)
Reference: D A Weber et al. "MIRD: Radionuclide and decay schemes",
The Society of Nuclear Medicine Inc. New York, 1989.
Table 2. Physical Decay Chart for Technetium-99m
The specific gamma ray constant for technetium-99m is 0.19 mGy/MBq-h
at 1 cm. The first half value thickness of lead (Pb) for technetium-99m is
0.2 mm. Attenuation by lead is given in Table 3.
Table 3. Radiation Attenuation by Lead Shielding
Shield Thickness mm Pb
Tc] succimer exhibits insignificant glomerular filtration but
is tubularly secreted with tubular binding in the renal cortex. It binds to
receptors in microsomes of proximal tubular cells. Renal clearance is slow
(10% in 1st hour) with 15% uptake in liver and 40 to 50% uptake in kidneys
at 3 hours. Plasma clearance is triexponential with half-lives of 40 minutes,
2.1 hours and 6 days.
Tc] succimer may be used as a static renal imaging
pharmaceutical and is particularly suited for evaluation of renal cortex,
delineation of renal space occupying lesions, determination of intrarenal
function distribution and identification of ectopic renal sites.
Radiopharmaceuticals should be used only by physicians who are qualified by
specific training in the safe use and handling of radionuclides.
Contents of the vial are intended only for use in the preparation of technetium[
The radioactivity of the dose should be checked with a suitable instrument
immediately prior to administration.
Disposal of all radioactive wastes should be carried out in accordance with the NH &
MRC "Code of Practice for the Disposal of Radioactive Wastes by the User" (1985).
Use in Pregnancy
Technetium-99m radiopharmaceuticals should only be given to a pregnant woman if
in the judgement of the treating physician the expected benefits outweigh the
Use during Lactation
Technetium-99m is excreted in human milk. Interruption to breast feeding is not
essential after the administration of technetium[
Tc] succimer (a mother can be
reassured by advising an interruption of 4hr). (Reference: L.K. Harding, A. Bossuyt,
S. Pellet, C. Reiners, J.N. Talbot, "Recommendations for nuclear medicine
physicians regarding breastfeeding mothers", Eur.J.Nucl.Med., 1995, 22, BP17).
For each patient, exposure to ionising radiation must be justifiable on the
basis of likely benefit. The activity administered must be such that the
resulting dose is as low as reasonably achievable bearing in mind the need
to obtain the intended diagnostic or therapeutic result.
Exposure to ionising radiation is linked with cancer induction and a potential
for development of hereditary defects. For diagnostic nuclear medicine
investigations the current evidence suggests that these adverse effects will
occur with low frequency because of the low radiation doses incurred.
For most diagnostic investigations using a nuclear medicine procedure the
radiation dose delivered (EDE) is less than 20 mSv. Higher doses may be
justified in some clinical circumstances.
Occasional “allergic reactions” have been reported in literature although to
date these have been inadequately described.
DOSAGE AND ADMINISTRATION
Recommended intravenous dose for the normal adult is 60-80 MBq.
Recommended normal child maximum dose is 30 MBq.
Table 4. Estimated Absorbed Dose from Intravenous Administration of
Reference for Estimated Absorbed Dose: ICRP Publication 53, Radiation
Dose To Patients from Radiopharmaceuticals (1987).
The Effective Doses have been calculated using the weighting factors
Commission on Radiological Protection (1991).
NOTE: If there is no vacuum, discard vial and do not deliver the sodium
Place DMSA Radpharm vial in shielding container.
Draw a suitable volume (2-5 mL) of sodium pertechnetate[
injection eluted from a technetium-99m generator, (up to 1.5 GBq), and
inject into the DMSA Radpharm vial. Mix by slow inversion for 20 seconds
and leave standing at room temperature for 10 minutes before use.
Determine the radioactivity per millilitre, label the container and calculate
the patient dose.
Tc] succimer solution is stable at room temperature
and may be used up to 6 hours after preparation.
Stability after Reconstitution with Technetium-99m
After reconstitution of DMSA Radpharm with sodium pertechnetate[
injection, (up to 1.5 GBq), the technetium[
Tc] succimer complex is stable
at room temperature for 6 hours.
STORAGE AND EXPIRY
The DMSA Radpharm vials must be stored at 2
C to 8
C (Refrigerate. Do
Expiry is 12 months from the date of manufacture. The expiry date is stated
on the vial and carton.
This product is manufactured by Radpharm Scientific, 54 - 59 Oatley Court,
Belconnen, 2617 ACT Australia.
Approved by TGA 20 September 2006
Kit for the Preparation of Technetium[
Tc] Succimer Injection for
Product DMS 1987/1
AUST R 14326
PO Box 3334 BMDC
Belconnen ACT 2617 AUSTRALIA
Telephone 61 2 6251 6533
Facsimile 61 2 6253 3325