1 Name of Medicine
Pentetic acid.
2 Qualitative and Quantitative Composition
Radpharm DTPA Kit consists of sterile, pyrogen free, lyophilised ingredients which need reconstitution with sodium pertechnetate (99mTc) injection to produce a technetium [99mTc] pentetate complex. The precise structure of the technetium [99mTc] pentetate complex is not known at this time.
Each vial contains the following active ingredient and excipient as a lyophilized powder:
Active ingredient.
5 mg of pentetic acid.
Excipient.
1 mg of stannous chloride.
The product contains no preservatives.3 Pharmaceutical Form
Radpharm DTPA is available as a dry white lyophilised powder in multi-dose 8 mL vacuum sealed vials for intravenous injection.
4.1 Therapeutic Indications
Technetium [99mTc] pentetate may be used as a renal perfusion imaging pharmaceutical.
4.2 Dose and Method of Administration
Recommended intravenous dose for the normal adult is 200 MBq.
Radiation dosimetry.
See Table 1.
Procedure.
Note.
If there is no vacuum, discard vial and do not deliver the sodium pertechnetate [99mTc] injection.
1. Place Radpharm DTPA vial in a shielding container.
2. Draw a suitable volume (1 to 4 mL) of sodium pertechnetate [99mTc] injection eluted from a technetium-99m generator (1 to 3 GBq) and inject into the Radpharm DTPA vial. Mix by inversion for 30 seconds and leave standing at room temperature for 10 minutes before use.
3. Determine the radioactivity per millilitre, label the container and calculate the patient dose.
4. The technetium [99mTc] pentetate solution is stable at room temperature and may be used up to 5 hours after preparation.4.3 Contraindications
None known.
4.4 Special Warnings and Precautions for Use
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/s are intended only for use in the preparation of technetium [99mTc] pentetate.
The radioactivity of the dose should be checked with a suitable instrument immediately prior to administration.
Use in the elderly.
No data available.
Paediatric use.
No data available.
Effects on laboratory tests.
No data available.4.5 Interactions with Other Medicines and Other Forms of Interactions
None known.
4.6 Fertility, Pregnancy and Lactation
Effects on fertility.
No data available.
(Category C)
Technetium-99m radiopharmaceuticals should only be given to a pregnant woman if in the judgement of the treating physician the expected benefits outweigh the potential hazards.
Technetium-99m is excreted in human milk. Interruption to breast feeding is necessary after the administration of technetium [99mTc] pentetate for a period less than 12 hr.
(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).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)
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.
In isolated cases the following adverse reactions have been reported: flushing, dizziness, dyspnoea, itch, urticaria and hypotension.
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
5.2 Pharmacokinetic Properties
Following intravenous administration of technetium [99mTc] pentetate to normal patients the radiopharmaceutical is rapidly distributed in the extracellular fluid space then cleared from the body through the kidneys. There is minimal binding to renal parenchyma and it clears the kidneys by glomerular filtration.
The images taken in the first minutes demonstrate kidney vascular pool and subsequent images represent technetium [99mTc] pentetate in both the collecting system and the renal pelvis.
5.3 Preclinical Safety Data
Genotoxicity.
No data available.
Carcinogenicity.
No data available.6 Pharmaceutical Particulars
6.1 List of Excipients
See Section 2 Qualitative and Quantitative Composition.
6.2 Incompatibilities
Incompatibilities were either not assessed or not identified as part of the registration of this medicine.
6.3 Shelf Life
In Australia, information on the shelf life of the Radpharm DTPA kit can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the vial and carton packaging.
After reconstitution of Radpharm DTPA with sodium pertechnetate [99mTc] injection, (1 to 3 GBq), the technetium [99mTc] pentetate complex is stable at room temperature for 5 hours.
6.4 Special Precautions for Storage
The Radpharm DTPA kit must be stored below 25°C.
6.5 Nature and Contents of Container
Radpharm DTPA kit is supplied as a carton of 5 sterile, pyrogen free, vacuum sealed multidose 8 mL glass Type 1 coloured vials with 1888 grey chlorobutyl lyophilisation stopper and aluminium seal with brown flip off.
6.6 Special Precautions for Disposal
In Australia, any unused medicine or radioactive waste material should be disposed off in accordance with Code for the disposal of radioactive wastes by the user which is published on the Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) website as Radiation Protection Series (RPS C-6).
6.7 Physicochemical Properties
Chemical structure.
Chemical formula: C14H23N3O10.
CAS number.
67-43-6.7 Medicine Schedule (Poisons Standard)
Unscheduled.
Summary Table of Changes
