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DIDA Radpharm - Tc99m Cold Kits
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Kit for the Preparation of Technetium[99mTc]
Etifenin Injection for Hepatobiliary Imaging
Product Data AUST R 14329
DESCRIPTION
This Kit consists of sterile, pyrogen free lyophilised ingredients which need reconstitution with sodium pertechnetate[99mTc] injection to produce a technetium[99mTc] etifenin complex suitable for hepatobiliary imaging.
The precise structure of the technetium[99mTc] etifenin complex is not known at this time.
Technetium[99mTc] etifenin is a diagnostic pharmaceutical administered by intravenous injection.
CONTENTS AND PRESENTATION
DIDA Radpharm is supplied as a carton of 5 sterile, pyrogen free, vacuum sealed multidose 5 mL vials.
Each vial contains 20 mg etifenin (N[2,6-diethylacetanilide]iminodiacetic acid) and 0.42 mg tin(II) chloride anhydrous as a lyophilised powder.
The product contains no preservatives.
PHARMACOLOGY
Following intravenous administration to normal patients, approximately 90% of the technetium[99mTc] etifenin is cleared from the blood into the liver with less than 7% excreted via the renal system. High serum bilirubin levels reduce blood clearance of technetium[99mTc] etifenin, renal excretion is increased and kidneys have a prolonged visualisation.
INDICATIONS
Technetium[99mTc] etifenin may be used as a hepatobiliary imaging pharmaceutical.
CONTRAINDICATIONS
None Known.
PRECAUTIONS
General
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] etifenin.
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 potential hazards.
Use during Lactation
Technetium-99m is excreted in human milk. Interruption to breast feeding is not essential after the administration of technetium[99mTc] etifenin (a mother can be reassured by advising an interruption of 4h). (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).
ADVERSE REACTIONS
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.
Adverse reactions have not been reported for this product, to date.
Any suspected adverse reaction should be reported to Adverse Drug Reactions Advisory Committee (ADRAC) TGA, PO Box 100 WODEN ACT 2606.
Tel: 06 289 8670 Fax: 06 289 7694.
DOSAGE AND ADMINISTRATION
Recommended intravenous dose for the normal adult is 90-260 MBq.
Procedure
NOTE: If there is no vacuum, discard vial and do not deliver the sodium pertechnetate[99mTc] injection.
1. Place DIDA Radpharm vial in shielding container.
2. Draw a suitable volume (2 to 6 mL) of sodium pertechnetate[99mTc] injection eluted from a technetium-99m generator, (up to 2GBq), and inject into the DIDA Radpharm vial. Mix by inversion for 20 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] etifenin solution is stable at room temperature and may be used up to 2 hours after preparation.
Stability after Reconstitution with Technetium-99m
After reconstitution of DIDA Radpharm with sodium pertechnetate[99mTc] injection, (up to 2 GBq), the technetium[99mTc] etifenin complex is stable at room temperature for 2 hours.
STORAGE AND EXPIRY
The DIDA Radpharm vials must be stored at 2 C to 8 C (Refrigerate. Do not freeze.)
Expiry is 12 months from the date of manufacture. The expiry date is stated on the vial and carton.
MANUFACTURER
This product is manufactured by Radpharm Scientific, Unit 3 Oatley Lane Belconnen, 2617 ACT Australia.
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