SCINTIMUN Kit for radiopharmaceutical preparation Ref.[27572] Active ingredients: Technetium ⁹⁹ᵐTc antigranulocyte antibody

This medicinal product is for use in designated nuclear medicine facilities only, and should only be handled by authorised personnel.

Posology

Adults

The recommended activity of technetium (^99mTc) besilesomab should be between 400 MBq and 800 MBq.

This corresponds to the administration of 0.25 to 1 mg of besilesomab.

For repeated use, see section 4.4.

Elderly

No dose adjustment is required.

Renal impairment / Hepatic impairment

Formal studies have not been performed in patients with renal or hepatic impairment. However, due to the nature of the molecule and the short half-life of technetium (^99mTc) besilesomab, dose adjustment is not necessary in such patients.

Paediatric population

The safety and efficacy of Scintimun in children and adolescents have not yet been established.

No data are available.

Method of administration

The radiolabelled solution should be administered intravenously as a single dose only.

This medicinal product should be reconstituted and radiolabelled before administration to the patient. For instructions on reconstitution and radiolabelling of the medicinal product before administration, see section 12.

For patient preparation, see section 4.4.

Image acquisition

Images acquisition should start 3 to 6 hours after administration. An additional acquisition 24 hours after initial injection is recommended. Acquisition can be performed using planar imaging.

Dosimetry

Technetium (^99mTc) is produced by means of a (⁹⁹Mo/^99mTc) generator and decays with the emission of gamma radiation with a mean energy of 140 keV and a half-life of 6.02 hours to technetium (⁹⁹Tc) which, in view of its long half-life of 2.13 × 10⁵ years can be regarded as quasi stable.

For each organ, or group of organs, the absorbed doses have been calculated using the methodology developed by the MIRD (Medical Internal Radiation Dose).

The effective dose has been calculated by using the absorbed doses determined for each individual organ, taking into account the weighting factors (radiation and tissue) to use according to the recommendations of the ICRP (International Commission of Radiological Protection, Publication 103).

Table 1. Values of the absorbed doses calculated for the individual male and female of reference:

The effective dose resulting from the administration of an activity of 800 MBq for an adult weighing 70 kg is 6.9 mSv.

For an administered activity of 800 MBq the typical radiation dose to the target organ bone is 14.2 mGy and the typical radiation doses to the critical organs, bone marrow, spleen and kidneys are 19.4 mGy, 21.7 mGy, and 16.8 mGy respectively.

No case of overdose has been reported.

In the event of administration of a radiation overdose with technetium (^99mTc) besilesomab, 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 frequent bladder voiding, and by the use of laxatives to promote faecal excretion.

3 years.

After radiolabelling: 3 hours. Do not store above 25°C after radiolabelling.

Store in a refrigerator (2°C–8°C).

Keep the vial in the outer carton in order to protect from light.

For storage conditions after reconstitution and radiolabelling of the medicinal product, see section 6.3.

Storage of radiopharmaceuticals should be in accordance with national regulation on radioactive materials.

Scintimun vial: 15 mL, colourless, type I glass vial, closed with chlorobutyl rubber stopper and aluminium crimped capsule (green) containing 5.02 mg of powder.

Solvent for Scintimun: 15 mL, colourless, type I glass vial, closed with chlorobutyl rubber stopper and crimped aluminium capsule (yellow) containing 2.82 mg of powder.

Pack sizes:

Kit of one multidose vial of Scintimun and one vial of solvent.
Kit of two multidose vials of Scintimun and two vials of solvent.

Not all pack sizes may be marketed.

General warning

Radiopharmaceuticals should be received, used and administered only by authorised persons in designated clinical settings. Their receipt, storage, use, transfer and disposal are subject to the regulations and/or appropriate licences of the competent official organisation.

Radiopharmaceuticals should be prepared in a manner which satisfies both radiation safety and pharmaceutical quality requirements. Appropriate aseptic precautions should be taken.

Contents of the vial are intended only for use in the preparation of technetium (^99mTc) besilesomab and are not to be administered directly to the patient without first undergoing the preparative procedure.

For instructions on reconstitution and radiolabelling of the medicinal product before administration, see sections 12.

If at any time in the preparation of this product the integrity of this vial is compromised it should not be used.

Administration procedures should be carried out in a way to minimise risk of contamination of the medicinal product and irradiation of the operators. Adequate shielding is mandatory.

The content of the kit before reconstitution is not radioactive. However, after sodium pertechnetate (^99mTc) is added, adequate shielding of the final preparation must be maintained.

The administration of radiopharmaceuticals creates risks for other persons from external radiation or contamination from spills of urine, vomiting, etc. Radiation protection precautions in accordance with national regulations must therefore be taken.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.