MIBI TECHNESCAN Kit for radiopharmaceutical preparation Ref.[27644] Active ingredients: Technetium ⁹⁹ᵐTc sestamibi

Posology

Adults and elderly population

Posology may vary depending on gamma camera characteristics and reconstruction modalities. The injection of activities greater than local DRLs (Diagnostic Reference Levels) should be justified.

The recommended activity range for intravenous administration to an adult patient of average weight (70 kg) is for:

Diagnosis of reduced coronary perfusion and myocardial infarction:

400–900 MBq

The recommended activity range for diagnosis of ischaemic heart disease according to the European procedural guideline is

• Two-day protocol: 600–900 MBq/study
• One-day protocol: 400–500 MBq for the first injection, three times more for the second injection.

Not more than a total of 2000 MBq should be administered for a one-day protocol and 1800 MBq for a twoday-protocol. For a one day protocol, the two injections (stress and rest) should be done at least two hours apart but may be performed in either order. After the stress injection, exercise should be encouraged for an additional one minute (if possible).

For diagnosis of myocardial infarction one injection at rest is usually sufficient.

For diagnosis of ischaemic heart disease two injections (stress and rest) are required in order to differentiate transiently from persistently reduced myocardial uptake.

Assessment of global ventricular function:

600–800 MBq injected as a bolus.

Scintimammography:

700–1000 MBq injected as a bolus usually in the arm opposite to the lesion.

Localisation of hyperfunctioning parathyroid tissue:

200-700 MBq injected as a bolus. The typical activity is between 500–700 MBq.

Posology may vary depending on gamma camera characteristics and reconstruction modalities.

The injection of activities greater than local DRLs (Diagnostic Reference Levels) should be justified.

Renal impairment

Careful consideration of the activity to be administered is required since an increased radiation exposure is possible in these patients.

Hepatic impairment

In general, activity selection for patients with a decreased hepatic function should be cautious, usually starting at the low end of the dosing range.

Paediatric population

The use in children and adolescents has to be considered carefully, based upon clinical needs and assessing the risk/benefit ratio in this patient group. The activities to be administered to children and adolescents may be calculated according to the recommendations of the European Association of Nuclear Medicine (EANM) paediatric dosage card; the activity administered to children and to adolescents may be calculated by multiplying a baseline activity (for calculation purposes) by the weight-dependent multiplies given in the table below.

A[MBq]Administered = Baseline Activity × Multiple

The baseline activity is 63 MBq as a cancer seeking agent. For cardiac imaging, the minimum and maximum baseline activities are 42 and 63 MBq, respectively, for the two-day protocol cardiac scan both at rest and stress. For the one-day cardiac imaging protocol, the baseline activity is 28 MBq at rest and 84 MBq at stress. The minimum activity for any imaging study is 80 MBq.

Method of administration

For intravenous use.

Because of potential tissue damage, extravasal injection of this radioactive product has to be strictly avoided.

For multidose use.

Precautions to be taken before handling or administration of the medicinal product

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

For patient preparation, see section 4.4.

Image acquisition

Cardiac Imaging

Imaging should begin approximately after 30-60 min after injection to allow for hepatobiliary clearance. Longer delay can be required for resting images and for stress with vasodilatators alone because of the risk of higher subdiaphragmatic technetium ( 99mTc) activity. There is no evidence for significant changes in myocardial tracer concentration or redistribution, therefore imaging for up to 6 hours post injection is possible. Test may be done in a one day or two days protocol.

Preferably tomographic imaging (SPECT) with or without ECG gating should be performed.

Scintimammography

Breast imaging is optimally initiated 5 to 10 minutes post injection with the patient in the prone position with breast freely pendant.

The product is administered in an arm vein contralateral to the breast with the suspected abnormality. If the disease is bilateral, the injection is ideally administered in a dorsal vein of the foot.

Conventional gamma camera:

The patient should then be repositioned so that the contralateral breast is pendant and a lateral image of it should be obtained. An anterior supine image may then be obtained with the patient’s arms behind her head.

Detector dedicated to breast imaging:

In case a detector dedicated to breast imaging is used, a relevant machine-specific protocol must be followed to obtain the best possible imaging performance.

Parathyroid imaging

Parathyroid image acquisition depends on the protocol chosen. The most used studies are either the subtraction and/or the dual-phase techniques, which can be performed together.

For the subtraction technique either sodium iodide (¹²³I) or sodium pertechnetate (^99mTc) can be used for imaging for the thyroid gland since these radiopharmaceuticals are trapped by functioning thyroid tissue. This image is subtracted from the technetium (^99mTc) sestamibi image, and pathological hyperfunctioning parathyroid tissue remains visible after subtraction. When sodium iodide (¹²³I) is used, 10 to 20 MBq are orally administered. Four hours after the administration, neck and thorax images may be obtained. After sodium iodide (¹²³I) image acquisition, 200 to 700 MBq of technetium (^99mTc) sestamibi are injected and images are acquired 10 minutes post injection in double acquisition with 2 peaks of gamma energy (140 keV for technetium (^99mTc) and 159 keV for iodine (¹²³I). When sodium pertechnetate (^99mTc) is used, 40- 150 MBq are injected and neck and thorax images are acquired 30 minutes later. Then 200 to 700 MBq of technetium (^99mTc) sestamibi are injected and a second acquisition of images is acquired 10 minutes later.

If the dual phase technique is used, 400 to 700 MBq of technetium (^99mTc) sestamibi are injected and the first neck and mediastinum image is obtained 10 minutes later. After a wash-out period of 1 to 2 hours, neck and mediastinum imaging is again performed.

The planar images may be complemented by early and delayed SPECT or SPECT/CT.

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.

The data listed below are from ICRP 80 and are calculated according to the following assumptions: After intravenous injection the substance is rapidly cleared from the blood and taken up predominantly mainly in muscular tissues (including heart), liver, and kidneys, with a smaller amount in salivary glands and thyroid.

When the substance is injected in conjunction with a stress test, there is a considerable increase of the uptake in heart and skeletal muscles, with a correspondingly lower uptake in all other organs and tissues. The substance is excreted by the liver and kidneys in the proportions 75% and 25%, respectively.

The effective dose has been calculated according to a voiding frequency of 3.5 hours in adults.

Cardiac imaging

The effective dose resulting from the administration of a maximal recommended activity of 2,000 MBq of technetium (^99mTc) sestamibi for an adult weighing 70 kg is about 16.4 mSv if implementing the one-day protocol with administration of 500 MBq at rest and 1,500 MBq at exercise. For this administered activity of 2,000 MBq the typical radiation dose to the target organ heart is 14 mGy and the typical radiation doses to the critical organs gall bladder, kidneys and upper large intestine are 69, 57 and 46.5 mGy, respectively.

The effective dose resulting from the administration of a maximal recommended activity of 1,800 MBq (900 MBq at rest and 900 MBq at exercise) of technetium (^99mTc) sestamibi for a two-day protocol for an adult weighing 70 kg is about 15.2 mSv.

For this administered activity of 1,800 MBq the typical radiation dose to the target organ heart is 12.2 mGy and the typical radiation doses to the critical organs gall bladder, kidneys and upper large intestine are 64.8, 55.8 and 44.1 mGy, respectively.

Scintimammography

The effective dose resulting from the administration of a maximal recommended activity of 1,000 MBq of technetium (^99mTc) sestamibi for an adult weighing 70 kg is about 9 mSv. For an administered activity of 1,000 MBq the typical radiation dose to the target organ breast is 3.8 mGy and the typical radiation doses to the critical organs gall bladder, kidneys and upper large intestine are 39, 36 and 27 mGy, respectively.

Parathyroid imaging

The effective dose resulting from the administration of a maximal recommended activity of 700 MBq of technetium (^99mTc) sestamibi for an adult weighing 70 kg is about 6.3 mSv. For an administered activity of 700 MBq the typical radiation dose to the target organ thyroid is 3.7 mGy and the typical radiation doses to the critical organs gall bladder, kidneys and upper large intestine are 27.3, 25.2 and 18.9 mGy, respectively.

In the event of administration of a radiation overdose with technetium (^99mTc) sestamibi the absorbed dose to the patient should be reduced where possible by increasing the elimination of the radionuclide from the body by frequent micturition and defaecation. It might be helpful to estimate the effective dose that was applied.

2 years.

After radiolabelling: 10 hours. Do not store above 25°C after radiolabelling.

Do not store above 25°C. Keep the vials in the outer carton in order to protect from light.

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

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

10 ml multi-dose glass vials, type 1 borosilicate glass (Ph. Eur.) sealed with a chlorobutyl rubber stopper.

Pack size: 5 vials.

General warnings

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) sestamibi and are not to be administered directly to the patient without first undergoing the preparative procedure.

For instructions on extemporary preparation of the medicinal product before administration, see section 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 extemporary preparation 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 spill of urine, vomiting or any other biological fluids. 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 for radioactive materials.