Source: Health Products Regulatory Authority (IE) Revision Year: 2019 Publisher: CIS bio International, Route Nationale 306 Saclay, BP 32, 91192 Gif-Sur-Yvette Cedex, France
This medicinal product is for diagnostic use only.
After radiolabelling with sodium pertechnetate (99mTc), the solution of technetium (99mTc) succimer obtained is indicated for:
The recommended activity is 30 to 120 MBq for a patient of 70 kg bodyweight.
Careful consideration of the activity to be administered is required since an increased radiation exposure is possible in these patients.
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 to adolescents may be calculated according to the recommendations of the European Association of Nuclear Medicine (EANM 2016) paediatric dosage card, by multiplying a baseline activity (for calculation purposes) by the weight-dependent multiples given in the table below: A[MBq]Administered = Baseline Activity x Multiple (with a baseline activity of 6.8)
| Body Mass | Multiple | Body Mass | Multiple | Body Mass | Multiple |
|---|---|---|---|---|---|
| 3 kg | 1* | 22 kg | 5.29 | 42 kg | 9.14 |
| 4 kg | 1.14* | 24 kg | 5.71 | 44 kg | 9.57 |
| 6 kg | 1.71* | 26 kg | 6.14 | 46 kg | 10.00 |
| 8 kg | 2.14* | 28 kg | 6.43 | 48 kg | 10.29 |
| 10 kg | 2.71* | 30 kg | 6.86 | 50 kg | 10.71 |
| 12 kg | 3.14 | 32 kg | 7.29 | 52-54 kg | 11.29 |
| 14 kg | 3.57 | 34 kg | 7.72 | 56-58 kg | 12.00 |
| 16 kg | 4.00 | 36 kg | 8.00 | 60-62 kg | 12.71 |
| 18 kg | 4.43 | 38 kg | 8.43 | 64-66 kg | 13.43 |
| 20 kg | 4.86 | 40 kg | 8.86 | 68 kg | 14.00 |
* If the result of the calculation is less than 18.5 MBq, the recommended minimum activity of 18.5 MBq should be used in order to obtain images of sufficient quality.
For intravenous use.
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.
The images can be obtained by static (planar or tomographic) acquisitions between 1 to 3 hours post-injection. Where there is renal impairment or obstruction, delayed views may be needed (6 to 24 hours respectively).
In the event of the administration of a radiation overdose with technetium (99mTc) succimer, 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. It might be helpful to estimate the effective dose that was applied.
Kit: 1 year.
After radiolabelling: 8 hours.
Do not store above 25°C.
Store kit in a refrigerator (2°C-8°C).
Store in the original package 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 regulations for radioactive materials.
15 ml, colourless, European Pharmacopoeia type I, drawn glass vials, closed with chlorobutyl rubber stoppers and aluminium capsules.
Pack size: 5 multidose vials
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.
Content of the vial is intended only for use in the preparation of technetium (99mTc) succimer and is not to be administered directly to the patient without undergoing the preparative procedure.
For instructions on extemporaneous 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 extemporaneous preparation is not radioactive. However, after sodium pertechnetate (99mTc) injection 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, or any other biological fluids.
Radiation protection precautions in accordance with national regulations must therefore be taken.
Any unused product or waste material should be disposed of in accordance with local requirements.
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