Source: Health Products Regulatory Authority (IE) Revision Year: 2020 Publisher: CIS bio International, BP 32, 91192 Gif-Sur-Yvette Cedex, France
This medicinal product is for diagnostic use only.
After radiolabelling with sodium pertechnetate (99mTc) solution the solution of technetium (99mTc) oxidronate obtained is indicated for bone scintigraphy, where it delineates areas of altered osteogenesis.
This medicinal product is intended for use in designated nuclear medicine facilities only, and should only be handled by authorised personnel.
The average activity administered by single intravenous injection is 500 MBq (300 ‑ 700 MBq) for an adult weighting 70 kg. Other activities may be justifiable. There is no special dosage regimen for the elderly patient.
Careful consideration of the activity to be administered is required since an increased radiation exposure is possible in these patients.
A dose adjustment can be required.
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 Paediatric Task Group of the EANM (2008). This activity can be calculated from the formula below using a multiplying coefficient based on the patient’s body mass (table 1).
Recommended activity [MBq] = 35 MBq x Factor (Table 1).
Table 1:
| Body weight | Factor | Body weight | Factor | Body weight | Factor |
|---|---|---|---|---|---|
| 3 kg | = 1* | 22 kg | = 5.29 | 42kg | = 9.14 |
| 4 kg | = 1.14* | 24 kg | = 5.71 | 44kg | = 9.57 |
| 6 kg | = 1.71 | 26 kg | = 6.14 | 46kg | = 10.00 |
| 8 kg | = 2.14 | 28 kg | = 6.43 | 48kg | = 10.29 |
| 10 kg | = 2.71 | 30 kg | = 6.86 | 50kg | = 10.71 |
| 12 kg | = 3.14 | 32 kg | = 7.29 | 52-54kg | = 11.29 |
| 14 kg | = 3.57 | 34 kg | = 7.72 | 56-58kg | = 12.00 |
| 16 kg | = 4.00 | 36 kg | = 8.00 | 60-62kg | = 12.71 |
| 18 kg | = 4.43 | 38 kg | = 8.43 | 64-66kg | = 13.43 |
| 20 kg | = 4.86 | 40 kg | = 8.86 | 68kg | = 14.00 |
* In very young children (up to 1 year) a minimum dose of 40 MBq is necessary in order to obtain images of sufficient quality.
This medicinal product should be reconstituted before administration to the patient. The radiolabelled solution is administered by a single intravenous injection.
For instructions on extemporaneous preparation of the medicinal product before administration, see section 12.
For patient preparation, see section 4.4.
Images obtained shortly after injection (e.g. in the so-called 3-phase bone scan procedure) will only partly reflect metabolic bone activity. Late phase static scintigraphy should be performed not earlier than 2 hours after injection.
In the event of the administration of a radiation overdose with technetium [99mTc] oxidronate 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.
1 year.
The expiry date is indicated on the outer packaging and on each vial.
After radiolabelling, do not store the labelled product above 25°C and use within 8 hours.
Store the kit at 2°C-8°C (in a refrigerator).
For storage conditions after radiolabelling, see section 6.3.
Storage for radiopharmaceuticals should be in accordance with national regulations on radioactive materials.
15ml, colourless, European Pharmacopoeia type I, drawn glass vials, closed with chlorobutyl rubber stoppers and aluminium caps.
Pack sizes: Kit of 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 by the user 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) oxidronate and is not administered directly without first 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 minimize 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 spill of urine, vomiting, etc. 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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