Source: Health Products Regulatory Authority (IE) Revision Year: 2016 Publisher: Mallinckrodt Medical B.V., Westerduinweg 3, 1755 LE Petten, The Netherlands
This medicinal product is for diagnostic use only.
After radiolabeling with sodium pertechnetate (99mTc) solution, the solution obtained is indicated for
A) In-vivo or in-vivo/in-vitro red blood cell labelling for blood pool scintigraphy.
Major indications are:
B) Determination of blood volume.
C) Spleen scintigraphy.
The average activity administered by single injection after in-vivo or in-vitro labelling is 890 MBq (740-925 MBq).
The average activity administered by single injection after in-vitro labelling is 3 MBq (1-5 MBq).
The average activity administered by single injection for in-vitro labelling of denaturated erythrocytes is 50 MBq (20-70 MBq).
The optimal amount of nonradioactive stannous tin for preparation of red blood cells in-vivo or in-vitro is 0.05 µg to 1.25 µg per ml of the total blood volume of the patient (near 5000 ml in a man of 70 kg weight). Especially in cases of in-vitro labelling this dose of stannous tin should not be exceeded. Sodium (99mTc) pertechnetate should be injected (in-vivo) or added to the incubation mixture (in-vitro) after 30 minutes. Scanning can be started immediately after injection of the tracer.
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 recommended range of adult activity and adjusted according to body weight or surface area.
However, the Paediatric Task Group of EANM recommends to calculate the administered activity from the body weight according to the following table.
Fraction of adult dose:
| 3kg = 0.1 | 4kg = 0.14 | 6kg = 0.19 | 8kg = 0.23 | 10kg = 0.27 |
| 12kg = 0.32 | 14 kg = 0.36 | 16kg = 0.40 | 18kg = 0.44 | 20kg = 0.46 |
| 22kg = 0.50 | 24 kg = 0.53 | 26kg = 0.56 | 28kg = 0.58 | 30kg = 0.62 |
| 32kg = 0.65 | 34kg = 0.68 | 36kg = 0.71 | 38kg = 0.73 | 40kg = 0.76 |
| 42kg = 0.78 | 44kg = 0.80 | 46kg = 0.82 | 48kg = 0.85 | 50kg = 0.88 |
| 52-54kg = 0.90 | 56-58kg = 0.92 | 60-62kg = 0.96 | 64-66kg = 0.98 | 68kg = 0.99 |
In very young children (up to 1 year) a minimum dose of 80 MBq is necessary in order to obtain images of sufficient quality. For spleen scintigraphy a minimum dose of 20 MBq is necessary.
Because of the long lasting fixation of stannous salts on red blood cells, it is recommended not to repeat the procedure before 3 months.
Administration is by intravenous injection. This medicinal product should be reconstituted before administration to the patient
The stannous pyrophosphate lyophilisate (non radioactive substance) is first reconstituted with isotonic sodium chloride solution for injection.
Injection of the reconstituted solution of the stannous pyrophosphate complex and consecutive injection of sodium 99mTc pertechnetate 30 minutes later.
In the event of administration of an overdose with Technescan PYP very little supportive treatment can be undertaken since its elimination is entirely dependent on the normal haemolytic process. Forced diuresis and frequent bladder voiding are recommended in the case of overdosage with 99mTc pertechnetate.
1 year.
After radiolabelling: 4 hours.
Store at 2°C-8°C after radiolabelling.
Store at 2-8°C. For storage conditions after radiolabeling of the medicinal product see section 6.3.
Storage of radiopharmaceuticals should be in accordance with national regulations for radioactive material.
10 ml glass vial (Type 1 Ph. Eur) closed with a bromobutyl rubber stopper sealed with an aluminium crimp cap. TechneScan PYP is supplied as five vials in a carton.
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 licenses of the competent official organisation.
Radiopharmaceuticals should be prepared in a manner which satisfies both radiological safety and pharmaceutical quality requirements. Appropriate aseptic precautions should be taken.
Contents of the vial are intended only for use in the preparation of Technescan PYP 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.
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 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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