TECHNESCAN LYOMAA Powder for suspension for injection Ref.[11090] Active ingredients: Technetium ⁹⁹ᵐTc macrosalb

Dosage instructions for pulmonary perfusion scintigraphy and venoscintigraphy

Adult and elderly patients

The recommended radioactivity intravenously administered is between 40 and 150 MBq, with a middle value of 100 MBq for planar pulmonary perfusion scintigraphy and up to 200 MBq for SPECT pulmonary perfusion scintigraphy. The average recommended number of particles for adults should fall within the range of 100,000 and 300,000. The maximum number of particles of 700,000 per administration must not be exceeded. The minimum number of particles per dosage administered should be 100,000 in order to obtain optimal image quality.

Adult and elderly patients with severe cardiovascular disease, with pulmonary

hypertension accompanied by respiratory insufficiency or with a right-to-left shunt The number of particles should be reduced to 100,000 to 200,000.

Paediatric patients

The Paediatric Task Group of the EANM recommends calculation of the activity administered to children on the basis of body weight in accordance with the following table:

Fraction of the adult dosage:

To ensure a sufficient image quality in small children, the administered activity should not be below 10 MBq.

Newborns: The number of particles is to be restricted to a maximum of 50,000.

One-year-old children: The number of particles is to be restricted to a maximum of 150,000.

Paediatric patients where a right-to-left shunt is present

Newborns: The number of particles should be limited to 1,000–5,000.

One-year-old children: The number of particles should be limited to 5,000–15,000.

5-10 year-old children: The number of particles should be limited to 20,000–30,000.

15-year-old adolescents: The number of particles should be limited to 20,000–70,000.

Method of administration and scintigraphic examination

This medicinal product must be reconstituted before use. Any unused suspension should be discarded 12 hours after reconstitution. Information on the preparation of the reconstituted product is provided in Section 12. After reconstitution and labelling the technetium [^99mTc] macrosalb injection is a white, aqueous suspension of particles which may precipitate on standing.

This medicinal product must be administered exclusively by authorised personnel (see section “General warnings” in section 4.4).

The contents of the syringe must be carefully swirled once again prior to the injection, in order to achieve a uniform distribution of the particles and in order to avoid the formation of larger-sized aggregates. A thin cannula should be used in order to disperse any complexes of aggregates present. Additional information on precautions regarding administration of the suspension may be found in section 4.4.

For the same reason, blood should never be drawn up into the syringe because that induces the formation of small clots, which are presented in the scintigram as false positive defects because of the occlusion of the bigger arterioles. If possible, the product should not be injected via an implanted venous access device, as this can result in inadequate mixing of the radioactivity in the pulmonary artery.

Patient Preparation

A thyroid blockade prior to application of the technetium [^99mTc] macrosalb injection suspension can help to reduce the radiation exposure of the thyroid by reducing the thyroid-uptake of technetium [^99mTc] pertechnetate which develops in lesser amounts by the metabolism.

After the patient has coughed and taken several deep breaths, the medicinal product is slowly injected intravenously over 3 to 5 respiratory cycles or for at least 30 seconds, if possible however, not via an implanted venous catheter. Great care must be taken to see that the radioactive product does not enter the surrounding tissues and that no blood is aspirated, as otherwise there is a danger that larger complexes of aggregates will form. The patient should lie on his back during the injection or as close to this position as possible for patients with orthopnea. The pulmonary investigation can begin immediately after the injection.

The intravenous injection is carried out on official recommendation in the supine position, the craniocaudal difference being thus evened out. On the other hand there are sources that advise carrying out the injection in the same position in which inhalation of the radioactive inert gas or of aerosols is undertaken, i.e. preferably in the sitting position, this position being taken up at least 5 minutes beforehand. In this way, as a consequence of the better ventilation of the lungs in the sitting position, the danger of false positive results in a staggered investigation of ventilation and perfusion is avoided.

Dosimetry

Technetium [^99mTc] decays with the emission of gamma radiation with energy of 140 keV and a half-life of 6 hours to technetium [⁹⁹Tc] which can be regarded as quasi stable.

Data on radiation exposure come from the ICRP publication 80.

The effective dose among adults for administration of 150 MBq of activity (maximum recommended dose for planar perfusion scintigraphy) is approximately1.7 mSv and 2.2 mSv for 200 MBq (maximum recommended dosage for SPECT scintigraphy).

The absorbed dose in the target organ, the lungs, is thus approximately 10 mGy, and in the critical organs – adrenal glands, bladder wall, liver, pancreas and spleen – is 1.0, 1.3, 2.4, 0.8 and 0.6 mGy, respectively.

When a dosage of 200 MBq is administered, the administered dosage in the lungs as target organ is around 13 mGy; in the critical organs – adrenal glands, bladder wall, liver, pancreas and spleen, the figures are 1.4, 1.7, 3.2, 1.1 and 0.8 mGy respectively.

The number of MAA particles per adult patient must not exceed 1.5 × 10⁶ (see section 12).

The dangers to be expected relating to inadvertent administration of excess radioactivity may be reduced by promoting a diuresis and frequent voiding of urine.

18 months.

After reconstitution: 12 hours.

Lyophilized product: Store at 2°C-8°C.

Labelled product: Store at 2°C-8°C.

Storage should be in accordance with national regulations for radioactive materia.

10 ml Type I (Ph. Eur.) glass vial closed with a bromobutyl rubber stopper.

Technescan LyoMAA is supplied as five vials in one carton.

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 by the user in a manner which satisfies both radiation safety and pharmaceutical quality requirements. Appropriate aseptic precautions should be taken.

The content of the kit before extemporary preparation is not radioactive. However, after sodium pertechnetate [^99mTc] solution (Ph. Eur.) 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.