PULMOCIS Kit for radiopharmaceutical preparation Ref.[27916] Active ingredients: Technetium ⁹⁹ᵐTc macrosalb

This medicinal product must be administered exclusively by authorised personnel (see section “General warnings” in section 6.6).

Posology

Adult

The recommended activities to be administered intravenously to an adult weighing 70 kg varies 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. For calculation of the amount of particles to be administered, see section 12.

For 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 between 100,000 and 200,000.

Renal impairment / Hepatic impairment

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

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 Paediatric Task Group of the EANM (2016) recommends calculation of the activity administered to the paediatric population on the basis of body weight in accordance with table 1. The activity administered to children and to adolescents may be calculated 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

The baseline activity is 5.6 MBq. The minimum activity is 10 MBq.

Table 1. Weight-dependent correction factors in the paediatric population according to the EANM‑2016 dosage card:

The number of particles should be kept as low as possible in order to embolise no more than 0.1% of the total lung capillary vessels. The number of particles to be administered to children and adolescents is recommended to be calculated according the recommendations of the European Association of Nuclear Medicine (EANM) guidelines for lung scintigraphy in children (2007):

In case of known or suspected severe decrease of the pulmonary vascular bed (more than 50%), the number of particles to be administered should be proportionally reduced. For evaluation of right to left shunts, the number of administered particles should be reduced to 10,000-20,000.

Method of administration

For multidose use.

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

Precautions to be taken before handling or administering the medicinal product

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.

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 scintigraphy 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.

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. 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.

If a ventilation/perfusion scintigraphy is performed, it is advised 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.

For patient preparation, see section 4.4.

Image acquisition

The pulmonary imaging can start immediately after injection.

The number of MAA particles per adult patient must not exceed 1.5 × 10⁶.

An administration of a very high number of particles can lead to a hemodynamically significant vascular blockage. When pronounced changes in respiration, pulse and blood pressure occur, respiratory and circulatory stabilising measures should be taken.

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

12 months.

The expiry date is indicated on the outer packaging and on each vial.

After radiolabelling: 8 hours.

Store at 2°C‑8°C.

Kit: Store in a refrigerator (2°C‑8°C).

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

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

15mL, colourless, Ph. Eur. type I, drawn glass vials, closed with rubber stoppers and aluminium capsules.

Pack size: 5 multidose vials.

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 in a manner which satisfies safety and pharmaceuticals requirements. Appropriate aseptic precautions should be taken.

The content of the vial is intended only for use in the preparation of technetium (^99mTc) macrosalb and is not to be administered directly to the patient without first undergoing the preparative procedure.

For instructions on reconstitution and radiolabelling 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) solution 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 or urine, vomiting, etc. 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.