PULMOTEC Kit for radiopharmaceutical preparation Ref.[27570] Active ingredients: Technetium ⁹⁹ᵐTc technegas

Radiopharmaceuticals should be received, used and administered only by authorised persons in designated clinical settings and receipt, storage, use, transfer and disposal are subject to the regulations and appropriate licences of the competent authorities.

Radiopharmaceuticals should be prepared in a manner which satisfies both radiation safety and pharmaceutical quality requirements.

Technegas should be administered ten minutes at most after preparation.

A careful assessment of the risk/benefit ratio should be made before use of the product in children, particularly since use of Technegas results in an increased effective dose and absorbed organ doses in children (see 11. Dosimetry).

The 300 microlitre Pulmotec Crucible shall only be used in a TechnegasPlus generator (or later model). The 300 microlitre Pulmotec crucible may be used in older model Technegas generators where those Technegas Generators have been modified and calibrated for use with the 300 microlitre Pulmotec crucible by an authorised service agent.

None known.

No interaction studies in vitro or in vivo with inhaled or any medicinal drugs have been performed.

When it is necessary to administer radioactive medicinal products to women of childbearing potential, information should always be sought about pregnancy. Any woman who has missed a period should be assumed to be pregnant until proven otherwise. Where uncertainty exists it is important that radiation exposure should be the minimum consistent with achieving the desired clinical information. Alternative techniques which do not involve ionising radiation should be considered.

Radionuclide procedures carried out on pregnant women also involve radiation doses to the foetus. Only imperative investigations should be carried out during pregnancy when likely benefit exceeds the risks incurred by mother and foetus.

Before administering a radioactive medicinal product to a mother who is breast-feeding consideration should be given to whether the investigation could be reasonably delayed until the mother has ceased breast-feeding and whether the most appropriate radiopharmaceutical product has been chosen, bearing in mind secretion in breast milk.

If the administration of this radioactive product is essential, breast feeding must be interrupted for at least 12 hours and the expressed milk must be discarded.

No studies on the effect on the ability to drive and use machines have been performed.

The frequencies for undesirable effects are defined as follows: Very common ≥1/10, Common ≥1/100 to <1/10, Uncommon ≥1/1000 to <1/100, Rare ≥1/10000 to <1/1000, Very rare <1/10000, Not known Cannot be estimated from the available data.

Rare cases of dizziness and nausea have been reported. These have been ascribed to hypoxia which may occur during inhalation of Technegas which initially contains no oxygen.

If a patient shows signs of hypoxia, he/she should immediately be allowed to breathe air and, if necessary, oxygen.

For each patient, exposure to ionising radiation must be justifiable on the basis of likely benefit. The activity administered must be such that the resulting radiation dose is as low as reasonably achievable bearing in mind the need to achieve the diagnosis.

Exposure to ionising radiation can lead to cancer or development of hereditary defects. The effective dose resulting from a inhaled activity of 40 MBq of this radiopharmaceutical being only 0.6 mSv (70 kg adult), these adverse events can be expected with a very low probability.

Reporting of suspected adverse reactions

Reporting of suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL-Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517. Website: www.hpra.ie, E-mail: medsafety@hpra.ie.

Not applicable.