PENTACIS Powder for solution for injection Ref.[49884] Active ingredients: Technetium ⁹⁹ᵐTc pentetic acid

Special warnings

This radiopharmaceutical may be received, used and administered only by authorised persons in designated clinical settings. Its receipt, storage, use, transfer and disposal are subject to the regulations and/or appropriate licences of the local competent official organisations.

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, complying with the requirements of Good Manufacturing Practice for pharmaceuticals.

Special precautions for use

In case of reduced renal function the radiation exposure can be increased, this should be considered in the assessment of the activity to be administered.

To reduce the radiation dose to the bladder, good hydration and frequent voiding of urine is recommended.

Many drugs may affect the function of tested organ and modify the uptake of technetium (⁹⁹mTc) pentetate (DTPA) i.e.

Diagnostic use of captopril: dynamic renal scanning performed under controlled conditions and again one hour after oral administration of captopril (25-50 mg) may reveal haemodynamic changes in a kidney affected by renal artery stenosis. The blood pressure should be carefully monitored as patients with vascular disease are at risk of significant hypotension and renal impairment.

Diagnostic use of furosemide: the administration of intravenous furosemide during dynamic renal scanning increases elimination of technetium (⁹⁹mTc) pentetate (DTPA) which may help to distinguish whether true obstruction exists in a dilated renal tract.

Cerebral angiography: psychotropic drugs increase blood flow in the territory of the external carotid artery. This may lead to the rapid uptake of tracer in the nasopharyngeal area during the arterial and capillary phases (hot nose phenomenon).

Women of childbearing potential

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.

Pregnancy

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

Lactation

Before administering a radioactive medicinal product to a mother who is breast feeding consideration should be given as to whether the investigation could be reasonably delayed until the mother has ceased breast feeding and as to whether the most appropriate choice of radiopharmaceutical has been made, bearing in mind the secretion of radioactivity in breast milk. If the administration is considered necessary the breast feeding should be interrupted for 12 hours and the expressed feeds discarded. Breast feeding can be restarted when the level in the milk will not result in a radiation dose to the child greater than 1 mSv.

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

In isolated cases the following adverse reactions have been reported: flushing, dizziness, dyspnoea, pruritus, urticaria and hypotension.

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 obtain the intended diagnostic or therapeutic result.

Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects. For diagnostic nuclear medicine investigations the current evidence suggests that these adverse effects will occur with low frequency because of the low radiation doses incurred.

For most diagnostic investigations using a nuclear medicine procedure the radiation dose delivered (E) is less than 20 mSv. Higher doses may be justified in some clinical circumstances.

Reporting of suspected adverse reactions

Reporting 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.

This medicinal product must not be mixed with other medicinal products except those mentioned in section 12.