TECHNESCAN PYP Kit for radiopharmaceutical preparation Ref.[11073] Active ingredients: Technetium ⁹⁹ᵐTc stannous agent labelled cells

Potential for hypersensitivity or anaphylactic reactions

If hypersensitivity or anaphylactic reactions occur, the administration of the medicinal product must be discontinued immediately and intravenous treatment initiated, if necessary. To enable immediate action in emergencies, the necessary medicinal products and equipment such as endotracheal tube and ventilator must be immediately available.

Individual benefit / risk justification

For each patient, the radiation exposure must be justifiable by the likely benefit. The activity administered should in every case be as low as reasonable achievable to obtain the required diagnostic information.

Paediatric population

For information on the use in paediatric population, see section 4.2. Careful consideration of the indication is required since the effective dose per MBq is higher than in adults (see section 11).

Patient preparation

The patient should be well hydrated before the start of the examination and urged to void as often as possible during the first hours after the study in order to reduce radiation.

Specific warnings

It is recommended that in-vivo (^99mTc) RBC labelling be performed prior to administration of iodinated contrast media. Otherwise, labelling efficiency will be adversely affected.

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially “sodiumfree”.

Precautions with respect to environmental hazard see section 6.6.

Reduction in red blood cell labelling yield has been reported with heparin, tin overload, aluminium, prazosin, methyldopa, hydralazin, digitalis related compounds, quinidine, ß-adrenergic blockers (e.g. propranolol), calcium channel blockers (e.g. verapamil, nifedipine), nitrates (e.g. nitroglycerin), anthracycline antibiotic, iodinated contrast agents and teflon catheter (the Sn⁺⁺ can react with the catheter).

Women of childbearing potential

When an administration of radioapharmaceutical to a woman of childbearing potential is intended, it is important to determine whether or not she is pregnant. Any woman who has missed a period should be assumed to be pregnant until proven otherwise. If in doubt about her potential pregnancy (if the woman has missed a period, if a period is very irregular etc) alternative techniques not using ionising radiation (if there are any) should be offered to the patient.

Pregnancy

Radionuclide procedures carried out on pregnant women also involve radiation doses to the foetus. Only essential investigations should, therefore, be carried out during pregnancy, when the likely benefit far exceeds the risk incurred by the mother and foetus. Administration of 925 MBq results in an absorbed dose to the uterus of 4.3 mGy. Doses above 0.5 mGy should be regarded as a potential risk to the foetus.

Breast-feeding

Before administering radiopharmaceuticals to a mother who is breast-feeding consideration should be given to the possibility of delaying administration of radionuclide until the mother has ceased breastfeeding and to what is the most appropriate choice of radiopharmaceuticals, learing in ind the secretion of activity in breast milk If the administration is considered necessary, breast-feeding should be interrupted and the expressed feeds discarded. Breast-feeding can be restarted about 12 hours post injection or when the level in milk will not result in a radiation dose to the child greater than 1 mSv.

Technescan PYP has no or negligible influence on the ability to drive and use machines.

Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects.

As the effective dose is 7.9 mSv when the maximal recommended activity of 925 MBq is administered these adverse reactions are expected to occur with a low probability.

Adverse reactions after the intravenous administration of both the unlabelled and the technetium-99m complexes. Are very rare <1/10,000.

The following effects have been described: flush, headache, vasodilatation, nausea, dizziness, swelling of the arm, erythema and itching at the injection site, diaphoresis and tinnitus, urticaria, generalized pruritus. Cardiac arrhythmia, facial oedema and coma have been reported.

This product contains no excipients that have a recognised action or effect, or knowledge of which is important for safe and effective use of the product.

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.