RENOCIS Kit for radiopharmaceutical preparation Ref.[27899] Active ingredients: Technetium ⁹⁹ᵐTc succimer

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 reasonably achievable to obtain the required diagnostic information.

Renal impairment

Careful consideration of the benefit risk ratio in these patients is required since an increased radiation exposure is possible (see section 4.2).

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 examination in order to reduce radiation.

Specific warnings

This medicinal product contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium- free’.

Precautions with respect to environmental hazard are in section 6.6.

Some chemical compounds or medicaments may affect the function of tested organs and influence the uptake of technetium (^99mTc) succimer:

• Ammonium chloride: may substantially reduce renal uptake and increase hepatic uptake of technetium (^99mTc) succimer.
• Sodium bicarbonate: reduction of renal uptake of technetium (^99mTc) succimer.
• Mannitol: reduction of renal uptake of technetium (^99mTc) succimer.
• ACE inhibitors (e.g. captopril) may cause reversible failure of tubule function as a result of the reduction in filtration pressure in a kidney that is affected by renal artery stenosis. This in turn leads to reduced renal concentration of technetium (^99mTc) succimer. To avoid these influences, treatment with any of the above chemical products should be interrupted where possible. Chemotherapy: Experimental research in animals has demonstrated that methotrexate, cyclophosphamide or vincristine can affect the biodistribution of technetium (^99mTc) succimer.

Women of childbearing potential

When an administration of radiopharmaceuticals 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 the 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 mother and foetus.

Breastfeeding

Before administering radiopharmaceuticals to a mother who is breast-feeding consideration should be given to the possibility of delaying the administration of radionuclide until the mother has ceased breast-feeding, and to what is the most appropriate choice of radiopharmaceuticals, bearing in mind the secretion of activity in breast milk. If the administration is considered necessary, breast-feeding should be interrupted for 4 hours and the expressed feeds discarded.

Fertility

No study on fertility has been performed.

Renocishas no or negligible influence on the ability to drive and use machines.

The adverse events are presented in the table below by the MedDRA System Organ Class and with a not known frequency (cannot be estimated from the available data):

Allergic reactions have been reported in the literature.

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

As the effective dose is 1.06 mSv when the maximal recommended activity of 120 MBq is administered these adverse effects are expected to occur with a low probability.

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.