ULTRA-TECHNEKOW FM Radionuclide generator Ref.[27727] Active ingredients: Technetium ⁹⁹ᵐTc pertechnetate

Radiopharmaceutical agents should be used only by qualified personnel with the appropriate government authorisations for the use and manipulations of radionuclides. This radiopharmaceutical may be received, used and administered only by authorised personnel in designated clinical settings. Its receipt, storage, use, transfer and disposal are subject to the regulations and/or appropriate licences of 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 Pharmaceutical Manufacturing Practice for radiopharmaceuticals.

Drug interactions have been reported in brain scintigraphy where there can be increased uptake of (^99mTc) pertechnetate in the walls of cerebral ventricles as a result of methotrexate-induced ventriculitis. In abdominal imaging drugs, such as atropine, isoprenaline and analgesics, can result in a delay in gastric emptying and redistribution of pertechnetate.

^99mTc (as free pertechnetate) has been shown to cross the placental barrier. When it is necessary to administer radioactive medicinal products to a woman 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 particularly important that the 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 the likely benefit exceeds the risk incurred by the mother and the foetus. Direct administration of 800 MBq sodium pertechnetate (^99mTc) to a patient results in an absorbed dose to the uterus of 6.5 mGy. Following pre-treatment of patients with a blocking agent, administration of 800 MBq sodium pertechnetate (^99mTc) results in an absorbed dose to the uterus of 5.3 mGy. Administration of 925 MBq ^99mTc labelled red blood cells 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.

Before administering the radioactive medicinal product to a woman 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. If the administration is considered necessary, breast-feeding should be interrupted and the expressed feeds discarded. Breast-feeding can be restarted when the activity level in the milk will not result in a radiation dose to the child greater than 1 mSv.

Effects on ability to drive and use machines have not been described.

Allergic reactions have been reported following intravenous injection of sodium pertechnetate (^99mTc) and include urticaria, facial oedema, vasodilation, pruritus, cardiac arrythmias and coma. For each patient, exposure to ionising radiation must be justifiable on the basis of likely clinical benefit. The activity administered must be such that the resulting radiation 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 is less than 20 mSv EDE. Higher doses may be justified in some clinical circumstances.

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

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 12.