Exametazime

Powder for injection.

Exametazime 0.5 mg.

(i) Technetium [99mTc] Exametazime Injection is indicated for brain scintigraphy. The product is to be used for the diagnosis of abnormalities of regional cerebral blood flow, such as those occurring following stroke and other cerebrovascular disease, epilepsy, Alzheimer's Disease and other forms of dementia, transient ischaemic attack, migraine and tumours of the brain.

(ii) Technetium [99mTc] Exametazime Injection is also indicated for in vitro technetium-99m leucocyte labelling, the labelled leucocytes subsequently being re-injected and scintigraphy carried out to image the sites of localisation. This procedure may be used in the detection of sites of focal infection (e.g. abdominal abscess), in the investigation of pyrexia of unknown origin and in the evaluation of inflammatory conditions not associated with infection such as inflammatory bowel disease.

The route of administration is direct intravenous injection for brain scintigraphy studies and intravenous injection of labelled leucocytes post labelling in vitro. (i) for brain scintigraphy, 350-500MBq (ii) for in vivo localisation of technetium-99m-labelled leucocytes, 200MBq Normally a once-only diagnostic procedure.

Technetium [99mTc]-Exametazime and Technetium-99m-labelled leucocytes are not recommended for administration to children.

As for other adults.

There are no specific contra-indications.

Radiopharmaceutical agents should only be used by qualified personnel with the appropriate government authorisation for the use and manipulation of radionuclides. They may be received, used and administered only by authorised persons in designated clinical settings. Their 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.

Normal safety precautions for the handling of blood products should be observed in the preparation and administration of labelled leucocytes. When preparing technetium-99m-labelled leucocytes it is essential that cells are washed free of sedimentation agents before they are re-injected into the patient as materials used in cell separation may cause hypersensitivity reactions

No drug interactions have been reported to date.

A very few cases of mild hypersensitivity evidenced by the development of an urticarial erythematous rash have been reported following direct intravenous injection of the reconstituted product.

A very few reports have also been received of hypersensitivity reactions, possibly anaphylactic in nature, following administration of technetium-99m- labelled leucocytes prepared using Technetium [99mTc]-exametazime.

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 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 (EDE) is less than 20 mSv. Higher doses may be justified in some clinical circumstances.

Amersham

(POM)

14 August 2009