DaTSCAN

Prior to administration appropriate resuscitation equipment should be available. DaTSCAN should only be used in adult patients referred by physicians experienced in the management of movement disorders and/or dementia. DaTSCAN should only be used by qualified personnel with the appropriate government authorisation for the use and manipulation of radionuclides within a designated clinical setting.

3 Posology Clinical efficacy has been demonstrated across the range 111 to 185 MBq. Do not exceed 185 MBq and do not use when the activity is below 110 MBq. Patients must undergo appropriate thyroid blocking treatment prior to injection to minimise thyroid uptake of radioactive iodine, for example by oral administration of approximately 120 mg potassium iodide 1 to 4 hours prior to injection of DaTSCAN.

Special populations Renal and hepatic impairment Formal studies have not been carried out in patients with significant renal or hepatic impairment. 4). Paediatric population The safety and efficacy of DaTSCAN in children aged 0 to 18 years has not been established.

No data are available. Method of Administration For intravenous use. DaTSCAN should be used without dilution. To minimise the potential for pain at the injection site during administration, a slow intravenous injection (not less than 15 to 20 seconds) via an arm vein is recommended.

Image acquisition SPECT imaging should take place between three and six hours post-injection. Images should be acquired using a gamma camera fitted with a high-resolution collimator and calibrated using the 159 keV photopeak and a ± 10% energy window.

Angular sampling should preferably be not less than 120 views over 360 degrees. For high resolution collimators the radius of rotation should be consistent and set as small as possible (typically 11-15cm). 5 mm for those systems currently in use.

A minimum of 500k counts should be collected for optimal images.

The following undesirable effects are recognised for DaTSCAN:

Tabulated summary of adverse reactions The frequencies of adverse reactions are defined as follows: 6 Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥ 1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Immune system disorders Not known:

Hypersensitivity Metabolism and nutrition disorders Uncommon: Appetite increased Nervous system disorders Common: Headache Uncommon: Dizziness, formication (paraesthesia), dysgeusia Ear and labyrinth disorders Uncommon: Vertigo Skin and subcutaneous tissue disorders Not known: Erythema, pruritus, rash, urticaria, hyperhidrosis Respiratory, thoracic and mediastinal disorders Not known: Dyspnea Gastrointestinal disorders Uncommon: Nausea, dry mouth Not known: Vomiting Vascular disorders Not known: Blood pressure decreased General disorders and administration site conditions Uncommon: Injection site pain (intense pain or burning sensation following administration into small veins) Not known: Feeling hot Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects.

63 mSv when the maximal recommended activity of 185 MBq is administered these adverse events 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 the national reporting system listed in Appendix V.

If hypersensitivity reactions occur, the administration of the medicinal product must be discontinued immediately and, if necessary, intravenous treatment initiated. g. endotracheal tube and ventilator) have to be readily available. 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 the appropriate licences of the local competent official organisations. 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 dose is as low as reasonably achievable bearing in mind the need to obtain the intended diagnostic result. 4 The patient should be well hydrated before and after the examination and urged to void as often as possible during the first 48 hours after the procedure in order to minimise radiation exposure.

Formal studies have not been carried out in patients with significant renal or hepatic impairment. In the absence of data, DaTSCAN is not recommended in cases of moderate to severe renal or hepatic impairment. 5 g/l (5% volume) ethanol (alcohol), up to 197 mg per dose, equivalent to 5 ml beer or 2 ml wine.

Harmful for those suffering from alcoholism. To be taken into account in high-risk groups such as patients with liver disease or epilepsy. Interpretation of DaTSCAN Images DaTSCAN images are interpreted visually, based upon the appearance of the striata.

Optimum presentation of the reconstructed images for visual interpretation is transaxial slices parallel to the anterior commissure-posterior commissure (AC-PC) line. Determination of whether an image is normal or abnormal is made by assessing the extent (as indicated by shape) and intensity (in relation to the background) of the striatal signal.

1. 6).