STRIASCAN

Striascan should only be used in adult patients referred by physicians experienced in the management of movement disorders and/or dementia. This medical product is for use in hospitals or in designated nuclear medicine facilities only.

Posology Clinical efficacy has been demonstrated across the range 110 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 Striascan.

Special populations Renal and hepatic impairment Formal studies have not been carried out in patients with significant renal or hepatic impairment. 4). Careful consideration of the activity to be administered is required since an increased radiation exposure is possible in these patients.

Paediatric population The safety and efficacy of Striascan in children and adolescents aged 0 to 18 years has not been established. No data are available. Method of administration Striascan is for intravenous use. For patient preparation, see section

The following undesirable effects are recognised for ioflupane (123I). 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) Not known (cannot be estimated from the available data) Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

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

6 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.

4. Precautions to be taken before handling or administering the medicinal product Striascan 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 11-15 cm). 5 mm for those systems currently in use.

A minimum of 500 k counts should be collected for optimal images. 1. 6). 4 Special warnings and precautions for use 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 / Hepatic impairment Formal studies have not been carried out in patients with significant renal or hepatic impairment.

In the absence of data, Striascan is not recommended in cases of moderate to severe renal or hepatic impairment. Careful consideration of the benefit risk ratio in these patients is required since an increased radiation exposure is possible.

1. 6).