STRIASCAN Solution for injection Ref.[27906] Active ingredients: Ioflupane ¹²³I

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. No data are available (see section 4.4). 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 4.4.

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). Experimental studies with a striatal phantom, suggest that optimal images are obtained with matrix size and zoom factors selected to give a pixel size of 3.5-4.5 mm for those systems currently in use. A minimum of 500 k counts should be collected for optimal images.

In the event of administration of a radiation overdose, frequent micturition and defaecation should be encouraged in order to minimise radiation dose to the patient. Care should be taken to avoid contamination from the radioactivity eliminated by the patient using such methods.

2.5 mL vial: 35 hours from the end of synthesis (7 hours from the activity reference time stated on the label).

5 mL vial: 48 hours from the end of synthesis (20 hours from the activity reference time stated on the label).

Do not store above 25°C. Do not freeze.

Store in the original lead shielding.

Storage of radiopharmaceuticals should be in accordance with national regulation on radioactive materials.

15 mL amber glass vial sealed with a rubber closure and metal overseal.

The vial is placed into a lead container for protective shielding and packed in a metal box.

Pack size: 1 vial containing 2.5 mL or 5 mL of solution.

Not all pack sizes may be marketed.

General warning

Radiopharmaceuticals should 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 competent official organisation.

Radiopharmaceuticals should be prepared in a manner which satisfies both radiation safety and pharmaceutical quality requirements. Appropriate aseptic precautions should be taken. If at any time in the preparation of this product the integrity of this vial is compromised it should not be used.

Administration procedures should be carried out in a way to minimise risk of contamination of the medicinal product and irradiation of the operators. Adequate shielding is mandatory.

The administration of radiopharmaceuticals creates risks for other persons from external radiation or contamination from spill of urine, vomiting etc. Radiation protection precautions in accordance with national regulations must therefore be taken.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.