CELSUNAX Solution for injection Ref.[50434] Active ingredients: Ioflupane ¹²³I

Prior to administration appropriate resuscitation equipment should be available.

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

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 Celsunax.

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 Celsunax in children aged 0 to 18 years has not been established. No data are available.

Method of administration

For intravenous use.

Vial for single use.

For patient preparation, see section 4.4.

Precautions to be taken before handling or administering the medicinal product

Celsunax 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 500k counts should be collected for optimal images. Normal images are characterised by two symmetrical crescent-shaped areas of equal intensity. Abnormal images are either asymmetric or symmetric with unequal intensity and/or loss of crescent.

In cases 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.

24 hours from the end of the synthesis (EOS) 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.

Sterile 10 mL glass vial (Type I) with a rubber stopper and a flip cap.

The vial is placed into a lead container for protective shielding.

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

Not all pack sizes may be marketed.

General warning

Normal safety precautions for handling radioactive materials should be observed.

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.