DATSCAN SOLUTION FOR INJECTION 74 MBQ/ML [SIN15325P]

Product Info

DATSCAN SOLUTION FOR INJECTION 74 MBQ/ML

[SIN15325P]

4.1 Therapeutic indications

DaTSCAN is a radiopharmaceutical indicated for striatal dopamine transporter visualisation using single photon emission computed tomography (SPECT) brain imaging to assist evaluation:

• In adult patients with clinically uncertain Parkinsonian Syndromes, for example those with early symptoms, in order to help differentiate Essential Tremor from tremor due to Parkinsonian Syndromes related to idiopathic Parkinson's Disease, Multiple System Atrophy and Progressive Supranuclear Palsy. DaTSCAN is unable to discriminate between Parkinson's Disease, Multiple System Atrophy and Progressive Supranuclear Palsy.

• In adult patients, to help differentiate probable dementia with Lewy bodies from Alzheimer's disease. DaTSCAN is unable to discriminate between dementia with Lewy bodies and Parkinson's disease dementia.

DaTSCAN is an adjunct to other diagnostic evaluations.

4.2 Posology and method of administration

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.

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. No data are available (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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.

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). 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.

4.3 Contraindications

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

• Pregnancy (see section 4.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).