PRESCRIBING INFORMATION DaTSCAN™ ioflupane (¹²³I) 74 MBq/ml solution for injection

Please refer to full Summary of Product Characteristics (SPC) before prescribing. Further information available on request.
PRESENTATIONSingle dose vials containing 185 MBq or 370 MBq ioflupane (¹²³I) at reference time.
INDICATIONS Detecting loss of functional dopaminergic neuron terminals in the striatum.
i) in adult patients with clinically uncertain Parkinsonian Syndromes in order to help differentiate Essential Tremor from Parkinsonian Syndromes related to idiopathic Parkinson's Disease (PD), Multiple System Atrophy (MSA), Progressive Supranuclear Palsy (PSP). DaTSCAN is unable to discriminate between PD, MSA and PSP.
ii)in adult patients to help differentiate probable dementia with Lewy bodies (DLB) from Alzheimer's disease. DaTSCAN is unable to discriminate between DLB and Parkinson's Disease dementia.
DOSAGE AND METHOD OF ADMINISTRATIONPrior to administration appropriate resuscitation equipment should be available. For use in patients referred by physicians experienced in the management of movement disorders/dementia. Clinical efficiency has been demonstrated across the range of 111-185 MBq; do not use outside this range. Appropriate thyroid blocking treatment must be given prior to injection of DaTSCAN. The safety and efficacy of DaTSCAN in children 0 to 18 years has not been established. No data are available in patients with significant renal or hepatic impairment. DaTSCAN should be used without dilution. Slow intravenous injection (15-20 seconds) via an arm vein is recommended. SPECT imaging should take place 3-6 hours after injection of DaTSCAN.
CONTRAINDICATIONS Pregnancy and hypersensitivity to the active substance or any of the excipients.
WARNINGS AND PRECAUTIONS If hypersensitivity reactions occur, the administration of the medicinal product must be discontinued immediately and, if necessary, intravenous treatment initiated. Resuscitative medicinal products and equipment (e.g. endotracheal tube and ventilator) have to be readily available. Radiopharmaceuticals should only be used by qualified personnel with appropriate government authorisation and should be prepared using aseptic and radiological precautions. 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. DaTSCAN is not recommended in cases of moderate to severe renal or hepatic impairment. Contains 39.5 g/l (5% volume) ethanol, up to 197mg per dose, harmful for those suffering from alcoholism. To be taken into account in high-risk groups such as patients with liver disease or epilepsy.
INTERACTIONS Consider current medication. Medicines that bind to the dopamine transporter with high affinity may interfere with diagnosis; these include amfetamine, benzatropine, buproprion, cocaine, mazindol, methylphenidate, phentermine and sertraline. Medicines shown during clinical trials not to interfere with DaTSCAN imaging include amantadine, trihexyphenidyl, budipine, levodopa, metoprolol, primidone, propranolol and selegiline. Dopamine agonists and antagonists acting on the postsynaptic dopamine receptors are not expected to interfere with DaTSCAN imaging and can therefore be continued if desired. In animal studies pergolide does not interfere with DaTSCAN imaging.