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DatSCAN™

DatSCAN™is registered for use in the following countries

As of November 2006, DaTSCAN™ is available in all EU countries, Norway and Switzerland.

Please refer to full national Summary of Product Characteristics (SPC) before prescribing. Indications and approvals may vary in different countries. Further information available on request.

Availability - Formulation

DaTSCAN™ is presented as a vial containing a solution for intravenous administration. DaTSCAN™ contains Ioflupane labelled with radioactive iodide in an ethanolic solution

Therapeutic Indications (When to use DatSCAN™)

DaTSCAN™ is a medicinal product for diagnostic use only.

DaTSCAN™ is indicated for detecting loss of functional dopaminergic neuron terminals in the striatum:

• In patients with clinically uncertain Parkinsonian Syndromes, in order to help differentiate Essential Tremor from 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.
• 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.

A diagnostic radiopharmaceutical is a product which, when injected, temporarily collects in a specific organ or area of the body. Because it contains a small amount of radioactivity it can be detected from outside the body using special cameras and a picture, known as a scan, can be taken. This scan will show the distribution of the radiopharmaceutical within the orga™n and the body. This gives the doctor valuable information about the function and structure of that organ. DaTSCAN™ binds to the dopamine transporters (DAT), on the neurons in specific areas of the brain. Certain diseases like Parkinson’s and some forms of dementia are characterized by significantly reduced number of DAT. By detecting the binding of DaTSCAN™ to the dopamine transporters your physician will have a clear visualisation of dopamine transporter integrity to help establish a clinical diagnosis.

Normal Case

In normal cases a transverse slice through the striatum shows a “crescent” or “comma” shaped putamen on each side and a circular "full stop" shaped caudate anteriorly.

Parkinson's Disease

Loss of uptake in the putamen/ “comma ” is regarded as abnormal. Uptake in the caudate/ “full stop” is initially preserved leaving just a circular image.

 

Contra-indications (When DatSCAN™ should not be used)

DaTSCAN™ is contraindicated in pregnancy and in patients with hypersensitivity to iodide or to any of the excipients. DaTSCAN™ is not recommended in patients with moderate to severe renal of hepatic impairment. The use in children or adolescents is not recommended either since there is not enough clinical experience.

It is not known whether ioflupane is secreted in human milk, therefore if administration is considered necessary, formula feeding should be substituted for breast-feeding.

How to take DaTSCAN™ (Ioflupane, 123-I FP-CIT)

DaTSCAN™ is a drug used as part of a diagnostic procedure called SPECT imaging.

DaTSCAN™ is administered to the patients via slow intravenous injection and a SPECT image is performed 3-6 hours after the injection. After its administration to the patient, the concentration of radiopharmaceutical is measured using a kind of scanner called a gamma-camera. SPECT imaging with DaTSCAN™ therefore produces images of the brain structures that are involved in the pathophysiology of parkinsonian syndromes. The procedure usually takes between 20 and 45 minutes depending on the type of gamma camera used. You will not need to remove your clothing, and it is advisable to wear something comfortable.
Before the administration of DaTSCAN™ you will not need to stop your current medication except in a minority of cases. The usual antiparkinsonian or essential tremor treatments do not need to be stopped, however amphetamine derivatives, some drugs used to stop smoking and some antidepressants should be ceased 7 days before DaTSCAN™ SPECT imaging. Tell your doctor about your current treatment and he/she will advise you if you need to take any precaution.

Before you receive DaTSCAN™, your doctor will ask you to take some iodine-rich tablets or liquid, which will prevent the accumulation of radioactivity in your thyroid gland. It is important that you follow your doctor’s instructions carefully.

Pregnancy and Lactation

See contra-indications

Possible Undesirable Effects of DatSCAN^™

No serious adverse effects have been reported. DaTSCAN™ is usually well tolerated with common side effects including headache, vertigo or increased appetite.

The amount of radioactivity in the body as a result of the injection of DaTSCAN™ is very small and will be passed out of the body in a few days without the need for special precautions. Although this exposure is less than in some types of X-ray investigation, your doctor will always consider the possible risks and benefits.

Useful Links & References

• The National Tremor Foundation
• GE Healthcare DaTSCAN™ site

Further Information

GE Healthcare

Global Headquarters
Pollards Wood
Nightingales Lane
Chalfont St. Giles
HP8 4SP
United Kingdom