Medicinal Products

DaTSCAN 74 MBq / mL

Generic Drug Therapeutic Class: Diagnostic Products or Other Therapeutic Products
Active ingredients: Ioflupane
laboratory: GE Healthcare Limited

Injectable solution
10 ml bottle filled with 2.5 ml
All forms

Indication

This medicine is for diagnostic use only.

DaTSCAN is indicated for the detection of a loss of functional dopaminergic neuronal terminals in the striatum:

• In adult patients with clinically suspicious Parkinson's Syndrome, to assist in the differential diagnosis between essential tremor and Parkinson's syndromes related to idiopathic Parkinson's disease, multi-system atrophy or progressive supranuclear palsy.

DaTSCAN does not differentiate between Parkinson's disease, multi-system atrophy and progressive supranuclear palsy.

• In adult patients, to help with the differential diagnosis between probable Lewy body dementia and Alzheimer's disease.

DaTSCAN does not differentiate between Lewy body dementia and Parkinsonian dementia.

Dosage DaTSCAN 74 MBq / mL Solution for injection 10 ml bottle filled with 2.5 ml

Appropriate resuscitation equipment must be available prior to administration.

DaTSCAN should only be used in patients referred by physicians with experience in the diagnosis and monitoring of patients with abnormal movements and / or dementia. Radiopharmaceuticals should only be used by qualified personnel who possess the governmental authorizations required for the use and handling of radioelements in specially equipped and authorized premises.

Dosage

Clinical efficacy has been demonstrated for activities ranging from 111 to 185 MBq. Do not use less than 110 MBq and not exceed 185 MBq.

Before administration, the patient should follow a treatment blocking the uptake of iodine by the thyroid gland to reduce the binding of radioactive iodine. This can, for example, be achieved by the oral administration of about 120 mg of potassium iodide, 1 to 4 hours before and again 12 to 24 hours after injection of DaTSCAN.

Special populations

Renal and hepatic insufficiency

No specific studies have been conducted in patients with significant renal or hepatic impairment. No data is available (see section Warnings and precautions for use ).

Pediatric population

The safety and effectiveness of DaTSCAN in children under 18 years of age have not been established. No data available.

Administration mode

Intravenous way

DaTSCAN should not be diluted. In order to avoid a possible painful sensation at the injection site, intravenous administration will be performed slowly (injection time of at least 15 to 20 seconds) in a vein of the arm.

The acquisition of single-photon emission tomoscintigraphy (TEMP) images should be done between three and six hours after injection, using a gammacamera equipped with high resolution collimators calibrated using the peak of total absorption of 159keV with an energy window of ± 10%. If possible, at least 120 projections over 360 ° should be made. The radius of rotation should be constant and as small as possible (11 - 15 cm). According to studies done with a striatal ghost on commonly used systems, the image is optimized when the size of the matrix and the zoom are selected to obtain a pixel size of 3.5 - 4.5 mm. A minimum of 500, 000 shots should be collected to obtain optimal images. Normal images are characterized by two crescent-shaped symmetrical areas of equal intensity. Abnormal images are either asymmetrical or of symmetrical appearance but with unequal capture with or without loss of the crescent shape.

Against indications

Hypersensitivity to the active substance or to any of the excipients.

Pregnancy (see section Pregnancy and breast-feeding ).

Datscan side effects

Summary of the job security profile

No serious adverse reactions have been reported following administration of DaTSCAN.

Summary table of adverse effects

The frequencies of adverse effects are defined as follows:

Very common (≥ 1/10), common (≥ 1/100, <1/10), uncommon (≥ 1/1000, <1/100), rare (≥ 1/10 000, <1/1000) ), very rare (<1 / 10, 000) and not known (can not be estimated from the available data). Within each frequency group, adverse effects are presented in descending order of severity.

Immune system disorders

Not known: Hypersensitivity

Metabolism and nutrition disorders

Common: Increased appetite

Nervous system disorders

Common: Headache, paresthesia

Affections of the ear and labyrinth

Frequent: Dizziness

General disorders and injection site abnormalities

Uncommon: Injection site pain (severe pain after administration in a small vein)

Exposure to ionizing radiation can potentially induce cancer or the development of congenital anomalies. Since most diagnostic tests in nuclear medicine are performed at low doses of less than 20 mSy, the occurrence of these adverse events is unlikely. The effective dose is 4.35 mSy when using the maximum recommended activity of 185 MBq.

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