Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
ioflupane (123l)
GE Healthcare B.V.
V09AB03
ioflupane (123l)
Diagnostic radiopharmaceuticals
Tomography, Emission-Computed, Single-Photon; Lewy Body Disease; Parkinson Disease; Alzheimer Disease
This medicinal product is for diagnostic use only.DaTSCAN is indicated for detecting loss of functional dopaminergic neuron terminals in the striatum:In adult patients with clinically uncertain Parkinsonian syndromes, for example those with early symptoms, 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.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.
Revision: 23
Authorised
2000-07-27
21 B. PACKAGE LEAFLET 22 PACKAGE LEAFLET: INFORMATION FOR THE USER DATSCAN 74 MBQ/ML SOLUTION FOR INJECTION Ioflupane ( 123 I) _ _ READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU . − Keep this leaflet. You may need to read it again. − If you have any further questions, ask your nuclear medicine doctor who will supervise the procedure. − If you get any side effects, talk to your nuclear medicine doctor. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What DaTSCAN is and what it is used for 2. What you need to know before DaTSCAN is used 3. How DaTSCAN is used 4. Possible side effects 5. How DaTSCAN is stored 6. Contents of the pack and other information 1. WHAT DATSCAN IS AND WHAT IT IS USED FOR DaTSCAN contains the active substance ioflupane ( 123 I) which is used to help identify (diagnose) conditions in the brain. It belongs to a group of medicines called “radiopharmaceuticals”, which contain a small amount of radioactivity. • When a radiopharmaceutical is injected, it collects in a specific organ or area of the body for a short time. • Because it contains a small amount of radioactivity it can be detected from outside the body using special cameras. • A picture, known as a scan, can be taken. This scan will show exactly where the radioactivity is inside the organ and the body. This can give the doctor valuable information about how that organ is working. When DaTSCAN is injected into an adult, it is carried around the body in the blood. It collects in a small area of your brain. Changes in this area of the brain occur in: • Parkinsonism (including Parkinson’s disease) and • dementia with Lewy bodies. A scan will give your doctor information about any changes in this area of your brain. Your doctor may feel that the scan would help in finding out more about your condition and deciding on possible treatment. When DaTSCAN is used, you are exposed to small am Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS _ _ 2 1. NAME OF THE MEDICINAL PRODUCT DaTSCAN 74 MBq/ml solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains ioflupane ( 123 I) 74 MBq at reference time (0.07 to 0.13 μg/ml of ioflupane). Each 2.5 ml single dose vial contains 185 MBq ioflupane ( 123 I) (specific activity range 2.5 to 4.5 x 10 14 Bq/mmol) at reference time. Each 5 ml single dose vial contains 370 MBq ioflupane ( 123 I) (specific activity range 2.5 to 4.5 x 10 14 Bq/mmol) at reference time. _ _ Excipient(s) with known effect This medicinal product contains 39.5 g/l ethanol. For the full list of excipients see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use only. DaTSCAN is indicated for detecting loss of functional dopaminergic neuron terminals in the striatum: • In adult patients with clinically uncertain Parkinsonian Syndromes, for example those with early symptoms, 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. • 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. 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. 3 Posology Clinic Прочетете целия документ