Země: Izrael
Jazyk: angličtina
Zdroj: Ministry of Health
IOFLUPANE
ELDAN ELECTRONIC INSTRUMENTS CO LTD
V09AB03
SOLUTION FOR INJECTION
IOFLUPANE 74 MBQ/ML
I.V
Required
GE HEALTHCARE B.V., THE NETHERLAND
OTHER DOPAMINERGIC AGENTS
IODINE IOFLUPANE (123I)
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
2014-11-30
העדוה העדוה לע לע הרמחה הרמחה ( ( עדימ עדימ ןולעב )תוחיטב ןולעב )תוחיטב ל ל אפור אפור ןכדועמ( ןכדועמ( 05.2013 05.2013 ) ) :ךיראת 01.07.13 םש רישכת תילגנאב רפסמו :םושירה DATSCAN 74 MBQ/ML םש לעב םושירה : ELDAN ELECTRONIC INSTRUMENT ספוט הז דעוימ טורפל תורמחהה דבלב ! תורמחהה תושקובמה קרפ ןולעב טסקט יחכונ טסקט שדח 4.1 THERAPEUTIC INDICATIONS Therapoitic group; other dopaminergic agents This medicinal product is 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. 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 de Přečtěte si celý dokument
1 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. _ _ Posology Clinical efficacy has been demonstrated across the range 1 Přečtěte si celý dokument