Prescribing Information
PRESCRIBING INFORMATION DaTSCANTM
ioflupane (123I)
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.
PRESENTATION Vials containing 185 MBq or 370 MBq ioflupane (123I) at reference time.
INDICATIONSDetecting loss of functional dopaminergic neuron terminals in the striatum.
i) in 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) 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 ADMINISTRATION DaTSCAN is a 5% (v/v) ethanolic solution for intravenous injection and should be used without dilution. Clinical efficiency has been demonstrated across the range of 111-185 MBq; do not use outside this range. Slow intravenous injection (15-20seconds) via arm vein is recommended. Appropriate thyroid blocking treatment must be given prior to and post injection of DaTSCAN. SPECT imaging should take place 3-6 hours after injection of DaTSCAN. DaTSCAN is not recommended for use in children or adolescents. For use in patients referred by physicians experienced in the management of movement disorders/dementia.
CONTRAINDICATIONS Pregnancy and hypersensitivity to the active substance or any of the excipients.
WARNINGS AND PRECAUTIONS Radiopharmaceuticals should only be used by qualified personnel with appropriate government authorisation and should be prepared using aseptic and radiological precautions. DaTSCAN is not recommended in moderate to severe renal or hepatic impairment. Contains 5% volume ethanol, up to 197mg per dose, harmful for those suffering from alcoholism. To be taken into account in high-risk patients e.g. liver disease or epilepsy.
INTERACTIONS Consider current medication. Medicines that bind to the dopamine transporter may interfere with diagnosis; these include amfetamine, benzatropine, buproprion, cocaine, mazindol, methylphenidate, phentermine and sertraline. Drugs shown during clinical trials not to interfere with DaTSCAN imaging include amantadine, trihexyphenidyl, budipine, levodopa, metoprolol, primidone, propranolol
ioflupane (123I)
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.
PRESENTATION Vials containing 185 MBq or 370 MBq ioflupane (123I) at reference time.
INDICATIONSDetecting loss of functional dopaminergic neuron terminals in the striatum.
i) in 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) 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 ADMINISTRATION DaTSCAN is a 5% (v/v) ethanolic solution for intravenous injection and should be used without dilution. Clinical efficiency has been demonstrated across the range of 111-185 MBq; do not use outside this range. Slow intravenous injection (15-20seconds) via arm vein is recommended. Appropriate thyroid blocking treatment must be given prior to and post injection of DaTSCAN. SPECT imaging should take place 3-6 hours after injection of DaTSCAN. DaTSCAN is not recommended for use in children or adolescents. For use in patients referred by physicians experienced in the management of movement disorders/dementia.
CONTRAINDICATIONS Pregnancy and hypersensitivity to the active substance or any of the excipients.
WARNINGS AND PRECAUTIONS Radiopharmaceuticals should only be used by qualified personnel with appropriate government authorisation and should be prepared using aseptic and radiological precautions. DaTSCAN is not recommended in moderate to severe renal or hepatic impairment. Contains 5% volume ethanol, up to 197mg per dose, harmful for those suffering from alcoholism. To be taken into account in high-risk patients e.g. liver disease or epilepsy.
INTERACTIONS Consider current medication. Medicines that bind to the dopamine transporter may interfere with diagnosis; these include amfetamine, benzatropine, buproprion, cocaine, mazindol, methylphenidate, phentermine and sertraline. Drugs 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.
PREGNANCY AND LACTATION
Contraindicated in pregnancy. Information should be sought about pregnancy from women of child bearing potential. A woman who has missed her period should be assumed to be pregnant. If administration to a breast feeding woman is necessary, substitute formula feeding for breast feeding for 3 days.
UNDESIRABLE EFFECTS No serious adverse effects have been reported. Common side effects include headache, vertigo and increased appetite and formication. Exposure to ionising radiation is linked with cancer induction and a potential for hereditary defects and must be kept as low as reasonably achievable. Intense pain on injection has been reported uncommonly following administration into small veins.
DOSIMETRY Effective dose from 185 MBq is 4.35 mSv.
OVERDOSE Encourage frequent micturition and defecation.
MARKETING AUTHORISATION HOLDER GE Healthcare Limited, Amersham Place, Little Chalfont, Buckinghamshire, HP7 9NA, UK.
CLASSIFICATION FOR SUPPLY Subject to medical prescription.
MARKETING AUTHORISATION NUMBERS EU/1/00/135/001 (2.5ml) and EU/1/00/135/002 (5.0ml).
DATE OF REVISION OF TEXT
4 February 2008
NHS list price £391/185MBq
Information about mechanisms for adverse event reporting can be found at www.yellowcard.gov.uk Alternatively, adverse events can be reported to
GE Healthcare.
GE Healthcare Limited, Amersham Place, Little Chalfont, Buckinghamshire, England HP7 9NA www.gehealthcare.com
© 2008 General Electric Company
- All rights reserved. GE and GE Monogram are trademarks of General Electric Company.
DaTSCAN is a trademark of
GE Healthcare Limited.
PREGNANCY AND LACTATION
Contraindicated in pregnancy. Information should be sought about pregnancy from women of child bearing potential. A woman who has missed her period should be assumed to be pregnant. If administration to a breast feeding woman is necessary, substitute formula feeding for breast feeding for 3 days.
UNDESIRABLE EFFECTS No serious adverse effects have been reported. Common side effects include headache, vertigo and increased appetite and formication. Exposure to ionising radiation is linked with cancer induction and a potential for hereditary defects and must be kept as low as reasonably achievable. Intense pain on injection has been reported uncommonly following administration into small veins.
DOSIMETRY Effective dose from 185 MBq is 4.35 mSv.
OVERDOSE Encourage frequent micturition and defecation.
MARKETING AUTHORISATION HOLDER GE Healthcare Limited, Amersham Place, Little Chalfont, Buckinghamshire, HP7 9NA, UK.
CLASSIFICATION FOR SUPPLY Subject to medical prescription.
MARKETING AUTHORISATION NUMBERS EU/1/00/135/001 (2.5ml) and EU/1/00/135/002 (5.0ml).
DATE OF REVISION OF TEXT
4 February 2008
NHS list price £391/185MBq
Information about mechanisms for adverse event reporting can be found at www.yellowcard.gov.uk Alternatively, adverse events can be reported to
GE Healthcare.
GE Healthcare Limited, Amersham Place, Little Chalfont, Buckinghamshire, England HP7 9NA www.gehealthcare.com
© 2008 General Electric Company
- All rights reserved. GE and GE Monogram are trademarks of General Electric Company.
DaTSCAN is a trademark of
GE Healthcare Limited.
