United States - English - NLM (National Library of Medicine)

curium us llc - ioflupane i-123 (unii: 3mm99t8r5q) (ioflupane i-123 - unii:3mm99t8r5q) - ioflupane i 123 injection is indicated as an adjunct to other diagnostic evaluations for striatal dopamine transporter visualization using single photon emission computed tomography (spect) brain imaging in adult patients with:  ● suspected parkinsonian syndromes (ps) or ● suspected dementia with lewy bodies (dlb). ioflupane i 123 injection is contraindicated in patients with known serious hypersensitivity to ioflupane i-123 [see warnings and precautions ( 5.1)] .   risk summary radioactive iodine products cross the placenta and can permanently impair fetal thyroid function. administration of an appropriate thyroid blocking agent is recommended before use of ioflupane i 123 injection in a pregnant woman to protect the woman and fetus from accumulation of iodine-123 [see  dosage   and administration ( 2.2 ) ]. there are no available data on ioflupane i 123 injection use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. animal re

United States - English - NLM (National Library of Medicine)

medi-physics inc. dba ge healthcare. - ioflupane i-123 (unii: 3mm99t8r5q) (ioflupane i-123 - unii:3mm99t8r5q) - ioflupane i-123 2 mci in 1 ml - datscan is indicated as an adjunct to other diagnostic evaluations for striatal dopamine transporter visualization using single photon emission computed tomography (spect) brain imaging in adult patients with: - suspected parkinsonian syndromes (ps) or - suspected dementia with lewy bodies (dlb). datscan is contraindicated in patients with known serious hypersensitivity to ioflupane i 123 [see warnings and precautions (5.1)] . risk summary radioactive iodine products cross the placenta and can permanently impair fetal thyroid function. administration of an appropriate thyroid blocking agent is recommended before use of datscan in a pregnant woman to protect the woman and fetus from accumulation of iodine-123 [see dosage and administration (2.2)] . there are no available data on datscan use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. animal reproduction studies have not been conducted with ioflupane i 123. all radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. administration of datscan at a dose of 185 mbq (5 mci) results in an absorbed radiation dose to the uterus of 0.3 rad (3.0 mgy). radiation doses greater than 15 rad (150 mgy) have been associated with congenital anomalies but doses under 5 rad (50 mgy) generally have not. advise pregnant women of the potential risks of fetal exposure to radiation doses with administration of datscan. the estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. risk summary iodine-123, the radionuclide in datscan, is present in human milk. there is no information on the effects on the breastfed infant or on milk production. advise a lactating woman to interrupt breastfeeding and pump and discard breastmilk for at least 6 days (>10 physical half-lives) after datscan administration in order to minimize radiation exposure to a breastfed infant. the safety and efficacy of datscan have not been established in pediatric patients. in the two principal clinical studies of datscan for suspected parkinsonian syndromes, 45% of the subjects were aged 65 and over, while 10% were 75 and over [see clinical studies (14.1)] . no overall differences in safety or effectiveness were observed between these subjects and younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. datscan is excreted by the kidney and patients with severe renal impairment may have increased radiation exposure and altered datscan images.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

curium pharma uk ltd - ioflupane [i-123] - solution for injection - 74mbq/1ml

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

curium pharma uk ltd - ioflupane [i-123] - solution for injection - 74mbq/1ml

Israel - English - Ministry of Health

eldan electronic instruments co ltd - ioflupane - solution for injection - ioflupane 74 mbq/ml - iodine ioflupane (123i) - other dopaminergic agents - 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

Canada - English - Health Canada

ge healthcare canada inc - ioflupane (123i) - solution - 74mbq - ioflupane (123i) 74mbq - roentgenography

European Union - English - EMA (European Medicines Agency)

pinax pharma gmbh - ioflupane (123i) - radionuclide imaging; dementia; movement disorders - diagnostic radiopharmaceuticals - this medicinal product is for diagnostic use only.celsunax 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. celsunax 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. celsunax is unable to discriminate between dementia with lewy bodies and parkinson’s disease dementia.

European Union - English - EMA (European Medicines Agency)

cis bio international - ioflupane (123l) - radionuclide imaging; dementia; movement disorders - diagnostic radiopharmaceuticals - this medicinal product is for diagnostic use only.striascan 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. striascan 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. striascan is unable to discriminate between dementia with lewy bodies and parkinson’s disease dementia.

European Union - English - EMA (European Medicines Agency)

ge healthcare b.v. - ioflupane (123l) - tomography, emission-computed, single-photon; lewy body disease; parkinson disease; alzheimer disease - diagnostic radiopharmaceuticals - 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.

Singapore - English - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - ioflupane (123i) - injection, solution - ioflupane (123i) 74 mbq/ml at reference time