GE Healthcare: More than a Manufacturer. More than a manufacturer

 
More than a manufacturer
 
Increasing department efficiency and patient service
 
 
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98%
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Our global SPECT agent deliveries ensure confidence in patient scheduling and increase workflow efficiency*
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24
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Our customer service team aims to resolve all your queries within 24 hours of your call
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With access to our 24/7 e-ordering tool, you can order at your convenience
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You can be assured of quality in our services, with 99.9% customer satisfaction across 198,000 orders*
 
 
Committed to Supporting the Neuroimaging Community
GE Healthcare is your dedicated, forward-facing partner for neuroimaging:
 
 
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Continually investing in R&D
for innovative tracers and neuroimaging products to help you deliver the best for your patients
 
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Driving discussion
around the value of DaTscan imaging through education, congresses, advocacy, and expertise
 
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A dedicated Neurology Account Manager
collaborating with the referring neurology community to help drive referrals to your facility
 
 
 
For more than 11 years, GE Healthcare has been by your side – today and for the long term.
Visit us at SNMMI 2022 at booth 1425 to connect on current and future products.
SNMMI 2022 | June 11-14 | Vancouver, British Columbia
 
 
DaTscan Logo  
Confidence Inside the Vial and Far Beyond
 
 
Click here to learn more
 
 
PRODUCT INDICATION AND USE  
DaTscan (Ioflupane I 123 Injection) is a radiopharmaceutical indicated for striatal dopamine transporter visualization using single-photon emission computed tomography (SPECT) brain imaging to assist in the evaluation of adult patients with suspected parkinsonian syndromes (PSs). In these patients, DaTscan may be used to help differentiate essential tremor from tremor due to PS (idiopathic Parkinson's disease [PD], multiple system atrophy [MSA], and progressive supranuclear palsy [PSP]). DaTscan is an adjunct to other diagnostic evaluations. DaTscan was not designed to distinguish among PD, MSA, and PSP. The effectiveness of DaTscan as a screening or confirmatory test and for monitoring disease progression or response to therapy has not been established.
IMPORTANT SAFETY INFORMATION ABOUT DATSCAN
CONTRAINDICATIONS
DaTscan is contraindicated in patients with known hypersensitivity to the active substance, any of the excipients, or iodine.
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions: Hypersensitivity reactions, generally consisting of skin erythema and pruritus, have been reported following DaTscan administration.
Thyroid Accumulation: The DaTscan injection may contain up to 6% of free iodide (iodine123 or I-123). To decrease thyroid accumulation of I-123, block the thyroid gland at least one hour before administration of DaTscan; failure to do so may increase the long-term risk for thyroid neoplasia.
ADVERSE REACTIONS
In clinical trials, headache, nausea, vertigo, dry mouth, or dizziness of mild to moderate severity were reported. In post marketing experience, hypersensitivity reactions and injection-site pain have been reported.
DRUG INTERACTIONS
Drugs that bind to the dopamine transporter with high affinity may interfere with the DaTscan image. The impact of dopamine agonists and antagonists on DaTscan imaging results has not been established.
USE IN SPECIFIC POPULATIONS
Pregnancy: Radioactive iodine products cross the placenta and can permanently impair fetal thyroid function. Administration of a thyroid blocking agent is recommended before the use of DaTscan in a pregnant woman. All radiopharmaceuticals have potential to cause fetal harm. 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. Advise pregnant women of the potential risks of fetal exposure to radiation with the administration of DaTscan.
Lactation: Iodine 123 (I-123), the radionuclide in DaTscan, is present in human milk. There is no information on the effects on breastfed infants or on milk. Advise a lactating woman to interrupt breastfeeding and pump and discard breast milk for at least 6 days after DaTscan administration to minimize radiation exposure to a breastfeeding infant.
Pediatric Use: The safety and efficacy of DaTscan have not been established in pediatric patients.
Geriatric Use: There were no differences in responses between elderly patients and younger patients that would require a dose adjustment
Renal and Hepatic Impairment: The effect of renal or hepatic impairment on DaTscan imaging has not been established. The kidney excretes DaTscan; patients with severe renal impairment may have increased radiation exposure and altered DaTscan images.
OVERDOSAGE
It is unknown whether or not ioflupane is dialyzable. The major risks of overdosage relate to increased radiation exposure and long-term risk for neoplasia. In case of radioactivity overdosage, frequent urination and defecation should be encouraged to minimize radiation exposure to the patient.
PROCEDURE – Radiation Safety
DaTscan emits radiation and must be handled with safety measures to minimize radiation exposure to clinical personnel and patients.
Prior to DaTscan administration, please read the full Prescribing Information for additional Important Safety Information, here.
To report SUSPECTED ADVERSE REACTIONS, contact GE Healthcare at 800 654 0118 (option 2, then option 1) or the FDA at 800 FDA 1088 or www.fda.gov/medwatch.
 
 
*2018

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May 2022 JB07002US
 
 
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