GNH USA

Europe — EMA

Ioflupane (123i) Rotop

GNH USA supplies Ioflupane (123i) Rotop (Ioflupane), a radiopharmaceutical for evaluating Parkinsonian syndromes and movement disorders.

Ioflupane (123i)

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What is Ioflupane (123i)?

Ioflupane, the active ingredient in Ioflupane (123i) Rotop, is a radiopharmaceutical presented as an injection solution for intravenous use. It is employed to evaluate Parkinsonian syndromes and other movement disorders by visualizing dopaminergic neuron integrity. GNH USA supplies Ioflupane (123i) Rotop as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals and clinics worldwide.

What is Ioflupane (123i) used for?

Ioflupane (123i) Rotop is a radiopharmaceutical used in the assessment of dopaminergic pathways for neurological disorders. - Parkinsonian syndromes: enables visualization of presynaptic dopamine transporter loss to support diagnosis. - Parkinson's disease differential diagnosis: helps distinguish Parkinson's disease from other movement disorders. - Movement disorder assessment: provides quantitative data on dopamine transporter availability for clinical decision‑making.

What are the side effects of Ioflupane (123i)?

Ioflupane is generally well tolerated, but adverse reactions can occur.

Common Side Effects: - Injection site pain or erythema - Nausea or mild vomiting - Headache - Dizziness or light‑headedness - Transient hypotension - Flushing

Serious or Rare Side Effects: - Severe allergic reaction (anaphylaxis) - Significant hypotension requiring medical intervention - Radiation‑induced skin injury at the injection site - Pulmonary edema - Cardiac arrhythmias - Severe nausea or vomiting leading to dehydration

What precautions apply to Ioflupane (123i)?

Use of Ioflupane requires careful consideration of patient‑specific factors and handling requirements. - Pregnancy: safety not established; avoid unless essential. - Breastfeeding: unknown excretion; consider discontinuation of nursing. - Renal impairment: assess renal function as clearance may be altered. - Radiation exposure: limit cumulative dose and follow radiation safety guidelines. - Contraindications: known hypersensitivity to Ioflupane or any component of the formulation. - Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

What does Ioflupane (123i) interact with?

Ioflupane may interact with other agents that affect dopaminergic imaging or iodine handling.

Major Interactions (Avoid): - MAO‑B inhibitors: can modify tracer uptake and confound interpretation. - D2‑receptor antagonists (typical antipsychotics): may reduce DAT binding visibility. - Concurrent radiopharmaceuticals with overlapping emission spectra: can interfere with SPECT image quality.

Moderate Interactions (Monitor Closely): - Iodinated contrast agents used in CT/MRI: may affect subsequent Ioflupane imaging. - Thyroid hormone therapy: may alter iodine metabolism and tracer distribution. - Drugs affecting renal excretion (e.g., loop diuretics): monitor for altered clearance.

Frequently asked questions

What is Ioflupane (123i) Rotop used for?+
Ioflupane (123i) Rotop is a radiopharmaceutical used to image presynaptic dopamine transporters in the brain. It helps clinicians evaluate Parkinsonian syndromes, differentiate Parkinson's disease from other movement disorders, and assess overall dopaminergic neuron integrity through SPECT imaging.
How does Ioflupane work?+
After intravenous injection, Ioflupane binds selectively to dopamine transporters on neuronal membranes. The attached radioactive iodine emits gamma photons that are captured by a SPECT scanner, producing images that reflect the density and functional status of dopaminergic pathways.
What is the usual dose of Ioflupane (123i) Rotop?+
The administered activity of Ioflupane is determined by the prescribing physician or nuclear medicine specialist. Dosing is individualized based on patient weight, imaging protocol, and regulatory guidelines, and is not standardized across all patients.
Is Ioflupane safe in pregnancy or breastfeeding?+
Safety data for Ioflupane in pregnant or lactating women are limited. It is classified as having unknown risk, and use is generally avoided unless the diagnostic benefit outweighs potential fetal or infant exposure. Consultation with a specialist is essential.
How do I order Ioflupane (123i) Rotop from GNH USA?+
Enquiries are submitted via the product page on gnh-usa.com, where you specify the required quantity. GNH USA supplies hospitals, pharmacies, and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including cold‑chain where required), and necessary import documentation.
How does Ioflupane compare with other diagnostic agents for Parkinson's disease?+
Ioflupane is chemically identical to the FDA‑approved DaTscan and provides high‑resolution DAT imaging. Compared with non‑specific brain perfusion agents, Ioflupane offers superior specificity for dopaminergic neurons, allowing more accurate differentiation of Parkinsonian syndromes from other movement disorders.
What are the storage and handling requirements for Ioflupane (123i) Rotop?+
The product must be stored refrigerated at 2‑8 °C, protected from light, and never frozen or shaken. It should be kept in its original container until use, and any unused portion should be discarded according to local radiopharmaceutical waste regulations.
How is Ioflupane (123i) Rotop administered?+
Ioflupane is administered as a single intravenous injection by a qualified nuclear medicine professional. After injection, a waiting period of about 3–6 hours is typical before SPECT imaging to allow optimal tracer uptake and clearance of background activity.
What are the most serious risks associated with Ioflupane?+
Serious risks include severe allergic reactions such as anaphylaxis, significant hypotension, radiation‑induced skin injury at the injection site, and rare cardiac arrhythmias. Patients should be monitored during and after administration, and any adverse event should be reported promptly.
Who should not receive Ioflupane (123i) Rotop?+
Ioflupane is contraindicated in individuals with known hypersensitivity to Ioflupane or any excipients in the formulation. It should also be avoided in pregnant women unless absolutely necessary, and used with caution in patients with severe renal impairment or those receiving interfering medications.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Ioflupane (123i)
Route
Intravenous Use
Manufacturer
Rotop Radiopharmacy Gmbh
Origin
EU

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