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MIBGen Injection

MIBGen® Iobenguane [123I] Injection Diagnostic 

MIBGenlobenguaneInjection.jpg

MIBGen lobenguane Injection

Product Information (PI)          Consumer Medical Information (CMI)

 

Product Code 10007
Indications Diagnostic scintigraphic localisation of phaeochromocytomas, paragangliomas (chemodectomas), ganglioneuroblastomas and ganglioneuromas. Detection, staging and follow-up on therapy of neuroblastomas
Chemical Form meta-Iodobenzyl (123I) Guanidine in Isotonic Phosphate buffer containing 1% v/v Benzyl Alcohol
pH 4. 0 to 7.0
Radiochemical Purity Not less than 95% of the radioactivity of the chromatogram is found in the peak corresponding to iobenguane. Not more than 4% of the radioactivity is found in the peak corresponding to iodide and not more than 1% of the radioactivity is found on other peaks
Specific Radioactivity Not less than 10GBq of Iodine (I123) per gram of Iobenguane base
Radioactive Content 2mL - 180 to 220 MBq at calibration
4mL - 360 to 440 MBq at calibration
Radioactive Concentration 100 MBq Iodine (I-123) per mL (± 10%) at calibration
Calibration 0900 hours Sydney time Tuesday
Pack Size 200 MBq
400 MBq
Availability Made to order - order by 1300 hours Sydney time Friday for delivery the following Tuesday
Expiry 16 hours after calibration
Aust R 101670