Meta-Iodobenzylguanidine-131I (MIBG-131I) for diagnostic use, Solution for injection

Czystość radionuklidowa: 

≥ 99.9%

Czystość radiochemiczna: 

≥ 94%


7 days

Okres ważności: 

9 days from the manufacturing date (expiry date is stated on the label).

Warunki przechowywania: 

Store MIBG-131I in original container at the temperature below [-15oC] in accordance with regulations for radiation safety.
Protect from light. After defrosting store below 25oC for up to 4 hours. Transport in dry ice.

Postać farmaceutyczna: 

Solution for injection.

Skład jakościowy i ilościowy substancji czynnych: 

Meta-Iodo[131I]benzylguanidine sulphate,   10 - 37 MBq/ml

Wykaz substancji pomocniczych: 

meta-iodobenzylguanidine sulphate
sodium metabisulphite
copper (II) sulphate pentahydrate
sodium acetate trihydrate
acetic acid
benzyl alcohol
sodium chloride
water for injection

Rodzaj i zawartość opakowania: 

The MIBG-131I solution is delivered in 10 ml glass vials, with a possibility of drawing multidoses in an aseptic way. The vials are capped with rubber stoppers and aluminum caps and placed inside a lead shielding container. The outer transport packaging is a metal tin with styrofoam insert.

Wskazania do stosowania: 

Meta-Iodobenzylguanidine-131I(MIBG-131I) is a diagnostic radiopharmaceutical for gamma-scintigraphy. It is indicated for use in the detection and localization of primary or metastatic pheochromocytoma in adrenals and out of the adrenals, neuroblastoma, paraganglioma, imaging of neurondocrine tumors of gastroenteropancreatic tract, medullary thyroid carcinoma, and in the cardiac diagnostics in diseases resulting from myocardial ischemia and cardiomiopathy.



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