Meta-Iodobenzylguanidine-131I (MIBG-131I) for therapeutic use, solution for injection

Specyfikacja
Radionuclidic purity: 

≥ 99.9%

Radiochemical purity: 

≥ 92%

Calibration: 

24 hours

Expiration: 

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

Storage: 

Store MIBG-131I in an original container at the temperature below [-15oC], in accordance with regulations for radiation safety.  Transport in dry ice.
Protect from light. After defrosting store below 25oC for up to 2 hours. Transport in dry ice.

Pharmaceutical form: 

Solution for injection.

Active substance: 

Meta-Iodo[131I]benzylguanidine sulphate,   370 - 740 MBq/ml

Excipients: 

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

Package: 

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 shielded lead container. The outer transport packaging is a metal tin  with styrofoam insert.
Every source is accompanied with a certificate of radioactivity.

Indications: 

Meta-Iodobenzylguanidine-131I (MIBG-131I) is a radiopharmaceutical used in cancer therapy. It is used in treating disseminated, malignant, metastatic lesions, such as pheochromocytoma, paraganglioma, neuroblastoma, neuroendocrine tumors of gestroenteropancreatic tract, and sometimes medullary thyroid carcinoma.

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