NIOPAM Solution for injection Ref.[9480] Active ingredients: Iopamidol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Bracco Imaging spa, Via Egidio Folli 50, 20134, Milano Italy

Product name and form

NIOPAM 300, solution for injection.

Pharmaceutical Form

Solution for injection.

Clear aqueous solution filled into colourless glass ampoules or bottles.

Qualitative and quantitative composition

61.2% w/v Iopamidol equivalent to 300mg iodine/ml. Each contains 612 mg iopamidol.

For the full list of excipients, see 6.1.

Active Ingredient Description
Iopamidol

Iopamidol is contrast medium belonging to the new generation of non-ionic compound whose solubility is due to the presence of hydrophilic substitutes in the molecule. This results in a solution of low osmollity when compared with ionic media.

List of Excipients

Excipients are:

Trometamol
Hydrochloric acid
Edetate calcium disodium

Pack sizes and marketing

10ml clear, colourless type I glass ampoules.

20 and 30ml clear, colourless type I or type II glass vials with rubber closures and aluminium caps.

20, 50, 70, 100, 200 and 250ml clear, colourless type I or type II glass bottles with rubber closures and aluminium caps.

Marketing authorization holder

Bracco Imaging spa, Via Egidio Folli 50, 20134, Milano – Italy

Marketing authorization dates and numbers

PL 12032/0014

22/03/1982 / 05/12/2003

Drugs

Drug Countries
NIOPAM Ireland, United Kingdom

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