UROGRAFIN Solution for infusion Ref.[49858] Active ingredients: Diatrizoic acid

Source: Health Products Regulatory Authority (IE)  Revision Year: 2019  Publisher: Bayer Limited, The Atrium, Blackthorn Road, Dublin 18, Ireland

Product name and form

Urografin 30% w/v Solution for infusion.

Pharmaceutical Form

Solution for infusion.

A clear, colourless to faintly yellow, odourless, sterile aqueous solution.

Qualitative and quantitative composition

1 ml of Urografin 30% for infusion contains 0.04 g sodium amidotrizoate and 0.26 g meglumine amidotrizoate (sodium diatrizoate and meglumine diatrizoate) in aqueous solution, containing the equivalent of 146 mg of Iodine in combined form per ml.

Excipients: Contains 1.45mg (0.063mmol) sodium per ml (Each 250ml bottle contains 362.5mg sodium).

For a full list of excipients, see section 6.1.

Active Ingredient Description
Diatrizoic acid
List of Excipients

Sodium calcium edetate
Water for injection

Pack sizes and marketing

Bottle: colourless glass type II.

Stopper: stopper type I chlorobutyl-elastomer.

Presentation: Bottles of 250 ml.

Marketing authorization holder

Bayer Limited, The Atrium, Blackthorn Road, Dublin 18, Ireland

Marketing authorization dates and numbers

PA1410/012/001

Date of first authorization: 01 April 1988
Date of last renewal: 01 April 2008

Drugs

Drug Countries
UROGRAFIN Estonia, Spain, Ireland, Japan, Lithuania, New Zealand

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