GASTROGRAFIN Gastroenteral solution Ref.[50791] Active ingredients: Diatrizoic acid Meglumine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Bayer plc, 400 South Oak Way, Reading, RG2 6AD

Product name and form

Gastrografin gastroenteral solution.

Pharmaceutical Form

Gastroenteral solution.

Qualitative and quantitative composition

1 ml solution contains: 100 mg sodium amidotrizoate (sodium diatrizoate) and 660 mg meglumine amidotrizoate (meglumine diatrizoate).

Excipients with known effect: Gastografin contains sodium, see section 4.4.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Diatrizoic acid
Meglumine
List of Excipients

Disodium edetate
Sodium hydroxide
Saccharin sodium
Star anise oil
Polysorbate 80
Purified water

Pack sizes and marketing

Packs of 10 × 100 ml brown glass bottles with pilfer proof screw caps.

Marketing authorization holder

Bayer plc, 400 South Oak Way, Reading, RG2 6AD

Marketing authorization dates and numbers

PL 00010/0537

Date of First Authorisation: 01 May 2008

Drugs

Drug Countries
GASTROGRAFIN Canada, Cyprus, Spain, Finland, Hong Kong, Croatia, Ireland, Japan, Malta, New Zealand, Poland, Singapore, United Kingdom, United States

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