Active Ingredient: Urea ¹³C
13C-urea may be used for in vivo diagnosis of gastroduodenal Helicobacter pylori infection in:
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A: Powder, for solution oral, 75 milligrams urea ¹³C, one dose.
Regimen B: Tablet oral, 50 milligrams urea ¹³C, one dose.
Patients from the age of 12 must take 75 mg.
Powder for oral solution: For performance of the test, 200 ml 100% orange juice or 1 g citric acid in 200 ml water for patients from the age of 12 and older (as a pre-administered test meal), as well as tap water (for dissolving the 13C-urea powder) are necessary.
The patient must have fasted for over 6 hours, preferably overnight. The test procedure takes approximately 40 minutes.
In case it is necessary to repeat the test procedure, this should not be done until the following day.
Tablet: One tablet as a single dose at one test occasion. The patient should fast for at least six hours preceding the test. An initial breath test sample is taken after which the tablet is swallowed whole with a glass of water. A breath sample is taken after ten minutes.
The suppression of Helicobacter pylori might give false negative results. Therefore the test shall be used after at least four weeks without systemic antibacterial therapy and two weeks after last dose of acid antisecretory agents. Both might interfere with the Helicobacter pylori status. This is especially important after Helicobacter eradication therapy.
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