Chemical formula: CH₄N₂O Molecular mass: 61.048 g/mol PubChem compound: 636363
13C-urea is administered in the course of the breath test. After oral ingestion the labelled urea reaches the gastric mucosa. In the presence of Helicobacter pylori the 13C-urea is metabolised by the enzyme urease of Helicobacter pylori.
This medicinal substance has been classified in the anatomical therapeutic chemical (ATC) classification according to its main therapeutic use as follows:
| ATC code | Group title | Classification |
|---|---|---|
| V04CX05 | V Various → V04 Diagnostic agents → V04C Other diagnostic agents → V04CX Other diagnostic agents | |
Competent medicine agencies globally have authorized commercialization of this active ingredient according to these medication package inserts (MPIs):
| Title | Information Source | Document Type | |
|---|---|---|---|
| DIABACT UBT Tablet | Health Products Regulatory Authority (IE) | MPI, EU: SmPC | |
| HELICOBACTER Powder for oral solution | European Medicines Agency (EU) | MPI, EU: SmPC |
Urea ¹³C is an active ingredient of these brands:
Austria (AT)Croatia (HR)Estonia (EE)Finland (FI)France (FR)Hong Kong (HK)Ireland (IE)Italy (IT)Lithuania (LT)Poland (PL)Singapore (SG)United Kingdom (UK)Note the following: The list of brand names is continuously updated, and thus does not include the total of products circulating worldwide. |
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