Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: INFAI GmbH, Riehler Str. 36, D-50668 Köln, Germany
Helicobacter Test INFAI 75 mg powder for oral solution.
| Pharmaceutical Form |
|---|
|
White, crystalline powder for oral solution. |
One jar contains 75 mg of 13C-urea powder.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Urea ¹³C |
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. |
| List of Excipients |
|---|
|
None. |
A test set contains the following parts:
| No. | Component | Quantity |
|---|---|---|
| 1 | Jar (10 ml volume, polystyrene with polyethylene snap cap) containing 75 mg 13C-urea powder for oral solution | 1 |
| 2 | Labelled sample glass- or plastic-containers for sampling, storing and transporting the breath samples for analysis: Sampling time: 00-minute-value Sampling time: 30-minute-value | 2 2 |
| 3 | Bendable straw for collection of the breath samples into the corresponding sample containers | 1 |
| 4 | Data sheet for patient documentation | 1 |
| 5 | Package leaflet | 1 |
| 6 | Page of barcode labels and sticker | 1 |
INFAI GmbH, Riehler Str. 36, D-50668 Köln, Germany
EU/1/97/045/001
Date of first authorisation: 14 August 1997
Date of latest renewal: 14 August 2007
| Drug | Countries | |
|---|---|---|
| HELICOBACTER | Austria |
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