- What is Helicobacter Test INFAI?
- How is Helicobacter Test INFAI used?
- How does Helicobacter Test INFAI work?
- How has Helicobacter Test INFAI been studied?
- What benefit has Helicobacter Test INFAI shown during the studies?
- What is the risk associated with Helicobacter Test INFAI?
- Why has Helicobacter Test INFAI been approved?
HELICOBACTER TEST INFAI
EPAR summary for the public
This document is a summary of the European Public Assessment Report (EPAR). It explains how the Committee for Medicinal products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
What is Helicobacter Test INFAI?
Helicobacter Test INFAI is a diagnostic test. It is available as a jar containing a powder to be made up into a solution for drinking. The powder is the active substance
What is Helicobacter Test INFAI used for?
Helicobacter Test INFAI is used to diagnose Helicobacter pylori infection in the stomach and duodenum (the part of the gut just below the stomach). H. pylori is a bacterium that is a factor in diseases such as dyspepsia (heartburn, bloating and nausea), gastritis (inflammation of the stomach), and peptic ulcer disease (ulcers in the stomach or the duodenum).
Helicobacter Test INFAI can be used to test adults, adolescents who are likely to have peptic ulcer disease, and children aged three to 11 years. It can only be used in children when invasive tests (taking a sample from the stomach using a probe) cannot be carried out or have given questionable results, or to check that H. pylori has been eliminated after a specific treatment to clear up the infection.
The medicine can only be obtained with a prescription.
- Pylobactell - 13c-urea
Prescription drugs listed. Substance: "13C-urea"
How is Helicobacter Test INFAI used?
Helicobacter Test INFAI is a breath test: breath samples are collected, which are then sent out for analysis to a specialised laboratory.
To carry out the test, the patient must collect four samples, two before taking Helicobacter Test INFAI and two thereafter. The patient should not eat for at least six hours, preferably overnight, before taking the test. Firstly, the patient collects two breath samples, using the tubes or bags supplied with Helicobacter Test INFAI. The patient then takes a ‘test meal’ (either 200 ml of pure orange juice or
1 g of citric acid dissolved in 200 ml water), followed by the solution of Helicobacter Test INFAI dissolved in water. Finally, 30 minutes after drinking the solution, the patient collects a further two breath samples. In children aged three to 11 years, the ‘test meal’ should be 100 ml of pure orange juice. For full information on how the test is carried out, see the Package Leaflet.
How does Helicobacter Test INFAI work?
The active substance in Helicobacter Test INFAI,
H. pylori contain enzymes called ureases that make it able to break down urea into carbon dioxide, which is then removed in the breath. When the patient takes Helicobacter Test INFAI, the
How has Helicobacter Test INFAI been studied?
Helicobacter Test INFAI has been tested in four studies in adult patients involving a total of 561 patients and one study in 335 children and adolescents. All received 75 mg of
What benefit has Helicobacter Test INFAI shown during the studies?
- Pylobactell - V04CX
Prescription drugs listed. ATC Code: "V04CX"
In all studies, the results of the test done using Helicobacter Test INFAI agreed with the results obtained with the endoscopy and histology in over 95% of cases.
What is the risk associated with Helicobacter Test INFAI?
There are no known side effects of the test. However, if the patient vomits during the test, the test will need to be done again, but not until at least the following day.
Helicobacter Test INFAI should not be used in patients who have, or may have gastric (stomach) infection or atrophic gastritis (stomach inflammation that causes the breakdown of the stomach lining), as these might interfere with the breath test.
Why has Helicobacter Test INFAI been approved?
The Committee for Medicinal products for Human Use (CHMP) decided that Helicobacter Test INFAI’s benefits are greater than its risks for the in vivo diagnosis of gastroduodenal H. pylori infection in adults, adolescents who are likely to have peptic ulcer disease, and children aged three to 11 years for the evaluation of the success of eradication treatment, or when invasive tests cannot be performed, or when there are discordant results arising from invasive tests. The Committee recommended that Helicobacter Test INFAI be given marketing authorisation.
Other information about Helicobacter Test INFAI:
The European Commission granted a marketing authorisation valid throughout the European Union for Helicobacter Test INFAI to INFAI, Institut für biomedizinische Analytik &
The full EPAR for Helicobacter Test INFAI is available here.
This summary was last updated in