HELICOBACTER Powder for oral solution Ref.[8561] Active ingredients: Urea ¹³C

A positive test alone does not constitute indication for eradication therapy. Differential diagnosis with invasive endoscopic methods might be indicated in order to examine the presence of any other complicating conditions, e.g. ulcer, autoimmune gastritis and malignancies.

There is insufficient data on the diagnostic liability of the Helicobacter Test INFAI to recommend its use in patients with gastrectomy.

For children from the age of 3, Helicobacter Test INFAI for children aged 3 to 11 is available.

In individual cases of A-gastritis (atrophic gastritis) the breath test may have false positive results; other tests may be required to confirm the Helicobacter pylori status.

If the patient vomits during the test procedure, necessitating the repetition of the test, this should be done in fasted condition and not before the following day (see section 4.2).

Helicobacter Test INFAI will be affected by all treatments interfering with Helicobacter pylori status or urease activity.

It is not expected that the test procedure may be harmful during pregnancy or lactation. It is recommended to take notice of the product information of eradication therapy products for their use during pregnancy and lactation.

Helicobacter Test INFAI has no influence on the ability to drive and use machines.

None known.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

Not applicable.