Pylobactell · 4.5 Interaction with other medicinal products and other forms of interaction · 1

HOS-083510 · has-adverse-reaction-information · PDF-Seite 3

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.

HOS-083506 · has-contraindication-information · PDF-Seite 2

The test must not be used in patients with documented or suspected gastric infection that might interfere with the urea breath test. Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

HOS-083505 · has-indication-information · PDF-Seite 2

This medicinal product is for diagnostic use only. For in vivo diagnosis of gastroduodenal Helicobacter pylori infection.

HOS-083508 · has-interaction-information · PDF-Seite 3

The validity of the test result may be affected if the patient is currently being treated with antibiotics or a proton-pump inhibitor or has completed a course of treatment with these drugs. The results may be affected in general by all treatments interfering with H.pylori status or urease activity. Suppression of H. pylori might give false negative results. Therefore, the test must not be used until four weeks without systemic antibacterial therapy and two weeks after last dose of acid antisecretory agents. This is especially important after eradication therapy.

HOS-083509 · has-pregnancy-information · PDF-Seite 3

The endogenous production of urea amounts to 25 - 35 g/day. It is therefore unlikely that the dose of 100 mg urea should cause any adverse effect on pregnancy and lactation. The Pylobactell test is not expected to be harmful during pregnancy or to the health of the foetus / newborn child. Pylobactell can be used during pregnancy and lactation.

HOS-083507 · has-warning-information · PDF-Seite 2

A positive urea breath test alone does not clinically confirm that eradication therapy is indicated. Alternative diagnosis with invasive endoscopic methods might be indicated in 2 order to examine the presence of any other complicating conditions, eg. gastric ulcer, autoimmune gastritis and malignancies. In individual cases of atrophic gastritis, the breath test result may have a false positive outcome and other tests may be required to confirm the presence of H.pylori. If a repeat test is required, it should not be carried out until the following day. For patients who do not tolerate the recommended test meal, an alternative test meal should be given. Care should be taken in patients where fasting may have medical implications. There are insufficient data on the diagnostic reliability of the Pylobactell test to recommend its use in patients with partial gastrectomy and in patients younger than 18 years.