Helicobacter Test INFAI · 4.8 Undesirable effects · 3

HOS-083406 · has-adverse-reaction-information · PDF-Seite 9

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-083418 · has-adverse-reaction-information · PDF-Seite 22

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-083412 · has-adverse-reaction-information · PDF-Seite 16

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-083400 · 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-083402 · has-contraindication-information · PDF-Seite 9

The test must not be used in patients with documented or suspected gastric infection or atrophic gastritis, which might interfere with the urea breath test (see section 4.2).

HOS-083408 · has-contraindication-information · PDF-Seite 16

The test must not be used in patients with documented or suspected gastric infection or atrophic gastritis, which might interfere with the urea breath test (see section 4.2).

HOS-083414 · has-contraindication-information · PDF-Seite 22

The test must not be used in patients with documented or suspected gastric infection or atrophic gastritis, which might interfere with the urea breath test (see section 4.2).

HOS-083396 · has-contraindication-information · PDF-Seite 3

The test must not be used in patients with documented or suspected gastric infection or atrophic gastritis, which might interfere with the urea breath test (see section 4.2).

HOS-083413 · has-indication-information · PDF-Seite 21

Helicobacter Test INFAI may be used for in vivo diagnosis of gastroduodenal Helicobacter pylori infection in: - adults, - adolescents, who are likely to have peptic ulcer disease. This medicinal product is for diagnostic use only.

HOS-083401 · has-indication-information · PDF-Seite 8

Helicobacter Test INFAI may be used for in vivo diagnosis of gastroduodenal Helicobacter pylori infection in: - adults, - adolescents, who are likely to have peptic ulcer disease. This medicinal product is for diagnostic use only.

HOS-083407 · has-indication-information · PDF-Seite 15

Helicobacter Test INFAI for children of the age 3-11 may be used for in vivo diagnosis of gastroduodenal Helicobacter pylori infection: - for the evalutation of the success of eradication treatment, or, - when invasive tests cannot be performed, or - when there are discordant results arising from invasive tests. This medicinal product is for diagnostic use only.

HOS-083395 · has-indication-information · PDF-Seite 2

Helicobacter Test INFAI may be used for in vivo diagnosis of gastroduodenal Helicobacter pylori infection in: - adults, - adolescents, who are likely to have peptic ulcer disease. This medicinal product is for diagnostic use only.

HOS-083410 · has-interaction-information · PDF-Seite 16

Helicobacter Test INFAI for children of the age 3-11 will be affected by all treatments interfering with Helicobacter pylori status or urease activity.

HOS-083398 · has-interaction-information · PDF-Seite 3

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

HOS-083416 · has-interaction-information · PDF-Seite 22

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

HOS-083404 · has-interaction-information · PDF-Seite 9

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

HOS-083399 · has-pregnancy-information · PDF-Seite 3

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.

HOS-083411 · has-pregnancy-information · PDF-Seite 16

Not applicable.

HOS-083405 · has-pregnancy-information · PDF-Seite 9

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.

HOS-083417 · has-pregnancy-information · PDF-Seite 22

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.

HOS-083409 · has-warning-information · PDF-Seite 16

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 for children of the age 3-11 to recommend its use in patients with gastrectomy and in patients younger than 3 years of age. 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).

HOS-083403 · has-warning-information · PDF-Seite 9

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).

HOS-083397 · has-warning-information · PDF-Seite 3

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).

HOS-083415 · has-warning-information · PDF-Seite 22

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).