Overview

This 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 its 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).

Pylobactell is a diagnostic test. It is available as a kit that includes a white soluble tablet containing 100 mg of the active substance 13C-urea.

Pylobactell is used to diagnose Helicobacter pylori (H. 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).

The medicine can only be obtained with a prescription.

Pylobactell is a breath test: breath samples are collected in the tubes provided in the kit. These samples are then sent for analysis at a specialised laboratory.

To carry out the test, the patient must collect six breath samples, three before taking the Pylobactell tablet and three after taking it. The patient should fast for four hours before the test so that it is done on an empty stomach. If the patient has eaten a heavy meal then they should fast for six hours before the test.

First, the patient takes a ‘test meal’ (such as 200 ml of pure undiluted orange juice). Five minutes later, the patient collects three breath samples. After a further five minutes, the patient takes the Pylobactell tablet dissolved in water. Finally, 30 minutes later (40 minutes after the test meal), the patient collects a further three breath samples. For full information on how the test is carried out, see the Package Leaflet.

Pylobactell is not recommended for use in patients below 18 years of age because there is insufficient information on its effectiveness in this group.

The active substance in Pylobactell, 13C-urea, is the natural chemical urea that has been labelled with carbon-13 (13C). This means that it contains 13C, a rare form of the carbon atom, instead of carbon-12 (12C), the form that is the most common in nature.

H. pylori produces enzymes called ureases that break down urea into ammonia and carbon dioxide. The carbon dioxide is then removed from the body in the breath. If the patient has, the 13C-urea contained in the Pylobactell tablet is broken down and the carbon dioxide in the breath also contains 13C. This 13C-labelled carbon dioxide can be measured by specialised laboratories using a technique called mass spectrometry. If there is an increased level of labelled carbon dioxide in the breath sample after 30 minutes (a positive test), the patient may have H. pylori in the stomach or duodenum. If there is no increased level of labelled carbon dioxide in the breath, the patient might not have H. pylori in the stomach or duodenum.

The data to support the use of Pylobactell comes from two main studies of the use of antibiotics to treat H. pylori infection, where it was used as a test. A total of 366 patients underwent both a Pylobactell test and a standard biopsy test (where a sample from the stomach is analysed to see if it is infected). The results obtained were compared to see if they agreed.

Pylobactell was more than 95% sensitive in detecting infection with H. pylori.

There are no known side effects of the test.

Pylobactell should not be used in people who may be hypersensitive (allergic) to 13C-urea or any of the other ingredients in the tablet. Pylobactell should not be used in patients who have, or may have gastric (stomach) infection, which might interfere with the breath test.

The Committee for Medicinal Products for Human Use (CHMP) decided that Pylobactell’s benefits are greater than its risks for the in vivo diagnosis of gastroduodenal H. pylori infection. The Committee recommended that Pylobactell be given marketing authorisation.

The European Commission granted a marketing authorisation valid throughout the European Union for Pylobactell on 7 May 1998. The marketing authorisation was renewed on 7 May 2003 and on 7 May 2008. The marketing authorisation holder is Torbet Laboratories Limited.

Pylobactell : EPAR - Summary for the public

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Product information

Pylobactell : EPAR - Product Information

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Latest procedure affecting product information: T/0020

28/07/2023

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This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

Pylobactell : EPAR - All Authorised presentations

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Product details

Name of medicine
Pylobactell
Active substance
urea (13C)
International non-proprietary name (INN) or common name
13C-urea
Therapeutic area (MeSH)
  • Breath Tests
  • Helicobacter Infections
Anatomical therapeutic chemical (ATC) code
V04CX

Pharmacotherapeutic group

Diagnostic agents

Therapeutic indication

This medicinal product is for diagnostic use only.

For in vivo diagnosis of gastroduodenal Helicobacter pylori (H. pylori) infection.

Authorisation details

EMA product number
EMEA/H/C/000151
Marketing authorisation holder
Richen Europe S.R.L

Via San Cristoforo 78
20090 Trezzano Sul Naviglio (Ml)
Italy

Marketing authorisation issued
07/05/1998
Revision
12

Assessment history

Pylobactell : EPAR - Procedural steps taken and scientific information after authorisation

Pylobactell : EPAR - Steps taken after authorisation when a cutoff date has been used

Pylobactell : EPAR - Procedural steps taken before authorisation

Pylobactell : EPAR - Scientific Discussion

Topics

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