Helicobacter Test INFAI

1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 
 



 2 

1. NAME OF THE MEDICINAL PRODUCT 
 
Helicobacter Test INFAI 75 mg powder for oral solution 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
One jar contains 75 mg of 13C-urea powder. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
White, crystalline powder for oral solution. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
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. 
 
4.2 Posology and method of administration 
 
This medicinal product should be administered by a healthcare professional and under appropriate 
medical supervision. 
 
Posology 
 
Helicobacter Test INFAI is a breath test for single administration. Patients from the age of 12 must 
take the contents of 1 jar with 75 mg. 
 
Method of administration 
 
For performance of the test, 200 ml 100 % orange juice or 1 g citric acid in 200 ml water for patients 
from the age of 12 and older (as a pre-administered test meal), as well as tap water (for dissolving the 
13C-urea powder) are necessary. 
 
The patient must have fasted for over 6 hours, preferably overnight. The test procedure takes 
approximately 40 minutes. 
 
In case it is necessary to repeat the test procedure, this should not be done until the following day. 
 
The suppression of Helicobacter pylori might give false negative results. Therefore the test shall be 
used after at least four weeks without systemic antibacterial therapy and two weeks after last dose of 
acid antisecretory agents. Both might interfere with the Helicobacter pylori status. This is especially 
important after Helicobacter eradication therapy. 
 
It is important to follow the instructions for use adequately (see section 6.6), otherwise the reliability 
of the outcome will become questionable. 
 



 3 

4.3 Contraindications 
 
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). 
 
4.4 Special warnings and precautions for use 
 
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). 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Helicobacter Test INFAI will be affected by all treatments interfering with Helicobacter pylori status 
or urease activity. 
 
4.6 Fertility, pregnancy and lactation 
 
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. 
 
4.7 Effects on ability to drive and use machines 
 
Helicobacter Test INFAI has no influence on the ability to drive and use machines. 
 
4.8 Undesirable effects 
 
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. 
 
4.9 Overdose 
 
Due to the fact that only 75 mg of 13C-urea is delivered, an overdose is not expected. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Other diagnostic agents, ATC code: VO4CX 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


 4 

 
For the amount of 75 mg 13C-urea, which is administered per unit in the course of the breath test, no 
pharmacodynamic activity is described. 
 
After oral ingestion the labelled urea reaches the gastric mucosa. In the presence of Helicobacter 
pylori the 13C-urea is metabolised by the enzyme urease of Helicobacter pylori. 
 

2H2N(13CO)NH2 + 2H2O     Enzyme urease      4NH3 + 213CO2 
 
The carbon dioxide diffuses into the blood vessels. From there it is transported as bicarbonate into the 
lung and liberated as 13CO2 with the exhaled air. 
 
In the presence of bacterial urease the ratio of the 13C/12C-carbon isotopes is significantly changed. 
The portion of 13CO2 in the breath samples is determined by isotope-ratio-mass-spectrometry (IRMS) 
and stated as an absolute difference (-value) between the 00-minute- and the 30-minute-values. 
 
Urease is produced in the stomach only by Helicobacter pylori. Other urease producing bacteria were 
seldom found in the gastric flora. 
 
The cut off point for discriminating Helicobacter pylori-negative and positive patients is determined to 
be -value of 4 ‰, which means that an increase of the -value by more than 4 ‰ indicates an 
infection. In comparison to bioptic diagnostics of an infection with Helicobacter pylori, the breath test 
achieved in clinical trials on 457 patients, a sensitivity in the range of 96.5 % to 97.9 % [95 %-CI: 
94.05 %-99.72 %], and a specificity range from 96.7 % to 100 %. [95 %-CI: 94.17 %-103.63 %], 
whereas in clinical trials on 93 adolescents from the age 12–17, a sensitivity of 97.7 % [90 %-CI: 
91.3 %], and a specificity of 96.0 % [90 %-CI: 89.7 %] were achieved. 
 
In the absence of bacterial urease, the whole amount of the administered urea after absorption from the 
gastrointestinal tract will be metabolised like the endogenous urea. Ammonia which is produced as 
described above by the bacterial hydrolysis is included into the metabolism as NH4+. 
 
5.2 Pharmacokinetic properties 
 
The orally applied 13C-urea is metabolised to carbon dioxide and ammonia or is integrated into the 
body’s own urea cycle. Any increase in 13CO2 will be measured by isotopic analysis. 
 
Absorption and distribution of 13CO2 is faster than the urease reaction. Therefore, the rate-limiting step 
in the whole process is the cleavage of 13C-urea by Helicobacter's urease. 
 
Only in Helicobacter pylori-positive patients does the administration of 75 mg labelled urea lead to a 
significant increase of 13CO2 in the breath sample within the first 30 minutes. 
 
5.3 Preclinical safety data 
 
No concerns in relation to the clinical use of the product. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
None. 
 
6.2 Incompatibilities 
 
Not applicable. 
 



 5 

6.3 Shelf-life 
 
3 years 
 
6.4 Special precautions for storage 
 
Do not store above 25 °C. 
 
6.5 Nature and contents of container 
 
A test set contains the following parts: 
 

No. Component Quantity 

1 
Jar (10 ml volume, polystyrene with polyethylene snap cap) 
containing 75 mg 13C-urea powder for oral solution 1 

2 

Labelled sample glass- or plastic- containers for sampling, storing 
and transporting the breath samples for analysis: 
Sampling time: 00-minute-value 
Sampling time: 30-minute-value 

 
 
2 
2 

3 Bendable straw for collection of the breath samples into the corresponding sample containers 1 

4 Data sheet for patient documentation 1 
5 Package leaflet 1 
6 Page of barcode labels and sticker 1 

 
6.6 Special precautions for disposal and other handling 
 
1. The test is to be performed in the presence of a qualified person. 
2. Each patient should be documented according to the provided data sheet. It is recommended to 

perform the test with the patient being in a resting position. 
3. The test starts with the collection of samples for the determination of baseline-value (00-minute-

value): 
 Take the straw and the two sample tubes with the label 

“Sampling time: 00-minute-value” out of the test set. 
 Remove the stopper from one of the sample tubes, unwrap the straw and place the straw 

into the container. 
 Now the patient breathes gently through the straw until the inner surface of the sample 

tube steams up. 
 By continuously breathing the patient must pull out the straw and immediately close the 

sample tube with its stopper. 
(If the sample tube remains open for more than 30 seconds, the test result might be 
falsified.) 

 Hold the sample tube upright and stick the bar-code label marked “00-minute-value” 
round the sample tube, so that the lines of the bar-code are horizontal. 

4. Fill up the second sample tube (Label “Sampling time: 00-minute-value”) with breath by 
following the same procedure. 

5. Now 200 ml of 100 % orange juice or 1 g citric acid in 200 ml water must be drunk by the 
patient without delay. 

6. Now the preparation of the test solution follows: 
 The jar labelled “13C-urea powder” is taken from the test set, opened, and filled up to 

three quarters of its volume with tap water. 
 Close the jar and shake it carefully until all the powder is dissolved. Pour the contents 

into a drinking glass. 
 Fill the 13C-urea jar to the brim with water for a second and third time and add these 

contents to the drinking glass (total volume of tap water should be approximately 30 ml). 



 6 

7. This test solution must now be drunk immediately by the patient, and the time of application 
must be noted. 

8. Thirty minutes after administration of the test solution (point 7), collect the 30-minute-value 
samples in the two containers which are left in the test package (Label “Sampling time: 
30-minute-value”), as described under steps 3 to 4. Use the bar-code labels marked “30-minute-
value” for these samples. 

9. Put the relevant bar-code label on the data sheet for patient documentation. Finally seal the 
package with the sticker. 

10. The sample tubes have to be sent in the original packaging, for analysis, to a qualified 
laboratory. 

 
Analysis of breath samples and testing specification for laboratories 
 
The breath samples, collected in 10 ml glass- or plastic sample tubes, are analysed by isotope ratio 
mass spectrometry (IRMS). 
 
The analysis of the 13C/12C-ratio in carbon dioxide of breath is an integrated part of the diagnostic test 
Helicobacter Test INFAI. The accuracy of the test strongly depends on the quality of the breath 
analysis. The specification of breath analysis parameters like linearity, stability (reference gas 
precision), and precision of measurement are fundamental for the accuracy of the system. 
 
It has to be ensured that the analysis is carried out by a qualified laboratory. The method validated in 
the application is as follows: 
 
 Sample preparation for (IRMS) 
 
To determine the 13C/12C-ratio of carbon dioxide in breath by mass spectrometric analysis the carbon 
dioxide must be separated from the breath and introduced into the mass spectrometer. The automatic 
preparation system for isotope mass spectrometers which is dedicated for breath test analysis is based 
on a gas-chromatographic continuous flow separation technique. 
 
Water is removed from the sample by means of a Nafion water trap or the gas-chromatographic 
preparation system that separates the individual gases in a gas chromatographic column with Helium 
as eluent. Passing the column the separated gas species of breath are detected by an ionisation 
detector. The fraction of carbon dioxide gas, identified by its characteristic retention time, is 
introduced into mass spectrometer. 
 
 Mass spectrometric analysis 
 
To analyse the separated carbon dioxide sample gas its molecules must be ionised, formed into a 
beam, accelerated by an electric field, deflected in a magnetic field, and finally detected. These five 
processes take place in the analyser of a mass spectrometer, which consists of three separate sections: 
the source, flight tube, and collector. Ionisation, beam formation and acceleration all occur in the 
source, magnetic deflection takes place in the flight tube and detection takes place in the collector. 
 
 Sample inlet 
 
For introduction of the carbon dioxide into the analyser many sample inlet systems are available. For 
breath test analysis the individual balancing of the carbon dioxide of the sample to a reference 
standard gas is essential. This ensures the high accuracy of this system, as calculation of the isotopic 
content in carbon dioxide is done with respect to an independent standard. 
 
 Specifications for determining 13C/12C-ratios 
 
The breath test concept relies on the administration of a specifically 13C-labelled urea whose 
metabolite utilisation is monitored by measuring 13CO2 in the expired breath gas. 



 7 

 
 The mass spectrometer must be capable of: 
 
Multiple replicate analyses: Minimum of 3 replicate analyses of the same sample during operation 
 
Security access: Storing of operating parameters and of results under security access to 

avoid later manipulation 
 
Adjustment: 13C/12C-ratio with respect to Pee Dee Beliminate (PDB) 
 
Sample loop: < 200 µl 
 
The principal tests to verify the specifications are linearity, stability (reference gas precision), and 
precision of measurement. 
 
 All mass spectrometers for breath analysis must comply with the following specifications: 
 
Linearity:  0.5 ‰ for breath samples varying between 1 % and 7 % 

CO2-concentration 
 
Stability:  0.2 ‰ on 10 consecutive pulses 
 
Precision of measurement:  0.3 ‰ for 13C at natural abundance using a 10 ml breath sample tube 

with 3 % CO2 breath concentration 
 
Helicobacter pylori infection is present if the difference in 13C/12C of baseline-value and 30-minute-
value exceeds 4.0 ‰. 
 
Alternatively, any other suitable-validated method may be used, carried out by any objectively 
qualified laboratory. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
INFAI GmbH 
Riehler Str. 36 
D-50668 Köln 
Germany 
 
 
8. MARKETING AUTHORISATION NUMBER 
 
EU/1/97/045/001 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 14 August 1997 
Date of latest renewal: 14 August 2007 
 
 
10. DATE OF REVISION OF THE TEXT 
 
 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu. 

http://www.ema.europa.eu/


 8 

1. NAME OF THE MEDICINAL PRODUCT 
 
Helicobacter Test INFAI 75 mg powder for oral solution 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
One jar contains 75 mg of 13C-urea powder. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
White, crystalline powder for oral solution. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
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. 
 
4.2 Posology and method of administration 
 
This medicinal product should be administered by a healthcare professional and under appropriate 
medical supervision. 
 
Posology 
 
Helicobacter Test INFAI is a breath test for single administration. Patients from the age of 12 must 
take the contents of 1 jar with 75 mg. 
 
Method of administration 
 
For performance of the test, 200 ml 100 % orange juice or 1 g citric acid in 200 ml water for patients 
from the age of 12 and older (as a pre-administered test meal), as well as tap water (for dissolving the 
13C-urea powder) are necessary. 
 
The patient must have fasted for over 6 hours, preferably overnight. The test procedure takes 
approximately 40 minutes. 
 
In case it is necessary to repeat the test procedure, this should not be done until the following day. 
 
The suppression of Helicobacter pylori might give false negative results. Therefore the test shall be 
used after at least four weeks without systemic antibacterial therapy and two weeks after last dose of 
acid antisecretory agents. Both might interfere with the Helicobacter pylori status. This is especially 
important after Helicobacter eradication therapy. 
 
It is important to follow the instructions for use adequately (see section 6.6), otherwise the reliability 
of the outcome will become questionable. 
 



 9 

4.3 Contraindications 
 
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). 
 
4.4 Special warnings and precautions for use 
 
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). 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Helicobacter Test INFAI will be affected by all treatments interfering with Helicobacter pylori status 
or urease activity. 
 
4.6 Fertility, pregnancy and lactation 
 
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. 
 
4.7 Effects on ability to drive and use machines 
 
Helicobacter Test INFAI has no influence on the ability to drive and use machines. 
 
4.8 Undesirable effects 
 
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. 
 
4.9 Overdose 
 
Due to the fact that only 75 mg of 13C-urea is delivered, an overdose is not expected. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Other diagnostic agents, ATC code: VO4CX 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


 10 

 
For the amount of 75 mg 13C-urea, which is administered per unit in the course of the breath test, no 
pharmacodynamic activity is described. 
 
After oral ingestion the labelled urea reaches the gastric mucosa. In the presence of Helicobacter 
pylori the 13C-urea is metabolised by the enzyme urease of Helicobacter pylori. 
 

2H2N(13CO)NH2 + 2H2O     Enzyme urease      4NH3 + 213CO2 
 
The carbon dioxide diffuses into the blood vessels. From there it is transported as bicarbonate into the 
lung and liberated as 13CO2 with the exhaled air. 
 
In the presence of bacterial urease the ratio of the 13C/12C-carbon isotopes is significantly changed. 
The portion of 13CO2 in the breath samples is determined by non-dispersive infrared spectrometry and 
stated as an absolute difference (-value) between the 00-minute- and the 30-minute-values. 
 
Urease is produced in the stomach only by Helicobacter pylori. Other urease producing bacteria were 
seldom found in the gastric flora. 
 
The cut off point for discriminating Helicobacter pylori-negative and positive patients is determined to 
be -value of 4 ‰, which means that an increase of the -value by more than 4 ‰ indicates an 
infection. In comparison to bioptic diagnostics of an infection with Helicobacter pylori, the breath test 
achieved in clinical trials on 457 patients, a sensitivity in the range of 96.5 % to 97.9 % [95 %-CI: 
94.05 %-99.72 %], and a specificity range from 96.7 % to 100 %. [95 %-CI: 94.17 %-103.63 %]. 
 
In the absence of bacterial urease, the whole amount of the administered urea after absorption from the 
gastrointestinal tract will be metabolised like the endogenous urea. Ammonia which is produced as 
described above by the bacterial hydrolysis is included into the metabolism as NH4+. 
 
5.2 Pharmacokinetic properties 
 
The orally applied 13C-urea is metabolised to carbon dioxide and ammonia or is integrated into the 
body’s own urea cycle. Any increase in 13CO2 will be measured by isotopic analysis. 
 
Absorption and distribution of 13CO2 is faster than the urease reaction. Therefore, the rate-limiting step 
in the whole process is the cleavage of 13C-urea by Helicobacter's urease. 
 
Only in Helicobacter pylori-positive patients does the administration of 75 mg labelled urea lead to a 
significant increase of 13CO2 in the breath sample within the first 30 minutes. 
 
5.3 Preclinical safety data 
 
No concerns in relation to the clinical use of the product. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
None. 
 
6.2 Incompatibilities 
 
Not applicable. 
 



 11 

6.3 Shelf-life 
 
3 years 
 
6.4 Special precautions for storage 
 
Do not store above 25 °C. 
 
6.5 Nature and contents of container 
 
A test set contains 1 jar with the additional components: 
 

No. Component Quantity 

1 
Jar (10 ml volume, polystyrene with polyethylene snap cap) 
containing 75 mg 13C-urea powder for oral solution 1 

2 Breath bags: 
Sampling time: 00-minute-value 
Sampling time: 30-minute-value 

 
1 
1 

3 Bendable straw for collection of the breath samples into the corresponding breath bags 1 

4 Data sheet for patient documentation 1 
5 Package leaflet 1 
6 Page of barcode labels and sticker 1 

 
A test set contains 50 jars with the additional components:  
 

No. Component Quantity 

1 
Jar (10 ml volume, polystyrene with polyethylene snap cap) 
containing 75 mg 13C-urea powder for oral solution 50 

2 
Breath bags: 
Sampling time: 00-minute-value 
Sampling time: 30-minute-value 

 
50 
50 

3 Bendable straw for collection of the breath samples into the corresponding breath bags 50 

4 Data sheet for patient documentation 50 
5 Package leaflet 50 
6 Page of barcode labels and sticker 50 

 
6.6 Special precautions for disposal and other handling 
 
1. The test is to be performed in the presence of a qualified person. 
2. Each patient should be documented according to the provided data sheet. It is recommended to 

perform the test with the patient being in a resting position. 
3. The test starts with the collection of samples for the determination of baseline-value (00-minute-

value): 
 Take the straw and the breath bag with the label 

“Sampling time: 00-minute-value” out of the test set. 
 Remove the stopper from the breath bag, unwrap the straw and place the straw into the 

breath bag. 
 Now the patient breathes gently through the straw. 
 By continuously breathing the patient must pull out the straw and immediately close the 

breath bag with its stopper. 
(If the breath bag remains open for more than 30 seconds, the test result might be 
falsified.) 

 Hold the breath bag upright and stick the bar-code label marked “00-minute-value” on the 
breath bag. 



 12 

4. Now 200 ml of 100 % orange juice or 1 g citric acid in 200 ml water must be drunk by the 
patient without delay. 

5. Now the preparation of the test solution follows: 
 The jar labelled “13C-urea powder” is taken from the test set, opened, and filled up to 

three quarters of its volume with tap water. 
 Close the jar and shake it carefully until all the powder is dissolved. Pour the contents 

into a drinking glass. 
 Fill the 13C-urea jar to the brim with water for a second and third time and add these 

contents to the drinking glass (total volume of tap water should be approximately 30 ml). 
6. This test solution must now be drunk immediately by the patient, and the time of application 

must be noted. 
7. Thirty minutes after administration of the test solution (point 6), collect the 30-minute-value 

sample in the breath bag, which is left in the test package (Label “Sampling time: 30-minute-
value”), as described under step 3. Use the bar-code label marked “30-minute-value” for this 
sample. 

8. Put the relevant bar-code label on the data sheet for patient documentation. Finally seal the 
package with the sticker. 

9. The breath bags have to be sent in the original packaging, for analysis, to a qualified laboratory. 
 
Analysis of breath samples and testing specification for laboratories 
 
The breath samples, collected in 100 ml breath bags, are analysed by non-dispersive infrared 
spectrometry (NDIR). 
 
The analysis of the 13C/12C-ratio in carbon dioxide of breath is an integrated part of the diagnostic test 
Helicobacter Test INFAI. The accuracy of the test strongly depends on the quality of the breath 
analysis. The specification of breath analysis parameters like linearity, stability (reference gas 
precision), and precision of measurement are fundamental for the accuracy of the system. 
 
It has to be ensured that the analysis is carried out by a qualified laboratory. It is recommended to 
measure as soon as possible after the breath collection, in any case not later than 4 weeks. 
 
The method validated in the application is as follows: 
 
 Sample preparation for Infrared Spectroscopy (NDIR) 
 
The determination of 13C/12C-ratio in the carbon dioxide of the breath samples is carried out directly in 
the breath. The breath from the bags will be introduced into the NDIR spectrometer using a variable 
gas pump. The water content of the breath sample will be kept mostly constant through Nafion water 
trap. For calibration and measurement necessary CO2-free air (zero-gas) will be produced via an 
integrated CO2-absorber in the analysator. 
 
 Infrared spectroscopic analysis 
 
To analyse the carbon dioxide in breath a broad band infrared radiation bunch emitted by an infrared 
radiation source is alternately sent through the measuring chamber and a reference chamber by means 
of a beam chopper. The modulated infrared beams then enter the infrared detectors, which are double 
layer transmission detectors with a front, and a rear chamber each filled with one of the isotopicly pure 
gases (13CO2 or 12CO2, respectively) to be measured. The infrared radiation in the measuring chamber 
is weakened by the gas component to be measured. Thus the radiation equilibrium between measuring 
and comparative beam is disturbed. In consequence there is a temperature fluctuation, which in its turn 
causes a fluctuating pressure in the front chamber of the infrared detector. A membrane capacitor 
connected with this chamber, which is exposed to a high resistance direct voltage, transforms these 
pressure fluctuations into an alternating voltage, which is a measure of the isotopic composition of 
breath carbon dioxide. 
 



 13 

 Sample Inlet 
 
A semi-automatic sample inlet system injects the measuring gas in definite amounts into the zero gas 
circulating in the gas circuit of the infrared spectrometer. This enables measurement of the 
13C/12C-ratio at any CO2 concentration above 1 %. 
 
 Specifications for determining 13C/12C-ratios 
 
The breath test concept is based upon the oral administration of 13C-labelled urea whose enzymatic 
hydrolysis is monitored by measuring 13CO2 in breath using non-dispersive infrared spectrometry. 
 
 Infrared spectrometers for breath analysis must comply with the following specifications: 
 
Multiple replicate analyses: Minimum of 3 replicate analyses of the same sample during operation 
 
Security access: Storing of operating parameters and of results under security access to 

avoid later manipulation 
 
For verifying the specifications linearity, stability, and precision of measurement have to be tested. 
 
Zero point adjustment of the detectors by means of the zero gas generated in the spectrometer. End-
point adjustment of the detectors by means of calibration gases of precisely known concentration. 
 
Linearity:  0.5 ‰ for breath samples varying between 1 % and 7 % 

CO2-concentration 
 
Stability:  0.3 ‰ at 10 consecutive pulses 
 
Precision of measurement:  0.5 ‰ for 13C at natural abundance using a 100 ml breath bag with 

3 % CO2 breath concentration 
 
Helicobacter pylori infection is present if the difference in 13C/12C of baseline-value and 30-minute-
value exceeds 4.0 ‰. 
 
Alternatively, any other suitable-validated method may be used, carried out by any objectively 
qualified laboratory. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
INFAI GmbH 
Riehler Str. 36 
D-50668 Köln 
Germany 
 
 
8.  MARKETING AUTHORISATION NUMBERS 
 
EU/1/97/045/002 
EU/1/97/045/004 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 14 August 1997 
Date of latest renewal: 14 August 2007 
 



 14 

 
10. DATE OF REVISION OF THE TEXT 
 
 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu. 
 

http://www.ema.europa.eu/


 15 

1. NAME OF THE MEDICINAL PRODUCT  
 
Helicobacter Test INFAI for children of the age 3-11 45 mg powder for oral solution 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
One jar contains 45 mg of 13C-urea powder. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
White, crystalline powder for oral solution. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
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. 
 
4.2 Posology and method of administration 
 
This medicinal product should be administered by a healthcare professional and under appropriate 
medical supervision. 
 
Posology 
 
Helicobacter Test INFAI for children of the age 3-11 is a breath test for single administration. 
Children from the age of 3 to 11 must take the contents of 1 jar with 45 mg. 
 
Method of administration 
 
For performance of the test, 100 ml 100 % orange juice for patients from the age of 3 to 11 (as a pre-
administered test meal), as well as tap water (for dissolving the 13C-urea powder) are necessary. 
 
The patient must have fasted for over 6 hours, preferably overnight. The test procedure takes 
approximately 40 minutes. 
 
In case it is necessary to repeat the test procedure, this should not be done until the following day. 
 
The suppression of Helicobacter pylori might give false negative results. Therefore the test shall be 
used after at least four weeks without systemic antibacterial therapy and two weeks after last dose of 
acid antisecretory agents. Both might interfere with the Helicobacter pylori status. This is especially 
important after Helicobacter eradication therapy. 
 
It is important to follow the instructions for use adequately (see section 6.6), otherwise the reliability 
of the outcome will become questionable. 
 



 16 

4.3 Contraindications 
 
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). 
 
4.4 Special warnings and precautions for use 
 
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). 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Helicobacter Test INFAI for children of the age 3-11 will be affected by all treatments interfering with 
Helicobacter pylori status or urease activity. 
 
4.6 Fertility, pregnancy and lactation 
 
Not applicable. 
 
4.7 Effects on ability to drive and use machines 
 
None. 
 
4.8 Undesirable effects 
 
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. 
 
4.9 Overdose 
 
Due to the fact that only 45 mg of 13C-urea is delivered, an overdose is not expected. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Other diagnostic agents, ATC code: VO4CX 
 
For the amount of 45 mg 13C-urea, which is administered per unit in the course of the breath test, no 
pharmacodynamic activity is described. 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


 17 

 
After oral ingestion the labelled urea reaches the gastric mucosa. In the presence of Helicobacter 
pylori the 13C-urea is metabolised by the enzyme urease of Helicobacter pylori. 
 

2H2N(13CO)NH2 + 2H2O     Enzyme urease      4NH3 + 213CO2 
 
The carbon dioxide diffuses into the blood vessels. From there it is transported as bicarbonate into the 
lung and liberated as 13CO2 with the exhaled air. 
 
In the presence of bacterial urease the ratio of the 13C/12C-carbon isotopes is significantly changed. 
The portion of 13CO2 in the breath samples is determined by isotope-ratio-mass-spectrometry (IRMS) 
and stated as an absolute difference (-value) between the 00-minute- and the 30-minute-values. 
 
Urease is produced in the stomach only by Helicobacter pylori. Other urease producing bacteria were 
seldom found in the gastric flora. 
 
The cut off point for discriminating Helicobacter pylori-negative and positive patients is determined to 
be -value of 4 ‰, which means that an increase of the -value by more than 4 ‰ indicates an 
infection. In comparison to bioptic diagnostics of an infection with Helicobacter pylori, the breath test 
achieved in a clinical trial on 168 patients from the age of 3 to 11, a sensitivity of 98.4 % [90 %-CI: 
≥ 93.9 %], and a specificity of 98.1 % [90 %-CI: ≥ 95.1 %]. 
 
In the absence of bacterial urease, the whole amount of the administered urea after absorption from the 
gastrointestinal tract will be metabolised like the endogenous urea. Ammonia which is produced as 
described above by the bacterial hydrolysis is included into the metabolism as NH4+. 
 
5.2 Pharmacokinetic properties 
 
The orally applied 13C-urea is metabolised to carbon dioxide and ammonia or is integrated into the 
body’s own urea cycle. Any increase in 13CO2 will be measured by isotopic analysis. 
 
Absorption and distribution of 13CO2 is faster than the urease reaction. Therefore, the rate-limiting step 
in the whole process is the cleavage of 13C-urea by Helicobacter's urease. 
 
Only in Helicobacter pylori- positive patients does the administration of 45 mg labelled urea lead to a 
significant increase of 13CO2 in the breath sample within the first 30 minutes. 
 
5.3 Preclinical safety data 
 
No concerns in relation to the clinical use of the product. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
None. 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf-life 
 
3 years 
 



 18 

6.4 Special precautions for storage 
 
Do not store above 25 °C. 
 
6.5 Nature and contents of container 
 
A test set contains the following parts: 
 

No. Component Quantity 

1 
Jar (10 ml volume, polystyrene with polyethylene snap cap) 
containing 45 mg 13C-urea powder for oral solution 1 

2 

Labelled sample glass- or plastic- containers for sampling, storing 
and transporting the breath samples for analysis: 
Sampling time: 00-minute-value 
Sampling time: 30-minute-value 

 
 
2 
2 

3 Bendable straw for collection of the breath samples into the corresponding sample containers 1 

4 Data sheet for patient documentation 1 
5 Package leaflet 1 
6 Page of barcode labels and sticker 1 

 
6.6 Special precautions for disposal and other handling 
 
1. The test is to be performed in the presence of a qualified person. 
2. Each patient should be documented according to the provided data sheet. It is recommended to 

perform the test with the patient being in a resting position. 
3. The test starts with the collection of samples for the determination of baseline-value (00-minute-

value): 
 Take the straw and the two sample tubes with the label 

“Sampling time: 00-minute-value” out of the test set. 
 Remove the stopper from one of the sample tubes, unwrap the straw and place the straw 

into the container. 
 Now the patient breathes gently through the straw until the inner surface of the sample 

tube steams up. 
 By continuously breathing the patient must pull out the straw and immediately close the 

sample tube with its stopper. 
(If the sample tube remains open for more than 30 seconds, the test result might be 
falsified.) 

 Hold the sample tube upright and stick the bar-code label marked “00-minute-value” 
round the sample tube, so that the lines of the bar-code are horizontal. 

4. Fill up the second sample tube (Label “Sampling time: 00-minute-value”) with breath by 
following the same procedure. 

5. Now 100 ml of 100 % orange juice must be drunk by the patient without delay. 
6. Now the preparation of the test solution follows: 

 The jar labelled “13C-urea powder” is taken from the test set, opened, and filled up to 
three quarters of its volume with tap water. 

 Close the jar and shake it carefully until all the powder is dissolved. Pour the contents 
into a drinking glass. 

 Fill the 13C-urea jar to the brim with water for a second and third time and add these 
contents to the drinking glass (total volume of tap water should be approximately 30 ml). 

7. This test solution must now be drunk immediately by the patient, and the time of application 
must be noted. 

8. Thirty minutes after administration of the test solution (point 7), collect the 30-minute-value 
samples in the two containers which are left in the test package (Label “Sampling time: 
30-minute-value”), as described under steps 3 to 4. Use the bar-code labels marked “30-minute-
value” for these samples. 



 19 

9. Put the relevant bar-code label on the data sheet for patient documentation. Finally seal the 
package with the sticker. 

10. The sample tubes have to be sent in the original packaging, for analysis, to a qualified 
laboratory. 

 
Analysis of breath samples and testing specification for laboratories 
 
The breath samples, collected in 10 ml glass- or plastic sample tubes, are analysed by isotope ratio 
mass spectrometry (IRMS). 
 
The analysis of the 13C/12C-ratio in carbon dioxide of breath is an integrated part of the diagnostic test 
Helicobacter Test INFAI. The accuracy of the test strongly depends on the quality of the breath 
analysis. The specification of breath analysis parameters like linearity, stability (reference gas 
precision), and precision of measurement are fundamental for the accuracy of the system. 
 
It has to be ensured that the analysis is carried out by a qualified laboratory. The method validated in 
the application is as follows: 
 
 Sample preparation for (IRMS) 
 
To determine the 13C/12C-ratio of carbon dioxide in breath by mass spectrometric analysis the carbon 
dioxide must be separated from the breath and introduced into the mass spectrometer. The automatic 
preparation system for isotope mass spectrometers which is dedicated for breath test analysis is based 
on a gas-chromatographic continuous flow separation technique. 
 
Water is removed from the sample by means of a Nafion water trap or the gas-chromatographic 
preparation system that separates the individual gases in a gas chromatographic column with Helium 
as eluent. Passing the column the separated gas species of breath are detected by an ionisation 
detector. The fraction of carbon dioxide gas, identified by its characteristic retention time, is 
introduced into mass spectrometer. 
 
 Mass spectrometric analysis 
 
To analyse the separated carbon dioxide sample gas its molecules must be ionised, formed into a 
beam, accelerated by an electric field, deflected in a magnetic field, and finally detected. These five 
processes take place in the analyser of a mass spectrometer, which consists of three separate sections: 
the source, flight tube, and collector. Ionisation, beam formation and acceleration all occur in the 
source, magnetic deflection takes place in the flight tube and detection takes place in the collector. 
 
 Sample inlet 
 
For introduction of the carbon dioxide into the analyser many sample inlet systems are available. For 
breath test analysis the individual balancing of the carbon dioxide of the sample to a reference 
standard gas is essential. This ensures the high accuracy of this system, as calculation of the isotopic 
content in carbon dioxide is done with respect to an independent standard. 
 
 Specifications for determining 13C/12C-ratios 
 
The breath test concept relies on the administration of a specifically 13C-labelled urea whose 
metabolite utilisation is monitored by measuring 13CO2 in the expired breath gas.  
 
 The mass spectrometer must be capable of: 
 
Multiple replicate analyses: Minimum of 3 replicate analyses of the same sample during operation 
 



 20 

Security access: Storing of operating parameters and of results under security access to 
avoid later manipulation 

 
Adjustment: 13C/12C-ratio with respect to Pee Dee Beliminate (PDB) 
 
Sample loop: < 200 µl 
 
The principal tests to verify the specifications are linearity, stability (reference gas precision), and 
precision of measurement. 
 
 All mass spectrometers for breath analysis must comply with the following specifications: 
 
Linearity:  0.5 ‰ for breath samples varying between 1 % and 7 % 

CO2-concentration 
 
Stability:  0.2 ‰ on 10 consecutive pulses 
 
Precision of measurement:  0.3 ‰ for 13C at natural abundance using a 10 ml breath sample tube 

with 3 % CO2 breath concentration 
 
Helicobacter pylori infection is present if the difference in 13C/12C of baseline-value and 30-minute-
value exceeds 4.0 ‰. 
 
Alternatively, any other suitable-validated method may be used, carried out by any objectively 
qualified laboratory. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
INFAI GmbH 
Riehler Str. 36 
D-50668 Köln 
Germany 
 
 
8. MARKETING AUTHORISATION NUMBER 
 
EU/1/97/045/003 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 14 August 1997 
Date of latest renewal: 14 August 2007 
 
 
10. DATE OF REVISION OF THE TEXT 
 
 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu. 
 

http://www.ema.europa.eu/


 21 

1. NAME OF THE MEDICINAL PRODUCT 
 
Helicobacter Test INFAI 75 mg powder for oral solution 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
One jar contains 75 mg of 13C-urea powder. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
White, crystalline powder for oral solution. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
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. 
 
4.2 Posology and method of administration 
 
This medicinal product should be administered by a healthcare professional and under appropriate 
medical supervision. 
 
Posology 
 
Helicobacter Test INFAI is a breath test for single administration. Patients from the age of 12 must 
take the contents of 1 jar with 75 mg. 
 
Method of administration 
 
For performance of the test, 200 ml 100 % orange juice or 1 g citric acid in 200 ml water for patients 
from the age of 12 and older (as a pre-administered test meal), as well as tap water (for dissolving the 
13C-urea powder) are necessary. 
 
The patient must have fasted for over 6 hours, preferably overnight. The test procedure takes 
approximately 40 minutes. 
 
In case it is necessary to repeat the test procedure, this should not be done until the following day. 
 
The suppression of Helicobacter pylori might give false negative results. Therefore the test shall be 
used after at least four weeks without systemic antibacterial therapy and two weeks after last dose of 
acid antisecretory agents. Both might interfere with the Helicobacter pylori status. This is especially 
important after Helicobacter eradication therapy. 
 
It is important to follow the instructions for use adequately (see section 6.6), otherwise the reliability 
of the outcome will become questionable. 
 



 22 

4.3 Contraindications 
 
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). 
 
4.4 Special warnings and precautions for use 
 
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). 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Helicobacter Test INFAI will be affected by all treatments interfering with Helicobacter pylori status 
or urease activity. 
 
4.6 Fertility, pregnancy and lactation 
 
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. 
 
4.7 Effects on ability to drive and use machines 
 
Helicobacter Test INFAI has no influence on the ability to drive and use machines. 
 
4.8 Undesirable effects 
 
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. 
 
4.9 Overdose 
 
Due to the fact that only 75 mg of 13C-urea is delivered, an overdose is not expected. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Other diagnostic agents, ATC code: VO4CX 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


 23 

 
For the amount of 75 mg 13C-urea, which is administered per unit in the course of the breath test, no 
pharmacodynamic activity is described. 
 
After oral ingestion the labelled urea reaches the gastric mucosa. In the presence of Helicobacter 
pylori the 13C-urea is metabolised by the enzyme urease of Helicobacter pylori. 
 

2H2N(13CO)NH2 + 2H2O     Enzyme urease      4NH3 + 213CO2 
 
The carbon dioxide diffuses into the blood vessels. From there it is transported as bicarbonate into the 
lung and liberated as 13CO2 with the exhaled air. 
 
In the presence of bacterial urease the ratio of the 13C/12C-carbon isotopes is significantly changed. 
The portion of 13CO2 in the breath samples is determined by non-dispersive infrared spectrometry and 
stated as an absolute difference (-value) between the 00-minute- and the 30-minute-values. 
 
Urease is produced in the stomach only by Helicobacter pylori. Other urease producing bacteria were 
seldom found in the gastric flora. 
 
The cut off point for discriminating Helicobacter pylori-negative and positive patients is determined to 
be -value of 4 ‰, which means that an increase of the -value by more than 4 ‰ indicates an 
infection. In comparison to bioptic diagnostics of an infection with Helicobacter pylori, the breath test 
achieved in clinical trials on 457 patients, a sensitivity in the range of 96.5 % to 97.9 % [95 %-CI: 
94.05 %-99.72 %], and a specificity range from 96.7 % to 100 % [95 %-CI: 94.17 %-103.63 %]. 
 
In the absence of bacterial urease, the whole amount of the administered urea after absorption from the 
gastrointestinal tract will be metabolised like the endogenous urea. Ammonia which is produced as 
described above by the bacterial hydrolysis is included into the metabolism as NH4+. 
 
5.2 Pharmacokinetic properties 
 
The orally applied 13C-urea is metabolised to carbon dioxide and ammonia or is integrated into the 
body’s own urea cycle. Any increase in 13CO2 will be measured by isotopic analysis. 
 
Absorption and distribution of 13CO2 is faster than the urease reaction. Therefore, the rate-limiting step 
in the whole process is the cleavage of 13C-urea by Helicobacter's urease. 
 
Only in Helicobacter pylori-positive patients does the administration of 75 mg labelled urea lead to a 
significant increase of 13CO2 in the breath sample within the first 30 minutes. 
 
5.3 Preclinical safety data 
 
No concerns in relation to the clinical use of the product. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
None. 
 
6.2 Incompatibilities 
 
Not applicable. 
 



 24 

6.3 Shelf-life 
 
3 years 
 
6.4 Special precautions for storage 
 
Do not store above 25 °C. 
 
6.5 Nature and contents of container 
 
A test set contains 50 jars with the additional components:  
 

No. Component Quantity 

1 
Jar (10 ml volume, polystyrene with polyethylene snap cap) 
containing 75 mg 13C-urea powder for oral solution 50 

2 Data sheet for patient documentation 50 
3 Package leaflet 50 
4 Page of barcode labels and sticker 50 

 
6.6 Special precautions for disposal and other handling 
 
1. The test is to be performed in the presence of a qualified person. 
2. Each patient should be documented according to the provided data sheet. It is recommended to 

perform the test with the patient being in a resting position. 
3. The test starts with the collection of samples for the determination of baseline-value (00-minute-

value): 
 Take the straw and the breath sample containers (tubes or breath bag) with the label 

“Sampling time: 00-minute-value” out of the test set. 
 Remove the stopper from one of the breath sample containers (tube or breath bag), 

unwrap the straw and place the straw into the container. 
 Now the patient breathes gently through the straw into the breath sample container. 
 By continuously breathing the patient must pull out the straw and immediately close the 

breath sample container (tube or breath bag) with its stopper. 
(If the breath sample container remains open for more than 30 seconds, the test result 
might be falsified.) 

 Hold the sample tube or breath bag upright and stick the bar-code label marked 
“00-minute-value” on the container. 

4. Fill up the second sample tube (Label “Sampling time: 00-minute-value”) with breath by 
following the same procedure. For infrared analysis, only one breath bag is used. 

5. Now 200 ml of 100 % orange juice or 1 g citric acid in 200 ml water must be drunk by the 
patient without delay. 

6. Now the preparation of the test solution follows: 
 The jar labelled “13C-urea powder” is taken from the test set, opened, and filled up to 

three quarters of its volume with tap water. 
 Close the jar and shake it carefully until all the powder is dissolved. Pour the contents 

into a drinking glass. 
 Fill the 13C-urea jar to the brim with water for a second and third time and add these 

contents to the drinking glass (total volume of tap water should be approximately 30 ml). 
7. This test solution must now be drunk immediately by the patient, and the time of application 

must be noted. 
8. Thirty minutes after administration of the test solution (point 7), collect the 30-minute-value 

samples in the breath sample container (tube or breath bags) (Label “Sampling time: 30-minute-
value”), as described under steps 3 to 4. Use the bar-code labels marked “30-minute-value” for 
these samples. 

9. Put the relevant bar-code label on the data sheet for patient documentation. Finally seal the 
package with the sticker. 



 25 

10. The breath sample containers (tube or breath bags) have to be sent for analysis, to a qualified 
laboratory. 

 
Analysis of breath samples and testing specification for laboratories for infrared analyzer or mass 
spectrometry (IRMS) 
 
Infrared spectroscopy (NDIR) 
 
The breath samples, collected in 100 ml breath bags, are analysed by non-dispersive infrared 
spectrometry (NDIR). 
 
The analysis of the 13C/12C-ratio in carbon dioxide of breath is an integrated part of the diagnostic test 
Helicobacter Test INFAI. The accuracy of the test strongly depends on the quality of the breath 
analysis. The specification of breath analysis parameters like linearity, stability (reference gas 
precision), and precision of measurement are fundamental for the accuracy of the system. 
 
It has to be ensured that the analysis is carried out by a qualified laboratory. It is recommended to 
measure as soon as possible after the breath collection, in any case not later than 4 weeks. 
 
The method validated in the application is as follows: 
 
 Sample preparation for Infrared Spectroscopy (NDIR) 
 
The determination of 13C/12C-ratio in the carbon dioxide of the breath samples is carried out directly in 
the breath. The breath from the bags will be introduced into the NDIR spectrometer using a variable 
gas pump. The water content of the breath sample will be kept mostly constant through Nafion water 
trap. For calibration and measurement necessary CO2-free air (zero-gas) will be produced via an 
integrated CO2-absorber in the analysator. 
 
 Infrared spectroscopic analysis 
 
To analyse the carbon dioxide in breath a broad band infrared radiation bunch emitted by an infrared 
radiation source is alternately sent through the measuring chamber and a reference chamber by means 
of a beam chopper. The modulated infrared beams then enter the infrared detectors, which are double 
layer transmission detectors with a front, and a rear chamber each filled with one of the isotopicly pure 
gases (13CO2 or 12CO2, respectively) to be measured. The infrared radiation in the measuring chamber 
is weakened by the gas component to be measured. Thus the radiation equilibrium between measuring 
and comparative beam is disturbed. In consequence there is a temperature fluctuation, which in its turn 
causes a fluctuating pressure in the front chamber of the infrared detector. A membrane capacitor 
connected with this chamber, which is exposed to a high resistance direct voltage, transforms these 
pressure fluctuations into an alternating voltage, which is a measure of the isotopic composition of 
breath carbon dioxide. 
 
 Sample Inlet 
 
A semi-automatic sample inlet system injects the measuring gas in definite amounts into the zero gas 
circulating in the gas circuit of the infrared spectrometer. This enables measurement of the 
13C/12C-ratio at any CO2 concentration above 1 %. 
 
 Specifications for determining 13C/12C-ratios 
 
The breath test concept is based upon the oral administration of 13C-labelled urea whose enzymatic 
hydrolysis is monitored by measuring 13CO2 in breath using non-dispersive infrared spectrometry. 
 
 Infrared spectrometers for breath analysis must comply with the following specifications: 
 
Multiple replicate analyses: Minimum of 3 replicate analyses of the same sample during operation 



 26 

 
Security access: Storing of operating parameters and of results under security access to 

avoid later manipulation 
 
For verifying the specifications linearity, stability, and precision of measurement have to be tested. 
 
Zero point adjustment of the detectors by means of the zero gas generated in the spectrometer. End-
point adjustment of the detectors by means of calibration gases of precisely known concentration. 
 
Linearity:  0.5 ‰ for breath samples varying between 1 % and 7 % 

CO2-concentration 
 
Stability:  0.3 ‰ at 10 consecutive pulses 
 
Precision of measurement:  0.5 ‰ for 13C at natural abundance using a 100 ml breath bag with 

3 % CO2 breath concentration 
 
Helicobacter pylori infection is present if the difference in 13C/12C of baseline-value and 30-minute-
value exceeds 4.0 ‰. 
 
Alternatively, any other suitable-validated method may be used, carried out by any objectively 
qualified laboratory. 
 
Mass spectrometry (IRMS) 
 
The breath samples, collected in 10 ml glass- or plastic sample tubes, are analysed by isotope ratio 
mass spectrometry (IRMS). 
 
The analysis of the 13C/12C-ratio in carbon dioxide of breath is an integrated part of the diagnostic test 
Helicobacter Test INFAI. The accuracy of the test strongly depends on the quality of the breath 
analysis. The specification of breath analysis parameters like linearity, stability (reference gas 
precision), and precision of measurement are fundamental for the accuracy of the system. 
 
It has to be ensured that the analysis is carried out by a qualified laboratory. The method validated in 
the application is as follows: 
 
 Sample preparation for (IRMS) 
 
To determine the 13C/12C-ratio of carbon dioxide in breath by mass spectrometric analysis the carbon 
dioxide must be separated from the breath and introduced into the mass spectrometer. The automatic 
preparation system for isotope mass spectrometers which is dedicated for breath test analysis is based 
on a gas-chromatographic continuous flow separation technique. 
 
Water is removed from the sample by means of a Nafion water trap or the gas-chromatographic 
preparation system that separates the individual gases in a gas chromatographic column with Helium 
as eluent. Passing the column the separated gas species of breath are detected by an ionisation 
detector. The fraction of carbon dioxide gas, identified by its characteristic retention time, is 
introduced into mass spectrometer. 
 
 Mass spectrometric analysis 
 
To analyse the separated carbon dioxide sample gas its molecules must be ionised, formed into a 
beam, accelerated by an electric field, deflected in a magnetic field, and finally detected. These five 
processes take place in the analyser of a mass spectrometer, which consists of three separate sections: 
the source, flight tube, and collector. Ionisation, beam formation and acceleration all occur in the 
source, magnetic deflection takes place in the flight tube and detection takes place in the collector. 
 



 27 

 Sample inlet 
 
For introduction of the carbon dioxide into the analyser many sample inlet systems are available. For 
breath test analysis the individual balancing of the carbon dioxide of the sample to a reference 
standard gas is essential. This ensures the high accuracy of this system, as calculation of the isotopic 
content in carbon dioxide is done with respect to an independent standard. 
 
 Specifications for determining 13C/12C-ratios  
 
The breath test concept relies on the administration of a specifically 13C-labelled urea whose 
metabolite utilisation is monitored by measuring 13CO2 in the expired breath gas. 
 
 The mass spectrometer must be capable of: 
 
Multiple replicate analyses: Minimum of 3 replicate analyses of the same sample during operation 
 
Security access: Storing of operating parameters and of results under security access to 

avoid later manipulation 
 
Adjustment: 13C/12C-ratio with respect to Pee Dee Beliminate (PDB) 
 
Sample loop: < 200 µl 
 
The principal tests to verify the specifications are linearity, stability (reference gas precision), and 
precision of measurement. 
 
 All mass spectrometers for breath analysis must comply with the following specifications: 
 
Linearity:  0.5 ‰ for breath samples varying between 1 % and 7 % 

CO2-concentration 
 
Stability:  0.2 ‰ on 10 consecutive pulses 
 
Precision of measurement:  0.3 ‰ for 13C at natural abundance using a 10 ml breath sample tube 

with 3 % CO2 breath concentration 
 
Helicobacter pylori infection is present if the difference in 13C/12C of baseline-value and 30-minute-
value exceeds 4.0 ‰. 
 
Alternatively, any other suitable-validated method may be used, carried out by any objectively 
qualified laboratory. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
INFAI GmbH 
Riehler Str. 36 
D-50668 Köln 
Germany 
 
 
8. MARKETING AUTHORISATION NUMBERS 
 
EU/1/97/045/005 
 
 



 28 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 14 August 1997 
Date of latest renewal: 14 August 2007 
 
 
10. DATE OF REVISION OF THE TEXT 
 
 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu. 

  

http://www.ema.europa.eu/


 29 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 
A. MANUFACTURER RESPONSIBLE FOR BATCH 

RELEASE 
 
B. CONDITIONS OR RESTRICTIONS REGARDING 

SUPPLY AND USE 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE 

MARKETING AUTHORISATION 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO 

THE SAFE AND EFFECTIVE USE OF THE MEDICINAL 
PRODUCT 

 



 30 

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturer responsible for batch release 
 
INFAI GmbH 
An der Kohlenbahn 39 
D-58135 Hagen 
Germany 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
Medicinal product subject to medical prescription. 
 
 
C.  OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
 Periodic Safety Update Reports 
 
The marketing authorisation holder shall submit periodic safety update reports for this product 
in accordance with the requirements set out in the list of Union reference dates (EURD list) 
provided for under Article 107c(7) of Directive 2001/83/EC and published on the European 
medicines web-portal. 
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 
 Risk Management Plan (RMP) 
 
Not applicable. 
 
 
 
  



 31 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
  



 32 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 
 
 
  



 33 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON, PACK OF 1 JAR AND 50 JARS 

 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Helicobacter Test INFAI 75 mg powder for oral solution 
13C-urea 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
1 jar containing 75 mg 13C-urea. 
 
 
3. LIST OF EXCIPIENTS 
 
None 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder for oral solution 
 
1 diagnostic test kit contains: 
1 jar containing 75 mg 13C-urea powder for oral solution 
4 containers for breath samples 
1 bendable straw 
Package leaflet 
Data sheet for patient documentation 
Page of labels and sticker 
 
1 diagnostic test kit contains: 
1 jar containing 75 mg 13C-urea powder for oral solution 
2 breath bags for breath samples 
1 bendable straw 
Package leaflet 
Data sheet for patient documentation 
Bar code labels and sticker 
 
1 diagnostic test kit contains: 
50 jars containing 75 mg 13C-urea powder for oral solution 
100 breath bags for breath samples 
50 bendable straws 
50 Package leaflet 
50 Data sheets for patient documentation 
50 Barcode labels and sticker 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use 
 



 34 

For Mass Spectrometry 
 

 
 
For Infrared Spectroscopy 
 

 
 
Please read enclosed instructions for use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP: {MM/YYYY} 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25C. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 



 35 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Marketing Authorisation Holder: 
INFAI GmbH 
Riehler Str. 36 
D-50668 Köln 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
Marketing Authorisation Number: 
EU/1/97/045/001 
EU/1/97/045/002 
EU/1/97/045/004 
 
 
13. BATCH NUMBER 
 
Batch: 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Helicobacter Test INFAI 75 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 
  



 36 

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 
 
INTERMEDIATE CARTON, PACK SIZE 50 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Helicobacter Test INFAI 75 mg powder for oral solution 
13C-urea 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
1 jar containing 75 mg 13C-urea 
 
 
3. LIST OF EXCIPIENTS 
 
None 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder for oral solution 
 
CLINIPAC 50 
 
50 jars containing 75 mg 13C-urea powder for oral solution 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP: {MM/YYYY} 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25C. 
 
 



 37 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
INFAI GmbH 
Riehler Str. 36 
D-50668 Köln 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
Marketing Authorisation Number: 
EU/1/97/045/004 
 
 
13. BATCH NUMBER 
 
Batch: 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Helicobacter Test INFAI 75 mg 
  



 38 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
JAR LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Helicobacter Test INFAI 75 mg powder for oral solution 
13C-urea 
Oral use 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP: {MM/YYYY} 
 
 
4. BATCH NUMBER 
 
Batch: 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
Jar contains 75 mg 13C-rea 
 
 
6. OTHER 
 
Single test 
Powder for oral solution 
Please read enclosed instructions for use. 
Keep out of the sight and reach of children. 
Do not store above 25 °C. 
Medicinal product subject to medical prescription. 
Marketing Authorisation Number: 
EU/1/97/045/001 
EU/1/97/045/002 
 
INFAI GmbH 
Riehler Str. 36 
D-50668 Köln 
Germany 
 



 39 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 

 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Helicobacter Test INFAI for children of the age 3-11 45 mg powder for oral solution 
13C-urea 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
1 jar containing 45 mg 13C-urea. 
 
 
3. LIST OF EXCIPIENTS 
 
None 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder for oral solution 
1 diagnostic test kit contains: 
1 jar containing 45 mg 13C-urea powder for oral solution 
4 containers for breath samples 
1 bendable straw 
Package leaflet 
Data sheet for patient documentation 
Page of labels and sticker 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use 
 
Please read the package leaflet before use. 
 

 
 



 40 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN 

 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP: {MM/YYYY} 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25C. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Marketing Authorisation Holder: 
INFAI GmbH 
Riehler Str. 36 
D-50668 Köln 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
Marketing Authorisation Number: 
EU/1/97/045/003 
 
 
13. BATCH NUMBER 
 
Batch: 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Helicobacter Test INFAI 45 mg 
 



 41 

 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 
  



 42 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
JAR LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Helicobacter Test INFAI for children of the age 3-11 45 mg powder for oral solution 
13C-urea 
Oral use 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP: {MM/YYYY} 
 
 
4. BATCH NUMBER 
 
Batch: 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
Jar contains 45 mg 13C-urea 
 
 
6. OTHER 
 
Single test 
Powder for oral solution 
Please read enclosed instructions for use. 
Keep out of the sight and reach of children. 
Do not store above 25 °C. 
Medicinal product subject to medical prescription. 
Marketing Authorisation Number: 
EU/1/97/045/003 
 
INFAI GmbH 
Riehler Str. 36 
D-50668 Köln 
Germany 
 
  



 43 

MINIMUM PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 
 
BREATH SAMPLE CONTAINERS: GLASS OR PLASTIC 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Helicobacter Test INFAI 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
INFAI GmbH 
Riehler Str. 36 
D-50668 Köln 
Germany 
 
 
3. EXPIRY DATE 
 
 
4. BATCH NUMBER 
 
 
5. OTHER 
 
Breath sample container 
 
00-minute value 
30-minute value 
 
Please stick round barcode label 
  



 44 

MINIMUM PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 
 
PAGE OF LABELS AND STICKERS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Helicobacter Test INFAI 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
INFAI GmbH 
Riehler Str. 36 
D-50668 Köln 
Germany 
 
 
3. EXPIRY DATE 
 
 
4. BATCH NUMBER 
 
 
5. OTHER 
 
Page of labels and sticker 
 
Barcode for data sheet for patient documentation 
 
Seal-Sticker 
 
Barcodes for 00-minute-value 
Barcodes for 30-minute-value 
 
  



 45 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON, PACK SIZE 50 

 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Helicobacter Test INFAI 75 mg powder for oral solution 
13C-urea 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
1 jar containing 75 mg 13C-urea. 
 
 
3. LIST OF EXCIPIENTS 
 
None 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder for oral solution 
 
CLINIPAC BASIC 
 
50 jars containing 75 mg 13C-urea powder for oral solution 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use 
 
Please read enclosed instructions for use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP: {MM/YYYY} 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25C. 
 
 



 46 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Marketing Authorisation Holder: 
INFAI GmbH 
Riehler Str. 36 
D-50668 Köln 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
Marketing Authorisation Number: 
EU/1/97/045/005 
 
 
13. BATCH NUMBER 
 
Batch: 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Helicobacter Test INFAI 75 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 
  



 47 

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 
 
INTERMEDIATE CARTON, PACK SIZE 50 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Helicobacter Test INFAI 75 mg powder for oral solution 
13C-urea 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
1 jar containing 75 mg 13C-urea 
 
 
3. LIST OF EXCIPIENTS 
 
None 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder for oral solution 
 
CLINIPAC BASIC 
 
50 jars containing 75 mg 13C-urea powder for oral solution 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP: {MM/YYYY} 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25C. 
 
 



 48 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
INFAI GmbH 
Riehler Str. 36 
D-50668 Köln 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
Marketing Authorisation Number: 
EU/1/97/045/005 
 
 
13. BATCH NUMBER 
 
Batch: 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Helicobacter Test INFAI 75 mg 
  



 49 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
JAR LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Helicobacter Test INFAI 75 mg powder for oral solution 
13C-urea 
Oral use 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP: {MM/YYYY} 
 
 
4. BATCH NUMBER 
 
Batch: 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
Jar contains 75 mg 13C-urea 
 
 
6. OTHER 
 
Single test 
Powder for oral solution 
Please read enclosed instructions for use. 
Keep out of the sight and reach of children. 
Do not store above 25 °C. 
Medicinal product subject to medical prescription. 
Marketing Authorisation Number: 
EU/1/97/045/005 
 
INFAI GmbH 
Riehler Str. 36 
D-50668 Köln 
Germany 
 
 
  



 50 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 



 51 

Package leaflet: Information for the user 
 

Helicobacter Test INFAI 75 mg powder for oral solution 
13C-urea 

 
Read all of this leaflet carefully before you start taking this medicine because it contains 
important information for you. 
 Keep this leaflet. You may need to read it again. 
 If you have any further questions, ask your doctor or pharmacist. 
 This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
 If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet: 
1. What Helicobacter Test INFAI is and what it is used for 
2. What you need to know before you take Helicobacter Test INFAI  
3. How to take Helicobacter Test INFAI  
4. Possible side effects 
5 How to store Helicobacter Test INFAI  
6. Contents of the pack and other information 
 
 
1. What Helicobacter Test INFAI is and what it is used for 
 
Helicobacter Test INFAI is for diagnostic use only. It is a breath test for adolescents from the age 
of 12 and adults to determine the presence of bacterium Helicobacter pylori in the stomach. 
 
Why do you need to take the Helicobacter Test INFAI? 
You may have a gastric infection caused by a bacterium called Helicobacter pylori. Your doctor has 
recommended that you have a Helicobacter Test INFAI for one of the following reasons: 
 

 Your doctor wants to confirm whether you are suffering from Helicobacter pylori infection to 
help diagnose your condition. 

 
 You have already been determined as being infected with Helicobacter pylori and have been 

taking medication aimed to clear up the infection. Your doctor now wishes to find out if the 
treatment has been successful. 

 
How does the test work? 
All foods contain a substance called carbon-13 (13C). This carbon-13 can be detected in the carbon 
dioxide you breathe out of your lungs. The actual amount of carbon-13 in the breath will depend on 
the kind of food that you have eaten. 
 
You will be asked to drink the “test meal”. Following the meal, samples of your breath will be taken. 
See “Special instructions for use”. These samples will be analysed to measure the “normal” amount of 
carbon-13 content in the carbon dioxide in your breath. 
 
You will then be asked to drink a solution of carbon-13-urea. Further samples of your breath will then 
be taken 30 minutes later and the amount of carbon-13 in the samples measured as before. The results 
will be compared and a significant increase in the amount of carbon-13 in the second set of samples 
will suggest to your doctor that Helicobacter pylori is present. 
 
 



 52 

2. What you need to know before you take Helicobacter Test INFAI 
 
Do not take Helicobacter Test INFAI 
 if you have or suspect that you have a stomach infection or a certain inflammation of the 

stomach lining (atrophic gastritis). 
This inflammation of the stomach lining may cause incorrect positive results of your breath test. 
Further investigations may be required to confirm the presence of Helicobacter pylori. 

 
Warnings and precautions 
Talk to your doctor or pharmacist before taking Helicobacter Test INFAI if you have any condition 
that can affect or be affected by the test. 
 
Even if the result of Helicobacter Test INFAI is positive, further tests might be necessary before a 
treatment of a Helicobacter pylori infection may be started. These are required to check for the 
presence of any other complications, such as: 
 stomach ulcer 
 inflammation of the stomach lining caused by immune system 
 tumours 
 
There is insufficient data on the reliability of the Helicobacter Test INFAI for recommending its use in 
patients with removal of parts of the stomach. 
 
If the patient vomits during the test procedure, repetition of the test is necessary. This should be done 
in fasted condition and not before the following day. 
 
Other medicines and Helicobacter Test INFAI 
Helicobacter Test INFAI is influenced by medicines influencing  
 Helicobacter pylori (see section 3, second paragraph under “Method of use”) 
 the enzyme urease, which stimulate the reduction of urea 
 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. 
 
Pregnancy and breast-feeding 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor or pharmacist for advice before taking this medicine. 
 
It is not expected that performing the breath test during pregnancy and lactation has a damaging effect. 
 
Driving and using machines 
Helicobacter Test INFAI has no influence on the ability to drive or to use machines. 
 
 
3. How to take Helicobacter Test INFAI 
 
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist 
if you are not sure. 
 
You should perform the test in the presence of your doctor or another qualified person. 
 
The recommended dose is 
Patients from the age of 12 must take the content of one jar for one test. 
 
Method of use 
You must have fasted for 6 hours before application, preferably overnight. Ask your doctor, if fasting 
is a problem, for example for diabetic patients. 
 



 53 

The test procedure lasts approximately 40 minutes. 
 
The test should be performed following at least: 
 4 weeks after a therapy against a bacterial infection  
 2 weeks after the last administration of a medicine to reduce release of stomach acid 
Both groups of medicines could influence the results of the Helicobacter Test INFAI. This is 
particularly after a therapy to remove Helicobacter pylori. It is important to follow the instructions for 
use exactly, otherwise the result may be questionable. 
 
Essential items not supplied with Helicobacter Test INFAI 
Before the breath test is performed a liquid test meal is taken to delay the stomach from emptying. The 
test meal is not provided within the kit. The following are suitable test meals: 
 200 ml 100 % orange juice or 
 1 g citric acid dissolved in 200 ml water 
If you cannot take either of these test meals, please tell your doctor, who will suggest an alternative. A 
drinking vessel and tap water is required to dissolve the 13C-urea powder. If the test needs to be 
repeated, this should be done on the following day at the earliest. 
 
Special instructions for use (for mass spectrometry) 
The test is to be performed after instruction by a healthcare professional and under appropriate 
medical supervision. The patient data should be documented using the provided data sheet. It is 
recommended that you take the test in a resting position. 
 
1. The test should be carried out after having fasted 6 hours before application, preferably 

overnight. If the test needs to be carried out later in the day, only a light meal like tea and toast 
is recommended. 

2. The test begins with the collection of samples for determining the baseline values: 
 The straw and sample tubes labelled “sampling time: 00-minute-value” are taken from the 

test set. 
 The stopper is removed from one of the sample containers and place the unwrapped straw 

into the container. 
 Now the patient breathes gently through the straw into the sample tube until the inside of 

the sample tube steams up. 
 The patient must continue to breathe through the straw while removing it from the sample 

tube, and then immediately seal the tube with its stopper. 
If the sample tube remains open for more than 30 seconds, the result could be inaccurate. 

 The sample container should be held upright and the bar-code label marked “00-minute-
value” will be stuck round the sample container so that the lines of the bar code are 
horizontal. 

3. Now the second sample container (labelled “sampling time: 00-minute-value”) has to be filled 
up with breath in the same way as described above. 

4. Then the patient must drink the recommended test meal (200 ml 100 % orange juice or 1 g citric 
acid in 200 ml water). 

5. Now the preparation of the test solution follows. 
 The jar labelled “13C-urea powder” is removed from the test set, opened, and filled up to 

about three quarters with tap water. 
 The jar is closed and carefully shaken until all the powder has dissolved completely. 
 The contents are poured into a drinking glass, the jar filled a second and third time with 

water and the contents transferred into the drinking glass, so that approximately 30 ml of 
test solution is obtained. 

6. The patient should drink this test solution immediately. The time of intake must be noted. 
7. 30 minutes after the test solution has been taken (point 6), the “30-minute-value” samples are 

collected in both containers, which remain in the pack (labelled “sampling time: 30-minute-
value”) as described under points 2 and 3. 
The bar-code labels marked “30-minute-value” must be used for these samples. 



 54 

8. The corresponding bar-code label must be put on the data sheet for patient documentation. All 
breath sample containers should be placed back into the original packaging. This packaging 
should be sealed with the remaining sticker. 

9. The package must be sent to a qualified laboratory for analysis. 
 
Medical or healthcare professionals can find detailed information on the analysis of breath samples and 
the testing specifications for laboratories, in section 6.6 of the Summary of Product Characteristics. 
 
If you take more Helicobacter Test INFAI than you should 
Because only 75 mg 13C-urea is provided overdose is not to be expected. 
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
No side effects are known. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly 
via the national reporting system listed in Appendix V. By reporting side effects you can help provide 
more information on the safety of this medicine. 
 
 
5. How to store Helicobacter Test INFAI 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The 
expiry date refers to the last day of that month. 
 
Do not store above 25C. 
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away  medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Helicobacter Test INFAI contains 
 The active substance is 13C-urea. 

One jar contains 75 mg 13C-urea. 
 There are no other ingredients. 
 
What Helicobacter Test INFAI looks like and contents of the pack 
Helicobacter Test INFAI is a white, crystalline powder for oral solution. 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


 55 

Content of the test kit: 
 

No. Component Quantity 

1 
Jar (10 ml volume, polystyrene with polyethylene snap cap) 
containing 75 mg 13C-urea powder for oral solution 1 

2 

Labelled sample glass- or plastic- containers for sampling, storing 
and transporting the breath samples for analysis: 
Sampling time: 00-minute-value 
Sampling time: 30-minute-value 

 
 
2 
2 

3 Bendable straw for collection of the breath samples into the 
corresponding sample containers 1 

4 Data sheet for patient documentation 1 
5 Package leaflet 1 
6 Page of barcode labels and sticker 1 

 
Marketing Authorisation Holder 
INFAI GmbH 
Riehler Str. 36 
D-50668 Köln 
Germany 
 
Manufacturer responsible for batch release 
INFAI GmbH 
An der Kohlenbahn 39 
D-58135 Hagen 
Germany 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
AT, BE, BG, CZ, DE, DK, EE, ES, FI, IS, IT, LT, LU, LV, MT, NL, NO, RO, SE 
INFAI GmbH, Tel / Tél / Teл. / Τηλ / Puh / Sími / Tlf.: +49 221 880 443 
Deutschland / Allemagne / Германия / Německo / Tyskland / Saksamaa / Alemania / Saksa / 
Þýskaland / Germania / Vokietija / Vācija / Il-Ġermanja / Duitsland 
CY, EL ANGELINI PHARMA HELLAS SA, Τηλ: +30 210 626 9200, Ελλάδα 
FR INFAI FRANCE SARL, Tél: +33 389 2043 82 
HR Pliva Hrvatska d.o.o, Tel: + 385 1 3720 000 
IE, UK INFAI UK Ltd., Tel: +44 1904 435 228, United Kingdom 
PL Dr Piktel Medic@l Systems, Tel: +48 85 744 7770 
PT Sermail – Logística Integrada Lda., Tel: +351 21 973 9120 
SL PLIVA LJUBLJANA d.o.o., Tel: +386 1 5890 390 
HU, SK ALLMEDICAL s.r.o, Tel: +421 903 654 103, Szlovákia / Slovenská republika 
 
This leaflet was last revised in MM/YYYY. 
 
Detailed information on this medicine is available on the European Medicines Agency website: 
http://www.ema.europa.eu. 
 
  

http://www.ema.europa.eu/


 56 

MINIMUM PARTICULARS TO APPEAR ON 
 
DATA SHEET FOR PATIENT DOCUMENTATION 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Helicobacter Test INFAI 
 
 
2. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
INFAI GmbH 
Riehler Str. 36 
D-50668 Köln 
Germany 
 
 
3. EXPIRY DATE 
 
 
4. BATCH NUMBER 
 
 
5. OTHER 
 
Date of test 
 
Patient ID 
 
Date of birth 
 
Barcode 
 
Doctor/Hospital Address 
 



 57 

Package leaflet: Information for the user 
 

Helicobacter Test INFAI 75 mg powder for oral solution 
13C-urea 

 
Read all of this leaflet carefully before you start taking this medicine because it contains 
important information for you. 
 Keep this leaflet. You may need to read it again. 
 If you have any further questions, ask your doctor or pharmacist. 
 This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
 If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet: 
1. What Helicobacter Test INFAI is and what it is used for 
2. What you need to know before you take Helicobacter Test INFAI 
3. How to take Helicobacter Test INFAI 
4. Possible side effects 
5 How to store Helicobacter Test INFAI 
6. Contents of the pack and other information 
 
 
1. What Helicobacter Test INFAI is and what it is used for 
 
Helicobacter Test INFAI is for diagnostic use only. It is a breath test for adolescents from the age 
of 12 and adults to determine the presence of bacterium Helicobacter pylori in the stomach. 
 
Why do you need to take the Helicobacter Test INFAI? 
You may have a gastric infection caused by a bacterium called Helicobacter pylori. Your doctor has 
recommended that you have a Helicobacter Test INFAI for one of the following reasons: 
 

 Your doctor wants to confirm whether you are suffering from Helicobacter pylori infection to 
help diagnose your condition. 

 
 You have already been determined as being infected with Helicobacter pylori and have been 

taking medication aimed to clear up the infection. Your doctor now wishes to find out if the 
treatment has been successful. 

 
How does the test work? 
All foods contain a substance called carbon-13 (13C). This carbon-13 can be detected in the carbon 
dioxide you breathe out of your lungs. The actual amount of carbon-13 in the breath will depend on 
the kind of food that you have eaten. 
 
You will be asked to drink the “test meal”. Following the meal, samples of your breath will be taken. 
See “Special instructions for use”. These samples will be analysed to measure the “normal” amount of 
carbon-13 content in the carbon dioxide in your breath. 
 
You will then be asked to drink a solution of carbon-13-urea. Further samples of your breath will then 
be taken 30 minutes later and the amount of carbon-13 in the samples measured as before. The results 
will be compared and a significant increase in the amount of carbon-13 in the second set of samples 
will suggest to your doctor that Helicobacter pylori is present. 
 
 



 58 

2. What you need to know before you take Helicobacter Test INFAI 
 
Do not take Helicobacter Test INFAI 
 if you have or suspect that you have a stomach infection or a certain inflammation of the 

stomach lining (atrophic gastritis). 
This inflammation of the stomach lining may cause incorrect positive results of your breath test. 
Further investigations may be required to confirm the presence of Helicobacter pylori. 

 
Warnings and precautions 
Talk to your doctor or pharmacist before taking Helicobacter Test INFAI if you have any condition 
that can affect or be affected by the test. 
 
Even if the result of Helicobacter Test INFAI is positive, further tests might be necessary before a 
treatment of a Helicobacter pylori infection may be started. These are required to check for the 
presence of any other complications, such as: 
 stomach ulcer 
 inflammation of the stomach lining caused by immune system 
 tumours 
 
There is insufficient data on the reliability of the Helicobacter Test INFAI for recommending its use in 
patients with removal of parts of the stomach. 
 
If the patient vomits during the test procedure, repetition of the test is necessary. This should be done 
in fasted condition and not before the following day. 
 
Other medicines and Helicobacter Test INFAI 
Helicobacter Test INFAI is influenced by medicines influencing 
 Helicobacter pylori (see section 3, second paragraph under “Method of use”) 
 the enzyme urease, which stimulate the reduction of urea 
 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. 
 
Pregnancy and breast-feeding 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor or pharmacist for advice before taking this medicine. 
 
It is not expected that performing the breath test during pregnancy and lactation has a damaging effect. 
 
Driving and using machines 
Helicobacter Test INFAI has no influence on the ability to drive or to use machines. 
 
 
3. How to take Helicobacter Test INFAI 
 
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist 
if you are not sure. 
 
You should perform the test in the presence of your doctor or another qualified person. 
 

The recommended dose is 
Patients from the age of 12 must take the content of one jar for one test. 
 
Method of use 
You must have fasted for 6 hours before application, preferably overnight. Ask your doctor, if fasting 
is a problem, for example for diabetic patients. 
 



 59 

The test procedure lasts approximately 40 minutes. 
 
The test should be performed following at least: 
 4 weeks after a therapy against a bacterial infection  
 2 weeks after the last administration of a medicine to reduce release of stomach acid 
Both groups of medicines could influence the results of the Helicobacter Test INFAI. This is 
particularly after a therapy to remove Helicobacter pylori. It is important to follow the instructions for 
use exactly, otherwise the result may be questionable. 
 
Essential items not supplied with Helicobacter Test INFAI 
Before the breath test is performed a liquid test meal is taken to delay the stomach from emptying. The 
test meal is not provided within the kit. The following are suitable test meals: 
 200 ml 100 % orange juice or 
 1 g citric acid dissolved in 200 ml water 
If you cannot take either of these test meals, please tell your doctor, who will suggest an alternative. A 
drinking vessel and tap water is required to dissolve the 13C-urea powder. If the test needs to be 
repeated, this should be done on the following day at the earliest. 
 
Special instructions for use (for infrared spectroscopy) 
The test is to be performed after instruction by a healthcare professional and under appropriate 
medical supervision. The patient data should be documented using the provided data sheet. It is 
recommended that you take the test in a resting position. 
 
1. The test should be carried out after having fasted 6 hours before application, preferably 

overnight. If the test needs to be carried out later in the day, only a light meal like tea and toast 
is recommended. 

2. The test begins with the collection of samples for determining the baseline values: 
 The straw and the breath bag labelled “sampling time: 00-minute-value” are taken from 

the test set. 
 The stopper is removed from the breath bag and place the unwrapped straw into the 

breath bag. 
 Now the patient breathes gently through the straw into the breath bag. 
 The patient must continue to breathe through the straw while removing it from the breath 

bag, and then immediately seal the breath bag with its stopper. 
If the breath bag remains open for more than 30 seconds, the result could be inaccurate. 

 The breath bag should be held upright and the bar-code label marked “00-minute-value” 
will be stuck on the breath bag. 

3. Then the patient must drink the recommended test meal (200 ml 100 % orange juice or 1 g citric 
acid in 200 ml water). 

4. Now the preparation of the test solution follows. 
 The jar labelled “13C-urea powder” is removed from the test set, opened, and filled up to 

about three quarters with tap water. 
 The jar is closed and carefully shaken until all the powder has dissolved completely. 
 The contents are poured into a drinking glass, the jar filled a second and third time with 

water and the contents transferred into the drinking glass, so that approximately 30 ml of 
test solution is obtained. 

5. The patient should drink this test solution immediately. The time of intake must be noted. 
6. 30 minutes after the test solution has been taken (point 5), the “30-minute-value” sample is 

collected in the breath bag, which remains in the pack (labelled “sampling time: 30-minute-
value”) as described under point 2. 
The bar-code label marked “30-minute-value” must be used for this sample. 

7. The corresponding bar-code label must be put on the data sheet for patient documentation. All 
breath bags should be placed back into the original packaging. This packaging should be sealed 
with the remaining sticker. 

8. The package must be sent to a qualified laboratory for analysis. 
 



 60 

Medical or healthcare professionals can find detailed information on the analysis of breath samples and 
the testing specifications for laboratories, in section 6.6 of the Summary of Product Characteristics. 
 
If you take more Helicobacter Test INFAI than you should 
Because only 75 mg 13C-urea is provided overdose is not to be expected. 
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
No side effects are known. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly 
via the national reporting system listed in Appendix V. By reporting side effects you can help provide 
more information on the safety of this medicine. 
 
 
5. How to store Helicobacter Test INFAI 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The 
expiry date refers to the last day of that month. 
 
Do not store above 25C. 
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Helicobacter Test INFAI contains 
 The active substance is 13C-urea. 

One jar contains 75 mg 13C-urea. 
 There are no other ingredients. 
 
What Helicobacter Test INFAI looks like and contents of the pack 
Helicobacter Test INFAI is a white, crystalline powder for oral solution. 
 
Content of the test kit with 1 jar: 
 

No. Component Quantity 

1 
Jar (10 ml volume, polystyrene with polyethylene snap cap) 
containing 75 mg 13C-urea powder for oral solution 1 

2 
Breath bags: 
Sampling time: 00-minute-value 
Sampling time: 30-minute-value 

 
1 
1 

3 Bendable straw for collection of the breath samples into the corresponding breath bags 1 

4 Data sheet for patient documentation 1 
5 Package leaflet 1 
6 Page of barcode labels and sticker 1 

 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


 61 

Content of the test kit with 50 jars: 
 

No. Component Quantity 

1 
Jar (10 ml volume, polystyrene with polyethylene snap cap) 
containing 75 mg 13C-urea powder for oral solution 50 

2 
Breath bags: 
Sampling time: 00-minute-value 
Sampling time: 30-minute-value 

 
50 
50 

3 Bendable straw for collection of the breath samples into the corresponding breath bags 50 

4 Data sheet for patient documentation 50 
5 Package leaflet 50 
6 Page of barcode labels and sticker 50 

 
Marketing Authorisation Holder 
INFAI GmbH 
Riehler Str. 36 
D-50668 Köln 
Germany 
 
Manufacturer responsible for batch release 
INFAI GmbH 
An der Kohlenbahn 39 
D-58135 Hagen 
Germany 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
AT, BE, BG, CZ, DE, DK, EE, ES, FI, IS, IT, LT, LU, LV, MT, NL, NO, RO, SE 
INFAI GmbH, Tel / Tél / Teл. / Τηλ / Puh / Sími / Tlf.: +49 221 880 443 
Deutschland / Allemagne / Германия / Německo / Tyskland / Saksamaa / Alemania / Saksa / 
Þýskaland / Germania / Vokietija / Vācija / Il-Ġermanja / Duitsland 
CY, EL ANGELINI PHARMA HELLAS SA, Τηλ: +30 210 626 9200, Ελλάδα 
FR INFAI FRANCE SARL, Tél: +33 389 2043 82 
HR Pliva Hrvatska d.o.o, Tel: + 385 1 3720 000 
IE, UK INFAI UK Ltd., Tel: +44 1904 435 228, United Kingdom 
PL Dr Piktel Medic@l Systems, Tel: +48 85 744 7770 
PT Sermail – Logística Integrada Lda., Tel: +351 21 973 9120 
SL PLIVA LJUBLJANA d.o.o., Tel: +386 1 5890 390 
HU, SK ALLMEDICAL s.r.o, Tel: +421 903 654 103, Szlovákia / Slovenská republika 
 
This leaflet was last revised in MM/YYYY. 
 
Detailed information on this medicine is available on the European Medicines Agency website: 
http://www.ema.europa.eu. 
 
  

http://www.ema.europa.eu/


 62 

MINIMUM PARTICULARS TO APPEAR ON 
 
DATA SHEET FOR PATIENT DOCUMENTATION 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Helicobacter Test INFAI 
 
 
2. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
INFAI GmbH 
Riehler Str. 36 
D-50668 Köln 
Germany 
 
 
3. EXPIRY DATE 
 
 
4. BATCH NUMBER 
 
 
5. OTHER 
 
Date of test 
 
Patient ID 
 
Date of birth 
 
Barcode 
 
Doctor/Hospital Address 
 



 63 

Package leaflet: Information for the user 
 

Helicobacter Test INFAI for children of the age 3-11 45 mg powder for oral solution 
13C-urea 

 
Read all of this leaflet carefully before you start taking this medicine because it contains 
important information for you. 
 Keep this leaflet. You may need to read it again. 
 If you have any further questions, ask your doctor or pharmacist. 
 This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
 If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet: 
1. What Helicobacter Test INFAI for children of the age 3-11 is and what it is used for 
2. What you need to know before you take Helicobacter Test INFAI for children of the age 3-11 
3. How to take Helicobacter Test INFAI for children of the age 3-11 
4. Possible side effects 
5 How to store Helicobacter Test INFAI for children of the age 3-11 
6. Contents of the pack and other information 
 
 
1. What Helicobacter Test INFAI for children of the age 3 to 11 is and what it is used for 
 
Helicobacter Test INFAI for children of the age 3-11 is for diagnostic use only. It is a breath test for 
children aged 3-11 years to determine the presence of bacterium Helicobacter pylori in the 
stomach or duodenum. 
 
Why do you need to take the Helicobacter Test INFAI for children of the age 3-11? 
You may have a gastric or duodenum infection caused by a bacterium called Helicobacter pylori. Your 
doctor has recommended that you have a Helicobacter Test INFAI for children of the age 3-11 for one 
of the following reasons: 
 

 Your doctor wants to confirm whether you are suffering from Helicobacter pylori infection to 
help diagnose your condition. 

 
 You have already been determined as being infected with Helicobacter pylori and have been 

taking medication aimed to clear up the infection. Your doctor now wishes to find out if the 
treatment has been successful. 

 
How does the test work? 
All foods contain a substance called carbon-13 (13C). This carbon-13 can be detected in the carbon 
dioxide you breathe out of your lungs. The actual amount of carbon-13 in the breath will depend on 
the kind of food that you have eaten. 
 
You will be asked to drink the “test meal”. Following the meal, samples of your breath will be taken. 
See “Special instructions for use”. These samples will be analysed to measure the “normal” amount of 
carbon-13 content in the carbon dioxide in your breath. 
 
You will then be asked to drink a solution of carbon-13-urea. Further samples of your breath will then 
be taken 30 minutes later and the amount of carbon-13 in the samples measured as before. The results 
will be compared and a significant increase in the amount of carbon-13 in the second set of samples 
will suggest to your doctor that Helicobacter pylori is present. 
 
 



 64 

2. What you need to know before you take Helicobacter Test INFAI for children of the 
age 3-11 

 
Do not take Helicobacter Test INFAI for children of the age 3-11 
 if you have or suspect that you have a stomach infection or a certain inflammation of the 

stomach lining (atrophic gastritis). 
This inflammation of the stomach lining may cause incorrect positive results of your breath test. 
Further investigations may be required to confirm the presence of Helicobacter pylori. 

 
Warnings and precautions 
Talk to your doctor or pharmacist before taking Helicobacter Test INFAI for children of the age 3-11 
if you have any condition that can affect or be affected by the test. 
 
Even if the result of Helicobacter Test INFAI for children of the age 3-11 is positive, further tests 
might be necessary before a treatment of a Helicobacter pylori infection may be started. These are 
required to check for the presence of any other complications, such as: 
 stomach ulcer 
 inflammation of the stomach lining caused by immune system 
 tumours 
 
There is insufficient data on the reliability of the Helicobacter Test INFAI for children of the age 3-11 
for recommending its use in patients with removal of parts of the stomach. 
 
If the patient vomits during the test procedure, repetition of the test is necessary. This should be done 
in fasted condition and not before the following day. 
 
Other medicines and Helicobacter Test INFAI for children of the age 3-11 
Helicobacter Test INFAI for children of the age 3-11 is influenced by medicines influencing 
 Helicobacter pylori (see section 3, second paragraph under “Method of use”) 
 the enzyme urease, which stimulate the reduction of urea 
 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. 
 
 
3. How to take Helicobacter Test INFAI for children of the age 3-11 
 
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist 
if you are not sure. 
 
You should perform the test in the presence of your doctor or another qualified person. 
 
The recommended dose is 
Children aged 3-11 years must take the content of one jar for one test. 
 
Method of use 
You must have fasted for 6 hours before application, preferably overnight. Ask your doctor, if fasting 
is a problem, for example for diabetic patients. 
 
The test procedure lasts approximately 40 minutes. 
 
The test should be performed following at least: 
 4 weeks after a therapy against a bacterial infection  
 2 weeks after the last administration of a medicine to reduce release of stomach acid 



 65 

Both groups of medicines could influence the results of the Helicobacter Test INFAI for children of 
the age 3-11. This is particularly after a therapy to remove Helicobacter pylori. It is important to 
follow the instructions for use exactly, otherwise the result may be questionable. 
 
Essential items not supplied with Helicobacter Test INFAI for children of the age 3-11 
Before the breath test is performed a liquid test meal is taken to delay the stomach from emptying. The 
test meal is not provided within the kit. The following is a suitable test meal: 
 100 ml 100 % orange juice 
If you cannot take this test meal, please tell your doctor, who will suggest an alternative. A drinking 
vessel and tap water is required to dissolve the 13C-urea powder. If the test needs to be repeated, this 
should be done on the following day at the earliest. 
 
Special instructions for use (for mass spectrometry) 
The test is to be performed after instruction by a healthcare professional and under appropriate 
medical supervision. The patient data should be documented using the provided data sheet. It is 
recommended that you take the test in a resting position. 
 
1. The test should be carried out after having fasted 6 hours before application, preferably 

overnight. If the test needs to be carried out later in the day, only a light meal like tea and toast 
is recommended. 

2. The test begins with the collection of samples for determining the baseline values: 
 The straw and sample tubes labelled “sampling time: 00-minute-value” are taken from the 

test set. 
 The stopper is removed from one of the sample containers and place the unwrapped straw 

into the container. 
 Now the patient breathes gently through the straw into the sample tube until the inside of 

the sample tube steams up. 
 The patient must continue to breathe through the straw while removing it from the sample 

tube, and then immediately seal the tube with its stopper. 
If the sample tube remains open for more than 30 seconds, the result could be inaccurate. 

 The sample container should be held upright and the bar-code label marked “00-minute-
value” will be stuck round the sample container so that the lines of the bar code are 
horizontal. 

3. Now the second sample container (labelled “sampling time: 00-minute-value”) has to be filled 
up with breath in the same way as described above. 

4. Then the patient must drink the recommended test meal (100 ml 100 % orange juice). 
5. Now the preparation of the test solution follows. 

 The jar labelled “13C-urea powder” is removed from the test set, opened, and filled up to 
about three quarters with tap water. 

 The jar is closed and carefully shaken until all the powder has dissolved completely. 
 The contents are poured into a drinking glass, the jar filled a second and third time with 

water and the contents transferred into the drinking glass, so that approximately 30 ml of 
test solution is obtained. 

6. The patient should drink this test solution immediately. The time of intake must be noted. 
7. 30 minutes after the test solution has been taken (point 6), the “30-minute-value” samples are 

collected in both containers, which remain in the pack (labelled “sampling time: 30-minute-
value”) as described under points 2 and 3. 
The bar-code labels marked “30-minute-value” must be used for these samples. 

8. The corresponding bar-code label must be put on the data sheet for patient documentation. All 
breath sample containers should be placed back into the original packaging. This packaging 
should be sealed with the remaining sticker. 

9. The package must be sent to a qualified laboratory for analysis. 
 
Medical or healthcare professionals can find detailed information on the analysis of breath samples and 
the testing specifications for laboratories, in section 6.6 of the Summary of Product Characteristics. 
 



 66 

If you take more Helicobacter Test INFAI for children of the age 3-11 than you should 
Because only 45 mg 13C-urea is provided overdose is not to be expected. 
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
No side effects are known. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly 
via the national reporting system listed in Appendix V. By reporting side effects you can help provide 
more information on the safety of this medicine. 
 
 
5. How to store Helicobacter Test INFAI for children of the age 3-11 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The 
expiry date refers to the last day of that month. 
 
Do not store above 25C. 
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Helicobacter Test INFAI for children of the age 3-11contains 
 The active substance is 13C-urea. 

One jar contains 45 mg 13C-urea. 
 There are no other ingredients. 
 
What Helicobacter Test INFAI for children of the age 3-11 looks like and contents of the pack 
Helicobacter Test INFAI for children of the age 3-11 is a white, crystalline powder for oral solution. 
 
Content of the test kit: 
 

No. Component Quantity 

1 
Jar (10 ml volume, polystyrene with polyethylene snap cap) 
containing 45 mg 13C-urea powder for oral solution 1 

2 

Labelled sample glass- or plastic containers for sampling, storing 
and transporting the breath samples for analysis: 
Sampling time: 00-minute-value 
Sampling time: 30-minute-value 

 
 
2 
2 

3 Bendable straw for collection of the breath samples into the corresponding sample containers 1 

4 Data sheet for patient documentation 1 
5 Package leaflet 1 
6 Page of barcode labels and sticker 1 

 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


 67 

Marketing Authorisation Holder 
INFAI GmbH 
Riehler Str. 36 
D-50668 Köln 
Germany 
 
Manufacturer responsible for batch release 
INFAI GmbH 
An der Kohlenbahn 39 
D-58135 Hagen 
Germany 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
AT, BE, BG, CZ, DE, DK, EE, ES, FI, IS, IT, LT, LU, LV, MT, NL, NO, RO, SE 
INFAI GmbH, Tel / Tél / Teл. / Τηλ / Puh / Sími / Tlf.: +49 221 880 443 
Deutschland / Allemagne / Германия / Německo / Tyskland / Saksamaa / Alemania / Saksa / 
Þýskaland / Germania / Vokietija / Vācija / Il-Ġermanja / Duitsland 
CY, EL ANGELINI PHARMA HELLAS SA, Τηλ: +30 210 626 9200, Ελλάδα 
FR INFAI FRANCE SARL, Tél: +33 389 2043 82 
HR Pliva Hrvatska d.o.o, Tel: + 385 1 3720 000 
IE, UK INFAI UK Ltd., Tel: +44 1904 435 228, United Kingdom 
PL Dr Piktel Medic@l Systems, Tel: +48 85 744 7770 
PT Sermail – Logística Integrada Lda., Tel: +351 21 973 9120 
SL PLIVA LJUBLJANA d.o.o., Tel: +386 1 5890 390 
HU, SK ALLMEDICAL s.r.o, Tel: +421 903 654 103, Szlovákia / Slovenská republika 
 
This leaflet was last revised in MM/YYYY. 
 
Detailed information on this medicine is available on the European Medicines Agency website: 
http://www.ema.europa.eu. 
 
  

http://www.ema.europa.eu/


 68 

MINIMUM PARTICULARS TO APPEAR ON 
 
DATA SHEET FOR PATIENT DOCUMENTATION 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Helicobacter Test INFAI 
 
 
2. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
INFAI GmbH 
Riehler Str. 36 
D-50668 Köln 
Germany 
 
 
3. EXPIRY DATE 
 
 
4. BATCH NUMBER 
 
 
5. OTHER 
 
Date of test 
 
Patient ID 
 
Date of birth 
 
Barcode 
 
Doctor/Hospital Address 
 
 



 69 

Package leaflet: Information for the user 
 

Helicobacter Test INFAI 75 mg powder for oral solution 
CliniPac Basic 

without breath sample containers 
13C-urea 

 
Read all of this leaflet carefully before you start taking this medicine because it contains 
important information for you. 
 Keep this leaflet. You may need to read it again. 
 If you have any further questions, ask your doctor or pharmacist. 
 This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
 If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet: 
1. What Helicobacter Test INFAI is and what it is used for 
2. What you need to know before you take Helicobacter Test INFAI 
3. How to take Helicobacter Test INFAI 
4. Possible side effects 
5 How to store Helicobacter Test INFAI 
6. Contents of the pack and other information 
 
 
1. What Helicobacter Test INFAI is and what it is used for 
 
Helicobacter Test INFAI is for diagnostic use only.  It is a breath test for adolescents from the age 
of 12 and adults to determine the presence of bacterium Helicobacter pylori in the stomach. 
 
Why do you need to take the Helicobacter Test INFAI? 
You may have a gastric infection caused by a bacterium called Helicobacter pylori. Your doctor has 
recommended that you have a Helicobacter Test INFAI for one of the following reasons: 
 

 Your doctor wants to confirm whether you are suffering from Helicobacter pylori infection to 
help diagnose your condition. 

 
 You have already been determined as being infected with Helicobacter pylori and have been 

taking medication aimed to clear up the infection. Your doctor now wishes to find out if the 
treatment has been successful. 

 
How does the test work? 
All foods contain a substance called carbon-13 (13C). This carbon-13 can be detected in the carbon 
dioxide you breathe out of your lungs. The actual amount of carbon-13 in the breath will depend on 
the kind of food that you have eaten. 
 
You will be asked to drink the “test meal”. Following the meal, samples of your breath will be taken. 
See “Special instructions for use”. These samples will be analysed to measure the “normal” amount of 
carbon-13 content in the carbon dioxide in your breath. 
 
You will then be asked to drink a solution of carbon-13-urea. Further samples of your breath will then 
be taken 30 minutes later and the amount of carbon-13 in the samples measured as before. The results 
will be compared and a significant increase in the amount of carbon-13 in the second set of samples 
will suggest to your doctor that Helicobacter pylori is present. 
 
 



 70 

2. What you need to know before you take Helicobacter Test INFAI 
 
Do not take Helicobacter Test INFAI 
 if you have or suspect that you have a stomach infection or a certain inflammation of the 

stomach lining (atrophic gastritis). 
This inflammation of the stomach lining may cause incorrect positive results of your breath test. 
Further investigations may be required to confirm the presence of Helicobacter pylori. 

 
Warnings and precautions 
Talk to your doctor or pharmacist before taking Helicobacter Test INFAI if you have any condition 
that can affect or be affected by the test. 
 
Even if the result of Helicobacter Test INFAI is positive, further tests might be necessary before a 
treatment of a Helicobacter pylori infection may be started. These are required to check for the 
presence of any other complications, such as: 
 stomach ulcer 
 inflammation of the stomach lining caused by immune system 
 tumours 
 
There is insufficient data on the reliability of the Helicobacter Test INFAI for recommending its use in 
patients with removal of parts of the stomach. 
 
If the patient vomits during the test procedure, repetition of the test is necessary. This should be done 
in fasted condition and not before the following day. 
 
Other medicines and Helicobacter Test INFAI 
Helicobacter Test INFAI is influenced by medicines influencing 
 Helicobacter pylori (see section 3, second paragraph under “Method of use”) 
 the enzyme urease, which stimulate the reduction of urea 
 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. 
 
Pregnancy and breast-feeding 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor or pharmacist for advice before taking this medicine. 
It is not expected that performing the breath test during pregnancy and lactation has a damaging effect. 
 
Driving and using machines 
Helicobacter Test INFAI has no influence on the ability to drive or to use machines. 
 
 
3. How to take Helicobacter Test INFAI 
 
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist 
if you are not sure. 
 
You should perform the test in the presence of your doctor or another qualified person. 
 
The recommended dose is 
Patients from the age of 12 must take the content of one jar for one test. 
 
Method of use 
You must have fasted for 6 hours before application, preferably overnight. Ask your doctor, if fasting 
is a problem, for example for diabetic patients. 
 
The test procedure lasts approximately 40 minutes. 



 71 

 
The test should be performed following at least: 
 4 weeks after a therapy against a bacterial infection 
 2 weeks after the last administration of a medicine to reduce release of stomach acid 
Both groups of medicines could influence the results of the Helicobacter Test INFAI. This is 
particularly after a therapy to remove Helicobacter pylori. It is important to follow the instructions for 
use exactly, otherwise the result may be questionable. 
 
Essential items not supplied with Helicobacter Test INFAI 
Before the breath test is performed a liquid test meal is taken to delay the stomach from emptying. The 
test meal is not provided within the kit. The following are suitable test meals: 
 200 ml 100 % orange juice or  
 1 g citric acid dissolved in 200 ml water 
If you cannot take either of these test meals, please tell your doctor, who will suggest an alternative. A 
drinking vessel and tap water is required to dissolve the 13C-urea powder. If the test needs to be 
repeated, this should be done on the following day at the earliest. 
 
Special instructions for use (for infrared spectroscopy or mass spectrometry) 
The test is to be performed after instruction by a healthcare professional and under appropriate 
medical supervision. The patient data should be documented using the provided data sheet. It is 
recommended that you take the test in a resting position. 
 
1. The test should be carried out after having fasted 6 hours before application, preferably 

overnight. If the test needs to be carried out later in the day, only a light meal like tea and toast 
is recommended. 

2. For mass spectrometric analysis, please use sample tubes for collection the breath samples; for 
infrared spectroscopy, use breath bags. Both are not included in the package. 

3. The test begins with the collection of samples for determining the baseline values: 
 Use the straw and the breath sample container described under point 2 labelled “sampling 

time: 00-minute-value”. 
 The stopper is removed from one of the breath sample containers described under point 2 

and place the unwrapped straw into the breath sample container. 
 Now the patient breathes gently through the straw into the breath sample container. 
 The patient must continue to breathe through the straw while removing it from the breath 

sample container, and then immediately seal the breath sample container with its stopper. 
If the breath sample container remains open for more than 30 seconds, the result could be 
inaccurate. 

 The breath sample container should be held upright and the bar-code label marked 
“00-minute-value” will be stuck on the breath sample container. 

4. Now the second breath sample container (labelled “sampling time: 00-minute-value”) has to be 
filled up with breath in the same way as described above. The second breath sample container is 
only required for mass spectrometry. For infrared spectroscopy, only one breath bag is required. 

5. Then the patient must drink the recommended test meal (200 ml 100 % orange juice or 1 g citric 
acid in 200 ml water). 

6. Now the preparation of the test solution follows. 
 The jar labelled “13C-urea powder” is removed from the pack, opened, and filled up to 

about three quarters with tap water. 
 The jar is closed and carefully shaken until all the powder has dissolved completely. 
 The contents are poured into a drinking glass, the jar filled a second and third time with 

water and the contents transferred into the drinking glass, so that approximately 30 ml of 
test solution is obtained. 

7. The patient should drink this test solution immediately. The time of intake must be noted. 
8. 30 minutes after the test solution has been taken (point 7), the “30-minute-value” samples are 

collected in the breath sample containers labelled “sampling time: 30-minute-value” as 
described under point 3 and 4. 
The bar-code labels marked “30-minute-value” must be used for these samples. 



 72 

9. The corresponding bar-code label must be put on the data sheet for patient documentation. 
10. All breath sample containers and the patient documentation must be sent to a qualified 

laboratory for analysis. 
 
Medical or healthcare professionals can find detailed information on the analysis of breath samples and 
the testing specifications for laboratories, in section 6.6 of the Summary of Product Characteristics. 
 
If you take more Helicobacter Test INFAI than you should 
Because only 75 mg 13C-urea is provided overdose is not to be expected. 
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
No side effects are known. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly 
via the national reporting system listed in Appendix V. By reporting side effects you can help provide 
more information on the safety of this medicine. 
 
 
5. How to store Helicobacter Test INFAI 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The 
expiry date refers to the last day of that month. 
 
Do not store above 25C. 
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Helicobacter Test INFAI contains 
- The active substance is 13C-urea. 

One jar contains 75 mg 13C-urea. 
- There are no other ingredients. 
 
What Helicobacter Test INFAI looks like and contents of the pack 
Helicobacter Test INFAI is a white, crystalline powder for oral solution. 
 
Content of the test kit with 50 jars: 
 

No. Component Quantity 

1 
Jar (10 ml volume, polystyrene with polyethylene snap cap) 
containing 75 mg 13C-urea powder for oral solution 50 

2 Data sheet for patient documentation 50 
3 Package leaflet 50 
4 Barcode labels and stickers 50 

 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


 73 

Marketing Authorisation Holder 
INFAI GmbH 
Riehler Str. 36 
D-50668 Köln 
Germany 
 
Manufacturer responsible for batch release 
INFAI GmbH 
An der Kohlenbahn 39 
D-58135 Hagen 
Germany 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
AT, BE, BG, CZ, DE, DK, EE, ES, FI, IS, IT, LT, LU, LV, MT, NL, NO, RO, SE 
INFAI GmbH, Tel / Tél / Teл. / Τηλ / Puh / Sími / Tlf.: +49 221 880 443 
Deutschland / Allemagne / Германия / Německo / Tyskland / Saksamaa / Alemania / Saksa / 
Þýskaland / Germania / Vokietija / Vācija / Il-Ġermanja / Duitsland 
CY, EL ANGELINI PHARMA HELLAS SA, Τηλ: +30 210 626 9200, Ελλάδα 
FR INFAI FRANCE SARL, Tél: +33 389 2043 82 
HR Pliva Hrvatska d.o.o, Tel: + 385 1 3720 000 
IE, UK INFAI UK Ltd., Tel: +44 1904 435 228, United Kingdom 
PL Dr Piktel Medic@l Systems, Tel: +48 85 744 7770 
PT Sermail – Logística Integrada Lda., Tel: +351 21 973 9120 
SL PLIVA LJUBLJANA d.o.o., Tel: +386 1 5890 390 
HU, SK ALLMEDICAL s.r.o, Tel: +421 903 654 103, Szlovákia / Slovenská republika 
 
This leaflet was last revised in MM/YYYY. 
 
Detailed information on this medicine is available on the European Medicines Agency website: 
http://www.ema.europa.eu. 
 
  

http://www.ema.europa.eu/


 74 

MINIMUM PARTICULARS TO APPEAR ON 
 
DATA SHEET FOR PATIENT DOCUMENTATION 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Helicobacter Test INFAI 
 
 
2. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
INFAI GmbH 
Riehler Str. 36 
D-50668 Köln 
Germany 
 
 
3. EXPIRY DATE 
 
 
4. BATCH NUMBER 
 
 
5. OTHER 
 
Date of test 
 
Patient ID 
 
Date of birth 
 
Barcode 
 
Doctor/Hospital Address 
 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET