Helicobacter Test INFAI for children of the age 3-11 45 mgpowder for oral solution

3-11

Please tell your doctor if you suffer from any medical condition that you think may affect, or be affected by the test. It is also important that you tell your doctor if any of the following circumstances apply to you:

Do not take Helicobacter Test INFAI for children of the age 3-11

• if you have or if it is suspected that you have a gastric infection or an atrophic gastritis (special form of gastritits), because this might interfere with the urea breath test.

Take special care with Helicobacter Test INFAI for children of the age 3-11

Even if the result of Helicobacter Test INFAI is positive, further tests might be necessary before a treatment of a Helicobacter pylori infection (eradication therapy) may be started. Various diagnostic tests, including invasive endoscopic tests, could be required to check for the presence of any other complications, such as gastric ulcer, infection of the gastric mucosa caused by an autoimmune reaction, and tumours.

There is insufficient data on the diagnostic reliability of the Helicobacter Test INFAI for children of the age 3-11 for recommending its use in patients with gastrectomy.

• In individual cases of A-gastritis (atrophic gastritis), the breath test can lead to false positive results; other tests may therefore be necessary to confirm the presence of Helicobacter pylori.
• 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.

Taking other medicines

Helicobacter Test INFAI for children of the age 3-11 is influenced by all medicines related to Helicobacter pylori or urease activity.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Always take Helicobacter Test INFAI for children of the age 3-11 exactly as your doctor has told you. You should 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.

Dosage
The following information applies, unless your doctor has otherwise prescribed Helicobacter Test INFAI for children of the age 3-11. Please follow the instructions for use, as otherwise the Helicobacter Test INFAI for children of the age 3-11 years may not work properly.

How much Helicobacter Test INFAI for children of the age 3-11 should be used and how often?

Patients from the age of 3-11 must take the content of one jar with 45 mg for one test.

How and when should Helicobacter Test INFAI for children of the age 3-11 be used? You must have fasted for 6 hours before application, preferably overnight. If fasting is a problem, for example for diabetic patients, please tell your doctor.

The test procedure lasts approximately 40 minutes.

The test should be performed following at least four weeks without antibacterial therapy and two weeks after the last administration of an antisecretory medication. Both of these substances could influence the results of the Helicobacter Test INFAI for children of the age 3-11. This is particularly true after Helicobacter eradication therapy. 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 stomach emptying. The test meal is not provided with the kit. Pure orange juice (100 ml) can be used as a test meal. If there is a medical (or other) reason why 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 not be done until the following day.

Special Instructions for use (for mass spectrometry)
The test is to be performed after instruction by a healthcare professional and under appropriate medical supervision. Each patient 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, the straw unwrapped and placed 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 test result might be falsified.)
• 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 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 is poured into a drinking glass, the jar a second and third time filled 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 remains in the pack (labelled ?sampling time: 30-minute-value?) as described above. 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 samples 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.

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.

Always take Helicobacter Test INFAI for children of the age 3-11 exactly as your doctor has told you. You should 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.

Dosage
The following information applies, unless your doctor has otherwise prescribed Helicobacter Test INFAI for children of the age 3-11. Please follow the instructions for use, as otherwise the Helicobacter Test INFAI for children of the age 3-11 years may not work properly.

How much Helicobacter Test INFAI for children of the age 3-11 should be used and how often?

Patients from the age of 3-11 must take the content of one jar with 45 mg for one test.

How and when should Helicobacter Test INFAI for children of the age 3-11 be used? You must have fasted for 6 hours before application, preferably overnight. If fasting is a problem, for example for diabetic patients, please tell your doctor.

The test procedure lasts approximately 40 minutes.

The test should be performed following at least four weeks without antibacterial therapy and two weeks after the last administration of an antisecretory medication. Both of these substances could influence the results of the Helicobacter Test INFAI for children of the age 3-11. This is particularly true after Helicobacter eradication therapy. 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 stomach emptying. The test meal is not provided with the kit. Pure orange juice (100 ml) can be used as a test meal. If there is a medical (or other) reason why 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 not be done until the following day.

Special Instructions for use (for mass spectrometry)
The test is to be performed after instruction by a healthcare professional and under appropriate medical supervision. Each patient 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, the straw unwrapped and placed 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 test result might be falsified.)
• 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 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 is poured into a drinking glass, the jar a second and third time filled 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 remains in the pack (labelled ?sampling time: 30-minute-value?) as described above. 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 samples 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.

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.

Keep out of the reach and sight of children.

Do not use after the expiry date which is stated on the label and carton.

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Keep out of the reach and sight of children.

Do not use after the expiry date which is stated on the label and carton.

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

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 years is a clear, colourless 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 tubes 1 4 Data sheet for patient documentation 1 5 Package leaflet 1 6 Page of barcode labels and sticker 1

Marketing Authorisation Holder and Manufacturer

INFAI, Institut für biomedizinische Analytik und NMR-Imaging GmbH
Universitätsstraße 142
D-44799 Bochum
Germany

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

BelgiëBelgiqueBelgien INFAI, Institut für biomedizinische Analytik und NMR-Imaging GmbH Universitätsstraße 142 D-44799 Bochum TélTel 49 234 971130 LuxembourgLuxemburg INFAI, Institut für biomedizinische Analytik und NMR-Imaging GmbH Universitätsstraße 142 D-44799 Bochum TélTel 49 234 971130 INFAI, Institut für biomedizinische Analytik und NMR-Imaging GmbH Universitätsstraße 142 D-44799 Bochum Te. 49 234 971130 Magyarország INFAI, Institut für biomedizinische Analytik und NMR-Imaging GmbH Universitätsstraße 142 D-44799 Bochum Tel. 49 234 971130 eská republika INFAI, Institut für biomedizinische Analytik und NMR-Imaging GmbH Universitätsstraße 142 D-44799 Bochum Tel 49 234 971130 Malta INFAI, Institut für biomedizinische Analytik und NMR-Imaging GmbH Universitätsstraße 142 D-44799 Bochum Tel 49 234 971130 Denmark BioCare Nordic ApS Langebjergvaenget 8A DK-4000 Roskilde Tlf 45 4646 1191 Nederland INFAI, Institut für biomedizinische Analytik und NMR-Imaging GmbH Universitätsstraße 142 D-44799 Bochum Tel 49 234 971130 Deutschland INFAI, Institut für biomedizinische Analytik und NMR-Imaging GmbH Universitätsstraße 142 D-44799 Bochum Tel 49 234 971130 Norge INFAI, Institut für biomedizinische Analytik und NMR-Imaging GmbH Universitätsstraße 142 D-44799 Bochum Tlf 49 234 971130 Eesti INFAI, Institut für biomedizinische Analytik und NMR-Imaging GmbH Universitätsstraße 142 D-44799 Bochum Tel 49 234 971130 Österreich INFAI, Institut für biomedizinische Analytik und NMR-Imaging GmbH Universitätsstraße 142 D-44799 Bochum Tel 49 234 971130 Faran Laboratories s.a. GR-14564 30 210 626 9200 Polska INFAI, Institut für biomedizinische Analytik und NMR-Imaging GmbH Universitätsstraße 142 D-44799 Bochum Tel. 49 234 971130 Portugal Goldfarma Lda Rua Professor Francisco Gentil No 22-F P-2620-097 Povoa de Santo Adrião Tel 351 219383280 España INFAI, Institut für biomedizinische Analytik und NMR-Imaging GmbH Universitätsstraße 142 D-44799 Bochum Tel 49 234 971130

France Bioprojet Pharma 9, rue Rameau F-75002 Paris Tél 33 1 470 366 33 România INFAI, Institut für biomedizinische Analytik und NMR-Imaging GmbH Universitätsstraße 142 D-44799 Bochum Tel 49 234 971130 Slovenija PLIVA Ljubljana d.o.o. Pot k sejmiu 35 SI-1231 Ljubljana-rnue Tel 386 1 58 90 390 Ireland INFAI UK Ltd. York Science Park Innovation Centre University Road, Heslington GB-York YO10 5DG Tel 44 1904 435 228 Slovenská republika ALLMEDICAL s.r.o. Popradská 7 SK-040 01 Koice Tel 421 57 44 50030 Ísland INFAI, Institut für biomedizinische Analytik und NMR-Imaging GmbH Universitätsstraße 142 D-44799 Bochum Sími 49 234 971130 Italia INFAI Italia S.r.l. via Borgogna 2 I-20112 Milano Tel. 39 0481 790350 SuomiFinland INFAI, Institut für biomedizinische Analytik und NMR-Imaging GmbH Universitätsstraße 142 D-44799 Bochum PuhTel 49 234 971130 INFAI, Institut für biomedizinische Analytik und NMR-Imaging GmbH Universitätsstraße 142 D-44799 Bochum 49 234 971130 Sverige INFAI, Institut für biomedizinische Analytik und NMR-Imaging GmbH Universitätsstraße 142 D-44799 Bochum Tel 49 234 971130 Latvija INFAI, Institut für biomedizinische Analytik und NMR-Imaging GmbH Universitätsstraße 142 D-44799 Bochum Tel 49 234 971130 United Kingdom INFAI UK Ltd. York Science Park Innovation Centre University Road, Heslington GB-York YO10 5DG Tel. 44 1904 435 228 Lietuva INFAI, Institut für biomedizinische Analytik und NMR-Imaging GmbH Universitätsstraße 142 D-44799 Bochum Tel 49 234 971130

This leaflet was last approved in MM/YYYY

-------------------------------------------------------------------------------------------------------------------------------- The following information is intended for medical or healthcare professionals only:

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 13C12C-ratios

The breath test concept relies on the administration of a specifically 13C-labelled urea whose metabolite utilisation is monitored by measuring 13CO 2 in the expired breath gas.

The mass spectrometer must be capable of:

Multiple replicate analyses Minimum of 3 replicate analyses on the same sample during operation

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

Adjustment 13C12C-ratio with respect to Pee Dee Beliminate PDB

Sample loop 200 l

The principle 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 CO2concentration

Stability 0.2 on 10 consecutive pulses

Precision of measurement 0.3 for 13C at natural abundance using a 10ml breath sample tube with 3 CO2 breath concentration

C12C of baseline-value and 30-minute-Helicobacter pylori infection is present if the difference in 13value exceeds 4.0 .

Alternatively, any other suitable-validated method may be used, carried out by any objectively qualified laboratory.

MINIMUM PARTICULARS TO APPEAR ON

DATA SHEET FOR PATIENT DOCUMENTATION

1. NAME OF THE MEDICINAL PRODUCT

Helicobacter Test INFAI

2. NAME OF THE MARKETING AUTHORISATION HOLDER

INFAI, Institut für biomedizinische Analytik und NMR-Imaging GmbH Universitätsstr. 142
D-44799 Bochum
Germany

3. EXPIRY DATE

4. BATCH NUMBER

5. OTHER

Date of test

Patient´s full name

Date of birth

Barcode

Doctor/Hospital Address