Helicobacter Test Infai - urea 13C: detailed information

Package leaflet: Information for the user

Helicobacter Test INFAI 75 mg oral solution powder

urea C
Please read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
If any adverse reaction occurs, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Helicobacter Test INFAI is and what it is used for
What you need to know before taking Helicobacter Test INFAI
How to take Helicobacter Test INFAI
Possible side effects
How to store Helicobacter Test INFAI
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 aged 12 years and older, and adults, to determine the presence of the bacterium Helicobacter pylori in the stomach.

Why take Helicobacter Test INFAI?
You may have a gastric infection caused by a bacterium called Helicobacter pylori. Your doctor has recommended that you take the Helicobacter Test INFAI for one of the following reasons:

your doctor wants to confirm an active Helicobacter pylori infection as part of diagnosing your gastrointestinal health;
you have already been diagnosed with a Helicobacter pylori infection and have undergone treatment to eliminate it: your doctor wants to check whether the treatment has been effective.

How does the test work?
All food contains a substance called carbon-13 (C). Its presence can be detected in the carbon dioxide exhaled from the lungs. The actual amount of carbon-13 in exhaled breath depends on the types of food ingested.
You will be required to take the "test meal". Afterwards, a breath sample will be collected. See "Special Instructions for Use". These samples will be analyzed to measure the "normal" level of carbon-13 in your exhaled carbon dioxide.
Next, you will take a solution of carbon-13-urea. Thirty minutes later, another breath sample will be collected and the amount of carbon-13 in it measured. By comparing the two sets of results, it is possible to determine the presence of Helicobacter pylori, which is indicated by a significant increase in carbon-13 levels in the second set of samples.

2. What you need to know before taking Helicobacter Test INFAI

Do not take Helicobacter Test INFAI

if you have or suspect you have a stomach infection or a specific inflammation of the stomach mucosa (atrophic gastritis).
This inflammation of the stomach mucosa may lead to falsely positive breath test results. Further tests 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
illness that could affect the test or be affected by it.
Even if the result of Helicobacter Test INFAI is positive, additional testing may be necessary
before starting treatment for Helicobacter pylori infection. These tests are needed
to check for any other complications, such as:

gastric ulcer
inflammation of the stomach mucosa caused by the immune system
tumours

There is insufficient reliability data to recommend the use of Helicobacter Test INFAI in
patients who have undergone partial or total removal of the stomach.
If the patient vomits during the test, the test must be repeated. The repeat test should
be performed on an empty stomach and not earlier than the following day.

Other medicines and Helicobacter Test INFAI
Helicobacter Test INFAI is affected by medicines that act

against Helicobacter pylori (see section 3, second paragraph under “Instructions for use”)
on the urease enzyme, which catalyses the breakdown of urea

Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicine.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding,
consult your doctor or pharmacist before taking this medicine.
There is no reason to believe that performing the test during pregnancy or breastfeeding
has harmful effects.

Driving and using machines
Helicobacter Test INFAI does not impair the ability to drive or operate machinery.

3. How to take Helicobacter Test INFAI

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The test must be performed in the presence of the attending physician or another qualified person.
Recommended dose
Patients from the age of 12 years must take the contents of one container for one test.
Instructions for use
You must remain fasting for 6 hours before the test, preferably overnight.
Consult your doctor if fasting poses a problem, for example in diabetic patients.
The test procedure takes approximately 40 minutes.
The test must be performed no sooner than:

4 weeks after antibacterial therapy
2 weeks after the last dose of any medication that reduces gastric acid secretion

Both groups of medications may influence the results of the Helicobacter Test INFAI, particularly after treatment aimed at eradicating Helicobacter pylori. It is important to follow the instructions for use exactly; otherwise, the result may be inconclusive.

Essential components not included in Helicobacter Test INFAI
Before performing the breath test, a test meal must be taken to delay gastric emptying. This test meal is not included in the kit. Suitable test meals are:

200 ml of 100% orange juice, or
1 g of citric acid dissolved in 200 ml of water

If neither of these test meals can be taken, inform your doctor, who will suggest an alternative. A glass and drinking water are required to dissolve the C-urea powder. Any repeat testing should not be performed earlier than the following day.

Special instructions for use (for mass spectrometry)
This medicine should be administered by medical or paramedical personnel under appropriate medical supervision. Patient data must be documented using the form provided. It is recommended to perform the test while the patient is at rest.

The patient must remain fasting for 6 hours before the test, preferably overnight. If the test is performed later in the day, a light meal such as tea and a slice of toast is recommended.
The test begins with the collection of samples to determine the baseline value.
- Take from the test kit the straw and the sampling tubes labelled: “sampling time: 00-minute value”.
- Remove the cap from one of the sampling containers and insert the straw into the container after discarding its wrapper.
- Now exhale slowly through the straw into the sampling tube until the inside of the tube becomes foggy.
- Continue exhaling through the straw while removing it from the tube, then immediately close the tube tightly with its cap. If the tube remains open for more than 30 seconds, results may be inaccurate.
- The container must be held vertically, and the label with the barcode marked “00-minute value” must be attached around the tube so that the barcode lines are horizontal.
Now fill the second tube (labelled “sampling time: 00-minute value”) with exhaled breath, in the same manner described above.
Then drink the recommended test meal (200 ml of 100% orange juice or 1 g of citric acid in 200 ml of water).
Next, prepare the test solution:
- Take from the test kit the container labelled “C-urea powder”, open it, and fill it with water up to about three-quarters full.
- Close the container and shake it thoroughly until the powder is completely dissolved.
- Pour the contents into a glass. Then fill the container a second and a third time with water, shaking each time, and transfer all contents into the glass to obtain approximately 30 ml of test solution.
This test solution must be drunk immediately. The time of ingestion must be recorded.
30 minutes after taking the test solution (step 6), collect the “30-minute value” breath samples in both remaining tubes in the kit (labelled “sampling time: 30-minute value”), as described in steps 2 and 3. For these samples, use the barcode labels marked “30-minute value”.
Attach the corresponding barcode label to the patient documentation form. All breath sample tubes must be returned to the original packaging. Seal the package with the adhesive label provided.
The package must be sent to a qualified laboratory for analysis.

Detailed information on the analysis of breath samples and test specifications for laboratories can be found by physicians and healthcare professionals in section 6.6 of the Summary of Product Characteristics.
If you take more Helicobacter Test INFAI than you should
Since only 75 mg of C-urea is provided, overdose is not expected.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

No side effects are known.
Reporting of side effects
If you experience any side effect, talk to your doctor or pharmacist. You can also
report side effects directly through the national reporting system listed in
Annex 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 on the carton after
Exp. The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Helicobacter Test INFAI contains

The active substance is urea-C. Each vial contains 75 mg of urea-C.
There are no other components.

Description of the appearance of Helicobacter Test INFAI and contents of the pack
Helicobacter Test INFAI is a white, crystalline powder for oral solution.
Contents of the kit:

No.	Components	Quantity
1	Vial (10 ml volume, polystyrene with snap cap in polyethylene) containing 75 mg of 13C-urea powder for oral solution	1
2	Labeled containers, in glass or plastic, for sampling, storage and transport of the exhaled sample for analysis: Sampling time: value-00-minutes Sampling time: value-30-minutes	2 2
3	Flexible straw for collecting exhaled samples into the respective sampling containers	1
4	Patient documentation form	1
5	Package leaflet	1
6	Sheet with bar-coded labels and adhesive	1

Marketing Authorisation Holder and Manufacturer
INFAI GmbH
An der Kohlenbahn 39
D-58135 Hagen
Germany
For further information on this medicinal product, please contact the local representative of the
Marketing Authorisation Holder.
AT, BE, BG, CZ, DE, DK, EE, ES, FI, IS, IT, LT, LU, LV, NL, NO, RO, SE
INFAI GmbH, Tel / Tél / Teл. / Τηλ / Puh / Sími / Tlf.: +49 2331 349 310
Deutschland / Allemagne / Германия / Německo / Tyskland / Saksamaa / Alemania / Saksa /
Þýskaland / Germania / Vokietija / Vācija / Duitsland
CY, EL Fertithera Labs Φαρμακευτικη Μονοπρόσωπη ΙΚΕ, Τηλ: +30 699 308 8000, Ελλάδα
FR Bioprojet, Tél: +33 1 47 03 66 33
HR POLIKLINIKA LABPLUS, Tel: + 385 1 299 3595, E-Mail: [email protected]
IE, UK INFAI UK Ltd., Tel: +44 1904 217 123, United Kingdom
MT Fertithera Labs Pharmaceutical Uniku Proprjetà, Tel: +30 699 308 8000, il-Greċja
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
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu .
MINIMUM INFORMATION TO BE INDICATED ON THE
PATIENT DOCUMENTATION CARD

1. NAME OF THE MEDICINAL PRODUCT

Helicobacter Test INFAI

2. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

MARKETING AUTHORISATION HOLDER
INFAI GmbH
An der Kohlenbahn 39
D-58135 Hagen
Germany

3. EXPIRY DATE

Exp. {MM/YYYY}

4. BATCH NUMBER

Batch {number}

5. CONTENT IN WEIGHT, VOLUME OR UNITS

Test date
Patient identification code
Date of birth
Barcode
Physician/Hospital address

Package leaflet: information for the user

Helicobacter Test INFAI 75 mg oral solution powder

urea C
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Helicobacter Test INFAI is and what it is used for
What you need to know before taking Helicobacter Test INFAI
How to take Helicobacter Test INFAI
Possible side effects
How to store Helicobacter Test INFAI
Contents of the pack and other information

1. What Helicobacter Test INFAI is and what it is used for

the doctor wishes to confirm an ongoing Helicobacter pylori infection as part of diagnosing your gastrointestinal health status;
you have previously been diagnosed with a Helicobacter pylori infection and have already taken medication to eradicate the infection: the doctor wishes to verify whether the treatment has been effective.

How does the test work?
All food contains a substance called carbon-13 (¹³C). Its presence can be detected in the carbon dioxide exhaled from the lungs. The actual amount of carbon-13 in the exhaled breath depends on the types of food ingested.

You will be required to ingest the "test meal". Subsequently, a breath sample will be collected. See "Special instructions for use". These samples will be analyzed to measure the "baseline" amount of carbon-13 in the exhaled carbon dioxide.

Then, you will ingest a solution of carbon-13-urea. Thirty minutes later, another breath sample will be collected and analyzed to measure the amount of carbon-13 present in the sample. By comparing the two results, it is possible to determine the presence of Helicobacter pylori, which is indicated by a significant increase in the amount of carbon-13 in the second set of samples.

2. What you need to know before taking Helicobacter Test INFAI

Do not take Helicobacter Test INFAI

if you have or suspect you have a stomach infection or a specific inflammation of the stomach mucosa (atrophic gastritis).
This inflammation of the stomach mucosa may lead to falsely positive breath test results. Further tests may be required to confirm the presence of Helicobacter pylori.

Warnings and precautions
Consult your doctor or pharmacist before taking Helicobacter Test INFAI if you have any
disease that may affect the test or be affected by it.
Even if the result of Helicobacter Test INFAI is positive, additional tests might be necessary
before starting treatment for Helicobacter pylori infection. These are required
to check for any other complications, such as:

gastric ulcer
inflammation of the stomach mucosa caused by the immune system
tumours

Data on the reliability of Helicobacter Test INFAI are insufficient to recommend its use in
patients who have undergone partial or total removal of the stomach.
If the patient vomits during the test, the test must be repeated. The repeat test should
be performed on an empty stomach and not before the following day.

Other medicines and Helicobacter Test INFAI
Helicobacter Test INFAI may be affected by medicines that act

on Helicobacter pylori (see section 3, second paragraph under “Instructions for use”)
on the urease enzyme, which catalyses the breakdown of urea

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding,
please consult your doctor or pharmacist before taking this medicine.
There is no reason to believe that performing the test during pregnancy or breastfeeding has a harmful effect.

Driving and using machines
Helicobacter Test INFAI does not impair the ability to drive or operate machinery.

3. How to take Helicobacter Test INFAI

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The test must be performed in the presence of your physician or another qualified person.
Recommended dose
Patients from the age of 12 years must take the contents of one container for one test.
Instructions for use
You must remain fasting for 6 hours before the test, preferably overnight.
Consult your doctor if fasting poses a problem, for example in diabetic patients.
The test procedure lasts approximately 40 minutes.
The test must be performed no sooner than:

4 weeks after antibacterial therapy
2 weeks after the last dose of any medication that reduces gastric acid secretion

Both groups of medications may influence the results of the Helicobacter Test INFAI, particularly after treatment aimed at eradicating Helicobacter pylori. It is important to strictly follow the instructions for use; otherwise, the result may be unreliable.

Essential components not included in Helicobacter Test INFAI
Before performing the breath test, a liquid test meal must be taken to delay gastric emptying. This test meal is not included in the kit. Suitable test meals are:

200 ml of 100% orange juice, or
1 g of citric acid dissolved in 200 ml of water

If neither of these test meals can be taken, inform your doctor, who will suggest an alternative. A glass and drinking water are required to dissolve the C-urea powder. Any repeat testing must not be performed earlier than the following day.

Special instructions for use (for infrared spectrometry)
This medicine should be administered by paramedical personnel under appropriate medical supervision. Patient data must be documented using the form provided. It is recommended to perform the test while the patient is resting.

The patient must remain fasting for 6 hours before the test, preferably overnight. If the test is performed later in the day, a light meal such as tea and a slice of toast is recommended.
The test begins with collection of baseline samples.
- Take from the test kit the straw and the breath collection bag labelled: “sampling time: value-00-minutes”.
- Remove the cap from the breath collection bag and insert the straw after removing its packaging.
- Now slowly exhale through the straw into the breath collection bag.
- Continue exhaling through the straw while removing it from the bag, then immediately seal the breath collection bag tightly with its cap. If the breath collection bag remains open for more than 30 seconds, results may be inaccurate.
The breath collection bag must be kept upright, and the barcode label marked “value-00-minutes” must be attached to the breath collection bag.
Then drink the recommended test meal (200 ml of 100% orange juice or 1 g of citric acid in 200 ml of water).
Next, prepare the test solution:
- Remove from the test kit the container labelled “C-urea powder”, open it, and fill it with water up to about three-quarters full.
- Close the container and shake thoroughly until the powder is completely dissolved.
- Pour the contents into a glass. Refill the container with water a second and third time, shaking each time, and transfer the contents to the glass to obtain approximately 30 ml of test solution.
This test solution must be drunk immediately. The time of ingestion must be recorded.
30 minutes after taking the test solution (step 5), collect the “value-30-minutes” sample into the remaining breath collection bag in the kit (labelled “sampling time: value-30-minutes”), as described in step 2.
For this sample, use the barcode label marked “value-30-minutes”.
The corresponding barcode label must be affixed to the patient documentation form. All breath collection bags must be returned to the original test kit packaging. This package must be sealed with the adhesive label provided.
The package must be sent to a qualified laboratory for analysis.

Physicians and healthcare professionals can find detailed information on breath sample analysis and test specifications for laboratories in section 6.6 of the Summary of Product Characteristics.
If you take more Helicobacter Test INFAI than you should
Since only 75 mg of C-urea is provided, overdose is not expected.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

No adverse reactions are known.
Reporting of side effects
If you experience any side effect, talk to your doctor or pharmacist. You can also
report side effects directly through the national reporting system listed in
Annex 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 stated on the label and on the carton after
Exp. The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer used. This will help protect the environment.

6. Contents of the package and other information

What Helicobacter Test INFAI contains

The active substance is urea-C. One vial contains 75 mg of urea-C.
There are no other components.

Description of the appearance of Helicobacter Test INFAI and contents of the pack
Helicobacter Test INFAI is a white, crystalline powder for oral solution.
Contents of the kit with 1 vial:

No.	Components	Quantity
1	Vial (10 ml volume, polystyrene with snap cap in polyethylene) containing 75 mg of 13C-urea powder for oral solution.	1
2	Exhaled air collection bags Sampling time: value-00-minutes Sampling time: value-30-minutes	1 1
3	Flexible straw for collecting exhaled air samples into the respective exhaled air collection bags	1
4	Patient documentation card	1
5	Package leaflet	1
6	Sheet with barcode labels and adhesive	1

Contents of the kit with 50 pots:

No.	Component	Quantity
1	Vial (volume 10 ml, in polystyrene with snap cap in polyethylene) containing 75 mg of 13C-urea oral solution powder	50
2	Exhaled air bags Sampling time: value-00-minutes Sampling time: value-30-minutes	50 50
3	Flexible straw for collecting exhaled air samples into the respective exhaled air bags	50
4	Patient documentation card	50
5	Package leaflet	50
6	Sheet with barcode labels and adhesive	50

Marketing Authorisation Holder and Manufacturer
INFAI GmbH
An der Kohlenbahn 39
D-58135 Hagen
Germany
For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
AT, BE, BG, CZ, DE, DK, EE, ES, FI, IS, IT, LT, LU, LV, NL, NO, RO, SE
INFAI GmbH, Tel / Tél / Teл / Τηλ / Puh / Sími / Tlf.: +49 2331 349 310
Deutschland / Allemagne / Германия / Německo / Tyskland / Saksamaa / Alemania / Saksa /
Þýskaland / Germania / Vokietija / Vācija / Duitsland
CY, EL Fertithera Labs Φαρμακευτικη Μονοπρόσωπη ΙΚΕ, Τηλ: +30 699 308 8000, Ελλάδα
FR Bioprojet, Tél: +33 1 47 03 66 33
HR POLIKLINIKA LABPLUS, Tel: + 385 1 299 3595, E-Mail: [email protected]
IE, UK INFAI UK Ltd., Tel: +44 1904 217 123, United Kingdom
MT Fertithera Labs Pharmaceutical Uniku Proprjetà, Tel: +30 699 308 8000, il-Greċja
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
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu .
MINIMUM INFORMATION TO BE INDICATED ON THE
PATIENT DOCUMENTATION CARD

1. NAME OF THE MEDICINAL PRODUCT

Helicobacter Test INFAI

2. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

MARKETING AUTHORISATION
INFAI GmbH
An der Kohlenbahn 39
D-58135 Hagen
Germany

3. EXPIRY DATE

Exp. {MM/YYYY}

4. LOT NUMBER

Lot {number}

5. CONTENT IN WEIGHT, VOLUME OR UNITS

Test date
Patient identification code
Date of birth
Barcode
Physician/Hospital address

Package leaflet: information for the user

Helicobacter Test INFAI for children aged 3-11 years

45 mg oral solution powder
urea C
Please read this leaflet carefully before taking this medicine as it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Helicobacter Test INFAI for children aged 3-11 years is and what it is used for
What you need to know before taking Helicobacter Test INFAI for children aged 3-11 years
How to take Helicobacter Test INFAI for children aged 3-11 years
Possible side effects
How to store Helicobacter Test INFAI for children aged 3-11 years
Contents of the pack and other information

1. What is Helicobacter Test INFAI for children aged 3-11 years and what is it used for?

Helicobacter Test INFAI for children aged 3-11 years is for diagnostic use only. It is a breath test
for children aged 3-11 years to determine the presence of the bacterium Helicobacter pylori in the stomach or
duodenum.
Why take Helicobacter Test INFAI for children aged 3-11 years?
The patient may be suffering from a gastric or duodenal infection caused by a bacterium called
Helicobacter pylori. Your doctor has recommended that the patient undergo a Helicobacter Test INFAI for
children aged 3-11 years for one of the following reasons:

the doctor wishes to confirm an ongoing Helicobacter pylori infection as part of diagnosing the patient's health condition;
the patient has already been diagnosed with a Helicobacter pylori infection and has already taken medication to eradicate the infection: the doctor wishes to check whether the treatment has been effective.

How does the test work?
All foods contain a substance called carbon-13 (\textsuperscript{13}C). Its presence can be
detected in the carbon dioxide exhaled from the lungs. The actual amount of carbon-13 in the exhaled breath
depends on the type of food ingested.
The patient will be required to take the "test meal". Subsequently, a breath sample will be collected. See "Special instructions for use". These samples will be analyzed to
measure the "normal" amount of carbon-13 contained in the exhaled carbon dioxide.
After this, the patient will take a solution of carbon-13-urea. Thirty minutes later, another breath sample will be collected and the amount of carbon-13 present in the samples will be measured. By comparing the results, it will be possible to determine the possible presence of Helicobacter
pylori, indicated by a significant increase in the amount of carbon-13 in the second set of
samples.

2. What you should know before taking Helicobacter Test INFAI for children aged 3–11 years

Do not take Helicobacter Test INFAI for children aged 3–11 years

if you have or suspect you have a stomach infection or a specific inflammation of the stomach lining (atrophic gastritis).
This inflammation of the stomach lining may lead to falsely positive breath test results. Further tests may be required to confirm the presence of Helicobacter pylori.

Warnings and precautions
Consult your doctor or pharmacist before taking Helicobacter Test INFAI for children aged 3–11 years if you have any disease that could affect the test or be affected by it.
Even if the result of Helicobacter Test INFAI for children aged 3–11 years is positive, additional tests may be necessary before starting treatment for Helicobacter pylori infection. These are needed to check for any other complications, such as:

gastric ulcer
inflammation of the stomach lining caused by the immune system
tumours

Data on the reliability of Helicobacter Test INFAI for children aged 3–11 years are insufficient to recommend its use in patients who have undergone partial removal of the stomach.
If the patient vomits during the test, the test must be repeated. The repeat test must be performed on an empty stomach and not earlier than the following day.

Other medicines and Helicobacter Test INFAI for children aged 3–11 years
Helicobacter Test INFAI for children aged 3–11 years may be affected by medicines that act

on Helicobacter pylori (see section 3, second paragraph under “Instructions for use”)
on the urease enzyme, which catalyses the breakdown of urea

Inform 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 aged 3–11 years

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The test must be performed in the presence of the attending physician or another qualified person.
Recommended dose
Children aged 3–11 years must ingest the contents of one vial for one test.
Instructions for use
The child must remain fasting for 6 hours before the test, preferably overnight.
Consult your doctor if fasting poses a problem, for example in diabetic patients.
The test procedure takes approximately 40 minutes.
The test must be performed no sooner than:

4 weeks after antibiotic therapy for bacterial infection
2 weeks after the last dose of any medication that reduces gastric acid secretion

Both groups of medications may affect the results of the Helicobacter Test INFAI in children aged 3–11 years, particularly following therapy aimed at eradicating Helicobacter pylori. It is essential to follow the instructions precisely; otherwise, the test result may be unreliable.
Essential components not included in Helicobacter Test INFAI for children aged 3–11 years
Before performing the breath test, a test meal must be consumed to delay gastric emptying. This test meal is not included in the kit. Suitable test meals include:

100 ml of 100% orange juice

If this test meal cannot be consumed, inform the doctor, who will suggest an alternative. A glass and drinking water are required to dissolve the C-urea powder. Any repeat testing must not be performed earlier than the following day.

Special instructions for use (for mass spectrometry)
This medicine should be administered by medical or paramedical personnel under appropriate medical supervision. Patient data must be documented using the enclosed form. It is recommended to perform the test while the patient is at rest.

The patient must remain fasting for 6 hours before the test, preferably overnight. If the test is performed later in the day, a light meal such as tea and a slice of toast is recommended.
The test begins with collection of baseline breath samples.
- From the test kit, take the straw and the sampling tubes labeled: “sampling time: 00-minutes”.
- Remove the cap from one of the sampling containers and insert the straw into the container after discarding its protective sheath.
- Slowly exhale through the straw into the sampling tube until the inside of the tube becomes foggy.
- Continue exhaling through the straw while removing it from the tube, then immediately close the tube tightly with its cap. If the tube remains open for more than 30 seconds, the results may be inaccurate.
- The container must be held upright, and the barcode label marked “00-minutes” must be affixed around the tube so that the barcode lines are horizontal.
Now fill the second tube (labeled “sampling time: 00-minutes”) with breath, using the same method described above.
Then drink the recommended test meal (100 ml of 100% orange juice).
Next, prepare the test solution:
- Take from the kit the vial labeled “C-urea powder”, open it, and fill it with water up to about three-quarters full.
- Close the vial and shake thoroughly until the powder is completely dissolved.
- Pour the contents into a glass. Fill the vial a second and third time with water, and transfer each portion to the glass, to obtain approximately 30 ml of test solution.
This test solution must be drunk immediately. The time of ingestion must be recorded.
30 minutes after taking the test solution (step 6), collect the “30-minute” breath samples into both remaining tubes in the kit (labeled “sampling time: 30-minutes”), as described in steps 2 and 3. For these samples, use the barcode labels marked “30-minutes”.
Affix the corresponding barcode label to the patient documentation sheet. All breath sample tubes must be returned to the original test kit. This package must be sealed with the adhesive label provided.
The package must be sent to a qualified laboratory for analysis.

Detailed information for physicians and healthcare professionals on breath sample analysis and test specifications for laboratories can be found in section 6.6 of the product characteristics summary.
If you take more Helicobacter Test INFAI for children aged 3–11 years than you should
Since only 45 mg of C-urea is provided, overdose is not expected.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

No side effects are known.
Reporting of side effects
If you experience any side effects, contact your doctor or pharmacist. You can also
report side effects directly via the national reporting system listed in
Annex 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 aged 3–11 years

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and the carton, following "Exp". The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Helicobacter Test INFAI for children aged 3-11 contains

The active substance is urea-C. One vial contains 45 mg of urea-C.
There are no other components.

Description of the appearance of Helicobacter Test INFAI for children aged 3-11 and contents of the
package
Helicobacter Test INFAI for children aged 3-11 is a white, crystalline powder for oral solution.
Kit contents:

No.	Components	Quantity
1	Vial (10 ml volume, polystyrene with snap cap in polyethylene) containing 45 mg of 13C-urea powder for oral solution.	1
2	Labeled containers, in glass or plastic, for sampling, storage and transport of the breath sample for analysis: Sampling time: value-00-minutes Sampling time: value-30-minutes	2 2
3	Flexible straw for collection of breath samples into the respective sampling containers	1
4	Patient documentation form	1
5	Package leaflet	1
6	Sheet with barcode labels and adhesive	1

Marketing Authorisation Holder and Manufacturer
INFAI GmbH
An der Kohlenbahn 39
D-58135 Hagen
Germany
For further information about this medicinal product, please contact the local representative of the
Marketing Authorisation Holder.
AT, BE, BG, CZ, DE, DK, EE, ES, FI, IS, IT, LT, LU, LV, NL, NO, RO, SE
INFAI GmbH, Tel / Tél / Teл / Τηλ / Puh / Sími / Tlf.: +49 2331 349 310
Deutschland / Allemagne / Германия / Německo / Tyskland / Saksamaa / Alemania / Saksa /
Þýskaland / Germania / Vokietija / Vācija / Duitsland
CY, EL Fertithera Labs Φαρμακευτικη Μονοπρόσωπη ΙΚΕ, Τηλ: +30 699 308 8000, Ελλάδα
FR Bioprojet, Tél: +33 1 47 03 66 33
HR POLIKLINIKA LABPLUS, Tel: +385 1 299 3595, E-Mail: [email protected]
IE, UK INFAI UK Ltd., Tel: +44 1904 217 123, United Kingdom
MT Fertithera Labs Pharmaceutical Uniku Proprjetà, Tel: +30 699 308 8000, il-Greċja
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
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu .
MINIMUM INFORMATION TO BE INDICATED ON THE
PATIENT DOCUMENTATION CARD

1. NAME OF THE MEDICINAL PRODUCT

Helicobacter Test INFAI

2. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

MARKETING AUTHORISATION HOLDER
INFAI GmbH
An der Kohlenbahn 39
D-58135 Hagen
Germany

3. EXPIRY DATE

Exp. {MM/YYYY}

4. BATCH NUMBER

Batch {numero}

5. CONTENT IN WEIGHT, VOLUME OR UNITS

Test date
Patient identification code
Date of birth
Barcode
Physician/Hospital address

Package leaflet: information for the user

Helicobacter Test INFAI 75 mg oral solution powder

CliniPac Basic
without breath sample containers
urea C
Please read this leaflet carefully before taking this medicine, because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be dangerous.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Helicobacter Test INFAI is and what it is used for
What you need to know before taking Helicobacter Test INFAI
How to take Helicobacter Test INFAI
Possible side effects
How to store Helicobacter Test INFAI
Package contents 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 aged 12 years and older and adults to determine the presence of the bacterium Helicobacter pylori in the stomach.

the doctor wishes to confirm an ongoing Helicobacter pylori infection as part of diagnosing your gastrointestinal health status;
you have previously been diagnosed with a Helicobacter pylori infection and have already taken medication to eradicate the infection: the doctor wishes to check whether the treatment has been effective.

How does the test work?
All foods contain a substance called carbon-13 (C). Its presence can be detected in the carbon dioxide exhaled by the lungs. The actual amount of carbon-13 in exhaled breath depends on the type of food ingested.
You will be required to take the "test meal". Subsequently, a breath sample will be collected. See "Special instructions for use". These samples will be analyzed to measure the "normal" amount of carbon-13 contained in the exhaled carbon dioxide.
At this point, you will be required to ingest a solution of carbon-13-urea. Thirty minutes later, another breath sample will be collected and the amount of carbon-13 present in this sample will be measured. By comparing the results, it will be possible to determine the possible presence of Helicobacter pylori, indicated by a significant increase in the amount of carbon-13 in the second set of samples.

2. What you need to know before taking Helicobacter Test INFAI

Do not take Helicobacter Test INFAI

if you have or suspect you have a stomach infection or a specific inflammation of the stomach mucosa (atrophic gastritis). This inflammation of the stomach mucosa may lead to falsely positive breath test results. Further investigations may be required to confirm the presence of Helicobacter pylori.

Warnings and precautions
Consult your doctor or pharmacist before taking Helicobacter Test INFAI if you have any
disease that could affect the test or be affected by it.
Even if the result of Helicobacter Test INFAI is positive, additional tests may be necessary
before starting treatment for Helicobacter pylori infection. These are required to check for any other complications, such as:

gastric ulcer
inflammation of the stomach mucosa caused by the immune system
tumours

Data on the reliability of Helicobacter Test INFAI are insufficient to recommend its use in
patients who have undergone partial removal of the stomach.
If the patient vomits during the test, the test must be repeated. The repeat test must be performed on an empty stomach and not earlier than the following day.
Other medicines and Helicobacter Test INFAI
Helicobacter Test INFAI may be influenced by medicines that affect:

Helicobacter pylori (see section 3, second paragraph under "Instructions for use")
the urease enzyme, which promotes the breakdown of urea

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
There is no reason to believe that performing the test during pregnancy or breastfeeding has a harmful effect.
Driving and using machines
Helicobacter Test INFAI does not impair the ability to drive or operate machinery.

3. How to take Helicobacter Test INFAI

Recommended dose
Patients aged 12 years and older must take the contents of one vial for one test.

Instructions for use
You must remain fasting for 6 hours before the test, preferably overnight.
Consult your doctor if fasting poses a problem, for example in diabetic patients.
The test procedure lasts approximately 40 minutes.

The test should be performed no sooner than:

4 weeks after antibiotic therapy for bacterial infection
2 weeks after the last dose of any medication that reduces gastric acid secretion

Both groups of medications may influence the results of the Helicobacter Test INFAI, particularly following therapy aimed at eradicating Helicobacter pylori. It is important to follow the instructions for use precisely; otherwise, the result may be unreliable.

Essential components not included in Helicobacter Test INFAI
Before performing the breath test, a test meal is administered to delay gastric emptying. This test meal is not included in the kit. Suitable test meals include:

200 ml of 100% orange juice, or
1 g of citric acid dissolved in 200 ml of water

If neither of these test meals can be taken, inform your doctor, who will suggest an alternative. A glass and drinking water are required to dissolve the C-urea powder. Any repeat testing must not be performed earlier than the following day.

Special instructions for use (for infrared spectroscopy or mass spectrometry)
This medicine should be administered by medical or paramedical personnel under appropriate medical supervision. Patient data must be documented using the enclosed form. It is recommended that the test be performed while the patient is at rest.

The patient must remain fasting for 6 hours before the test, preferably overnight. If the test is performed later in the day, a light meal such as tea and a slice of toast is recommended.
For analysis by mass spectrometry, use sample collection vials for breath samples; for infrared spectroscopy, use breath collection bags. These containers are not included in the package.
The test begins with collection of baseline samples:
- Use the straw and breath sample collection container described in point 2, labeled: “sampling time: 00-minutes”.
- Remove the cap from one of the breath sample collection containers described in point 2 and insert the straw into the container after discarding its packaging.
- Slowly exhale through the straw into the breath sample collection container.
- Continue exhaling through the straw while removing it from the container, then immediately seal the breath sample collection container tightly with its cap. If the container remains open for more than 30 seconds, results may be inaccurate.
- The breath sample collection container must be kept upright, and the barcode label marked “00-minutes” must be affixed to the container.
Now fill a second breath sample collection container (labeled “sampling time: 00-minutes”) with exhaled breath, using the same method described above. The second container is required only for mass spectrometry. For infrared spectroscopy, only one breath sample collection container is needed.
Then drink the recommended test meal (200 ml of 100% orange juice or 1 g of citric acid in 200 ml of water).
Next, prepare the test solution:
- Remove the vial labeled “C-urea powder” from the packaging, open it, and fill it with water up to approximately three-quarters full.
- Close the vial and shake thoroughly until the powder is completely dissolved.
- Pour the contents into a glass. Rinse the vial twice more with water, each time transferring the rinse water to the glass, to obtain approximately 30 ml of test solution.
This test solution must be drunk immediately. The time of ingestion must be recorded.
30 minutes after taking the test solution (point 7), collect the “30-minute” breath samples into the breath sample collection containers (labeled “sampling time: 30-minutes”) as described in points 3 and 4. For these samples, use the barcode labels marked “30-minutes”.
Affix the corresponding barcode label to the patient documentation form.
All breath sample collection containers and the patient documentation must be sent to a qualified laboratory for analysis.

If you take more Helicobacter Test INFAI than you should
Since only 75 mg of C-urea is provided, overdose is not expected.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

No adverse reactions are known.
Reporting of adverse reactions
If you experience any adverse reaction, consult your doctor or pharmacist. You may also
report adverse reactions directly through the national reporting system listed in
Annex V.
By reporting adverse reactions, you can help provide more information on the safety of
this medicinal product.

5. How to store Helicobacter Test INFAI

6. Contents of the pack and other information

What Helicobacter Test INFAI contains

The active substance is urea-C. Each vial contains 75 mg of urea-C.
There are no other components.

Description of the appearance of Helicobacter Test INFAI and contents of the pack
Helicobacter Test INFAI is a white, crystalline powder for oral solution.
Contents of the kit with 50 vials:

No.	Components	Quantity
1	Vial (10 ml volume, polystyrene with snap-cap in polyethylene) containing 75 mg of 13C-urea oral solution powder.	50
2	Patient documentation card	50
3	Package leaflet	50
4	Labels with barcodes and adhesives	50

Marketing Authorisation Holder and Manufacturer
INFAI GmbH
An der Kohlenbahn 39
D-58135 Hagen
Germany
For further information on this medicinal product, please contact the local representative of the
Marketing Authorisation Holder.
AT, BE, BG, CZ, DE, DK, EE, ES, FI, IS, IT, LT, LU, LV, NL, NO, RO, SE
INFAI GmbH, Tel / Tél / Teл / Τηλ / Puh / Sími / Tlf.: +49 2331 349 310
Germany / Allemagne / Германия / Německo / Tyskland / Saksamaa / Alemania / Saksa /
Þýskaland / Germania / Vokietija / Vācija / Duitsland
CY, EL Fertithera Labs Φαρμακευτικη Μονοπρόσωπη ΙΚΕ, Τηλ: +30 699 308 8000, Greece
FR Bioprojet, Tél: +33 1 47 03 66 33
HR POLIKLINIKA LABPLUS, Tel: +385 1 299 3595, E-Mail: [email protected]
IE, UK INFAI UK Ltd., Tel: +44 1904 217 123, United Kingdom
MT Fertithera Labs Pharmaceutical Uniku Proprjetà, Tel: +30 699 308 8000, Malta
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, Slovakia / Slovenská republika
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu .
MINIMUM INFORMATION TO BE INDICATED ON THE
PATIENT DOCUMENTATION CARD

1. NAME OF THE MEDICINAL PRODUCT

Helicobacter Test INFAI

2. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

FOR PLACING ON THE MARKET
INFAI GmbH
An der Kohlenbahn 39
D-58135 Hagen
Germany

3. EXPIRY DATE

Exp. {MM/YYYY}

4. LOT NUMBER

Lot {number}

5. WEIGHT, VOLUME OR UNIT CONTENT

Test date
Patient identification code
Date of birth
Barcode
Physician/Hospital address