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Helicobacter Test INFAI (13C-urea) – Package leaflet - V04CX

Updated on site: 07-Oct-2017

Medication nameHelicobacter Test INFAI
ATC CodeV04CX
Substance13C-urea
ManufacturerINFAI, Institut für biomedizinische Analytik

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.

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.

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.

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.

Content of the test kit:

No.

Component

Quantity

Jar (10 ml volume, polystyrene with polyethylene snap cap)

containing 75 mg 13C-urea powder for oral solution

 

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

Bendable straw for collection of the breath samples into the

 

corresponding sample containers

 

 

Data sheet for patient documentation

Package leaflet

Page of barcode labels and sticker

Marketing Authorisation Holder and Manufacturer

INFAI, Institut für biomedizinische Analytik & NMR-Imaging GmbH

Universitätsstraße 142

D-44799 Bochum

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, Institut für biomedizinische Analytik & NMR-Imaging GmbH

Tel / Tél / Teл. / Τηλ / Puh / Sími / Tlf.: +49 234 971 130

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

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

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, Institut für biomedizinische Analytik & NMR-Imaging GmbH Universitätsstr. 142

D-44799 Bochum Germany

3.EXPIRY DATE

4.BATCH NUMBER

5.OTHER

Date of test

Patient ID

Date of birth

Barcode

Doctor/Hospital Address

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.

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.

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.

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

Jar (10 ml volume, polystyrene with polyethylene snap cap)

containing 75 mg 13C-urea powder for oral solution

 

Breath bags:

 

Sampling time: 00-minute-value

 

Sampling time: 30-minute-value

Bendable straw for collection of the breath samples into the

corresponding breath bags

 

 

Data sheet for patient documentation

Package leaflet

Page of barcode labels and sticker

 

 

Content of the test kit with 50 jars:

No.

Component

Quantity

Jar (10 ml volume, polystyrene with polyethylene snap cap)

containing 75 mg 13C-urea powder for oral solution

 

Breath bags:

 

Sampling time: 00-minute-value

 

Sampling time: 30-minute-value

Bendable straw for collection of the breath samples into the

corresponding breath bags

 

 

Data sheet for patient documentation

Package leaflet

Page of barcode labels and sticker

Marketing Authorisation Holder and Manufacturer

INFAI, Institut für biomedizinische Analytik & NMR-Imaging GmbH

Universitätsstraße 142

D-44799 Bochum

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, Institut für biomedizinische Analytik & NMR-Imaging GmbH

Tel / Tél / Teл. / Τηλ / Puh / Sími / Tlf.: +49 234 971 130

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

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

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, Institut für biomedizinische Analytik & NMR-Imaging GmbH Universitätsstr. 142

D-44799 Bochum Germany

3. EXPIRY DATE

4. BATCH NUMBER

5. OTHER

Date of test

Patient ID

Date of birth

Barcode

Doctor/Hospital Address

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.

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

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.

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

Jar (10 ml volume, polystyrene with polyethylene snap cap)

containing 45 mg 13C-urea powder for oral solution

 

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

Bendable straw for collection of the breath samples into the

corresponding sample containers

 

 

Data sheet for patient documentation

Package leaflet

Page of barcode labels and sticker

Marketing Authorisation Holder and Manufacturer

INFAI, Institut für biomedizinische Analytik & NMR-Imaging GmbH

Universitätsstraße 142

D-44799 Bochum

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, Institut für biomedizinische Analytik & NMR-Imaging GmbH Tel / Tél / Teл. / Τηλ / Puh / Sími / Tlf.: +49 234 971 130

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

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

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, Institut für biomedizinische Analytik & NMR-Imaging GmbH Universitätsstr. 142

D-44799 Bochum Germany

3. EXPIRY DATE

4. BATCH NUMBER

5. OTHER

Date of test

Patient ID

Date of birth

Barcode

Doctor/Hospital Address

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.

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.

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.

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

Jar (10 ml volume, polystyrene with polyethylene snap cap)

containing 75 mg 13C-urea powder for oral solution

Data sheet for patient documentation

Package leaflet

Barcode labels and stickers

Marketing Authorisation Holder and Manufacturer

INFAI, Institut für biomedizinische Analytik & NMR-Imaging GmbH

Universitätsstraße 142

D-44799 Bochum

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, Institut für biomedizinische Analytik & NMR-Imaging GmbH

Tel / Tél / Teл. / Τηλ / Puh / Sími / Tlf.: +49 234 971 130

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

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

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, Institut für biomedizinische Analytik & NMR-Imaging GmbH Universitätsstr. 142

D-44799 Bochum Germany

3. EXPIRY DATE

4. BATCH NUMBER

5. OTHER

Date of test

Patient ID

Date of birth

Barcode

Doctor/Hospital Address

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