Helicobacter Test INFAI - patient leaflet, side effects, dosage

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 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:

Marketing Authorisation Holder

INFAI GmbH

Riehler Str. 36

D-50668 Köln

Germany

Manufacturer responsible for batch release

INFAI GmbH

An der Kohlenbahn 39

D-58135 Hagen

Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

AT, BE, BG, CZ, DE, DK, EE, FI, IS, IT, LT, LU, LV, MT, NL, NO, RO, SE

INFAI GmbH, Tel / Tél / Ten. / TnX / Puh / Sími / Tlf.: +49 221 880 443

Deutschland / Allemagne / repMaHua / Německo / Tyskland / Saksamaa / Saksa / Pýskaland /

Germania / Vokietija / Väcija / Il-Germanja / Duitsland

CY, EL ANGELINI PHARMA HELLAS SA, Tql: +30 210 626 9­200, EUáSa

ES Farmacia Calderón C.B., Tel.: +34 964 22 40 64

FR INFAI FRANCE SARL, Tél: +33 389 2043 82

HR POLIKLINIKA LABPLUS, Tel: + 385 1 299 3595, E-Mail:

IE, UK INFAI UK Ltd., Tel: +44 1904 435 228, United Kingdom

PL Dr Piktel Medic@l Systems, Tel: +48 85 744 7770

PT Sermail – Logística Integrada Lda., Tel: +351 21 973 9120

SL PLIVA LJUBLJANA d.o.o., Tel: +386 1 5890 390

HU, SK ALLMEDICAL s.r.o, Tel: +421 903 654 103, Szlovákia / Slovenská republika

This leaflet was last revised in MM/YYYY.

Detailed information on this medicine is available on the European Medicines Agency website:

MINIMUM PARTICULARS TO APPEAR ON

DATA SHEET FOR PATIENT DOCUMENTATION

• 1. NAME OF THE MEDICINAL PRODUCT

Helicobacter Test INFAI

• 2. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

INFAI GmbH Riehler Str. 36 D-50668 Köln Germany | 3. EXPIRY DATE

• 4. BATCH NUMBER

• 5. OTHER