HELICOBACTER TEST INFAI 45 mg ORAL SOLUTION POWDER for children aged 3 to 11 years

Introduction

Package Leaflet: Information for the User

Helicobacter Test INFAI for Children from 3 to 11 Years

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 symptoms 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.

Contents of the package leaflet:

1. What is Helicobacter Test INFAI for children from 3 to 11 years and what is it used for
2. What you need to know before you take Helicobacter Test INFAI for children from 3 to 11 years
3. How to take Helicobacter Test INFAI for children from 3 to 11 years
4. Possible side effects
5. 5 Storage of Helicobacter Test INFAI for children from 3 to 11 years
6. Contents of the pack and further information

1. What is Helicobacter Test INFAI for children from 3 to 11 years and what is it used for

Helicobacter Test INFAI for children from 3 to 11 years is for diagnostic use only. It is a breath test for children from 3 to 11 years to determine the presence of a stomach or duodenal infection caused by the bacteriumHelicobacter pylori.

Why should you take Helicobacter Test INFAI for children from 3 to 11 years?

You may have a gastric or duodenal infection caused by the bacterium Helicobacter pylori. Your doctor has recommended that you undergo a Helicobacter INFAI test for children from 3 to 11 years for one of the following reasons:

? The doctor wants to confirm whether you have a Helicobacter pyloriinfection in order to diagnose your condition.

? You have already been diagnosed with a Helicobacter pyloriinfection and are being treated to cure it. Now your doctor wants to know if the treatment has been successful.

What does this test consist of?

All foods contain a substance called carbon 13 (13C). This carbon 13 can be detected in the carbon dioxide that is breathed out from the lungs. The actual amount of carbon 13 contained in the breath depends on the type of food that has been ingested.

The test consists of ingesting the "test meal". Then, breath samples are taken. See "Special instructions for use". These samples will be analyzed to measure the "normal" amount of carbon 13 content in the carbon dioxide of your breath.

Next, you will need to drink a solution of carbon 13-urea. Thirty minutes after administration of the test solution, more breath samples will be taken, whose carbon 13 content will be measured again as described above. The results obtained will be compared, and if a significant increase in carbon 13 content is detected in the second set of samples, this suggests to your doctor the presence of the bacterium Helicobacter pylori.

2. What you need to know before you take Helicobacter Test INFAI for children from 3 to 11 years

Do not take Helicobacter Test INFAI for children from 3 to 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 can generate incorrect positive results from the breath test. Additional 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 from 3 to 11 years if you have any condition that may affect or be affected by the test.

Even if the result of the Helicobacter INFAI test for children from 3 to 11 years is positive, other tests may be necessary before treatment for Helicobacter pyloriinfection can be started. These are required to check for the presence of any other complications, such as:

• stomach ulcer
• infection of the stomach lining caused by the immune system
• tumors

There is not enough data on the reliability of Helicobacter Test INFAI for children from 3 to 11 years to recommend its use in patients who have had part of their stomach removed.

If the patient vomits during the test procedure, the test must be repeated. The repeat test must be done on an empty stomach and not before the next day.

Using Helicobacter Test INFAI for children from 3 to 11 years with other medicines

Medicines that influence

• Helicobacter pylori(see section 3, second paragraph in "Method of administration")
• the enzyme urease, which stimulates the reduction of urea

influence the Helicobacter Test INFAI for children from 3 to 11 years.

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.

3. How to take Helicobacter Test INFAI for children from 3 to 11 years

Follow the instructions for administration of this medicine exactly as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The test must be performed in the presence of your doctor or another qualified person.

The recommended dose is

Children from 3 to 11 years should take the contents of 1 vial for each test.

Method of administration

The patient must be fasting from 6 hours before the application, preferably during the previous night. Consult your doctor if fasting is a problem, for example, in diabetic patients.

The procedure takes approximately 40 minutes.

The test must be performed after at least:

• 4 weeks after any treatment for a bacterial infection
• 2 weeks after the last administration of any medicine to reduce acid release in the stomach

Both groups of medicines can influence the results of the Helicobacter Test INFAI for children from 3 to 11 years. Especially after treatment to eradicate Helicobacter pylori. It is important to follow the instructions for use exactly, particularly after a therapy to eradicate Helicobacter, otherwise the result may be questionable.

Essential elements not included in Helicobacter Test INFAI for children from 3 to 11 years

Before performing the breath test, the test meal must be ingested to delay stomach emptying. This test meal is not included in the package. The following are suitable test meals:

• 100 ml of pure orange juice

If there is a reason why you should not take this test meal, notify your doctor so that they can suggest an alternative. You will need a glass and water to dissolve the 13C-urea powder. If you need to repeat the test, it must not be done before the next day.

Special instructions for use(for mass spectrometry)

This medicine should only be administered by a medical professional and under adequate medical supervision. The patient's data must be documented on the data sheet provided. It is recommended to perform the test at rest.

1. The patient must be fasting from 6 hours before the application, preferably during the previous night. If the test is performed later in the day, it is recommended to have only a light meal, perhaps a cup of tea and a toast.
2. The test begins with the collection of samples for the determination of baseline values.
   • Remove the flexible tube and the two containers with the label: "sampling time: value-minute-00" from the equipment.
   • Remove the cap from one of the containers and place the flexible tube without the wrapping inside the container
   • Now exhale gently through the tube into the sample container.
   • Continue exhaling while removing the tube and immediately close the container with its cap. If the sample tube is left open for more than 30 seconds, the result may be inaccurate.
   • Keep the sample container in a vertical position and attach the label with the barcode, marked "value-minute-00", around the container, so that the barcode is horizontal.
3. Now fill the second sample container (labeled: "sampling time: value-minute-00") by exhaling in the same way as described before.
4. The patient should now drink the test meal (100 ml of pure orange juice)
5. Now prepare the test solution in the following way:
   • Remove the vial labeled: "13C-urea powder" from the equipment, open it and fill it with water up to about three-quarters full
   • Close the vial and shake carefully until all the powder is dissolved
   • Pour the contents into a glass of water, fill the vial a second and third time with water and add the contents to the same glass to obtain approximately 30 ml of test solution.
6. The patient should drink this test solution immediately. The time of ingestion should be noted.
7. 30 minutes after administration of the test solution (point 6), the "value-minute-30" samples are collected in both remaining containers in the test package (labeled "sampling time: value-minute-30") as described in points 2 and 3.

Use the labels with the barcode marked "value-minute-30" for these samples.

1. The relevant label with the barcode is placed on the patient's data sheet. The four sample containers must be returned to the original packaging. This packaging must be sealed with the blue adhesive label.
2. The package must be sent for analysis to a qualified laboratory.

Medical professionals or healthcare professionals can find detailed information on breath sample analysis and laboratory test specifications in section 6.6 of the Summary of Product Characteristics.

If you take more Helicobacter Test INFAI for children from 3 to 11 years than you should

Since only 45 mg of 13C-urea is supplied, an overdose is not 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 experience any side effects, 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. Storage of Helicobacter Test INFAI for children from 3 to 11 years

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 package after EXP. The expiry date is the last day of the month stated.

Do not store above 25°C.

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

6. Contents of the pack and further information

Composition of Helicobacter Test INFAI

• The active substance is 13C-urea.

One vial contains 75 mg of 13C-urea.

• It does not contain any other ingredients.

Appearance of the product and pack contents

The Helicobacter INFAI test is a white and crystalline powder for oral solution.

A test kit contains the following parts:

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

You can obtain further information on this medicine from the local representative of the Marketing Authorisation Holder.

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

INFAI GmbH, Tel / Tél / Te?. / Τηλ / Puh / Sími / Tlf.: +49 221 880 443

Deutschland / Allemagne / ???????? / Nemecko / Tyskland / Saksamaa / Alemania / Saksa / Þýskaland / Germania / Vokietija / Vacija / Il-Germanja / Duitsland

CY, ELANGELINI PHARMA HELLAS SA, Τηλ: +30 210 626 9200, Ελλ?δα

FRINFAI FRANCE SARL, Tél: +33 389 2043 82

HRPOLIKLINIKA LABPLUS, Tel: + 385 1 299 3595, E-Mail: [email protected]

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

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

PTSermail Logística Integrada Lda., Tel: +351 21 973 9120

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

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

Date of last revision of this leaflet: {MM/AAAA}.

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