Helicobacter Test INFAI
13C-urea
13C-urea
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 Helicobacter Test INFAI is and what it is used for
What you need to know before you take Helicobacter Test INFAI
How to take Helicobacter Test INFAI
Possible side effects
5 How to store Helicobacter Test INFAI
6. Contents of the pack and other information
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.
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.
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.
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.
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.
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.
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.
Helicobacter Test INFAI has no influence on the ability to drive or to use machines.
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.
Patients from the age of 12 must take the content of one jar for one test.
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.
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.
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.
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.
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.
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.
Then the patient must drink the recommended test meal (200 ml 100 % orange juice or 1 g citric acid in 200 ml water).
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.
The patient should drink this test solution immediately. The time of intake must be noted.
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.
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.
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.
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.
No side effects are known.
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.
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 25C.
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.
The active substance is 13C-urea.
One jar contains 75 mg 13C-urea.
There are no other ingredients.
Helicobacter Test INFAI is a white, crystalline powder for oral solution.
Content of the test kit:
No. | Component | Quantity |
1 | Jar (10 ml volume, polystyrene with polyethylene snap cap) containing 75 mg 13C-urea powder for oral solution | 1 |
2 | Labelled sample glass- or plastic- containers for sampling, storing and transporting the breath samples for analysis: Sampling time: 00-minute-value Sampling time: 30-minute-value | 2 2 |
3 | Bendable straw for collection of the breath samples into the corresponding sample containers | 1 |
4 | Data sheet for patient documentation | 1 |
5 | Package leaflet | 1 |
6 | Page of barcode labels and sticker | 1 |
INFAI GmbH
Riehler Str. 36 D-50668 Köln
Germany
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:
INFAI GmbH, Tel / Tél / Teл. / Τηλ / Puh / Sími / Tlf.: +49 221 880 443
Deutschland / Allemagne / Германия / Německo / Tyskland / Saksamaa / Saksa / Þýskaland / Germania / Vokietija / Vācija / Il-Ġermanja / Duitsland
Helicobacter Test INFAI
INFAI GmbH
Riehler Str. 36 D-50668 Köln
Germany
Date of test Patient ID Date of birth Barcode
Doctor/Hospital Address