PDF B. PACKAGE LEAFLET - European Commission

[Pages:9]B. PACKAGE LEAFLET

Please read the following information carefully. It contains important information you need to know when using this medicine. Please ask your doctor or pharmacist if you have any questions.

1. NAME OF THE MEDICINAL PRODUCT

Helicobacter Test INFAI 13C-urea

2. FULL STATEMENT OF THE ACTIVE SUBSTANCE AND EXCIPIENTS 1 jar of powder contains 13C-urea 75mg as pharmacologically active substance and no excipients

3. PHARMACEUTICAL FORM AND CONTENTS

Content of the Test Kit

No.

Component

1 Jar (10 ml volume, polystyrene with polyethylene snap cap) containing 75 mg 13C-urea powder for oral solution

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

3 Bendable straw for collection of the breath samples into the

corresponding sample containers

4 Data sheet for patient documentation

5 Patient leaflet

6 Page of labels and sticker

Quantity 1

2 2 1

1 1 1

4. PHARMACOTHERAPEUTIC GROUP Diagnostic agent.

5. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

INFAI, Institut f?r biomedizinische Analytik & NMR-Imaging GmbH, Universit?tsstra?e 142, D-44799 Bochum, Germany.

6. THERAPEUTIC INDICATIONS

Helicobacter Test INFAI is a breath test which can be used to determine whether or not you have an infection in the stomach caused by the bacterium Helicobacter pylori.

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7. LIST OF INFORMATION NECESSARY BEFORE TAKING THE MEDICINAL PRODUCT

Contra-indications: When you should not use Helicobacter Test INFAI The test must not be used in patients with documented or suspected gastric infection or atrophic gastritis, which could interfere with the Helicobacter Test INFAI.

What should you be aware of during pregnancy and lactation? It is not expected that performing the breath test during pregnancy and lactation has a damaging effect. If you are a patient taking a drug for eradication therapy it is recommended to check the patient information leaflet of that drug with respect to the details on pregnancy and lactation.

What precautions should be taken? A positive test result does not constitute the only basis for eradication therapy. Various diagnostic tests, including invasive endoscopic tests, could be required to check for the presence of any other complications, such as gastric ulcer, infection of the gastric mucosa caused by an autoimmune reaction, and tumors.

There is insufficient data on the diagnostic reliability of the Helicobacter Test INFAI for recommending its use in patients with gastrectomy, and in patients younger than 18 years of age.

- In individual cases of A-gastritis (atrophic gastritis), the breath test can lead to false positive results; other tests may therefore be necessary to confirm the presence of Helicobacter pylori.

- If the patient vomits during the test procedure, necessitating the repetition of the test, this should be done in fasted condition and not before the following day.

Which other medications influence the effect of Helicobacter Test INFAI and how does Helicobacter Test INFAI influence the action of other medications?

Helicobacter Test INFAI is influenced by all medications related to Helicobacter pylori or urease activity.

Please remember that this information can also apply to medications used recently.

REMEMBER TO KEEP THIS MEDICINAL PRODUCT OUT OF THE REACH OF CHILDREN

8. INSTRUCTIONS FOR PROPER USE

You should perform the test in the presence of your doctor or another qualified person.

Dosage: The following information applies, unless Helicobacter Test INFAI has been otherwise prescribed by your doctor. Please follow the instructions for use, as otherwise the Helicobacter Test INFAI may not work properly.

How much Helicobacter Test INFAI should be used and how often? Adults from the age of 18 take the contents of one jar for one test.

How and when should Helicobacter Test INFAI be used? You must have fasted for 6 hours before application, preferably overnight. The test procedure lasts approximately 40 minutes.

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200 ml 100% orange juice (as a pre-administered test meal) and tap water (to dissolve the 13C-urea powder) are required for carrying out the test.

If the test needs to be repeated, this should not be done until the following day.

The test should be performed following at least four weeks without antibacterial therapy and four weeks after the last administration of an antisecretory medication. Both of these substances could influence the results of the Helicobacter Test INFAI. This is particularly true after Helicobacter eradication therapy. It is important to follow the instructions for use exactly, otherwise the result may be questionable.

Special Instructions for Use

1. Each patient should be documented using the provided data sheet. It is recommended that you take the test in a resting position.

2. The test begins with the collection of samples for determining the baseline values: ? Take the straw and both sample tubes labelled "sampling time: 00-minute-value" from the test set. ? Remove the stopper from one of the sample containers, unwrap the straw and place it into the container. ? Now breathe gently through the straw until the inside of the sample tube steams up. ? 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 test result could be falsified). The sample container should be held upright and the bar-code label marked 00-minute-value should be stuck round the sample container so that the lines of the bar-code are horizontal.

3. Now fill up the second sample container (labelled "sampling time: 00-minute-value") with breath in the same way as described above.

4. Then immediately drink the 200ml 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.

? Close the jar and shake it carefully until all the powder has dissolved completely. ? Pour the contents into a drinking glass, fill the jar a second and third time with water and

transfer the contents into the drinking glass, so that you obtain approximately 30ml of test solution. 6. You should drink this test solution immediately. The time of intake must be noted. 7. 30 minutes after taking the test solution (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 to 3. The bar-code labels marked "30-minute-value" must be used for these samples. 8. The relevant bar-code label must be put on the data sheet for patient documentation. All four breath samples 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.

What should be done if the Helicobacter Test INFAI is taken in too large amounts (intentional or inadvertent overdose)? Because only 75mg 13C-urea is provided, overdose is not to be expected.

IN CASE OF DOUBT DO NOT HESITATE TO CONSULT YOUR PHYSICIAN

9. DESCRIPTION OF UNDESIRABLE EFFECTS UNDER NORMAL USE

No side effects are known.

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Should you notice any side effects please inform your physician or pharmacist.

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10. REFERENCE TO THE EXPIRY DATE INDICATED ON THE LABEL

The expiry date for this pack is printed on the outer package and the jar. Please do not use this test after the date stated. The solution should be taken as soon as it has been prepared. Store between + 15?C and + 25?C.

11. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST REVISED

12. OTHER INFORMATION

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

For Germany, Austria, Belgium, Luxemburg, Netherlands: INFAI GmbH, Universit?tsstr. 142, 44799 Bochum, Germany; Tel.: ++49 234 971130

For UK, Ireland, Sweden, Denmark, Finland: Innovation Centre University Road Heslington York YO1 5DG UK Tel.: ++44 1904 435228

For Greece: NEOFARAN Laboratories SA, Agias Trizinas 14564 Nea Kifissia Greece; Tel.: ++30 1 8070002

For France: INFAI France SARL Eurocentre Tertiaire 50, Av. d'Alsace 68027 Colmar France Tel.: ++33 3 89204382

For Italy: SOFAR S.p.A. Via Firenze 40 20060 Trezzano Rosa MI Italy Tel.: ++39 02 9093621

For Portugal: BIOPURA Empresa Farmaceutica, Ida. Rua Marques de Pombal, N?77 1?Dt? 2735 Cancem Portugal

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Tel.: ++351 1 9135333 For Spain: NUCLEAR IBERICA, S.A. Hierro, 9 28045 - Madrid Spain Tel.: ++ 34 91 5306611

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13. Analysis of breath samples and testing specification

The breath samples, collected in 10 ml glass- or plastic sample containers, are analysed by isotope ratio mass spectrometry (IRMS).

The analysis of the 13C/12C-ratio in carbon dioxide of breath is an integrated part of the diagnostic kit Helicobacter Test INFAI. The accuracy of the test strongly depends on the quality of the breath analysis. The specification of mass spectrometer parameters like linearity, stability (reference gas precision), and precision of measurement are fundamental for the accuracy of the system.

It has to be ensured that the analysis is carried out by qualified laboratories. The method validated in the application is as follows:

13.1 Sample preparation

To determine the 13C/12C-ratio of carbon dioxide in breath by mass spectrometric analysis the carbon dioxide must be separated from the breath and introduced to the mass spectrometer. The automatic preparation system for isotope mass spectrometers which is dedicated for breath test analysis is based on a gas-chromatographic continuous flow separation technique.

Water is removed from the sample by means of a Nafion water trap or the gas-chromatographic preparation system which separates the individual gases in a gas chromatographic column with Helium as eluent. Passing the column the separated gas species of breath are detected by an ionisation detector. The fraction of carbon dioxide gas, identified by its characteristic retention time, is introduced to mass spectrometer.

13.2 Mass spectrometric analysis

To analyse the separated carbon dioxide sample gas its molecules must be ionised, formed into a beam, accelerated by an electric field, deflected in a magnetic field, and finally detected. These five processes take place in the analyser of a mass spectrometer which consists of three separate sections: the source, flight tube, and collector. Ionisation, beam formation and acceleration all occur in the source, magnetic deflection takes place in the flight tube and detection takes place in the collector.

13.3 Sample Inlet

For introduction of the carbon dioxide into the analyser many sample inlet systems are available. For breath test analysis the individual balancing of the carbon dioxide of the sample to a reference standard gas is essential. This ensures the high accuracy of this system, as calculation of the isotopic content in carbon dioxide is done with respect to an independent standard.

13.4 Specifications for 13C/12C-ratio determination

The breath test concept relies on the administration of a specifically 13C-labelled urea whose metabolite utilisation is monitored by measuring 13CO2 in the expired breath gas.

The mass spectrometer must be capable of:

Multiple replicate analysis: Minimum of 3 replicate analyses on the same sample during operation

Security access:

Storing of operating parameters and of results under security access to

avoid later manipulation

Adjustment:

13C/12C-ratio with respect to PDB (Pee Dee Beliminate)

Sample loop:

< 200 ?l

The principle tests to verify the specifications are linearity, stability (reference gas precision), and precision of measurement.

All mass spectrometers for breath analysis must comply with the following specifications:

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