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AstraZeneca

Pylobactell
13C-urea

PACKAGE LEAFLET: INFORMATION FOR THE USER


Pylobactell 100mg soluble tablet

13C-Urea


Read all of this leaflet carefully before you start using this medicine because it contains important information for you.


The contents of this kit are sufficient for a single test. If you need to repeat the test, a new kit will be required and it should not be carried out until the following day.


Marketing Authorisation Holder


Torbet Laboratories Ireland Limited, 20 Holles Street, Dublin 2, Ireland Tel. +44 (0)1953 607856

Fax. +44 (0)1953 713649

E-mail enquiries@torbetlaboratories.co.uk


Manufacturer


Idifarma Desarrollo Farmaceutico S.L., Polígono Mocholí, C/ Noáin, No.1, 31110 Noáin, Navarra, , Spain.


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


This leaflet was last revised in


.eu.

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Analysis of breath samples and testing specification


The accuracy and precision of the test depends heavily on the quality of the analysis and therefore only laboratories having appropriate certification are considered qualified to analyse the breath samples.


Satisfactory specificity and sensitivity have been demonstrated in clinical studies where breath was analysed using isotope ratio mass spectrometry (IRMS).


Breath samples collected during a test must remain in the original containers before analysis by IRMS. IRMS instruments may be of continuous flow or dual inlet configuration.

A multi-position autosampler and bar code reader should be used to allow samples to be tracked throughout the analysis.


IRMS source parameters and tuning must be optimised daily.



Instruments must be linear over a wide range of CO2 concentrations, typically 1.0 - 6.0%. This should be checked routinely.


Internal analytical precision must be less than + 0.3 ‰ 13C for 20 replicate analyses of the same reference gas sample and remain within 3SD’s of the mean for breath analyses.


Transfer of the breath sample through the analytical system must be accomplished without isotope fractionation.


The IRMS must possess a triple collector to allow the simultaneous detection of the ions at mass/charge ratio 44, 45 and 46 to allow for fluctuations in the oxygen isotope content.


There must be provision for correction of instrumental drift during an analysis.


Reference gases must be standardised against an appropriate international standard to allow inter- laboratory comparison of results.


Alternatively, any other suitably-validated method may be used, carried out by any objectively qualified laboratory.


Explanation of results:-


13C:- Difference in parts per thousand (‰) with respect to an accepted international standard

Excess 13C:- Difference between pre- and post-urea sample measurements


H. pylori status: - < 3.5 excess 13C = Negative

> 3.5 excess 13C = Positive

ANALYSIS REQUEST FORM:

Pylobactell [13Carbon] -UREA BREATH TEST (13C-UBT) for Helicobacter pylori ANALYSIS REQUEST FORM - Please complete in block capitals

Please state clearly address for return of results: Centre:

Patient Name:

Date of Birth: Patient Reference: Date of Test: Referring Doctor:


AFFIX BAR-CODE LABEL HERE

PLEASE PLACE BAR-CODE LABEL ON PATIENT RECORDS, IF APPLICABLE


    1. Number: EU/1/98/064/001

      Marketing Authorisation Holder: Torbet Laboratories Ireland Limited, 20 Holles Street, Dublin 2, Ireland


      MEDICATION RECORD TEST CHECK LIST

      Medical History - has the patient taken :

      Type

      &Date

      Mins Test Check List Time


      1. antibiotics in the last 28 days? If so, please indicate type and when last taken


      2. proton pump inhibitors (PPIs) in the last 14 days?

        If so, please indicate type and

        when last taken.

        t = 0 Note time patient drinks test meal


        t = 5 Collect Pre-Urea samples (White Caps - 3 times)


      3. eradication therapy in the last 28 days?

        If so, please indicate when treatment ended


      4. other medication (if applicable)

        t = 10 Patient to drink urea solution, then fill bottle to line again and drink.


        t = 40 Collect Post-Urea samples (Red Caps - 3 times).


      5. patient fasted for hours


        Please note that (i) - (iii) will affect result of test.


        Laboratory use only Date received: Analytical file reference: Laboratory code: Samples logged on by :

        Check Bar-code label and all details entered on Analysis Request Form.

        1. x Pre/Post sample reserved in store.

        2. x Pre/Post samples + this form for return to a qualified laboratory.


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