Author: Torbet Laboratories Limited


Long information

What is it and how is it used?

Pylobactell is a breath test. It is used to determine the presence of the bacterium Helicobacter pylori ( H. pylori) in the gut (stomach and adjacent bowel). This bacterium may be the reason for your stomach (gastric) condition.

13C-Urea breath test, for one of the following Your doctor has recommended that you have a reasons-

  • Your doctor wants to confirm whether you are suffering from H. pylori infection to help diagnose your condition.
  • You have already been diagnosed with H.pylori and have been taking medicines aimed to clear up the infection. Your doctor now wants to find out if the treatment has worked.

This medicine is for diagnostic use only.

How does the test work?
All foods contain a substance called carbon 13 ( 13C), in varying amounts. This 13C can be detected in the carbon dioxide that you breathe out of your lungs. The actual amount of 13C in the breath will depend on the type of food that you have eaten.

C-urea solution in your You will be asked to drink a test meal. This will help keep the test 13stomach.

Following the meal, 3 samples of your breath will be taken. These samples will be analysed to measure the normal amount of 13C in the carbon dioxide in your breath.

You will then drink the Pylobactell 13C-urea solution. If H.pylori is present and active in your stomach, these bacteria will break down the 13C-urea and this is detected in the carbon dioxide in your breath.

A further 3 samples of your breath will then be taken 30 minutes later.

The amount of 13C in these samples will be compared to your normal level. If there is a significant increase in the amount of this will let your doctor know that active H. pylori is present.

Table of Contents
What do you have to consider before using it?
How is it used?
What are possible side effects?
How should it be stored?
Further information

What do you have to consider before using it?

DO NOT take Pylobactell if you:
- are allergic (hypersensitive) to 13C-urea or to any of the other ingredients in the tablets (see section 6).

  • suffer from any medical condition that you think may affect, or be affected by, the test.

Take special care

It is important that you tell your doctor if:

  • part of your stomach has been removed (partial gastrectomy) as the reliability of the test has not been proven in these patients.
  • you have or suspect you have a gastric infection.
  • you have long term stomach problems (atrophic gastritis) as the breath test may give the wrong result and other tests may be required to confirm the presence of H. pylori.
  • fasting (not taking food) may have medical implications for you.
  • you are under 18 years.

Taking other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Do not take the test if:

  • You have taken antibiotics or medication to treat Helicobacter pylori within the last 28 days.
  • You have taken proton pump inhibitors (stops indigestion) in the last 14 days.
  • You have taken H2 antagonists or antacids (relieves indigestion) on the same day of the test.
Do not stop taking medication without the advice of your doctor.

Taking Pylobactell with food and drink

You should fast for at least 4 hours before the test, so that the test is carried out on an empty stomach. If you have eaten a heavy meal, it will be necessary to fast for 6 hours before the test.
You can drink water during the fasting period.
If fasting is a problem (e.g. for diabetic patients), please tell your doctor.

Pregnancy and breast-feeding

Pylobactell can be used during pregnancy and breast-feeding.

Driving and using machines
This test should not affect your ability to drive or use machines.

How is it used?

The test will take about 45 minutes. A supply of drinking water will be needed. It is recommended that the breath test is performed while you are in a seated position. You must not smoke before or during the test.

The test procedure involves the following steps:
(A brief form of these instructions is included on the back of the Analysis Request Form)

1. Fasting: You should fast for 4 hours before taking the test (See section 2,Taking Pylobactell with food and drink)

2. Test Meal: Drink the recommended test meal. This is not included in this kit but may have been supplied separately. If no test meal has been supplied, the most suitable test meal is 200 ml of pure undiluted orange juice. If you cannot take the recommended test meal, your doctor will advise you of an alternative test meal.

3. Wait 5 minutes

4. Pre-testBreath Samples (3 White Capped Tubes) i. Remove the cap from the tube. ii. Breathe out through your mouth, using a straw, into the sample tube. iii. Gradually remove the straw from the tube as you breathe out. iv. Immediately replace the cap. v. Repeat with remaining white capped tubes.

It is not necessary to blow hard into the tubes, just breathe normally and cap them quickly.

Try to avoid getting saliva in the tubes.

5.Preparing the 13Carbon-urea solution Open the tablet sachet and empty the tablet into the mixer vial. Add water to the mark on the vial and replace the cap. Gently shake the vial to dissolve the tablet. Drink the solution. Note the time upon drinking. Fill the vial to the mark again with water and drink.

6. Wait 30 minutes from the time of drinking the Pylobactell 13C-urea solution. Do not smoke, eat or drink during this time. This is important for the proper functioning of the test.

7. Post-test Breath Samples (3 Red Capped Tubes) Using the red-capped, take samples of your breath as before (see step 4).

8. Analysis Request Form Fill out the analysis request form with the patient details on the left hand side of the form and the doctor?s name and address on the right hand side.

9. Test is now complete

Put your breath samples and the completed Analysis Request Form back into the carton and send to the address supplied by your doctor. Your doctor will tell you when the results of your test will be available and who to contact for these results.

Dispose of the empty sachet, mixing vial and straws as normal waste, but keep this leaflet for reference.

If a repeat test is required, it should not be carried out until the following day.

What are possible side effects?

No side effects to Pylobactell have been reported. If you notice any side effects, please inform your doctor or pharmacist.
13C and urea are harmless naturally occurring substance s which are found in your body.

How should it be stored?

Keep out of the reach and sight of children.
Do not store the kit above 25°C.
The tablet must be taken when dissolved.
Do not use Pylobactell after the expiry date which is stated on the carton.

Further information

What the Pylobactell tablet contains

- The active substance is 13C-urea. Each tablet contains 100 mg of 13C-urea The other ingredients are povidone E1201, microcrystalline cellulose E460i, colloidal anhydrous silica and sodium benzoate E211.

Each Pylobactell Breath Test kit contains:

  • 1 Sachet containing1 tablet.
  • 6 glass tubes, 3 with white caps and 3 with red caps.
  • 30 ml glass mixing tube with cap.
  • 2 straws.
  • 1 Analysis Request Form.
  • 1 Security Label and 3 additional bar code labels.

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 Limited, 14D Wendover Road, Rackheath Industrial Estate, Norwich, NR13 6LH, United KingdomTel. +44 (0)1603 735200
Fax. +44 (0)1603 735217
E-mail. customerservices@typharm.com

Manufacturer

PackPharm Limited, 14D Wendover Road, Rackheath Industrial Estate, Norwich, NR13 6LH, United Kingdom.

This leaflet was last approved in

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The following information is intended for laboratory use only:

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.

concentrations typically 1.0 - 6.0. This Instruments must be linear over a wide range of CO2should 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 2 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 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

M.A. Number: EU/1/98/064/001
Marketing Authorisation Holder: Torbet Laboratories Limited, 14D Wendover Road, Rackheath Industrial Estate, Norwich, NR13 6LH, United Kingdom

TEST CHECK LIST Test Check List MEDICATION RECORD Medical History - has the patient taken Type Date Mins Time

i antibiotics in the last 28 days t 0 Note time patient drinks test meal If so, please indicate type and when last taken t 5 ii proton pump inhibitors PPIs Collect Pre-Urea samples White Caps - 3 times in the last 14 days If so, please indicate type and when last taken.

iii eradication therapy in the last t 10 28 days Patient to drink urea solution, then fill bottle to line again and drink. If so, please indicate when treatment ended t 40 iv other medication if Collect Post-Urea samples Red Caps - 3 times. applicable

v patient fasted for hours Check Please note that i - iii will affect result of test. Bar-code label and all details entered on Analysis Request Form. 1 x PrePost sample reserved in store. 2 x PrePost samples this form for return to a qualified laboratory. Comments Laboratory use only Date received Analytical file reference Laboratory code

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