Pylobactell

1 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX I 

 

SUMMARY OF PRODUCT CHARACTERISTICS



 

2 

1. NAME OF THE MEDICINAL PRODUCT 

 

Pylobactell, 100 mg, Soluble Tablet 

 

 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

 

Active substance  Quantity per tablet 

 
13C-urea   100 mg 

 

For a full list of excipients, see section 6.1. 

 

 

3. PHARMACEUTICAL FORM 

 

Soluble tablet 

A white, biconvex tablet. 

 

 

4. CLINICAL PARTICULARS 

 

4.1 Therapeutic indications 

 

This medicinal product is for diagnostic use only.  

For in vivo diagnosis of gastroduodenal Helicobacter pylori infection. 

 

4.2 Posology and method of administration 
 

Pylobactell is not recommended for use in children below the age of 18 years due to 

insufficient data on efficacy. 

 

The Pylobactell tablet is for oral administration. 

 

Adults:  The tablet is to be dissolved in water and taken 10 minutes after the start of the breath 

test procedure. 

 

The patient should fast for at least 4 hours before the test so that the test is taken on an empty 

stomach. If the patient has eaten a heavy meal then it will be necessary to fast for six hours 

prior to the test.  

 

It is important to follow the instructions for use described in Section 6.6 adequately, otherwise 

the validity of the test result will be questionable. 

 

4.3 Contraindications 

 

The test must not be used in patients with documented or suspected gastric infection that 

might interfere with the urea breath test. 

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 

 

4.4 Special warnings and precautions for use 

 

A positive urea breath test alone does not clinically confirm that eradication therapy is 

indicated.  Alternative diagnosis with invasive endoscopic methods might be indicated in 



 

3 

order to examine the presence of any other complicating conditions, eg. gastric ulcer, 

autoimmune gastritis and malignancies. 

 

In individual cases of atrophic gastritis, the breath test result may have a false positive 

outcome and other tests may be required to confirm the presence of H.pylori. 

 

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

For patients who do not tolerate the recommended test meal, an alternative test meal should 

be given.  Care should be taken in patients where fasting may have medical implications. 

 

There are insufficient data on the diagnostic reliability of the Pylobactell test to recommend 

its use in patients with partial gastrectomy and in patients younger than 18 years. 

 

4.5 Interaction with other medicinal products and other forms of interaction 

 

The validity of the test result may be affected if the patient is currently being treated with 

antibiotics or a proton-pump inhibitor or has completed a course of treatment with these 

drugs.  The results may be affected in general by all treatments interfering with H.pylori 

status or urease activity. 

 

Suppression of H. pylori might give false negative results. Therefore, the test must not be 

used until four weeks without systemic antibacterial therapy and two weeks after last dose of 

acid antisecretory agents. This is especially important after eradication therapy. 

 

4.6 Fertility, pregnancy and lactation 
 

The endogenous production of urea amounts to 25 - 35 g/day.  It is therefore unlikely that the 

dose of 100 mg urea should cause any adverse effect on pregnancy and lactation. 

 

The Pylobactell test is not expected to be harmful during pregnancy or to the health of the 

foetus / newborn child. Pylobactell can be used during pregnancy and lactation. 

 

4.7 Effects on ability to drive and use machines 

 

Not relevant. 

 

4.8 Undesirable effects 
 

None known. 

 

Reporting of suspected adverse reactions  

Reporting suspected adverse reactions after authorisation of the medicinal product is 

important. It allows continued monitoring of the benefit/risk balance of the medicinal product. 

Healthcare professionals are asked to report any suspected adverse reactions via the national 

reporting system listed in Appendix V. 

 

4.9 Overdose 

 

Overdose is unlikely to occur in the intended clinical circumstances. No case of overdose has 

been reported. 

 

 

5. PHARMACOLOGICAL PROPERTIES 

 

5.1  Pharmacodynamic properties 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


 

4 

 

Pharmacotherapeutic group:  Other diagnostic agents 

 

ATC code:  V04C X. 

 

In the case of infection with H.pylori, orally ingested 13C-urea is metabolised by the enzyme 

urease which is present in H.pylori. 

 

H2N(13CO)NH2 + H2O → 2NH3 + 13CO2 
 

The carbon dioxide which is liberated diffuses into the blood vessels and is transported as 

bicarbonate to the lungs where it is then liberated as 13CO2 in exhaled air.  Infection with 

H.pylori will significantly change the 13C/12C - carbon isotope ratio. 

 

The proportion of 13CO2 in the breath samples may be determined by isotope-ratio-mass 

spectrometry (IRMS) or by another suitably-validated method carried out by any qualified 

laboratory, and stated as an absolute difference (excess) in the value between the pre-urea and 

post-urea breath samples (see Section 6.6). 

 

The cut off point for discriminating between H.pylori negative and positive patients is set to 

an excess value of 3.5, i.e. <3.5 is negative and 3.5 is positive. 

 

In comparison with biopsy based techniques for diagnosing H.pylori infection, using data 

from two therapeutic trials, Pylobactell achieved during different conditions (prestudy and 

follow-up visits) sensitivity estimates above 95 % with lower one-sided 95 % confidence limit 

ranging from 93 % to 98 %. The specificity estimates were all above 90 % with 

corresponding lower confidence limits ranging from 85 % to 90 %.  

 

5.2 Pharmacokinetic properties 

 

Urea is rapidly absorbed from the gastro-intestinal tract and distributed into extracellular and 

intracellular fluids including lymph, bile, cerebrospinal fluid and blood.  It is reported to cross 

the placenta and penetrate the eye.  It is excreted unchanged in the urine. 

 

5.3 Preclinical safety data 

 

There are no concerns in relation to the clinical use of the product. 

 

 

6. PHARMACEUTICAL PARTICULARS 

 

6.1 List of excipients 

 

Povidone (E1201) 

Microcrystalline Cellulose (E460i)  

Colloidal Anhydrous Silica  

Sodium Benzoate (E211) 

 

6.2 Incompatibilities 

 

Not applicable. 

 

6.3 Shelf life 

 

3 years.  The dissolved tablet must be taken immediately. 



 

5 

 

6.4 Special precautions for storage 

 

Do not store above 25°C. 

 

6.5 Nature and contents of container 
 

The Pylobactell 13C-urea breath test kit contains a sachet containing the Pylobactell tablet, six 

glass tubes with caps and bar code labels, three additional bar code labels, a 30 ml mixing and 

administration glass vial with cap, two straws, a package leaflet and an Analysis Request 

Form.  A security label for re-sealing the kit is also provided. 

 

The Pylobactell breath test procedure includes the administering of a suitable test meal. This 

is not supplied within the box. 

The Pylobactell tablet container is a heat-sealed PET/aluminium foil/LDPE laminated sachet. 

 

6.6 Special precautions for disposal and other handling 

 

The patient should fast for at least 4 hours before the test so that the test is taken on an empty 

stomach. If the patient has eaten a heavy meal then it will be necessary to fast for six hours 

prior to the test. 

 

It is recommended that the breath test is performed while the patient is in a seated position. 

 

Sampling instructions 

 

t = 0 minutes Note the time the patient drinks the test meal. 

 

t = 5 minutes Collect pre-urea breath samples. Three tubes of breath are to be taken by 

breathing normally through a straw held at the base of a small tube (white top).  The patient 

must expire as the straw is slowly and completely withdrawn from the tube, which is then 

immediately capped.  These breath samples are used to measure the natural level of 13C in the 

carbon dioxide of the breath. 

 

t = 10 minutes The Pylobactell tablet is placed in the 30 ml mixing vial and water added to 

the marked line. The bottle is capped and shaken well to dissolve the tablet.  The entire 

contents must be swallowed immediately by the patient, the bottle is refilled with water to the 

line and the entire contents are again swallowed by the patient. 

 

t = 40 minutes Collect post-urea (red top) breath samples. Three tubes of breath are to be 

taken, which are used to measure the presence of excess levels of 13C, which will be present if 

the patient is H.pylori positive. 

 

On completion of the test retain one pre-urea sample (white top) and one post-urea sample 

(red top).  Return two pre-urea and two post-urea samples to the box. Safely discard the 30 ml 

mixing vial.  Complete the Analysis Request Form; attach one of three spare bar code labels 

to the area marked "AFFIX BAR CODE LABEL HERE".  This bar code is the doctor's 

reference number used at the analysing laboratory as a patient identifier; the two spare bar 

code labels are for the doctor's use on the patient notes/files etc. 

 

After placing the four sample tubes and paperwork into the box, use the security label 

provided to seal the lid of the box, and send to a qualified laboratory for analysis. 

 

The optimal test meal recommended is 200 ml pure undiluted orange juice. 

 



 

6 

 

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 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 

 

 

 

7. MARKETING AUTHORISATION HOLDER 

 

Torbet Laboratories Ireland Limited 



 

7 

20 Holles Street 

Dublin 2 

Ireland 

 

+44 (0)1953 607856 

+44 (0)1953 713649 

enquiries@torbetlaboratories.co.uk 

 

 

8. MARKETING AUTHORISATION NUMBER 

 

EU/1/98/064/001  

 

 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 

 

Date of first authorisation: 07 May 1998 

Date of latest renewal:   07 May 2008 

 

 

  

10. DATE OF REVISION OF THE TEXT 

 

 

 

 

Detailed information on this medicinal product is available on the website of the European 

Medicines Agency http://www.ema.europa.eu. 

 

 

 

 

http://www.ema.europa.eu/


 

8 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX II 

 

A. MANUFACTURER RESPONSIBLE FOR BATCH 

RELEASE 

 

B. CONDITIONS OR RESTRICTIONS REGARDING 

SUPPLY AND USE 

 

C. OTHER CONDITIONS AND REQUIRMENTS OF 

THE MARKETING AUTHORISATION 

 

D. CONDITIONS OR RESTRICTIONS WITH 

REGARD TO THE SAFE AND EFFECTIVE USE OF 

THE MEDICINAL PRODUCT 

 

 



 

9 

 

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 

 

Name and address of the manufacturer responsible for batch release 

 

Idifarma Desarrollo Farmaceutico S.L. 

Polígono Mocholí 

C/ Noáin, No.1 

31110 Noáin 

Navarra,  

Spain 

 

 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE  

 

Medicinal product subject to medical prescription 

 

 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 

 

• Periodic Safety Update Reports 
 

The requirements for submission of periodic safety update reports for this medicinal product 

are set out in the list of Union reference dates (EURD list) provided for under  Article 107c(7) 

of Directive 2001/83/EC and any subsequent updates published on the European medicines 

web-portal. 

 

 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 

 

Not applicable 

 

 

 

 



 

10 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX III 

 

LABELLING AND PACKAGE LEAFLET 



 

11 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

A. LABELLING



 

12 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

OUTER CARTON/CARDBOARD BOX 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Pylobactell, 100 mg, soluble tablet 
13C-urea 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

One tablet contains: 100 mg 13C-urea  

 

3. LIST OF EXCIPIENTS 

 

Povidone (E1201), Microcrystalline Cellulose (E460i), Colloidal Anhydrous Silica, Sodium 

Benzoate (E211). 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

The kit contains: 

 

A sachet containing one Pylobactell 100 mg soluble tablet. 

Six glass tubes, with caps and bar code labels. 

30 ml mixing and administration glass vial with cap. 

Two straws. 

Package Leaflet. 

Analysis Request Form. 

Security Label and three additional bar code labels. 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Diagnostic test kit 

FOR ORAL ADMINISTRATION  

Read the package leaflet before use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE 

STORED OUT OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

8. EXPIRY DATE 

 

EXP: {MM/YYYY} 

 

 

9. SPECIAL STORAGE CONDITIONS 

 



 

13 

Do not store above 25C 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Torbet Laboratories Ireland Ltd, 20 Holles Street, Dublin 2, Ireland. 

 

12. MARKETING AUTHORISATION NUMBER(S)  

 

EU/1/98/064/001  

 

 

13. BATCH NUMBER 

 

BN 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

Medicinal product subject to medical prescription. 

 

 

16. INFORMATION IN BRAILLE 

 

Pylobactell 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

Not applicable 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

Not applicable 

 

 

 

 

 



 

14 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING 

UNITS 

 

SACHET LABEL  

 

 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF 

ADMINISTRATION 

 

Pylobactell, 100 mg, soluble tablet 
13C-urea 

Oral 

 

 

2. METHOD OF ADMINISTRATION 

 

To be dissolved in water and taken orally. Read the package leaflet before use. 

 

3. EXPIRY DATE 

 

EXP {MM/YYYY} 

 

4. BATCH NUMBER 

 

Batch 

 

5.  CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 

 

One tablet 

 

6.  OTHER 

 

Torbet Laboratories Ireland Limited, 20 Holles Street, Dublin 2, Ireland. 

 

EU/1/98/064/001 

 

 



 

15 

  

ADDITIONAL KIT ITEM: MIXING AND ADMINISTRATION VIAL 

 

LABEL 

 

Fill to line with water 

Dissolve tablet from sachet 

Shake well to dissolve 

When dissolved, drink entire contents 

Refill with water to line, shake bottle and drink 

Discard this bottle after use 

Do not return with kit 

 

 

ADDITIONAL KIT ITEM: SECURITY LABEL 

 

LABEL 

 

Seal lid of box before returning samples for analysis 

 

 

 

 

 



 

16 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

B. PACKAGE LEAFLET



 

17 

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. 

- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor, pharmacist or nurse. 
- This medicine has been prescribed for you. 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, 

pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 

4. 

 

 

What is in this leaflet:  

1. What Pylobactell is and what it is used for 

2. What you need to know before you use Pylobactell 

3. How to use Pylobactell 

4. Possible side effects 

5. How to store Pylobactell 
6. Contents of the pack and other information 

 

 

1. WHAT PYLOBACTELL IS AND WHAT IT IS USED FOR 
 

Pylobactell is a breath test for determining the presence of the bacterium, Helicobacter pylori (H. 

pylori) in the gut (stomach and adjacent bowel) which may be the reason for your stomach (gastric) 

condition.  

 

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

 

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

stomach. 

 

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 13C, this will let your doctor know that active H. pylori is present.  

 



 

18 

2. WHAT YOU NEED TO KNOW BEFORE YOU USE PYLOBACTELL 
 

DO NOT use Pylobactell if you: 

- are allergic to 13C-urea or to any of the other ingredients of this medicine (listed in Section 6). 

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

 

Warnings and precautions 

Talk to your doctor, pharmacist or nurse before using Pylobactell 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. 
 

Other medicines and Pylobactell 

Please tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take 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 in the last 14 days 

 

• You have taken H2 antagonists or antacids 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 taken on an empty stomach. If you 

have eaten a heavy meal it will be necessary to fast for six 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, pharmacist or nurse. 

 

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. 

 

3. HOW TO USE PYLOBACTELL  
 

Always use this medicine exactly as your doctor, pharmacist or nurse has told you. Check with your 

doctor, pharmacist or nurse if you are not sure. 

 

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) 



 

19 

 

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, an alternative test meal 

should be taken. Your doctor will advise you. 

 

3. Wait 5 minutes 

 

4. Pre-test Breath 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 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. 

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 

 

 

4. POSSIBLE SIDE EFFECTS 

 

No side effects to Pylobactell have been reported. 13C and urea are harmless naturally occurring 

substances which are found in your body.  

 

Reporting of side effects 

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side 

effects not listed in this leaflet. You can also report side effects directly via the national reporting 



 

20 

system listed in Appendix V.  By reporting side effects you can help provide more information on the 

safety of this medicine. 

 

 

5. HOW TO STORE PYLOBACTELL 

 

Keep out of the sight and reach 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 after EXP. The expiry date 

refers to the last day of that month. 

 

6. CONTENTS OF THE PACK AND OTHER 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 containing 1 tablet. 

• 6 glass tubes, 3 with white caps and 3 with red caps.  

• 30 ml glass mixing tube with cap. 

• 2 straws. 

• Package Leaflet  

• Analysis Request Form. 

• 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 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  

 

Detailed information on this medicine is available on the European Medicines Agency web site: 

http://www.ema.europa.eu. 

 

 

 

 

 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


 

21 

 

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 

 

 

 

 

 

 

 

 

 

 

 



 

22 

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 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 
 

(i) antibiotics in the last 28 days? 
If so, please indicate type and 
when last taken 

 t = 0 
 

Note time patient drinks test 
meal 
 

 

 
(ii) proton pump inhibitors (PPIs) 
in the last 14 days? 
If so, please indicate type and 
when last taken. 
 

 t = 5 
 

Collect Pre-Urea samples 
(White Caps - 3 times) 
 

 

(iii) eradication therapy in the last  
28 days?  
If so, please indicate when 
treatment ended 

 t = 10 
 

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

 

 
(iv) other medication (if 
applicable) 
 

 t = 40 
 

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

 

(v) patient fasted for   hours  
 
Please note that (i) - (iii) will affect 
result of test. 

  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. 

 

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

 
Comments:   
  

 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET