Breathquality-UBT

PATIENT INFORMATION LEAFLET

Patient Information Leaflet: Information for the Patient

BREATHQUALITY-UBT 75 mg/10 ml oral solution

C-urea
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What BREATHQUALITY-UBT is and what it is used for
2. What you need to know before taking BREATHQUALITY-UBT
3. How to use BREATHQUALITY-UBT
4. Possible side effects
5. How to store BREATHQUALITY-UBT
6. Contents of the pack and other information

1. What BREATHQUALITY-UBT is and what it is used for

BREATHQUALITY-UBT is a test for the diagnosis of gastro-duodenal infection caused by a bacterium,
Helicobacter pylori, in adults and children.
BREATHQUALITY-UBT is a breath test, requiring a sample of exhaled air.
BREATHQUALITY-UBT is for diagnostic use only.

2. What you need to know before taking BREATHQUALITY-UBT

Do not take BREATHQUALITY-UBT

• If you are allergic to C-urea or to any of the other components of this medicinal product (listed in section 6).
• If you have atrophic gastritis or have confirmed or suspected gastric infection caused by pathogens other than Helicobacter pylori, which could interfere with the urea breath test.

Warnings and precautions
Talk to your doctor or pharmacist before using BREATHQUALITY-UBT. A positive result obtained after performing the 13C-Urea Breath Test does not in itself constitute an indication for eradication therapy. Further investigations might be necessary to determine the pathology associated with Helicobacter pylori infection, as well as the type and severity of gastritis. Use in patients who have undergone gastrectomy is not recommended. If the patient vomits during the test, making it necessary to repeat the procedure, the repeat test should be performed preferably on an empty stomach and not before the following day.

Children and adolescents
Under normal conditions of use, BREATHQUALITY-UBT is harmless and reliable for testing in pediatric age groups.

Other medicines and BREATHQUALITY-UBT
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

The result of the BREATHQUALITY-UBT test will be influenced by all treatments that interfere with the presence of Helicobacter pylori or with urease activity.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding with breast milk, consult your doctor or pharmacist before using this medicinal product. There is no reason to believe that performing the test could be harmful during pregnancy or breastfeeding.

Driving and using machines
There are no known effects of the active substance on the ability to drive vehicles or operate machinery.

3. How to use BREATHQUALITY-UBT

Use this medicine exactly as described in this leaflet or as directed by your
doctor, pharmacist, or nurse. If you have any doubts, consult your doctor, pharmacist, or nurse.

Test Procedure
The test procedure lasts approximately 40 minutes

1. Before starting the test, you must have fasted for at least 6 hours, or preferably since the previous evening.
2. Your doctor or pharmacist will ask you to blow through a straw to collect an initial breath sample (BASE sample) into a test tube or a bag.
3. This procedure may be repeated to collect a second baseline sample.
4. Dilute the entire contents of the BREATHQUALITY-UBT bottle in approximately 200 ml of drinking water and drink the solution.
5. Rest.
6. 30 minutes after drinking the solution, your doctor or pharmacist will ask you to blow again through a straw to collect a second breath sample (POST sample) into a test tube or a bag.
7. This procedure may be repeated to collect a second POST sample.
8. The doctor or pharmacist will process the samples for laboratory analysis.

If it is necessary to repeat the test, it should be performed the following day.
The C-urea breath test must be carried out at least two months after completion of antibiotic treatment,
as it could yield falsely negative results if performed earlier.
Since antacids may interfere with the growth of Helicobacter pylori by creating an unfavorable microenvironment for this microorganism, it is recommended to discontinue their use at least 15 days before performing the test.
For instructions for use, see section “Information for healthcare professionals”.

4. Possible side effects

No known side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via the national reporting system at the following website: http://www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store BREATHQUALITY-UBT

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and vial.
Store the medicine at a temperature not exceeding 25°C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer required. This will help protect the environment.

6. Package contents and other information

What BREATHQUALITY-UBT contains

• The active substance is C-urea.
• The other components are: citric acid monohydrate and purified water.

Description of the appearance of BREATHQUALITY-UBT and contents of the pack
BREATHQUALITY-UBT is a liquid solution in a 10 ml vial with screw cap.

Marketing Authorization Holder
AB ANALITICA srl
Via Svizzera 16 - 35127 PADOVA, ITALY
Tel. 049 761698
Fax 049 8709510
E-mail: [email protected]

Manufacturer:
ZETA FARMACEUTICI Spa
Via Galvani 10 (Z.I.) - 36066 SANDRIGO (VI), ITALY
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INFORMATION FOR HEALTHCARE PROFESSIONALS

The following information is intended exclusively for healthcare professionals:

The test should be performed with the patient at rest and preferably after fasting for at least 6 hours or overnight.
Two different instruments may be used to determine CO derived from administered C-urea:

• Mass spectrometer (IRMS: isotope ratio mass spectrometry)
• Infrared analyzer (NDIRS: non-dispersive infrared spectrometry with isotope selectivity), both suitably modified for the detection of stable isotopes.

1) Determination using mass spectrometry
A) The test begins with collection of samples to determine the baseline value:

• Label two tubes marked as "baseline" with patient information
• Open one tube and insert a straw
• Instruct the patient to inhale deeply and then blow through the straw into the tube until the inner surface becomes fogged. The patient must completely exhale all air from the lungs
• Immediately reclose the tube (if the tube remains open for more than 30 seconds, the test result may be unreliable)
• Repeat the procedure with the second tube
  B) Label the two tubes marked as "post" with patient information
  C) Dilute the C-urea and citric acid solution from the vial in a glass of water (approximately 200 mL)
  D) Have the patient drink the solution and keep them at rest
  E) Wait 30 minutes
  F) Collect expired air samples into the two tubes using the procedure described above
  G) Analyze the air samples from the four tubes using mass spectrometry

2) Determination using infrared analyzer
A) As with mass spectrometry, the test begins with collection of baseline samples:

• Label the aluminum bag marked as "baseline" with patient information
• Remove the cap from the bag and insert a straw
• Instruct the patient to inhale deeply and then blow into the bag until it is completely filled. The patient must completely exhale all air from the lungs
  B) Label the bag marked as "post" with patient information
  C) Dilute the C-urea and citric acid solution from the vial in a glass of water (approximately 200 mL)
  D) Have the patient drink the solution and keep them at rest
  E) Wait 30 minutes
  F) Collect expired air sample into the bag using the procedure described above
  G) Analyze the air samples from the two bags using the infrared analyzer

Analysis of expired air samples and test specifications
As stated above, analysis of samples can be performed using either IRMS or NDIRS, yielding satisfactory sensitivity and specificity values.
Alternatively, any other validated method may be used for analysis of expired air samples, to be conducted in qualified centers.

Technical description of the IRMS analysis and sampling system:
To determine the C/C ratio of carbon dioxide in expired breath, carbon dioxide must be separated from the expired air and introduced into the mass spectrometer. The automated separation system for isotopic mass spectrometers dedicated to breath test analysis is based on continuous-flow gas chromatographic separation technique.
The sample, drawn from the tube using a gas needle, is carried by a helium flow to a sampling valve and then into a gas chromatograph, where carbon dioxide, nitrogen, and oxygen present in the breath are separated. Water is removed from the sample by means of a trap, which varies depending on the instrument (magnesium perchlorate or diffusion system).
The gas chromatograph for CO purification is directly connected to the mass spectrometer via a special continuous-flow interface.
The analyzer (MS) consists of an electron-impact ion source, a magnetic sector, and a triple collector (Faraday collector) for analysis of masses 46 (C O O), 45 (C O ), and 44 (C O ).
Depending on the instrument, samples are measured by comparison with an internal reference gas or by comparison among external standard samples.

Instrumental specifications for IRMS:

• Precision: 0.01% δ CO or <0.0001 atom%
• Calibration reliability: internal or external using standard gas
• CO concentration: 0.5 - 10%
• Sample volume: 2 mL out of 10 mL
• Measurement time: 2 minutes

Technical description of the NDIRS analysis and sampling system:
Using NDIRS, sample bags containing expired air can be analyzed directly.
Up to eight sample bags can be directly connected to the NDIRS spectrometer for sequential measurement.
The infrared spectra of linear carbon dioxide molecules CO and CO differ slightly in their asymmetric stretching mode 3 and are separated by approximately 66 cm⁻¹.
Since no other compound present in expired air absorbs near the wavelength of the asymmetric stretching vibration of carbon dioxide (2240–2290 cm⁻¹), no further sample purification is required.

Instrumental specifications for NDIRS:

• Precision: 0.3‰ δ in the 13C/12C ratio
• CO₂ concentration: 0.5 - 5 vol.%
• Minimum sample volume: 300 mL
• Measurement time: 2 minutes per sample

Interpretation of results:
δ C: difference in parts per thousand (‰) relative to an international standard
Excess δ C: difference between pre- and post-dose sample measurements
H. pylori status:
A) < 4‰ = negative
B) > 4‰ = positive
C) values close to 4‰ = presence of urease associated with H. pylori is considered indeterminate.

Any unused product and waste material derived from this medicinal product must be disposed of in accordance with local legal requirements.