BREATHQUALITY-UBT 75 mg /10 Ml Oral Solution
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Інструкція із застосування BREATQUALITY-UBT
Зміст інструкції
BREATHQUALITY-UBT 75 mg/ 10 ml oral solution
C-urea
Read this leaflet carefully before you start to use this medicine as it contains important
information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
- If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
Contents of this leaflet:
- 1. What BREATHQUALITY-UBTis and what it is used for
- 2. What you need to know before you take 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 is BREATHQUALITY-UBT and what is it used for?
BREATHQUALITY-UBTis a test for the diagnosis of gastro-duodenal infection caused by a bacterium,
Helicobacter pyloriin adults and children.
BREATHQUALITY-UBT is a breath test where an air sample is required
from exhaled breath
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 any of the other ingredients of this medicine (listed in section 6).
- If you have atrophic gastritis or if you suffer from confirmed or suspected gastric infection caused by pathogens other than Helicobacter pylori, which could interfere with the urea breath test. Warnings and precautionsTalk 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 may be necessary to define the pathology associated with Helicobacter pyloriinfection, as well as the type and severity of gastritis. Use is not recommended in patients who have undergone gastrectomy. If the patient vomits during the test, making repetition necessary, this should be done possibly fasting and not before the following day. Children and adolescentsUnder normal conditions of use, BREATHQUALITY-UBTis harmless and reliable for testing in pediatric age. Other medicines and BREATHQUALITY-UBTTell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The result of the test with BREATHQUALITY-UBT will be affected by all treatments that interfere
with the presence of Helicobacter pylori or with the activity of urease.
Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before using this medicine. There is no reason to believe that performing the test may be harmful during pregnancy or breastfeeding.
Driving and operating machinery
No known effects of the active ingredient on the ability to drive vehicles and operate machinery.
3. How to use BREATHQUALITY-UBT
Use this medicine following exactly as stated in this leaflet or as instructed 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 be fasting for at least 6 hours or preferably from the eveningbefore.
- 2. Your doctor or pharmacist will ask you to blow through a straw to collect a first exhaled sample (BASE- sample) into a test tube or bag.
- 3. This procedure may be repeated to collect a second baseline sample.
- 4. Dilute the entire contents of the BREATHQUALITY-UBTvial 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 exhaled sample (POST- sample) into a test tube or bag.
- 7. This procedure may be repeated to collect a second POST sample.
- 8. Your doctor or pharmacist will process the sample for laboratory analysis.
If the test needs to be repeated, it must be performed the following day.
The C-urea breath test must be performed at least two months after the end of antibiotic treatment
, as it may provide falsely negative results if performed before this period.
Since antacids can interfere with the growth of Helicobacter pylori by creating a unfavorable microenvironment
for this microorganism, it is recommended to discontinue them for at least 15 days before
performing the test.
For instructions for use see section “Information for healthcare professionals”.
4. Possible side effects
No known undesirable effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your
doctor, pharmacist or nurse. You can also report side effects directly through the
national reporting system at: 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 which is stated on the box and the bottle.
Store the medicine at a temperature not exceeding 25°C.
Do not dispose of any medicine in the wastewater or household waste. Ask your pharmacist how to dispose of
medicines that you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What BREATHQUALITY-UBT contains
- The active ingredient is C-urea.
- The other ingredients are: citric acid monohydrate and purified water. Description of the appearance of BREATHQUALITY-UBT and contents of the packBREATHQUALITY-UBT is a liquid solution in a 10 ml bottle with a screw cap. Marketing Authorisation HolderAB 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 <-----------------------------------------------------------------------------------------------------------------------------> INFORMATION FOR HEALTHCARE PROFESSIONALSThe following information is intended exclusively for healthcare professionals:It is recommended to perform the test with the patient in a resting condition and possibly fasting for at least 6 hours or overnight. Two different instruments can be used to determine the CO , derived from the decomposition of C-urea administered:
- isotope ratio mass spectrometry (IRMS: isotope ratio mass spectrometry)
- isotope selective nondispersive infrared spectrometry (NDIRS: isotope selective nondispersive infrared spectrometry) both suitably modified for the determination of stable isotopes.
- 1) Determination with mass spectrometryA) The test begins with the collection of samples to determine the baseline value:
- fill the labels of two tubes described as “base” with the patient’s data
- open one tube and insert a straw
- have the patient breathe deeply and blow into the tube until the inner surface fogs up. The patient must completely exhale air from their lungs
- immediately close 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) fill the labels of two tubes described as “post” with the patient’s data
C) dilute the C-urea and citric acid solution contained in the bottle in a glass of water (about 200 ml)
D) have the patient drink the solution and keep them at rest
E) wait 30 minutes.
F) sample the air exhaled by the patient into the two tubes, using the procedure described above
G) analyze the air sampled in the 4 tubes with the mass spectrometer
- 2) Determination with infrared analyzerA) As for the analysis with the mass spectrometer, the test begins with the collection of samples to determine the baseline value:
- fill the label of the aluminum bag described as “base” with the patient’s data
- remove the cap of the bag and insert a straw
- have the patient breathe deeply and blow into the bag until it is completely full. The patient must completely exhale air from their lungs B) fill the label of the bag described as “post” with the patient’s data C) dilute the C-urea and citric acid solution contained in the bottle in a glass of water (about 200 ml) D) have the patient drink the solution and keep them at rest E) wait 30 minutes. F) sample the air exhaled by the patient into the bag, using the procedure described above G) analyze the air sampled in the two bags with the infrared analyzer.
Analysis of exhaled air samples and test specifications
As already reported above, the analysis of the samples can be performed by IRMS and NDIRS, obtaining
satisfactory sensitivity and specificity values.
Alternatively, any other validated method can be used for the analysis of exhaled air
samples, to be carried out in qualified centers.
Technical description of the analysis and sampling system with IRMS:
To determine the C/ C ratio of carbon dioxide in the expired air, carbon dioxide must be
separated from the expired air and introduced into the mass spectrometer. The automatic separation system for
isotopic mass spectrometers dedicated to the analysis of the expired air test is based on a continuous flow gas chromatography technique.
The sample, taken from the tube with a gas needle, is transported by a helium flow to a sampling valve and from there to a gas chromatograph where carbon dioxide, nitrogen and oxygen contained 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 the purification of CO is directly connected to the mass spectrometer via
a particular continuous flow interface.
The analyzer (MS) consists of an electron impact ion source, a magnetic sector and a triple
collector (Faraday collector) for the analysis of masses 46 ( C O O), 45 ( C O) and 44 ( C O).
Depending on the instrument, the samples are measured by comparing them with an internal reference gas, or
by comparing samples of external standard with each other.
IRMS instrumental specifications
- Precision 0.01% δ CO or <0.0001 atoms%
- Reliability internal or external calibration with standard gases
- CO concentration 0.5 - 10%
- Sample volume 2 mL on 10 mL
- Measurement time 2 minutes
Technical description of the analysis and sampling system with NDIRS:
With NDIRS, the bags containing the expired air can be analyzed directly.
Eight sample bags can be directly connected to the NDIRS spectrometer for sequential measurement.
The infrared spectrum of linear carbon monoxide molecules CO and CO differ slightly in the
asymmetric stretching of type 3 and are separated by about 66 cm .
Since no other compound present in the expired air absorbs near the wavelength of the asymmetric stretching of carbon dioxide (2240-2290 cm ), no further purification of the
samples is required.
NDIRS instrumental specifications:
- 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 (‰) compared to the international standard
Excess of δ C: difference between the measurements of pre- and post-samples
H. pyloristatus:
A) < 4‰ = negative
B) >4‰ = positive
C) values close to 4‰ = the presence of urease associated with H.pyloriis considered indeterminate.
The unused product and waste derived from this medicine must be disposed of in accordance with
local legal requirements.
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- Країна реєстрації
- Лікарська формаOral solution, 75MG/10ML
- Код АТХV04CX05
- Діюча речовина
- Потрібен рецептТак
- Виробник
- Ця інформація надана лише для ознайомлення і не є медичною порадою. Рішення щодо лікування завжди приймає лікар.
- Альтернативи до BREATQUALITY-UBTЛікарська форма: Powder for oral solution, 75 MGДіюча речовина: 13C-мочевинаВиробник: RICHEN EUROPE S.R.L.Рецепт не потрібенЛікарська форма: Soluble tablet, 100 MGДіюча речовина: 13C-мочевинаВиробник: ALFASIGMA S.P.A.Рецепт не потрібенЛікарська форма: Powder for oral solution, 75 MGДіюча речовина: 13C-мочевинаПотрібен рецепт
Аналоги BREATQUALITY-UBT в інших країнах
Препарати з тією самою діючою речовиною, доступні в інших країнах.
Аналог BREATQUALITY-UBT у Іспанія
Аналог BREATQUALITY-UBT у Україна
Лікарі онлайн щодо BREATQUALITY-UBT
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Отримайте в будь-якій аптеці
Електронний рецепт надсилається на вашу пошту — дійсний по всій Польщі.
Часті запитання
BREATQUALITY-UBT потребує рецепта в Італія. Ви можете обговорити з лікарем онлайн, чи підходить цей лікарський засіб для вашої ситуації.
Діюча речовина у BREATQUALITY-UBT — 13C-мочевина. Це допомагає визначити препарати з тим самим складом, але під іншими торговими назвами.
BREATQUALITY-UBT виробляється компанією AB ANALITICA S.R.L.. Назва бренду та упаковка можуть відрізнятися залежно від дистрибʼютора.
Лікарі, зокрема Сімейні лікарі, Психіатри, Дерматологи, Кардіологи, Ендокринологи, Гастроентерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Інфекціоністи, Алергологи, Геріатри, Педіатри, Онкологи, можуть оцінити доцільність застосування BREATQUALITY-UBT з урахуванням вашого стану та місцевих правил. Ви можете записатися на онлайн-консультацію, щоб обговорити симптоми та можливі подальші кроки.
Польща має добре розвинену систему охорони здоров'я у великих містах, таких як Варшава, Краків, Вроцлав і Гданськ. Аптеки широко доступні та працюють відповідно до чинного законодавства, забезпечуючи доступ до рецептурних препаратів.
Ви можете придбати BREATQUALITY-UBT у Варшаві, Кракові, Вроцлаві або Гданську в будь-якій аптеці за наявності дійсного рецепта.
Щоб отримати рецепт, ви можете скористатися Oladoctor:
Інші препарати з тією самою діючою речовиною (13C-мочевина) включають KITREDIKI UBT KIT, EXPIROBAKTER, ELIKOBAKTER TEST INFAI - UREA 13 K. Вони можуть відрізнятися торговою назвою або формою випуску, але містять той самий терапевтичний компонент. Перед зміною або початком прийому нового препарату варто проконсультуватися з лікарем.
