EXPIROBACTER 100 mg Растворимая Таблетка
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Инструкция по применению EXPIROBAKTER
Содержание инструкции
Expirobacter 100 mg soluble tablet
C Urea
Read this leaflet carefully before using 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 or pharmacist.
- 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 or pharmacist. See section 4.
Contents of this leaflet:
- 1. What Expirobacter is and what it is used for
- 2. What you need to know before you use Expirobacter
- 3. How to use Expirobacter
- 4. Possible side effects
- 5. How to store Expirobacter
- 6. Contents of the pack and other information
1. What is Expirobacter and what is it used for?
Expirobacter is a test for the diagnosis of gastro-duodenal infection caused by a bacterium,
Helicobacter pylori, in adults and children.
Expirobacter is a breath test where an air sample is required
exhaled.
This medicine is for diagnostic use only.
2. What you need to know before you use Expirobacter
Do not use Expirobacter
- if you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using Expirobacter.
The examination must be performed while fasting. It is important throughout the duration of the examination not to eat
food, drinks, or smoke.
The test result may be invalidated if you have recently taken antibiotics or bismuth compounds
(gastric mucosa protectors).
Children and adolescents
Expirobacter is intended for use in children and adolescents.
Other medicines and Expirobacter
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Do not use Expirobacter together with other medicines as it may alter their absorption.
If you have recently taken antibiotics, bismuth compounds or medicines that reduce acidity and
neutralize stomach acid (proton pump inhibitors), such as omeprazole, lansoprazole,
pantoprazole, a negative test result may occur without actual eradication of the
bacterium. In this case, it is advisable to wait 3-4 weeks after the end of therapy with these medicines
before performing the test.
Expirobacter with food and drink
Use Expirobacter only while fasting (see section “How to use Expirobacter”) and do not eat or
drink for the entire duration of the examination.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.
Expirobacter can be used during pregnancy and breastfeeding.
Driving and using machines
Expirobacter does not impair the ability to drive vehicles and use machines.
3. How to use Expirobacter
Use this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts
consult your doctor or pharmacist.
The test with Expirobacter must be performed while fasting. It is important not to take food, or drinks and not
smoke for the entire duration of the examination.
Expirobacter allows you to diagnose Helicobacter pyloriinfection through two different methods:
the classical method using mass spectrometry, or a method based on infrared spectrometry
such as molecular correlation spectrometry (e.g. Breath ID).
Determination by mass spectrometry
Test procedure
- 1- The doctor or pharmacist will ask you to blow through a straw to collect a first sample of exhaled air inside a test tube.
- 2- You will be asked to drink half a glass of water in which the 100 mg Expirobacter tablet and the 1.4 g sachet of citric acid have been dissolved. 3- 30 minutes after taking the solution, the doctor or pharmacist will ask you to blow through a straw again to collect a second sample of exhaled air inside a test tube. 4- The labels, already applied to the 4 test tubes, will be completed with your data and the date the test was performed.
The doctor or pharmacist will send the 4 test tubes containing the collected samples to the laboratory that will perform
the instrumental analysis. The doctor will inform you when the test results will be available and will indicate
who to contact to obtain them.
Determination by infrared molecular correlation spectrometry
Test procedure:
- 1. Wear the nasal goggles (Breath ID device) to collect the exhaled air sample.
- 2. The device will detect baseline exhaled air levels.
- 3. At the end of the baseline level recording, you will be asked to drink half a glass of water in which the 100 mg Expirobacter tablet and the 1.4 g sachet of citric acid have been dissolved.
- 4. The device will start the exhaled air analysis procedure.
- 5. Remain connected to the device until the device signals the end of the test.
The duration of the test may vary up to a maximum of 20 minutes.
Alternatively, your doctor will indicate that you go to qualified centers that use any other validated method
for the analysis of exhaled air samples.
Use in children and adolescents
In children, the dosage of Expirobacter may be halved.
If you take more Expirobacter than you should
There is no evidence of overdose risks with Expirobacter.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
No side effects have been reported with the use of Expirobacter.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Expirobacter
Keep this medicine out of sight and reach of children.
Keep the package in the outer packaging to protect the medicine from light and heat sources.
Do not use this medicine after the expiry date that is reported on the package after “Scad”. The expiry
date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines that you no longer use. This will help protect the environment.
6. Package Contents and Other Information
What Expirobacter Contains
- The active ingredient is urea marked with carbon 13 C-Urea. Each soluble tablet of Expirobacter contains 100 mg of C-Urea.
- The other ingredients are: sodium benzoate, sodium starch glycolate, microcrystalline cellulose, colloidal silica.
Description of the Appearance of Expirobacter and Package Contents
Expirobacter is available in the following packages:
- Expirobacter 100 mg soluble tablet
- Expirobacter 100 mg soluble tablet + oral suspension granules (citric acid)
One package of Expirobacter 100 mg soluble tablet contains 1 aluminum sachet which has inside
1 soluble tablet of 100 mg of C-Urea.
One package of Expirobacter 100 mg soluble tablet + oral suspension granules contains:
- 1 aluminum sachet which has inside 1 soluble tablet of 100 mg of C-Urea
- 1 sachet of citric acid of 1.4 g
Accessories:
- 2 test tubes labeled with white cap
- 2 test tubes labeled with blue cap
- 1 spatula
- 2 straws
Not all packages may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Alfasigma S.p.A. - Via Ragazzi del ’99, n. 5 - 40133 Bologna (BO)
Manufacturer
SOFAR S.p.A.
Via Firenze, 40
20060 Trezzano Rosa (MI)
INFORMATION FOR HEALTHCARE PROFESSIONALS
The following information is intended exclusively for healthcare professionals:
Expirobacter allows the diagnosis of gastroduodenal infection from Helicobacter pylori through two
different methods: the classic mass spectrometry method, or through methodologies based on
infrared spectrometry such as molecular correlation spectrometry (e.g. Breath ID ).
Determination with mass spectrometry
- 1. Open the test tube with the white cap and insert the straw into the test tube to about 1 cm from the bottom. Blow into it for about 5-10 seconds until condensation appears on the glass. At this point, continue to blow, slowly removing the straw from the test tube which must be immediately closed. Repeat the operation with the second test tube with a white cap (T0).
- 2. Dissolve the 1.4g sachet of citric acid together with the C-Urea tablet in half a glass of water. Stir and drink. Note the time and minutes of intake.
- 3. 30 minutes after taking the product, collect the breath samples into the two test tubes with the blue cap, operating as in point 1 (T30).
- 4. Complete the labels, already applied on the 4 test tubes, with the patient's name and date.
The containers of the breath samples must then be sent to the laboratory responsible for performing
the instrumental analysis.
Determination with molecular correlation infrared spectrometry
BreathID is a validated diagnostic system in which the patient is connected by nasal glasses to the
device that performs continuous reading of the exhaled air.
The analysis of the exhaled air is carried out simultaneously with the examination, the system uses infrared spectrometry with molecular correlation for the analysis of the
sample.
The test duration can vary up to a maximum of 20 minutes.
- 1. Have the patient wear the nasal glasses to collect the sample
- 2. Detect the baseline levels recorded by the device;
- 3. At the end of the baseline recording, administer to the patient orally 1 tablet of 100 mg of C-Urea, dissolved in a solution containing a 1.4 g sachet of citric acid;
- 4. Start the procedure for detecting exhaled air;
- 5. Keep the patient connected to the device until the device has obtained sufficient results to determine the positivity or negativity of the test, giving a signal of test completion.
Alternatively, any other method validated at qualified centers can be used for the analysis
of exhaled air samples.
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- Страна регистрации
- Форма выпускаSoluble tablet, 100 MG
- Код АТХV04CX05
- Действующее вещество
- Отпускается по рецептуНет
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги EXPIROBAKTERФорма выпуска: Oral solution, 75MG/10MLДействующее вещество: 13C-мочевинаПроизводитель: AB ANALITICA S.R.L.Отпускается по рецептуФорма выпуска: Powder for oral solution, 75 MGДействующее вещество: 13C-мочевинаПроизводитель: RICHEN EUROPE S.R.L.Отпускается без рецептаФорма выпуска: Powder for oral solution, 75 MGДействующее вещество: 13C-мочевинаОтпускается по рецепту
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Аналог EXPIROBAKTER в Украина
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Часто задаваемые вопросы
EXPIROBAKTER не требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество EXPIROBAKTER — 13C-мочевина. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
EXPIROBAKTER производится компанией ALFASIGMA S.P.A.. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
Врачи, включая Семейные врачи, Психиатры, Дерматологи, Кардиологи, Эндокринологи, Гастроэнтерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Инфекционисты, Аллергологи, Гериатры, Педиатры, Онкологи, могут оценить целесообразность применения EXPIROBAKTER с учетом вашей ситуации и местных правил. Вы можете записаться на онлайн-консультацию, чтобы обсудить возможные варианты.
Польша имеет хорошо развитую систему здравоохранения в крупных городах, таких как Варшава, Краков, Вроцлав и Гданьск. Аптеки широко доступны и работают в соответствии с действующим законодательством, обеспечивая доступ к рецептурным препаратам.
Вы можете купить EXPIROBAKTER в Варшаве, Кракове, Вроцлаве или Гданьске в любой аптеке при наличии действующего рецепта.
Чтобы получить рецепт, вы можете воспользоваться Oladoctor:
Другие лекарства с тем же действующим веществом (13C-мочевина) включают BREATQUALITY-UBT, KITREDIKI UBT KIT, ELIKOBAKTER TEST INFAI - UREA 13 K. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
