PYLOBACTELL 100 mg Tabletki
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Treść ulotki
- WHAT IS PYLOBACTELL AND WHAT IS IT FOR
- WHAT YOU NEED TO KNOW BEFORE USING PYLOBACTELL
- HOW TO USE PYLOBACTELL
- POSSIBLE UNDESIRABLE EFFECTS
- HOW TO STORE PYLOBACTELL
- CONTENTS OF THE PACK AND OTHER INFORMATION
- Pylobactell [ Carbon]-BREATH TEST WITH UREA ( C-UBT) for the detection
Pylobactell, 100mg 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, pharmacist or nurse.
- This medicine has been prescribed for you personally. Never give it to others. Indeed, this medicine could be dangerous for other individuals, even if their symptoms are the same as yours.
- If any of the side effects worsen, or if you notice any side effect not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
Contents of this leaflet:
- 1. What Pylobactell is and what it is used for
- 2. What you need to know before using 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 IS PYLOBACTELL AND WHAT IS IT FOR
Pylobactell is a breath test. It is used for the detection of the bacterium Helicobacterpylori( H. pylori)
in the digestive tract (stomach and adjacent intestine). This bacterium may be responsible
for your gastric condition (of the stomach).
Your doctor may recommend performing the C-urea breath test for one of the following
reasons:
- confirmation of Helicobacter pyloriinfection may be helpful in diagnosing the condition from which the patient is suffering;
- if Helicobacter pyloriinfection has already been diagnosed and has already been followed by eradication therapy and the doctor wants to verify its effectiveness.
This medicine is for diagnostic use only.
How does the test work?
All foods contain the isotope 13 of carbon (C) in varying amounts. This can be detected
in the exhaled carbon dioxide. The amount of C exhaled depends on the type of food ingested.
You will be asked to take a "test meal" to delay gastric emptying.
After the meal, 3 samples of exhaled air will be taken, which will be analyzed to measure the
normal amount of C contained in the carbon dioxide of the exhaled air.
You will be given Pylobactell C-urea solution to drink. If active H. pyloriis present and active in your
stomach, it will break down the C-labeled urea which is detected in the carbon dioxide of the exhaled air.
Another 3 samples of exhaled air will be taken from you after 30 minutes.
The amount of C in the samples taken will be compared to that of normal levels. A significant
increase in C suggests the presence of active Helicobacter pylori.
2. WHAT YOU NEED TO KNOW BEFORE USING PYLOBACTELL
Do not use Pylobactell:
- if you are allergicto urea C or to any of the other ingredients of this medicine (listed in section 6).>
- if you have any medical conditionthat may affect the test or vice versa.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Pylobactell if:
- you have undergone partial removal of the stomach(partial gastrectomy), as the reliability of the Pylobactell breath test has not been validated in such patients;
- you have or suspect a gastric infection
- you have long-term stomach problems(atrophic gastritis), as the breath test may give inaccurate results and other tests may be needed to confirm the presence of
- H. pylori.
- fasting(not eating) may have medical implications for you;
- you are under 18 years of age.
Other medicines and Pylobactell
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might
take any other medicines, including those available without a prescription.
Do not take the test if:
- you have taken antibiotics or medicines for the treatment of Helicobacter pylori in the last 28 days.
- you have taken proton pump inhibitors (to stop indigestion) in the last 14 days;
- you have taken H2 antagonists or antacids (to relieve indigestion) on the same day as thetest;
Do not stop taking your medicines without consulting a doctor.
Taking Pylobactell with food and drink
You must fast for at least 4 hours before the test so that the test is performed on an empty
stomach. After a heavy meal, you will need to fast for 6 hours before performing the
test.
During the fasting period, you are allowed to drink water.
Tell your doctor, pharmacist or nurse if fasting is a problem (e.g. in the case
of diabetic patients).
Pregnancy and breastfeeding
Pylobactell can be used during pregnancy and breastfeeding.
Driving and operating machinery
The test does not impair the ability to drive or operate machinery.
3. HOW TO USE PYLOBACTELL
Use this medicine following exactly the instructions of your doctor, pharmacist or
nurse. If you have any doubts, ask your doctor, pharmacist or nurse.
The test lasts approximately 45 minutes. Drinkable water will be required.
It is recommended to perform the breath test while remaining in a seated position.
Do not smoke before or during the test.
The test is carried out in the following steps:
(a brief description of these instructions is printed on the back of the test request form)
- 1. Fasting:You must fast for at least 4 hours before the test (see section 2, Taking Pylobactell with food and drink)
- 2. Test Meal: drink the recommended test meal. This meal is not supplied with the kit but can be provided separately. If it has not been provided, the most suitable test meal consists of 200 ml of undiluted orange juice. If it is not possible to take the recommended test meal, your doctor will indicate an alternative one.
- 3. Wait 5 minutes
- 4. Pre-test samples(3 tubes with white caps).
- i. Remove the cap from the tube. ii. Using a straw, exhale air from your mouth into the tube. iii. Slowly remove the straw from the tube as the air is exhaled. iv. Immediately close the tube.
- v. Repeat with the remaining tubes with white caps.
You do not need to blow hard into the tubes; it is sufficient to exhale normally. Close the
tubes quickly.
Avoid getting saliva into the tubes.
- 5. Preparation of the carbon-labeled urea solutionC (C-urea)Open the sachet and pour the tablet into the mixing bottle. Add water up to the indicated level and cap. Shake the bottle to dissolve the tablet. Drink the solution. Note the time the product was taken. Refill the bottle with water up to the indicated level and drink.
- 6. For the test to work correctly, wait 30 minutes after taking it. Do not smoke, eat or drink at this point. This is important for the correct functioning of the test.
- 7. Post-test samples(3 tubes with red caps). Using the tubes with red caps, take the exhaled air samples following the procedure indicated previously (see point 4).
- 8. Test request form.Fill in the request form with the patient details on the left side of the form and the doctor's name and address on the right side.
- 9. The test is now complete.
Place the tubes with the air and the test request form in the packaging and send them
to the address indicated by the doctor. The doctor will inform you when the test results will be available and indicate who to contact to obtain them.
Dispose of the empty sachet, the mixing bottle and the straws as normal waste,
but keep this leaflet for reference.
If the test needs to be repeated, you must wait until the next day to perform it.
If you have any questions about the use of this medicine, ask your doctor, pharmacist or
nurse.
4. POSSIBLE UNDESIRABLE EFFECTS
No side effects of Pylobactell have been reported.
C and urea are harmless substances normally present in nature and in our body.
Reporting of undesirable effects
If you experience any undesirable effect, including those not listed in this leaflet, please contact
your doctor, pharmacist or nurse. You can also report undesirable effects directly
through the national reporting system described in Annex V. By reporting undesirable effects
you can contribute to providing more information on the safety of this medicine.
5. HOW TO STORE PYLOBACTELL
Keep this medicine out of the sight and reach of children.
Store the kit at a temperature not exceeding 25°C.
The solution must be taken when dissolved.
Do not use this medicine after the expiry date which is stated on the pack after EXP. The expiry
date refers to the last day of that month.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Pylobactell contains:
- The active ingredient is C-urea. Each tablet contains 100 mg of C-urea
- The excipients are povidone (E1201), microcrystalline cellulose (E460i), colloidal anhydrous silica, sodium benzoate (E211).
Material provided in the Pylobactell breath test kit:
- one bag containing 1 tablet.
- 6 glass vials, 3 with white caps and 3 with red caps.
- 30 ml vial with cap, for mixing;
- 2 straws;
- 1 test request form;
- 1 safety label and 3 additional barcode labels.
The kit contents are sufficient for performing only one test. If the test needs to be repeated, a new kit is
required and wait until the next day.
Marketing Authorisation Holder
Richen Europe S.R.L
VIA San Cristoforo
78-20090
Trezzano Sul Naviglio (Ml)
Italy
Tel: +39 327 972 2938
Email: [email protected]
Manufacturer
J L Bragg Limited, 33-34 Boss Hall Road, Ipswich, Suffolk, IP1 5BN, United Kingdom.
More detailed information on this medicine is available on the European Medicines Agency website:
http://www.ema.europa.eu .
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The following information is intended exclusively for laboratory use.
Analysis of exhaled air samples and test specifications
The accuracy and precision of the test depend heavily on the quality of the analysis and therefore only
laboratories that possess the corresponding specialist certification can be considered
qualified to analyze air samples.
Satisfactory specificity and sensitivity were found in clinical studies in which air samples
were analyzed using isotope ratio mass spectrometry (IRMS).
Air samples collected during a test must remain in their original containers before
IRMS analysis.
The IRMS instrument configuration must be continuous flow or dual inlet
Use a multi-position autosampler and a barcode reader to allow
sample tracking during analysis.
Origin parameters and IRMS tuning must be optimized daily.
The instrumentation must be linear over a wide range of CO concentrations (typically 1.0 –
6.0%). It must be checked regularly.
Internal analytical precision must be less than + 0.3‰ C for 20 replicate analyses of the same
gas reference sample and remain within 3SD of the mean for UBT analyses.
The transfer of air sample through the analytical system must be performed without
isotope fractionation
The IRMS must have a comprehensive triple collector to allow simultaneous detection
of ions with mass/charge ratio fluctuations 44, 45 and 46 in the isotopic content of oxygen.
Correction for movements in the instruments during analysis must be provided.
Reference gases must be standardized in relation to an appropriate international standard
to allow comparison of results from different laboratories.
Alternatively, any other suitable and approved method may be used, performed by an
objectively qualified laboratory.
Explanation of results:-
C:- Difference in parts per thousand (‰) compared to an accepted international standard.
Excess C:- Difference between pre- and post-urea sample measurements
H. pyloriStatus: <3.5 excess C = Negative
>3.5 excess C = Positive
TEST REQUEST FORM
Pylobactell [ Carbon]-BREATH TEST WITH UREA ( C-UBT) for the detection
of Helicobacterpylori
REQUEST FORM FOR ANALYSIS - Fill in capital letters
Clearly indicate the address for sending the results
Center:
Patient Name:
Date of birth:
Patient Reference:
Test Date:
Requesting Physician:
APPLY THE LABEL WITH BARCODE HERE
ADD THE LABEL WITH BARCODE TO THE PATIENT'S DOCUMENTATION, IF REQUIRED
Marketing authorization number(s): EU/1/98/064/001
Marketing authorization holder:
Richen Europe S.R.L
VIA San Cristoforo
78-20090
Trezzano Sul Naviglio (Ml)
Italy
PATIENT CLINICAL DATA CHECKLIST
OF THE TEST
Medical history - has the patient been administered
Type and
date Minut
es
Test checklist
Temp
o
- (i) antibiotics in the last 28 days? If yes, indicate the type and last administration. t = 0 Note the time the patient drinks the test meal.
t = 5 Collection of pre-urea samples
(ii) proton pump inhibitors (PPIs) (white caps – 3 times).
in the last 14 days?
If yes, indicate the
type and last administration.
(iii) eradication therapy in the
last
28 days?
If yes, indicate
when the treatment ended
t = 10 The patient drinks the solution
with urea then refills the
bottle up to the
indicated point and drinks the
solution.
t = 40 Collection of post-urea samples
(iv) other medications, if
administered?-
- (v) Has the patient been fasting for.......hours Check Barcode label and all details reported on the analysis form.
1 x pre/post sample
reserved in storage.
2 x pre/post samples + this
form to be returned to a
specialized laboratory.
For laboratory use only
Date of receipt:
Analytical file reference:
Laboratory code:
Samples registered by:
Please note that (i)-(iii) will affect the
test result
Comments:
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- Kraj rejestracji
- Postać farmaceutycznaTablet, 100 MG
- Kod ATCV04CX05
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki PYLOBAKTELLPostać farmaceutyczna: Oral solution, 75MG/10MLSubstancja czynna: 13C-ureaProducent: AB ANALITICA S.R.L.Wymaga receptyPostać farmaceutyczna: Powder for oral solution, 75 MGSubstancja czynna: 13C-ureaProducent: RICHEN EUROPE S.R.L.Bez receptyPostać farmaceutyczna: Soluble tablet, 100 MGSubstancja czynna: 13C-ureaProducent: ALFASIGMA S.P.A.Bez recepty
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PYLOBAKTELL wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w PYLOBAKTELL jest 13C-urea. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
PYLOBAKTELL jest produkowany przez RICHEN EUROPE S.R.L.. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie PYLOBAKTELL jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
Polska posiada dobrze rozwiniętą infrastrukturę ochrony zdrowia w dużych miastach, takich jak Warszawa, Kraków, Wrocław i Gdańsk. Apteki są łatwo dostępne i działają zgodnie z obowiązującymi przepisami, zapewniając dostęp do leków na receptę.
Możesz kupić PYLOBAKTELL w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
Aby uzyskać receptę, możesz skorzystać z Oladoctor:
Inne leki zawierające tę samą substancję czynną (13C-urea) to m.in. BREATQUALITY-UBT, KITREDIKI UBT KIT, EXPIROBAKTER. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
