PIL
DIABACT UBT 50MG TABLET PRODUCT LEAFLET (CONSUMER MEDICINE)
INFORMATION
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AUS
PACKAGE LEAFLET:
DIABACT UBT 50MG TABLETS
13
C-UREA
INFORMATION FOR THE USER
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
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 any of the side effects gets serious, or if you notice any side
effects not listed in this
leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Diabact UBT is and what it is used for
2.
Before you take Diabact UBT
3.
How to take Diabact UBT
4.
Possible side effects
5.
How to store Diabact UBT
6. Further
information
1.
WHAT DIABACT UBT IS AND WHAT IT IS USED FOR
This medicine is for diagnostic use only to determine the presence
of _Helicobacter pylori_.
Diabact UBT is a breath test that can be used to determine whether or
not you have a primary
or remaining infection in the stomach caused by the
bacterium _Helicobacter pylori._
_2. _
BEFORE YOU TAKE DIABACT UBT_ _
DO NOT TAKE DIABACT UBT
- if you are allergic (hypersensitive) to
13
C-urea or to any of the other ingredients of
Diabact UBT.
- if you have an infection in the stomach, as it may cause a false
result.
USING OTHER MEDICINES
Diabact UBT may be affected by other medicines. Please tell your
doctor or pharmacist if you
are taking or have recently taken any other medicines, including
medicines obtained without a
prescription._ _
- The risk for obtaining wrong diagnosis is increased if the test
is performed within four
(4) weeks after using antibiotics and within two (2) weeks after the
last dose of acid
reduction treatments.
DIABACT UBT 50MG TABLET PRODUCT LEAFLET (CONSUMER MEDI
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DIABACT UBT 50MG TABLET AUSTRALIAN PRODUCT INFORMATION
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DIABACT UBT
AUSTRALIAN PRODUCT INFORMATION
NAME OF THE DRUG
Each tablet contains Urea [
13
C] 50mg.
Structural Formula:
O
| |
H
2
N -
13
C - NH
2
The structural formula of the
13
C-urea is identical to that of urea. The superscript (
13
) on the left
of the chemical symbol for carbon (C) indicates the enrichment of
the molecule with carbon-
13.
The CAS Registry Number for 97%
13
C-enriched urea is [58069-82-2]. There is no specific
CAS Registry Number for
13
C-urea enriched to not less than 99% with carbon-13.
DESCRIPTION
Urea [
13
C] is urea enriched with
13
C –stable non-radioactive isotope. The chemical properties of
13
C-urea do not differ from those of natural urea, which
contains the
13
C isotope at a
concentration of approximately 1%. It is very soluble in water,
soluble in ethanol and
practically insoluble in dichloromethane. Its molecular weight is
61.05.
Diabact UBT 50mg is presented as a diagnostic kit (1 tablet)
or a tablet pack (10 tablets), the
components of which are detailed in the PRESENTATION section of this
document.
For excipients, see the PRESENTATION section of this document.
PHARMACOLOGY
PHARMACODYNAMIC PROPERTIES
Pharmacotherapeutic group: Other diagnostic agents.
ATC-code: V04C X
After oral ingestion
13
C-urea labeled urea tablets will rapidly disintegrate on reaching
the
stomach. In case of infection with _Helicobacter pylori_ (_H.
pylori_)
13
C-urea is metabolized by the
enzyme urease, which is present in _H. pylori_:
Enzyme urease
H
2
N(
13
CO)NH
2
+ H
2
O
2NH
3
+
13
CO
2
The carbon dioxide, which is liberated, diffuses into the blood
vessels and is transported as
bicarbonate to the lungs where it is then released as
13
CO
2
in exhaled air.
In the presence of bact
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PIL ![Urea(13C); 13C-Urea or Urea [13C]](/web/img/edge.svg){kind=small}