DIABACT UBT urea[13C] 50 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

urea(13C), Quantity: 50 mg

Available from:

Medical Diagnostics Australasia Pty Ltd

INN (International Name):

urea(13C)

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: magnesium stearate; colloidal anhydrous silica; croscarmellose sodium; purified talc; microcrystalline cellulose; citric acid

Administration route:

Oral

Units in package:

10 tablets

Prescription type:

Not Scheduled after consideration by Committee

Therapeutic indications:

This medicinal product is for diagnostic use only. Diabact UBT is for in vivo diagnosis of gastroduodenal Helicobacter pylori infection.

Product summary:

Visual Identification: white, round, convex uncoated tablet; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 4 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2008-06-16

Patient Information leaflet

DIABACT UBT 50MG TABLET PRODUCT LEAFLET (CONSUMER MEDICINE)
INFORMATION
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 BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
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 only. Do not pass it on to
others. It may harm
them, even if their symptoms are the same as yours.
-
If you experience any side effects, talk to your doctor or pharmacist.
This includes any
posible side effects not listed in this leaflet. See seciton 4.
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._
_ _
WHAT YOU NEED TO KNOW 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.
OTHER MEDICINES AND DIABACT UBT
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.
Page 1 of 5
DIABACT UBT 50MG TABLET PRODUCT LEAFLET (CONSUMER MEDICINE)
INFORMATION
TAKING DIABACT UBT WITH FOOD AND DRINK
-
You shoul

Summary of Product characteristics

DIABACT UBT 50MG TABLET AUSTRALIAN PRODUCT INFORMATION
Page 1 of 7
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 bacterial urease the ratio of the
13
C/
12
C-carbon isotopes is significantly
changed.
The
proportion
of
13
CO
2
in
the
breath
samples
is
determined
by
isotope-ratio-mass-
spectrometry (IRMS) or Infra-red spectroscopy and stated as the
absolute difference (excess