Consumer medicine information

Diabact UBT

Urea (13C)

BRAND INFORMATION

Brand name

Diabact UBT

Active ingredient

Urea (13C)

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Diabact UBT.

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 13C-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.

Taking Diabact UBT with food and drink

  • You should not eat for at least 6 hours before the test is performed. You may drink some water up to the time the test is performed.

Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine. It is not expected that performing the breath test during pregnancy and lactation has a damaging effect.

Driving and using machines
Diabact UBT has no known effects on the ability to drive or to use machines.

3. How to take Diabact UBT

Always take Diabact UBT exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

You should be fasting for at least 6 hours before the test is performed. The usual dose is one tablet as single dose. The tablet should be swallowed as whole with a glass of water. If the tablet is chewed, the test must be performed again as the risk of false results increase. A new test may be performed at the earliest the following day.

Stepwise description of the test procedure

To perform the test, 4 test tubes with stoppers and a straw are used.

  1. You should begin the procedure with the two 00-MINUTES test tubes with blue stopper.
  • Unscrew the stopper
  • Place the straw in the bottom of the test tube
  • Take a deep breath and blow gently into the tube.
  • Remove the straw from the tube and close the tube with the stopper.
  • Check that the stopper is properly closed.
  • Repeat the test with the other 00-MINUTES test tube
  1. Swallow the tablet with a glass of water.
  2. Wait for 10 minutes in an upright position (standing or sitting)
  3. Blow into the two 10-MINUTES tubes with red stoppers in the way described above.

After the test has been performed, the tubes should be placed in the box, if the Diabact UBT kit is used. The address of the testing laboratory is to be filled in on the designated place on the underside of the box.

If you have any further questions on the use of this product, please ask your doctor or pharmacist.

If you take more Diabact UBT than you should
Because only 1 tablet is provided in each kit, no overdose is expected. If you are uncertain, please contact your doctor.

4. Possible side effects

Like all medicines Diabact UBT can cause side effects, although not everybody gets them.

Taste disturbance has been commonly reported. Stomach pains, nausea, vomiting, fatigue and distortion of the sense of smell (parosmia) have also been reported. These effects are usually mild and short-lived.

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.

Reporting of side effects

If you are experiencing an adverse event or think you may be experiencing one, including any possible side effects not listed in this leaflet, please seek advice from a doctor or pharmacist as soon as possible. The adverse event should then be reported in accordance with the Australian Adverse Drug Reaction Reporting System (https://www.ebs.tga.gov.au/ebs/ADRS/ADRSRepo.nsf?OpenDatabase).

If you need urgent medical help call 000. If you have experienced an overdose or suspected poisoning, call the Poisons Information Centre, 24 hours a day on 13 11 26.

5. How to store Diabact UBT

Keep out of the reach and sight of children.

Do not use Diabact UBT after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.

Store in the original package to protect from light.
Store below 25°C.

Tablets individually sealed in foil. Do not use if foil is broken.

Do not dispose of medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information

What Diabact UBT contains

  • The active substance is 13C-urea enriched stable isotope. Each tablet contains 50 mg 13C-Urea
  • The other ingredients are anhydrous citric acid, colloidal anhydrous silica, croscarmellose sodium, microcrystalline cellulose, magnesium stearate and talc.

What Diabact UBT looks like and contents of the pack

Diabact UBT is a white round convex tablet.

Pack sizes:
1 tablet (kit)
10 x 1 tablets (without sample tubes and disposable straw).

EU Marketing Authorisation Holder

Kibion AB
Box 303
SE-751 05 Uppsala Sweden
Phone: +46 18 780 88 00

Manufacturer

Idifarma Desarrollo Farmacéutico, S. L.
Poligono Mocholi
Calle Noáin No. 1
31110 Noáin (Navarra)
Spain

Distributed in Australia by

Medical Diagnostics Australasia Pty Ltd
18/632-642 Clayton Road
Clayton South Vic 3169
Australia

This medicinal product is authorised in the Member States of the EEA under the following names:

Diabact UBT (SE)

Diabact UBT 50mg Tabletten (AT), (DE)

Diabact UBT 50mg Tablet (UK), (IE)

Diabact UBT 50mg (DK), (FI), (NO)

This leaflet was revised in February 2016

AUST R 135657 DIABACT UBT 13C urea tablet blister pack with other components kit;

AUST R 146728 DIABACT UBT 13C urea 50 mg tablet blister pack

Published by MIMS November 2017

BRAND INFORMATION

Brand name

Diabact UBT

Active ingredient

Urea (13C)

Schedule

Unscheduled

 

Name of the medicine

Urea [13C].

Excipients.

Citric acid - anhydrous, silica - colloidal anhydrous, croscarmellose sodium, cellulose - microcrystalline, magnesium stearate, talc - purified.

Description

The structural formula of the 13C-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% 13C-enriched urea is [58069-82-2]. There is no specific CAS registry number for 13C-urea enriched to not less than 99% with carbon-13.
Urea [13C] is urea enriched with 13C-stable non-radioactive isotope. The chemical properties of 13C-urea do not differ from those of natural urea, which contains the 13C 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 50 mg 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 13C-urea labeled urea tablets will rapidly disintegrate on reaching the stomach. In case of infection with Helicobacter pylori (H. pylori) 13C-urea is metabolized by the enzyme urease, which is present in H. pylori:
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 13CO2 in exhaled air.
In the presence of bacterial urease the ratio of the 13C/12C-carbon isotopes is significantly changed.
The proportion of 13CO2 in the breath samples is determined by isotope-ratio-mass-spectrometry (IRMS) or infra-red spectroscopy and stated as the absolute difference (excess) in the 13CO2 value between a pre-urea (00-minute) and post-urea (10-minute) breath sample.
The cut-off point for differentiating between H. pylori positive and negative patients is set to an excess value of 1.5% i.e. < 1.5% is negative and > 1.5% is positive.
Urease is produced in the stomach only by Helicobacter pylori. Other urease-producing bacteria are seldom found in the gastric flora.
In the absence of bacterial urease, the whole amount of administered urea (after absorption from the gastrointestinal tract) will be metabolised like the endogenous urea. Ammonia, which is produced as described above by bacterial hydrolysis, is included in the metabolism as NH4+.

Pharmacokinetic properties.

Urea is rapidly absorbed from the gastrointestinal tract and distributed into extracellular and intracellular fluids including lymph, bile, cerebrospinal fluid and blood. It is reported to cross the placenta and penetrate the eye.
Absorption and distribution of 13CO2 is faster than the urease reaction. Therefore, the rate-limiting step in the whole process is the cleavage of 13C-urea by urease from H. pylori.
Only in H. pylori-positive patients would administration of 13C-urea result in a significant increase of 13CO2 in the breath sample within the first 10 minutes.
Urea is excreted unchanged in the urine.

Clinical Trials

In total 1,413 evaluable patients were involved in six open studies sponsored by Diabact AB (see Table 1). As a result of the studies it was determined that the optimal cut-off point for Diabact UBT is 1.5%0 (an increase in △ delta-value of 1.5 parts per thousand indicated H. pylori infection. Key or quality criteria for efficacy of this diagnostic test, which have to be satisfactorily addressed are accuracy, linearity, reproducibility, sensitivity and specificity in particular in comparison to the existing gold standards such as existing urea breath test products, biometric analysis and acid test meals. In study DB 01B Diabact UBT was used in the presence of acid suppression therapy (omeprazole).
The breath test was performed under fasting and non-fasting conditions. More accurate results were obtained after fasting.
13C-urea breath test is a non-invasive method to detect active gastroduodenal H. pylori infection. The clinical trials show a high efficacy of the breath test with the specified parameters dosage and cut off-point, independent of use after or before therapy of H. pylori infection. The sensitivity for the breath test, compared to bioptic diagnostics of an infection with H. pylori, obtained from Diabact AB sponsored studies was 96% (DB 008) and 98% (DB 004) and the specificity was 100% (DB 008 and DB 004).
The Receiver Operator Curve (ROC) after administration of this product after fasting follows (DB 008) (see Figure 1):

Indications

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

Contraindications

The test must not be used in patients with documented or suspected gastric infection which might interfere with the urea breath test.
Hypersensitivity to the active substance or to any of the excipients.

Precautions

A positive urea breath test alone does not clinically confirm that eradication therapy is indicated. Differential diagnosis with invasive endoscopic methods might be indicated in order to examine the presence of any other complicating conditions, e.g. gastric ulcer, autoimmune gastritis and malignancies.
In individual cases of atrophic-gastritis the breath test may have false positive results and other tests may be required to confirm the presence of H. pylori.
The tablet must be swallowed whole. If the patient chews the tablet, the test must be performed again as the risk of false positive outcomes increases. A new test may be performed the following day.
There are insufficient data on the diagnostic reliability the Diabact UBT test to recommend its use in patients with partial gastrectomy.

Use in children.

There are insufficient data to recommend the use of Diabact UBT in patients younger than 18 years.

Use in pregnancy.

(Category B2)
Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human foetus having been observed.
The endogenous production of urea amounts to 25-35 g/day. It is therefore unlikely that the dose of 50 mg urea should cause any adverse effects on pregnancy and lactation.
Diabact UBT is not expected to be harmful during pregnancy or to the health of the foetus/newborn child. Diabact UBT can be used during pregnancy.

Use in lactation.

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Diabact UBT is administered to a lactating woman. Diabact UBT can be used during lactation.

Effects on fertility.

No studies have been conducted with 13C-urea to evaluate its potential for the impairment of fertility. Studies of the genotoxic potential of urea have shown gene mutations, chromosomal damage (cytogenetic assays in vitro and in vivo) and DNA damage in vitro.

Carcinogenicity/mutagenicity.

No studies have been conducted with 13C-urea to evaluate its potential for carcinogenicity. Studies of the genotoxic potential of urea have shown gene mutations, chromosomal damage (cytogenetic assays in vitro and in vivo) and DNA damage in vitro.

Effects on laboratory tests.

None known.

Interactions

The validity of the test result may be affected if the patient is currently being treated with antibiotics or a proton-pump inhibitor or has completed a course of treatment with these drugs. The results may be affected in general by all treatments interfering with H. pylori status or urease activity.
Suppression of H. pylori may lead to false negative results. Therefore, the test must not be used before at least four (4) weeks after systemic antibacterial therapy and at least two (2) weeks after last dose of acid antisecretory agents. This is especially important after eradication therapy.

Adverse Effects

In clinical studies taste disturbance was commonly reported. Abdominal pain, nausea, vomiting, parosmia and fatigue were reported uncommonly. These adverse events were mild to moderate in severity, transient and resolved without further treatment.
Reporting of suspected adverse reactions is important as it allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reaction in accordance with the Australian Adverse Drug Reactions Reporting System (https://www.ebs.tga.gov.au/ebs/ADRS/ADRSRepo.nsf?OpenDatabase).

Dosage and Administration

Diabact UBT is a breath test. It is for oral administration.

Adults.

One tablet as a single dose on one test occasion. The patient should fast for at least six hours preceding the test. An initial breath test sample is taken after which the tablet is swallowed whole with a glass of water. A breath sample is taken after ten minutes.
It is important to follow the instructions for use described below, otherwise the validity of the outcome will become questionable.

Administration of the test.

The test should be performed in the presence of a qualified person.
If the test is to be carried out in the morning, the patient should fast overnight and not eat breakfast. If the test is to be carried out later in the day, or if fasting is a problem for the patient, then a light breakfast only e.g. tea and toast, is recommended. If the patient has eaten a heavy meal then it will be necessary to fast for six hours prior to the test.

Stepwise description of the test procedure.

To perform the test, 4 test tubes with stoppers and a straw are used.
Keep one of the extra bar code labels as a reference label for the patient journal.
1. The patient should begin the procedure by blowing into the two 00-MINUTES test tubes (blue stopper).
Unscrew the stopper.
Place the straw in the bottom of the test tube.
Take a deep breath and blow gently into the tube.
Remove the straw from the tube and close the tube with the stopper.
Repeat the test with the other 00-MINUTES test tube.
2. Swallow the tablet with a glass of water.
3. Wait for 10 minutes.
4. Blow into the two 10-MINUTES tubes (red stopper) in the same way as described above.
After the test has been performed, the tubes should be placed in the box. The address of the testing laboratory is to be filled in on the designated place on the underside of the box.

Analysis of breath samples.

It must be ensured that the analysis is carried out by qualified (approved and certified) laboratories.
The proportion of 13CO2 in the breath samples is determined by isotope-ratio-mass-spectrometry (I RMS) or by another suitably validated method carried out by any qualified laboratory and stated as the absolute difference (excess) in the 13CO2 value between a pre-urea (00-minute) and post-urea (10-minute) breath sample.

Explanation of analysis results.

△ delta-value: Difference in parts per thousand (%0) between the 00-MINUTE and the 10-MINUTE value.
H. pylori status: < 1.5%0 △ delta-value - negative H. pylori status.
≥ 1.5%0 △ delta-value - positive H. pylori status.

Overdosage

Overdose is unlikely to occur in the intended clinical circumstances. No case of overdose has been reported with Diabact UBT.

Presentation

Diabact UBT 50 mg tablets are white, round and convex.
List of excipients: citric acid - anhydrous, silica - colloidal anhydrous, croscarmellose sodium, cellulose - microcrystalline, magnesium stearate, talc - purified.
See Table 2.
ARTG numbers: AUST R 135657 Diabact UBT 13C urea tablet blister pack with other components kit; AUST R 146728 Diabact UBT 13C urea 50 mg tablet blister pack.

Storage

Store below 25°C. Store in the original package, in order to protect from light.

Poison Schedule

Unscheduled.