DIABACT UBT Tablet Ref.[28028] Active ingredients: Urea ¹³C

Source: Health Products Regulatory Authority (IE) Revision Year: 2021 Publisher: Laboratoires Mayoly Spindler, 6 avenue de leurope BP 51, 78401 CHATOU Cedex, France

Product name and form

Diabact UBT 50 mg tablets.

Pharmaceutical Form
Tablets. A white, round convex tablet.

Qualitative and quantitative composition

Each tablet contains ¹³C Urea 50 mg enriched stable isotope.

For the full list of excipients, see section 6.1.

Active Ingredient	Description
Urea ¹³C	¹³C-urea is administered in the course of the breath test. After oral ingestion the labelled urea reaches the gastric mucosa. In the presence of Helicobacter pylori the ¹³C-urea is metabolised by the enzyme urease of Helicobacter pylori.

List of Excipients
Citric acid, anhydrous Silica, colloidal anhydrous Croscarmellose sodium Microcrystalline cellulose Magnesium stearate Talc

Pack sizes and marketing

Diabact UBT pack sizes:

1 tablet in aluminium blister, 2 sampling tubes with blue stopper and 2 sampling tubes with red stopper, 1 disposable straw and extra bar code labels.

10 × 1 tablets in aluminium blister (tablets only).

Not all pack sizes may be marketed.

Marketing authorization holder

Laboratoires Mayoly Spindler, 6 avenue de l’europe BP 51, 78401 CHATOU Cedex, France

Marketing authorization dates and numbers

PA1993/004/001

Date of First Authorisation: 11 October 2002
Date of Last Renewal: 22 October 2009

Drugs

Drug	Countries
DIABACT UBT	Austria, Finland, Hong Kong, Ireland, United Kingdom

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