DIABACT UBT Tablet (2021)
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Περιεχόμενα
1. Name of the medicinal product
Diabact UBT 50 mg tablets.
2. Qualitative and quantitative composition
Each tablet contains <sup>13</sup>C Urea 50 mg enriched stable isotope. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablets. A white, round convex tablet.
4.1. Therapeutic indications
This medicinal product is for diagnostic use only. For <em>In vivo</em> diagnosis of gastroduodenal primary or remaining <em>Helicobacter pylori</em> infection.
4.2. Posology and method of administration
Diabact UBT tablet is for oral administration. One tablet as a single dose at one test occasion. The patient should fast for at least six hours preceding the test. An initial breath test sample is taken ...
4.3. Contraindications
The test must not be used in patients with documented or suspected gastric infection that might interfere with the urea breath test. Hypersensitivity to the active substance or to any of the excipients ...
4.4. Special warnings and precautions for use
A positive urea breath test alone does not clinically confirm that eradication therapy is indicated. Alternative diagnosis with invasive endoscopic methods might be indicated in order to examine the presence ...
4.5. Interaction with other medicinal products and other forms of interaction
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 ...
4.6. Pregnancy and lactation
Pregnancy and breastfeeding 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. ...
4.7. Effects on ability to drive and use machines
Diabact UBT has no known or negligible influence on the ability to drive or to use machines.
4.8. Undesirable effects
Isolated reports of stomach pain, fatigue and distortion of the sense of smell (parosmia) have been reported in one clinical trial. Reporting of suspected adverse reactions Reporting suspected adverse ...
4.9. Overdose
Overdose is unlikely to occur in the intended clinical circumstances. No case of overdose has been reported.
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Other diagnostic agents <b>ATC code:</b> V04CX05 Mechanism of action After oral ingestion, <sup>13</sup>C-urea labelled urea tablets will rapidly disintegrate on reaching ...
5.2. Pharmacokinetic properties
Absorption Urea is rapidly absorbed from the gastro-intestinal tract. Distribution Urea is distributed into extracellular and intracellular fluids including lymph, bile, cerebrospinal fluid and blood. ...
5.3. Preclinical safety data
There are no risks relevant for the clinical use of the product.
6.1. List of excipients
Citric acid, anhydrous Silica, colloidal anhydrous Croscarmellose sodium Microcrystalline cellulose Magnesium stearate Talc
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
4 years.
6.4. Special precautions for storage
Do not store above 25°C. Store in the original package in order to protect from light.
6.5. Nature and contents of container
<u>Diabact UBT pack sizes:</u> 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 ...
6.6. Special precautions for disposal and other handling
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 ...
7. Marketing authorization holder
Laboratoires Mayoly Spindler, 6 avenue de leurope BP 51, 78401 CHATOU Cedex, France
8. Marketing authorization number(s)
PA1993/004/001
9. Date of first authorization / renewal of the authorization
Date of First Authorisation: 11 October 2002 Date of Last Renewal: 22 October 2009
10. Date of revision of the text
March 2021
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