Document: Diabact UBT tablet ENG SmPC change

• Diabact UBT tablet SmPC
• Diabact UBT tablet ENG SmPC

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SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE MEDICINAL PRODUCT

Diabact UBT 50 mg tablets

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains ¹³C 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. Clinical particulars

4.1 Therapeutic indications

This medicinal product is for diagnostic use only.

For In vivo diagnosis of gastroduodenal primary or remaining Helicobacter pylori 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 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 in section 6.6.

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 listed in section 6.1.

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 of any other complicating conditions, eg. gastric ulcer, autoimmune gastritis and malignancies.

The tablet must be swallowed whole. If the patient chews the tablet, the test must be performed again as the risk of false positive results increase. A new test may be performed the following day.

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

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 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 until after 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.

4.6 Fertility, 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.

The Diabact UBT test is not expected to be harmful during pregnancy or to the health of the foetus/newborn child. Diabact UBT can be used during 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.

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 reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V*.

4.9 Overdose

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

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Other diagnostic agents, ATC code: V04C X

After oral ingestion, ¹³C-urea labelled urea tablets will rapidly disintegrate on reaching the stomach. In the case of infection with H. pylori, ¹³C-urea is metabolised by the enzyme urease of 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 liberated as ¹³CO₂ in exhaled air. Infection with H. pylori will significantly change the ¹³C/¹²C – carbon isotope ratio.

The proportion of ¹³CO₂ in the breath samples is determined by (isotope-ratio-mass spectrometry IRMS) or by another suitably-validated method carried out by any qualified laboratory and stated as an absolute difference (excess) in the value between a pre-urea and post-urea breath sample (see section 6.6).

The cut off point for discriminating 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.

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. It is reported to cross the placenta and penetrate the eye.

Elimination

Urea is excreted unchanged in the urine.

5.3 Preclinical safety data

There are no risks relevant for the clinical use of the product.

6. PHARMACEUTICAL PARTICULARS

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^oC. Store in the original package in order to protect from light.

Diabact UBT pack sizes:

1 tablet (kit)

10 x 1 tablets (without sample tubes and disposable straw).

Not all pack sizes may be marketed.

I.1Component	I.21 tablet (kit)	I.310 x 1 tablet
Tablet in a blister	1	10
Sample tubes for 00 minute breath sample (blue stopper)	2
Sample tubes for 10 minute breath sample (red stopper)	2
Disposable straw	1
Patient information	1	1
Extra bar code labels	2

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 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

One must ensure that an approved and certified laboratory performs the analysis. Laboratories and analysis equipment used should comply with EU directive: Council Directive 93/42/EEC/98/79/EC. This directive implies that the analysis equipment should be CE marked and approved for analysis of breath tests.

Explanation of analysis results

 -value;

The difference in parts per thousand (‰ ) between the 00-MINUTE value and the 10 MINUTE value.

I.3.1.1H. pylori status:

<1.5 ‰  -value = Negative H. pylori status.

>1.5 ‰  -value = Positive H. pylori status.

Any unused product or waste material should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Kibion AB

Box 303

SE-751 05 Uppsala

SWEDEN

Tel.+46 18 78088 00

8. MARKETING AUTHORISATION NUMBER(S)

13108 (SE)

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

1999-10-22/2009-10-22

10. DATE OF REVISION OF THE TEXT

2014-10-06