Consumer medicine information

PYtest Breath test kit

Urea (14C)

BRAND INFORMATION

Brand name

PYtest

Active ingredient

Urea (14C)

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using PYtest Breath test kit.

1. Why am I using PYTEST?


The PYtest capsule contains the active ingredient Urea C14. The PYtest capsule is used to detect gastric urease as an aid in the diagnosis of Helicobacter pylori infection in the stomach.
For more information, see Section 1. Why am I using PYTEST? in the full CMI.

2. What should I know before I use PYTEST?


Do not use if you have ever had an allergic reaction to the PYtest capsule or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use PYTEST? in the full CMI.

3. What if I am taking other medicines?


Some medicines may interfere with the PYtest and affect how it works and produce false results.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use PYTEST?

  • The PYtest capsule will be administered under the supervision of a doctor, pathologist or healthcare professional who will instruct you on how to use the PYtest capsule
  • The PYtest capsule must be taken on an empty stomach, therefore you must not eat or drink anything (including water) for at least 4 hours prior to the test.
  • The dosage for adults is one capsule, swallowed whole with 20 mL water initally. Do not chew the capsule.

More instructions can be found in Section 4. How do I use PYTEST? in the full CMI.

5. What should I know while using PYTEST?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using the PYtest capsule.
  • Tell your doctor, pathologist or healthcare professional straight away if you feel unwell or are worried about any symptoms or conditions you have.
Driving or using machines
  • Be careful before you drive or use any machines or tools until you know how the PYtest affects you.
Looking after your medicine
  • Generally, PYtest capsule will be stored by your pathologist prior to use.

For more information, see Section 5. What should I know while using PYTEST? in the full CMI.

6. Are there any side effects?


There have been no reported side effects in patients using the PYtest capsule. If you notice anything that may be making you feel unwell tell your doctor, pathologist pharmacist or healthcare professional.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

BRAND INFORMATION

Brand name

PYtest

Active ingredient

Urea (14C)

Schedule

Unscheduled

 

1 Name of Medicine

Urea [14C].

2 Qualitative and Quantitative Composition

Each clear gelatin capsule contains 1 microgram yellow beads equivalent to 37 kBq 14C.
Each PYtest Kit (C14-Urea Breath Test) contains one capsule.
Excipients. Starch, sucrose, fluorescein sodium and gelatin.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Clear, hard gelatin capsules containing light yellow sugar spheres.

4 Clinical Particulars

4.9 Overdose

In the event of overdose, the patient should drink one glass of water (150 mL) every hour to hasten excretion of the radioisotope. Maximum excretion of urea is achieved at a urine output of > 2.0 mL/min.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Radiation safety. To allow radiation sources to be effectively compared emissions of various origins are expressed in terms of "effective dose" (ED). The ED of 14C takes into account the fraction of isotope sequestered in each organ tissue (as recommended by the International Commission for Radiological Protection 60 [ICRP-60] which is adopted in Australia), the biological half life of the isotope in that tissue, the effective energy of the beta particles compared with standard ionising radiation (200kV x-ray source) and the administered dose. ED is expressed in Sieverts (1 Sievert [Sv]; 10-6 Sv = 1 microSv). The maximum estimated ED received from a single administration of PYtest capsule (37 kBq of [14C]-urea) is 3 microSv; Figure 4 summarizes radiation exposure from the PYtest in comparison with other common sources of radiation exposure.
The Australian population is subjected to an annual radiation dose of about 1800 microSv to 2400 microSv per caput as a result of natural environmental radiation and the in vivo presence of radionuclides such as natural 14C and 40K in the body. 2400 microSv is equivalent to the radiation dose afforded by the ingestion of 800 PYtest capsules. A single PYtest procedure is the equivalent of about 11 hours of normal and essentially inevitable radiation exposure from the environment.
https://stagingapi.mims.com/au/public/v2/images/fulltablegif/PYTFIG04.gif Genotoxicity. No data available.
Carcinogenicity. No data available.
Radiation dosimetry. Maximum effective dose (ED) (H. pylori positive): 3 microSv/37 kBq.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. Molecular formula: NH214CONH2.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSUREA14.gif CAS number. 594-05-8.
Physical characteristics of 14C. Radiation emission: Beta-emission, 49 keV mean, 156 keVmax, no other emissions.
External emission: No external radiation hazard. Low-energy beta emissions only. Maximum range of 0.3 mm in water.
Physical half-life: 5730 years.

7 Medicine Schedule (Poisons Standard)

Not scheduled.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/PYTESTST.gif