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warnings and cautions
IV. Warnings and Precautions For in vitro diagnostic use only. The Pranactin ® -Citric drug solution is taken orally as part of the diagnostic procedure. Phenylketonurics: Contains Phenylalanine (one of the protein components of Aspartame), 84 mg per dosage unit. (For reference, 12 ounces of typical diet cola soft drinks contain approximately 80 mg of Phenylalanine.) A negative result does not rule out the possibility of Helicobacter pylori infection. False negative results do occur with this procedure. If clinical signs are suggestive of H. pylori infection, retest with a new sample or an alternate method. Antimicrobials, proton pump inhibitors, and bismuth preparations are known to suppress H. pylori . Ingestion of these within two (2) weeks prior to performing the BreathTek™ UBT may give false negative results. A false positive test may occur due to urease associated with other gastric spiral organisms observed in humans such as Helicobacter heilmannii. Premature POST-DOSE breath collection time can lead to a false negative diagnosis for a patient with a marginally positive BreathTek™ UBT result. A false positive test could occur in patients who have achlorhydria. 8 If particulate matter is visible in the reconstituted Pranactin ® -Citric solution after thorough mixing, the solution should not be used.