Medication info

Urea 13C Breath Test Kit (50 mg Urea)

Prescription medication
Ingredient · strength
Urea (13C)›50mg / 1 dose
Manufacturer / importer
SeJung Medical Industry
Appearance
1) 13C-Urea mixture 1 cup (3.3g): White powder in a white plastic container 2) Two respiratory sample collection tubes (including label stickers)
Packaging
1 kit/box
Approval status
Active

MFDS item code 201110672 · Notified 2011.12.08

Summary

Main use
Diagnosis of Helicobacter pylori infection
Who uses it
Adults
Adult dosage
1) Exhale into the enclosed tube for 4 seconds using your normal breathing, then immediately cap it. 2) Add 75 ml of water to the container containing the powder, dissolve thoroughly for 1 minute, and drink the entire solution. 3) Sit quietly for 30 minutes. 4) Measure the collected specimen using a mass spectrometer.

Ingredients

Importer
SeJung Medical Industry

Efficacy & effects

Diagnosis of Helicobacter pylori infection

View approved original text

Diagnosis of Helicobacter pylori infection is used for examinations of gastric inflammation or ulcers and the risk of gastric cancer. This medication accurately determines whether there is an infection with Helicobacter pylori bacteria, assisting in the direction of appropriate treatment. Therefore, it plays an important role in the diagnosis of gastrointestinal-related diseases.

Dosage and Administration

Adult dosage

1) Exhale into the enclosed tube for 4 seconds using your normal breathing, then immediately cap it. 2) Add 75 ml of water to the container containing the powder, dissolve thoroughly for 1 minute, and drink the entire solution. 3) Sit quietly for 30 minutes. 4) Measure the collected specimen using a mass spectrometer.

Precautions

This medication should not be used by pregnant women or women who may become pregnant. Furthermore, individuals who have had an allergic reaction to any component of this medication should not take it. Patients with end-stage chronic obstructive pulmonary disease should also avoid using this medication. Before using this drug, certain medications should not be taken, as they can affect the test results. For example, proton pump inhibitors or histamine H2 receptor antagonists that suppress gastric acid secretion should be discontinued at least 2 weeks prior. Antibiotics should be stopped 4 weeks prior, and bismuth preparations should be stopped 2 weeks prior. If barium tests are to be done on the same day, this medication should be administered before the barium test. Additionally, this should not be used in conjunction with other medications that diagnose Helicobacter pylori infection. During the test, deep breathing should be avoided, and normal, natural breathing should be maintained. It is important to remain quietly at ease during the examination. Before the test, a minimum of 4 hours should be maintained without eating or drinking, ensuring a fasting state. Finally, this medication should not be used for children under 6 years of age, as its safety and effectiveness have not been sufficiently established.

Storage

This medication should be stored in a sealed container to prevent air or moisture from entering, and it is recommended to store it at room temperature between 15 to 30 degrees Celsius. This way of storage will help maintain the medication's effectiveness over time.

Appearance and packaging

Appearance

1) 13C-Urea mixture 1 cup (3.3g): White powder in a white plastic container 2) Two respiratory sample collection tubes (including label stickers)

Package unit

1 kit/box

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.