Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
TABLET
**DOSAGE AND ADMINISTRATION** Usual adult dosage is one tablet \[100 mg of urea (13C)\] taken orally in a fasting condition. < **Recommended Procedure for 13C-Urea Breath Test** > 1. Collect pre-dose breath sample. 2. Instruct patient in a fasting condition to promptly (within 5 sec) swallow one tablet of UBIT Tablet 100mg with 100 mL of water without crushing or chewing the tablet. 3. Instruct patient to remain in left lateral decubitus position for 5 min, and then to return to sitting position until collection of post-dose breath sample. 4. Collect post-dose breath sample at 20 min after administration. 5. Measure 13CO2 level (ratio of 13CO2 to 12CO2) in each breath sample and calculate Δ13CO2 (difference between pre-dose and post-dose 13CO2 levels) for diagnosis of _H. pylori_ infection.
ORAL
Medical Information
**INDICATIONS** _In vivo_ diagnosis of _Helicobacter pylori_ ( _H. pylori_) infection
**5\. Contraindications** Hypersensitivity to active substance or to any of the excipients.
Manufacturer Information
NAGASE SINGAPORE (PTE) LTD.
Tokushima Factory, Otsuka Pharmaceutical Co., Ltd
Active Ingredients
Documents
Package Inserts
UBIT Tablet PI.pdf
Approved: September 10, 2020