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UBIT® TABLET 100 MG [SIN13253P]

Active ingredients: UBIT® TABLET 100 MG

Last updated 26 October 2025

Product Info

UBIT® TABLET 100 MG

[SIN13253P]

Product information

Active Ingredient and Strength

13C UREA - 100 MG

Dosage Form

TABLET

Manufacturer and Country

TOKUSHIMA FACTORY, OTSUKA PHARMACEUTICAL CO., LTD - JAPAN

Registration Number

SIN13253P

Licence Holder

NAGASE SINGAPORE (PTE) LTD

Forensic Classification

PRESCRIPTION ONLY MEDICINES

Anatomical Therapeutic Chemical (ATC) code

NA

INDICATIONS
In vivo diagnosis of Helicobacter pylori (H. pylori) infection

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.

5. Contraindications
Hypersensitivity to active substance or to any of the excipients.