Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
**4.2 POSOLOGY AND METHOD OF ADMINISTRATION** The intravenous administration of pantoprazole is recommended only if oral application is not appropriate.  **Special patient population** **_Paediatric patients_** The experience in children is limited. Pantoprazole-AFT powder for solution for injection is not recommended for use in patients below 18 years of age. **_Impaired hepatic function_** A daily dose of pantoprazole 20 mg should not be exceeded in patients with severe liver impairment (See section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **_Impaired renal function_** No dose adjustment is necessary in those with impaired renal function. **_Elderly patients_** Generally, no dose adjustment is necessary in elderly patients. However, the daily dose of 40 mg should not be exceeded in treatment of gastric or duodenal ulcer.
INTRAVENOUS
Medical Information
**4.1 THERAPEUTIC INDICATIONS** Short term use for symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion: - Duodenal ulcer - Gastric ulcer - Moderate and severe reflux esophagitis
**4.3 CONTRAINDICATIONS** Pantoprazole-AFT should not be used in cases of known hypersensitivity to any of the constituents.
A02BC02
pantoprazole
Manufacturer Information
APEX PHARMA MARKETING PTE. LTD.
HAINAN POLY PHARM. CO., LTD.
Active Ingredients
Documents
Package Inserts
PANTOPRAZOLE-AFT Powder for Injection PI.pdf
Approved: December 6, 2023