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HSA Approval

PANTOPRAZOLE-AFT POWDER FOR INJECTION 40MG/VIAL

SIN16905P

PANTOPRAZOLE-AFT POWDER FOR INJECTION 40MG/VIAL

PANTOPRAZOLE-AFT POWDER FOR INJECTION 40MG/VIAL

December 6, 2023

APEX PHARMA MARKETING PTE. LTD.

APEX PHARMA MARKETING PTE. LTD.

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantAPEX PHARMA MARKETING PTE. LTD.
Licence HolderAPEX PHARMA MARKETING PTE. LTD.

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore 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. ![Pantoprazole-AFT Dosage Table 1](https://cdn.medpath.com/drug/dosage/20240520/62f109159cdf5752665c72626138cf87.png) **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

Pantoprazole sodium sesquihydrate eqv pantoprazole

40.0 mg/vial

Pantoprazole

Documents

Package Inserts

PANTOPRAZOLE-AFT Powder for Injection PI.pdf

Approved: December 6, 2023

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PANTOPRAZOLE-AFT POWDER FOR INJECTION 40MG/VIAL - HSA Approval | MedPath