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PANTOPRAZOLE-AFT POWDER FOR INJECTION 40MG/VIAL [SIN16905P]
Active ingredients: PANTOPRAZOLE-AFT POWDER FOR INJECTION 40MG/VIAL
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Product Info
PANTOPRAZOLE-AFT POWDER FOR INJECTION 40MG/VIAL
[SIN16905P]
Product information
Active Ingredient and Strength | PANTOPRAZOLE SODIUM SESQUIHYDRATE EQV PANTOPRAZOLE - 40 MG/VIAL |
Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
Manufacturer and Country | HAINAN POLY PHARM. CO., LTD. - CHINA |
Registration Number | SIN16905P |
Licence Holder | APEX PHARMA MARKETING PTE. LTD. |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | A02BC02 |
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
4.2 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.
4.3 CONTRAINDICATIONS
Pantoprazole-AFT should not be used in cases of known hypersensitivity to any of the constituents.
