PANTOPRAZOLE KALCEKS POWDER FOR SOLUTION FOR INJECTION 40MG/VIAL [SIN17236P]
Active ingredients: PANTOPRAZOLE KALCEKS POWDER FOR SOLUTION FOR INJECTION 40MG/VIAL
Last updated 24 April 2026
Product Info
PANTOPRAZOLE KALCEKS POWDER FOR SOLUTION FOR INJECTION 40MG/VIAL
[SIN17236P]
Product information
Active Ingredient and Strength | PANTOPRAZOLE SODIUM SESQUIHYDRATE EQV PANTOPRAZOLE - 40 MG/VIAL |
Dosage Form | INJECTION, POWDER, FOR SOLUTION |
Manufacturer and Country | MEFAR ILAC SANAYII A.S. - TURKEY |
Registration Number | SIN17236P |
Licence Holder | GOLDPLUS UNIVERSAL PTE LTD |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | A02BC02 |
Prescription-only Medicines with Exemptions for Supply without Prescription | NA |
Indication
4.1 Therapeutic indications
Pantoprazole is indicated for short-term use in adults for symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion:
Moderate and severe reflux oesophagitis
Gastric and duodenal ulcer
Dosing
4.2 Posology and method of administration
This medicine should be administered by a healthcare professional and under appropriate medical supervision.
Intravenous administration of pantoprazole is recommended only if oral administration is not appropriate. Data are available on intravenous use for up to 7 days. Therefore, as soon as oral therapy is possible, intravenous treatment with pantoprazole should be discontinued and 40 mg of pantoprazole should be administered orally instead.
Posology
Gastric and duodenal ulcer, moderate and severe reflux oesophagitis
The recommended dose is 40 mg pantoprazole daily.
Special populations
Patients with hepatic impairment
A daily dose of 20 mg pantoprazole 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).
Patients with renal impairment
No dose adjustment is necessary in patients with impaired renal function (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Elderly
No dose adjustment is necessary in the elderly (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Paediatric population
The safety and efficacy of intravenous pantoprazole in children aged under 18 years of age have not been established. Therefore, this medicine is not recommended in children under 18 years of age. The currently available data are described in section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information. However, no dose recommendation can be made based on these data.
Method of administration
Intravenous use.
This medicinal product should be reconstituted, or reconstituted and diluted, before use. It should be administered intravenously over 2–15 minutes.
For instructions on reconstitution, or reconstitution and dilution of the medicinal product before administration, see section 6.7 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
Contraindications
4.3 Contraindications
Hypersensitivity to the active substance, substituted benzimidazoles, or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.