ESELAN POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 40MG/VIAL [SIN17423P]
Active ingredients: ESELAN POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 40MG/VIAL
Last updated 24 April 2026
Product Info
ESELAN POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 40MG/VIAL
[SIN17423P]
Product information
Active Ingredient and Strength | (POWDER) OMEPRAZOLE SODIUM EQV OMEPRAZOLE - 40 MG |
Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
Manufacturer and Country | ANFARM HELLAS S.A - GREECE |
Registration Number | SIN17423P |
Licence Holder | GOLDPLUS UNIVERSAL PTE LTD |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | A02BC01 |
Prescription-only Medicines with Exemptions for Supply without Prescription | NA |
Indication
Therapeutic indications
As alternative treatment of the oral formulation where fast and pronounced acidity inhibition is required for:
Duodenal ulcer
Benign gastric ulcer
Reflux esophagitis
Zollinger-Ellison syndrome
Dosing
DOSAGE AND ADMINISTRATION
Dosage
Omeprazole 40mg as once daily intravenous application is recommended in those incidental cases where oral therapy is inappropriate and pronounced acidity inhibition is essential. The mean reduction of acid production in the stomach during 24hours is circa 90%.
With Zollinger-Ellison patients the recommended initial dosage is 60mg omeprazole per day, given intravenously. Higher dosage can be necessary and the dosage of more than 60mg per day the administration of the daily dosage should be spread out the day.
A one-week treatment is usually sufficient.
Administration
Omeprazole sodium for injection is for intravenous administration only and must not be given by any other route. After reconstitution the injection should be given slowly over a period of at least 2.5 minutes at a maximum rate of 4 ml per minute.
Direction for reconstitution
Eselan solution for injection is obtained by dissolving the freeze-dried substance in the accompanying solvent. No other solvent should be used.
The stability of omeprazole is influenced by the pH of the solution for injection, which is why no other solvents or quantities should be used for dilution. Improperly prepared solutions can be identified by their yellow to brown discolouration and must not be used. Use only clear, colourless or pale yellowish-brown solutions.
Use in elderly
Dosage adjustment is not necessary.
Use in children
There is limited experience of use in children. Therefore, omeprazole injection is not recommended in children.
Impaired renal function
Dose adjustment is not required in patients with impaired renal function.
Impaired hepatic function
As half-life is increased in patients with impaired hepatic function, the dose requires adjustment, and a daily dose of 10–20 mg may be sufficient.
Contraindications
CONTRAINDICATIONS
Hypersensitivity to omeprazole, substituted benzimidazoles or to any of the excipients. Omeprazole like other proton pump inhibitors (PPIs) should not be used concomitantly with nelfinavir (See section Drug Interactions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).