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Esomeprazole NORMON contains 40 mg of esomeprazole, as a sodium salt. Each vial also contains disodium edetate and sodium hydroxide (<1 mmol of sodium).
Vials are for single use only. If the entire reconstituted content of the vial is not required for a single dose, any unused solution should be discarded.
For further information on dose recommendations and storage conditions, see Dosage & Administration and Storage sections.
Preparation and Administration of Reconstituted Solution: For the reconstitution of solution, withdraw the plastic cap of colour at the top of the vial of Esomeprazole NORMON and pierce the stopper in the centre of the designed circle, by maintaining the needle vertically, in order to be able to cross the stopper correctly.
The reconstituted solution for injection or infusion should be clear and colourless to very slightly yellow. It should be inspected visually for particulate matter and discolouration before administration and only clear solution should be used.
The shelf life after reconstitution in terms of chemical and physical stability has been demonstrated for 12 hours at 30°C. However, from a microbiological point of view, the product should be used immediately.
Esomeprazole NORMON injection: To prepare a solution for injection: Injection 40 mg: For 8 mg/ml esomeprazole reconstituted solution: Prepare the solution by adding 5 ml of 0.9% sodium chloride for intravenous use to the esomeprazole 40 mg vial.
The reconstituted solution for injection should be administered intravenously over a period of at least 3 minutes.
Esomeprazole NORMON infusion: To prepare a solution for infusion: Infusion 40 mg: Dissolve the content of one esomeprazole 40 mg vial in up to 100 ml of 0.9% sodium chloride for intravenous use.
Infusion 80 mg: Dissolve the contents of two esomeprazole 40 mg vials in up to 100 ml of 0.9% sodium chloride for intravenous use.
Disposal: Any unused product or waste material should be disposed of in accordance with local requirements.
