Incompatibilities: Gastro-resistant tablet: Not applicable.
Powder for solution for injection: This medicinal product should not be used with other medicinal products except those mentioned in Instruction for use and handling as follows.
Instructions for use and handling: Gastro-resistant tablet: Administration through gastric tube: 1. Put the tablet into an appropriate syringe and fill the syringe with approximately 25 mL water and approximately 5 mL air. For some tubes, dispersion in 50 mL water is needed to prevent the pellets from clogging the tube.
2. Immediately shake the syringe for approximately 2 minutes to disperse the tablet.
3. Hold the syringe with the tip up and check that the tip has not clogged.
4. Attach the syringe to the tube whilst maintaining the above position.
5. Shake the syringe and position it with the tip pointing down. Immediately inject 5-10 mL into the tube. Invert the syringe after injection and shake (the syringe must be held with the tip pointing up to avoid clogging of the tip).
6. Turn the syringe with the tip down and immediately inject another 5-10 mL into the tube. Repeat this procedure until the syringe is empty.
7. Fill the syringe with 25 mL of water and 5 mL of air and repeat step 5 if necessary to wash down any sediment left in the syringe. For some tubes, 50 mL water is needed.
Powder for solution for injection: Injection: A solution for injection is prepared by adding 5 mL of 0.9% sodium chloride for intravenous use to the vial with esomeprazole. The reconstituted solution for injection is clear and colourless to very slightly yellow.
The degradation of reconstituted solution is highly pH dependent and the product must therefore only be reconstituted in the specified volume of 0.9% sodium chloride for intravenous use. The reconstituted solution should not be mixed or co-administered in the same infusion set with any other drug.
The reconstitution solution should be inspected visually for particulate matter and discoloration prior to administration. Only clear solution should be used.
The reconstituted solution should be used within 12 hours. From a microbiological point of view, the product should be used immediately. Do not store above 30°C.
The reconstituted solution should be given as an intravenous injection over a period of at least 3 minutes.
Half of the volume should be given if 20 mg should be administrated. If the entire reconstituted content of the vial is not required for a single dose, any unused reconstituted solution should be discarded.
Infusion: A solution for infusion is prepared by dissolving the content of one vial with esomeprazole in up to 100 mL 0.9% sodium chloride for intravenous use.
The reconstituted solution for infusion is clear and colourless to very slightly yellow.
The degradation of reconstituted solution is highly pH dependent and the product must therefore only be reconstituted in the specified volume of 0.9% sodium chloride for intravenous use.
The reconstituted solution should not be mixed or co-administered in the same infusion set with any other drug.
The reconstituted solution should be administrated separately from other drugs.
The reconstituted solution should be inspected visually for particulate matter and discoloration prior to administration. Only clear solution should be used.
The reconstituted solution should be used within 12 hours. From a microbiological point of view, the product should be used immediately. Do not store above 30°C.
The reconstituted solution should be given as an intravenous infusion over a period of 10 to 30 minutes.
Half of the volume should be given if 20 mg should be administrated. If the entire reconstituted content of the vial is not required for a single dose, any unused reconstituted solution should be discarded.
Infusion 80 mg: A solution for infusion is prepared by dissolving the content of two vials of esomeprazole 40 mg in up to 100 ml of 0.9% sodium chloride for intravenous use.