Solvent for Losec^® i.v. Injection 40 mg.

Each ampoule contains 10ml of solvent for injection

For excipients, see 6.1.

Solvent for solution for injection

To be used as a Solvent for i.v. injection with 1 vial of powder for injection which contains Omeprazole sodium 42.6mg, equivalent to Omeprazole 40mg

Dosage and Administration

The intravenous solution is obtained by dissolving the lyophilised omeprazole in the solvent provided. No other solvent should be used and the solution must be given by intravenous injection and not added to any other solutions for injection. The injection should be given slowly over a period of 5 minutes. The solution should be used within 4 hours of preparation.

Use in the Elderly:

Dosage adjustment is not necessary.

Use in Children:

There is limited experience of use in children.

Known hypersensitivity macrogol 400 and citric acid monohydrate.

None stated

None stated

None stated

None stated

None stated

None stated

None stated

Macrogols entering the systemic circulation are predominantly excreted unchanged in the urine, low molecular-weight macrogols may be partly metabolised.

Citric acid and macrogols are commonly used in pharmaceutical preparations, no addition information is necessary.

Macrogol 400, Citric acid monohydrate and water for injections.

None known.

Unopened pack : 2 years.

Reconstituted solution : 4 hours.

Do not store above 25°C. Keep container in outer carton.

A clear, Type I (OPC) glass ampoule containing solvent for intravenous administration, packed in a plastic tray with a glass vial in a hard cardboard box.

The solvent in the ampoule is used to reconstitute lyophilised powder to provide a solution for i.v. injection.

Use on one patient during one treatment only.

DO NOT USE if any particles are present in the reconstituted solution.

From a microbiological point of view, once opened and reconstituted the product may be stored for a maximum of 4 hours at 25°C. Other in-use storage times and conditions are the responsibility of the user.

Any unused portion should be discarded.

Preparation:

NOTE: Stages 1 to 5 should be done in immediate sequence.

1. With a syringe draw 10ml of solvent from the ampoule.

2. Add approximately 5ml of the solvent to the vial with the lyophilised powder.

3. Withdraw as much air as possible from the vial back into the syringe in order to reduce positive pressure. This will make it easier to add the remaining solvent.

4. Add the remaining solvent into the vial, make sure that the syringe is empty.

5. Rotate and shake the vial to ensure all the lyophilised powder has been dissolved.

AstraZeneca UK Ltd,

600 Capability Green,

Luton, LU1 3LU, UK.

PL 17901/0167

18^th June 2002/7^th June 2006

7^th June 2006