SPC, UK: OMEPRAZOLE Powder for solution for infusion (2017)

Product Name and Form

Omeprazole 40 mg Powder for Solution for Infusion.

Pharmaceutical form

Powder for solution for infusion.

The powder for solution for infusion is a white to almost white powder.

The reconstituted solution has a pH of about 9-10.5.

The osmolarity of the solution reconstituted with 100 ml of 5% glucose solution is about 0.297Osmol/kg.

The osmolarity of the solution reconstituted with 100 ml of 0.9% saline is about 0.282 Osmol/kg.

Qualitative and Quantitative Composition

Each vial of powder for solution for infusion contains omeprazole sodium, equivalent to 40 mg omeprazole.

After reconstitution (see section 6.6), each 1 ml contains 0.4 mg omeprazole.

For a full list of excipients, see section 6.1.

List of excipients

Sodium hydroxide (for pH adjustment)
Disodium edetate

Pack sizes and Marketing

10 ml colourless glass vial Type I with a red bromobutyl rubber stopper, and an aluminium cramping cap with polypropylene cap.

Pack sizes: 1, 5, 10 or 20 vials.

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom

Date of first authorisation: 22 April 2008

Date of latest renewal: 19 December 2011

Marketing authorization number:

PL 04416/0701