Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2017 Publisher: Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom
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. |
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.
| Active Ingredient | Description | |
|---|---|---|
| Omeprazole |
Omeprazole, a racemic mixture of two enantiomers reduces gastric acid secretion through a highly targeted mechanism of action. It is a specific inhibitor of the acid pump in the parietal cell. It is rapidly acting and provides control through reversible inhibition of gastric acid secretion with once daily dosing. |
| List of Excipients |
|---|
|
Sodium hydroxide (for pH adjustment) |
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.
Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom
PL 04416/0701
Date of first authorisation: 22 April 2008
Date of latest renewal: 19 December 2011
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