NEXIUM Powder for solution for injection / infusion Ref.[6798] Active ingredients: Esomeprazole

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2017  Publisher: AstraZeneca UK Limited, 600 Capability Green, Luton, LU1 3LU, United Kingdom

Product name and form

Nexium I.V. 40 mg Powder for solution for injection/infusion.

Pharmaceutical Form

Powder for solution for injection/infusion.

White to off-white porous cake or powder.

Qualitative and quantitative composition

Each vial contains esomeprazole 40 mg (as sodium salt).

Excipient(s) with known effect: This medicinal product contains <1 mmol sodium (23 mg) per 40 mg, i.e. essentially sodium free.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Esomeprazole

Esomeprazole is the S-isomer of omeprazole and reduces gastric acid secretion through a specific targeted mechanism of action. Esomeprazole is a weak base and is concentrated and converted to the active form in the highly acidic environment of the secretory canaliculi of the parietal cell, where it inhibits the enzyme H+ K+ -ATPase – the acid pump and inhibits both basal and stimulated acid secretion.

List of Excipients

Disodium edetate
Sodium hydroxide (for pH adjustment)

Pack sizes and marketing

5ml vial made of colourless borosilicate glass, type I. Stopper made of bromobutyl latex-free rubber, cap made of aluminium and a plastic flip-off seal.

Pack sizes: 1 vial, 10 vials.

Not all pack sizes may be marketed.

Marketing authorization holder

AstraZeneca UK Limited, 600 Capability Green, Luton, LU1 3LU, United Kingdom

Marketing authorization dates and numbers

PL 17901/0221

Date of first authorisation: 10 March 2005
Date of latest renewal: 10 March 2010

Drugs

Drug Countries
NEXIUM Austria, Australia, Brazil, Canada, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Malta, Mexico, Nigeria, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States

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