INVANZ Powder for concentrate for solution for infusion Ref.[8101] Active ingredients: Ertapenem

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands

Product name and form

INVANZ 1 g powder for concentrate for solution for infusion.

Pharmaceutical Form

Powder for concentrate for solution for infusion.

White to off-white powder.

Qualitative and quantitative composition

Each vial contains 1.0 g ertapenem.

Excipient with known effect: Each 1.0 g dose contains approximately 6.0 mEq of sodium (approximately 137 mg).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Ertapenem

Ertapenem inhibits bacterial cell wall synthesis following attachment to penicillin binding proteins (PBPs). In Escherichia coli, affinity is strongest to PBPs 2 and 3.

List of Excipients

Sodium bicarbonate (E500)
Sodium hydroxide (E524) to adjust pH to 7.5

Pack sizes and marketing

15 mL Type I glass vials with a grey butyl stopper and a white plastic cap on a coloured aluminium band seal.

Supplied in packs of 1 vial or 10 vials.

Not all pack sizes may be marketed.

Marketing authorization holder

Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands

Marketing authorization dates and numbers

EU/1/02/216/001
EU/1/02/216/002

Date of first authorisation: 18 April 2002
Date of latest renewal: 22 December 2011

Drugs

Drug Countries
INVANZ Austria, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa

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