BRIDION Solution for injection Ref.[8695] Active ingredients: Sugammadex

Source: European Medicines Agency (EU)  Revision Year: 2022  Publisher: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands

Product name and form

Bridion 100 mg/mL solution for injection.

Pharmaceutical Form

Solution for injection (injection).

Clear and colourless to slightly yellow solution.

The pH is between 7 and 8 and osmolality is between 300 and 500 mOsm/kg.

Qualitative and quantitative composition

1 mL contains sugammadex sodium equivalent to 100 mg sugammadex.

Each vial of 2 mL contains sugammadex sodium equivalent to 200 mg sugammadex.

Each vial of 5 mL contains sugammadex sodium equivalent to 500 mg sugammadex.

Excipient(s) with known effect: Each mL contains up to 9.7 mg sodium (see section 4.4).

For the full list of excipients, see section 6.1.

Active Ingredient Description

Sugammadex is a modified gamma cyclodextrin which is a Selective Relaxant Binding Agent. It forms a complex with the neuromuscular blocking agents rocuronium or vecuronium in plasma and thereby reduces the amount of neuromuscular blocking agent available to bind to nicotinic receptors in the neuromuscular junction.

List of Excipients

Hydrochloric acid 3.7% (to adjust pH) and/or sodium hydroxide (to adjust pH)
Water for injections

Pack sizes and marketing

2 mL or 5 mL of solution in type I glass vial closed with chlorobutyl rubber stoppers with aluminium crimp-cap and flip-off seal.

Pack sizes: 10 vials of 2 mL or 10 vials of 5 mL.

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


Date of first authorisation: 25 July 2008
Date of latest renewal: 21 June 2013


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

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