ESMERON Solution for injection Ref.[50334] Active ingredients: Rocuronium

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Merck Sharp & Dohme (UK) Limited, 120 Moorgate, London, EC2M 6UR, UK

Product name and form

Esmeron 10 mg/ml solution for injection.

Pharmaceutical Form

Solution for injection.

pH: 3.8-4.2.

Qualitative and quantitative composition

Each ml Esmeron contains 10 mg rocuronium bromide.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Rocuronium

Rocuronium is a fast onset, intermediate acting non-depolarising neuromuscular blocking agent, possessing all of the characteristic pharmacological actions of this class of medicinal products (curariform agents). It acts by competing for nicotinic cholinoceptors at the motor end-plate.

List of Excipients

Esmeron contains the following excipients:

  • Sodium acetate (E262) (for pH adjustment)
  • Sodium chloride
  • Acetic acid (E260) (for pH adjustment)
  • Water

No preservative has been added.

Pack sizes and marketing

Esmeron 25 mg in 2.5 ml (10mg/ml):

Packaging of 10 vials each containing 25 mg rocuronium bromide.

Esmeron 50 mg in 5 ml (10mg/ml):

Packaging of 10 vials each containing 50 mg rocuronium bromide.

Esmeron 100 mg in 10 ml (10mg/ml):

Packaging of 10 vials each containing 100 mg rocuronium bromide.

Not all pack sizes may be marketed.

Type 1 Ph.Eur., clear, colourless, glass vial with a rubber closure and flip off cap. The rubber stopper of the vial does not contain latex.

In correspondence please quote lot number.

Marketing authorization holder

Merck Sharp & Dohme (UK) Limited, 120 Moorgate, London, EC2M 6UR, UK

Marketing authorization dates and numbers

PL 53095/0001

Date of first authorisation: 15th July 1996
Date of latest renewal: 7th May 2002

Drugs

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

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