Sugammadex Inj.Sol. 100mg/ml (2 & 5 ml Vial) (EU CTD Available)

Sugammadex Inj.Sol. 100mg/ml (2 & 5 ml Vial) (EU CTD Available)
Product Description

Sugammadex 100mg/ml (2 & 5 ml Vial) Solution for Injection
Reference Product: Bridion® / MSD
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. 
This results in the reversal of neuromuscular blockade induced by rocuronium or vecuronium. 
Sugammadex is used for the reversal of neuromuscular blockade induced by rocuronium or vecuronium in adults. 
For the paediatric population: Sugammadex is only recommended for routine reversal of rocuronium induced blockade in children and adolescents aged 2 to 17 years.
Dossier Status: EU CTD Available
Stability Studies: Zone II / Zone IVb
Shelf life (Originator): Three (3) years
Batch Sizes: 8,880 vials (2ml vial) & 3,700 vials (5ml vial)
Pack Sizes: BT x 1 & x 10 vial(s)

ANFARM HELLAS S.A.

  • GR
  • 2015
    On CPHI since
Specifications

ANFARM HELLAS S.A.

  • GR
  • 2015
    On CPHI since

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