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)
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Specifications

Categories Finished Dosage FormsInjectables; Finished Dosage FormsOut-licensing
Sales markets Middle East Region (e.g. UAE); Oceania; North America (USA, Canada); Africa; Central America (e.g. Mexico); Europe - EU countries; Europe - non EU (e.g. UK, Russia, ex-CIS countries); South America (e.g. Brazil, Colombia); South East Asia (e.g. Thailand, Philippines, Singapore)
Supplied from Greece

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

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