Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Ibigen Srl, via Fossignano 2, 04011, Aprilia (LT), Italy
Rocuronium bromide 10 mg/ml solution for injection/infusion.
| Pharmaceutical Form |
|---|
|
Solution for injection/infusion. Clear, colourless up to pale brown-yellowish solution. pH: 3.8-4.2 Osmolality: 270-330 mOsmol/kg |
Each ml of solution of Rocuronium bromide contains 10 mg rocuronium bromide.
Each ampoule/vial with 5 ml contains 50 mg rocuronium bromide.
Each ampoule/vial with 10 ml contains 100 mg rocuronium bromide
Excipients: sodium 1.6-3.7 mg per ml.
For a 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 |
|---|
|
Sodium acetate trihydrate |
For vials: Clear, colourless glass (type I), closed with bromobutyl rubber stopper and polypropylene flip-off cap.
For ampoules: Clear, colourless glass (type I).
Ampoules/Vials of 5 and 10 ml.
Pack sizes:
10x 5 ml
12x 5 ml
(6x 10) x 5 ml
10x 10 ml
(2x 10) x 10 ml
Not all pack sizes may be marketed.
Ibigen Srl, via Fossignano 2, 04011, Aprilia (LT), Italy
PL 31745/0029
15/05/2013
| Drug | Countries | |
|---|---|---|
| ROCURONIUM | Cyprus |
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