Bridion 100 mg/ml solution for injection
Table of Contents
1. Name of the medicinal product
Bridion 100mg/ml solution for injection
2. 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 9.7 mg sodium (see section 4.4).
For the full list of excipients, see section 6.1.
3. 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.
4. Clinical particulars
4.1 Therapeutic indications
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.
4.2 Posology and method of administration
Posology
Sugammadex should only be administered by, or under the supervision of an anaesthetist.
The use of an appropriate neuromuscular monitoring technique is recommended to monitor the recovery of neuromuscular blockade (see section 4.4).
The recommended dose of sugammadex depends on the level of neuromuscular blockade to be reversed.
The recommended dose does not depend on the anaesthetic regimen.
Sugammadex can be used to reverse different levels of rocuronium or vecuronium induced neuromuscular blockade:
Adults
Routine reversal:
A dose of 4 mg/kg sugammadex is recommended if recovery has reached at least 1-2 post-tetanic counts (PTC) following rocuronium or vecuronium induced blockade. Median time to recovery of the T4/T1 ratio to 0.9 is around 3 minutes (see section 5.1).
A dose of 2 mg/kg sugammadex is recommended, if spontaneous recovery has occurred up to at least the reappearance of T2 following rocuronium or vecuronium induced blockade. Median time to recovery of the T4/T1 ratio to 0.9 is around 2 minutes (see section 5.1).
Using the recommended doses for routine reversal will result in a slightly faster median time to recovery of the T4/T1 ratio to 0.9 of rocuronium when compared to vecuronium induced neuromuscular blockade (see section 5.1).
Immediate reversal of rocuronium-induced blockade:
If there is a clinical need for immediate reversal following administration of rocuronium a dose of 16 mg/kg sugammadex is recommended. When 16 mg/kg sugammadex is administered 3 minutes after a bolus dose of 1.2 mg/kg rocuronium bromide, a median time to recovery of the T4/T1 ratio to 0.9 of approximately 1.5 minutes can be expected (see section 5.1).
There is no data to recommend the use of sugammadex for immediate reversal following vecuronium induced blockade.
Re-administration of sugammadex:
In the exceptional situation of recurrence of neuromuscular blockade post-operatively (see section 4.4) after an initial dose of 2 mg/kg or 4 mg/kg sugammadex, a repeat dose of 4 mg/kg sugammadex is recommended. Following a second dose of sugammadex, the patient should be closely monitored to ascertain sustained return of neuromuscular function.
Re-administration of rocuronium or vecuronium after sugammadex:
For waiting times for re-administrationof rocuronium or vecuronium after reversal with sugammadex, see section 4.4.
Additional information on special po |
