Posology : מינונים

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-administration of rocuronium or vecuronium after reversal with sugammadex, see section 4.4.


Additional information on special population

Renal impairment:
The use of sugammadex in patients with severe renal impairment (including patients requiring dialysis (CrCl < 30 mL/min)) is not recommended (see sections 4.3, 4.4).
Studies in patients with severe renal impairment do not provide sufficient safety information to support the use of sugammadex in these patients (see also section 5.1).
For mild and moderate renal impairment (creatinine clearance ≥ 30 and < 80 mL/min): the dose recommendations are the same as for adults without renal impairment.


Elderly patients:
After administration of sugammadex at reappearance of T2 following a rocuronium induced blockade, the median time to recovery of the T4/T1 ratio to 0.9 in adults (18-64 years) was 2.2 minutes, in elderly adults (65-74 years) it was 2.6 minutes and in very elderly adults (75 years or more) it was 3.6 minutes. Even though the recovery times in elderly tend to be slower, the same dose recommendation as for adults should be followed (see section 4.4).

Obese patients:
In obese patients, including morbidly obese patients (body mass index ≥ 40 kg/m2), the dose of sugammadex should be based on actual body weight. The same dose recommendations as for adults should be followed.

Hepatic impairment:
Studies in patients with hepatic impairment have not been conducted and therefore patients with severe hepatic impairment should not be treateded with sugammadex.
(see section 4.3, 4.4).
Caution should be exercised when considering the use of sugammadex when hepatic impairment is accompanied by coagulopathy (see section 4.4).
For mild to moderate hepatic impairment: as sugammadex is mainly excreted renally no dose adjustments are required.


Paediatric population

The data for the paediatric population under the age of 12, are limited (one study only for reversal of rocuronium induced blockade at reappearance of T2) therefore SUGAMEDIN should not be used in that age group.


Method of administration
Sugammadex should be administered intravenously as a single bolus injection. The bolus injection should be given rapidly, within 10 seconds, into an existing intravenous line (see section 6.6). Sugammadex has only been administered as a single bolus injection in clinical trials.