pulation
Renal impairment:
The use of sugammadex in patients with severe renal impairment (including patients requiring dialysis (CrC1 < 30 ml/min)) is not recommended (see section 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, 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. Caution should be exercised when considering the use of sugammadex in patients with severe hepatic impairment or 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 are limited (one study only for reversal of rocuronium induced blockade at reappearance of T2).
Children and adolescents:
For routine reversal of rocuronium induced blockade at reappearance of T2 in children and adolescents (2-17 years) 2 mg/kg sugammadex is recommended.
Bridion 100 mg/ml may be diluted to 10 mg/ml to increase the accuracy of dosing in the paediatric population (see section 6.6).
Other routine reversal situations have not been investigated and are therefore not recommended until further data become available.
Immediate reversal in children and adolescents has not been investigated and is therefore not recommended until further data become available.
Term newborn infants and infants:
There is only limited experience with the use of sugammadex in infants (30 days to 2 years), and term newborn infants (less than 30 days) have not been studied. The use of sugammadex in term newborn infants and infants is therefore not recommended until further data become available.
Method of administration
Sugammadex should be administered intravenously as a single bolus injection. The bolus injection should be given rapidly, within 10 seconds directly into a vein or into an existing intravenous line (see section 6.6). Sugammadex has only been administered as a single bolus injection in clinical trials.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
As is normal post-anaesthetic practice following neuromuscular blockade, it is recommended to monitor the patient in the immediate post-operative period for untoward events including recurrence of neuromuscular blockade.
Monitoring respiratory function during recovery:
Ventilatory support is mandatory for patients until adequate spontaneous respiration is restored fol |
