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Method of administration: SUGAMMADEX should only be administered intravenously as a single bolus injection. The bolus dose should be administered rapidly, within 10 seconds, by bolus injection into a vein or into an intravenous line. SUGAMMADEX was administered as a single bolus injection in clinical trials only.
If the drug is administered through an infusion line that has been used with other drugs, it is important to flush the infusion line [e.g., with sodium chloride 9 mg/mL (0.9% solution)] between administration of sugammadex and other drugs known to be incompatible with sugammadex or drugs whose compatibility with sugammadex is unknown.
Sugammadex may be injected into an infusion line already in use for intravenous infusion of the following solutions: Sodium chloride 9 mg/mL (0.9% solution), glucose 50 mg/mL (5%), sodium chloride 4.5 mg/mL (0.45%) and glucose 25 mg/mL (2.5%), lactated Ringers solution, Ringers solution, glucose 50 mg/mL (5%) in sodium chloride 9 mg/mL (0.9%).
When used for children, the drug can be diluted with sodium chloride solution 9 mg/mL (0.9% solution) to create a concentration of 10 mg/mL.
Unused medicine or waste should be disposed of according to local regulations.
Posology: Sugammadex should be administered only by or under the supervision of a qualified anaesthetist.
Appropriate neuromuscular monitoring techniques should be used to monitor recovery of neuromuscular blockade. As is usual practice following anaesthesia using neuromuscular blockade, patients should be observed in the immediate postoperative period for signs of neuromuscular blockade, including recurrence of blockade (see Precautions). Patients who have received certain parenteral drugs within 6 hours prior to administration should be monitored for signs of blockade Use of sugammadex may cause substitution interactions (see Precautions and Interactions). The recommended dose of sugammadex depends on the degree of reversal of neuromuscular blockade.
This recommended dose is independent of the method of anaesthetic.
Sugammadex can be used to reverse varying degrees of neuromuscular blockade induced by rocuronium or vecuronium.
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 Pharmacology: Pharmacokinetics under Actions).
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 Pharmacology: Pharmacokinetics under Actions).
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 Pharmacology: Pharmacokinetics under Actions).
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 Pharmacology: Pharmacokinetics under Actions).
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 Precautions) 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 Precautions.
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 Precautions).
Studies in patients with severe renal impairment do not provide sufficient safety information to support the use of sugammadex in these patients (see Pharmacology: Pharmacokinetics under Actions).
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 Precautions).
Obese patients: In obese patients, the recommended dose of sugammadex should be based on the patient's actual body weight. The same recommended dose as for non-obese adults should be used.
Hepatic impairment: For mild to moderate hepatic impairment: As sugammadex is mainly excreted renally no dose adjustments are required.
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 Precautions).
Paediatric: Data from the paediatric population are limited (only 1 study on reversal of rocuronium blockade upon reappearance of T2).
Children and adolescents: Sugammadex 2 mg/kg should be used for routine reversal of rocuronium induced block when T2 recurs in children and adolescents (2-17 years). Other routine reversals have not been studied and therefore should not be used until further data are available.
There are no immediate reversal studies in children and adolescents and therefore the drug should not be used until further data are available.
The drug may be diluted to 10 mg/mL to increase the accuracy of dosing in pediatric patients (see previously mentioned).
Term newborn infants and infants: There is only limited experience with the use of sugammadex in infants (30 days to 2 years), and there are no studies in full-term neonates (less than 30 days). Therefore, sugammadex should not be used in term newborn infants and infants until further data are available.
