When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Updates to sections: 4.2, 4.4, 4.5, 4.6, 4.8, 4.9, 5.1, 5.2 and 10
4.4 Special warnings and precautions for use
Potential interactions: removed reference to "flucloxacillin". 4.5 Interaction with other medicinal products and other forms of interaction No interaction studies have been conducted in adults with sugammadex and other medicinal products. The information in this section is based on binding affinity between sugammadex and other medicinal products, non-clinical experiments, clinical studies and simulations using a model taking into account the pharmacodynamic effect of neuromuscular blocking agents and the pharmacokinetic interaction between neuromuscular blocking agents and sugammadex. Based on in-vitro data and taking into consideration pharmacokinetics and other relevant information these data, no clinically significant pharmacodynamic interaction with other medicinal products is expected, with exception of the following: For toremifene , flucloxacillin and fusidic acid displacement interactions could not be excluded (no clinically relevant capturing interactions are expected). For hormonal contraceptives a clinically relevant capturing interaction could not be excluded (no displacement interactions are expected).Interactions potentially affecting the efficacy of sugammadex (see also section 4.4): Toremifene: For toremifene, which has a relatively high affinity constant and relatively high plasma concentrations, some displacement of vecuronium or rocuronium from the complex with sugammadex could occur. The recovery of the T 4/T1 ratio to 0.9 could therefore be delayed in patients who have received toremifene on the same day of the operation. Intravenous administration of flucloxacillin and fusidic acid: Intravenous administration of fusidic acid and high dose flucloxacillin (infusion of 500 mg or more),may cause some displacement of rocuronium or vecuronium from sugammadex. The use of these medicinal products fusidic acid in the pre-operative phase may give some delay in the recovery of theT4/T1 ratio to 0.9. No re-occurrence of neuromuscular blockade is expected in the post-operative phase, since the infusion rate of fucidic acid is over a period of several hours and the blood levels are cumulative over 2-3 days. The use of these medicinal products in the post-operative phase after routine reversal during the surveillance period of 6 hours (see section 4.4) should be avoided. If administration of flucloxacillin or fusidic acid within this time period can not be avoided, ventilation should be closely observed, in particular during the first 15 minutes after dosing. For re-administration of sugammadex see section 4.2.
4.5 Interaction with other medicinal products and other forms of interaction
No interaction studies have been conducted in adults with sugammadex and other medicinal products.
The information in this section is based on binding affinity between sugammadex and other medicinal products, non-clinical experiments, clinical studies and simulations using a model taking into account the pharmacodynamic effect of neuromuscular blocking agents and the pharmacokinetic interaction between neuromuscular blocking agents and sugammadex. Based on in-vitro data and taking into consideration pharmacokinetics and other relevant information these data, no clinically significant pharmacodynamic interaction with other medicinal products is expected, with exception of the following: For toremifene
For toremifene
, flucloxacillin and fusidic acid displacement interactions could not be excluded (no clinically relevant capturing interactions are expected). For hormonal contraceptives a clinically relevant capturing interaction could not be excluded (no displacement interactions are expected).Interactions potentially affecting the efficacy of sugammadex (see also section 4.4): Toremifene: For toremifene, which has a relatively high affinity constant and relatively high plasma concentrations, some displacement of vecuronium or rocuronium from the complex with sugammadex could occur. The recovery of the T
Toremifene:
For toremifene, which has a relatively high affinity constant and relatively high plasma concentrations,
some displacement of vecuronium or rocuronium from the complex with sugammadex could occur.
The recovery of the T
4/T1 ratio to 0.9 could therefore be delayed in patients who have received toremifene on the same day of the operation. Intravenous administration of
Intravenous administration of
flucloxacillin and fusidic acid: Intravenous administration of fusidic acid and high dose flucloxacillin (infusion of 500 mg or more),may cause some displacement of rocuronium or vecuronium from sugammadex.
The use of these medicinal products fusidic acid in the pre-operative phase may give some delay in the recovery of theT4/T1 ratio to 0.9. No re-occurrence of neuromuscular blockade is expected in the post-operative phase, since the infusion rate of fucidic acid is over a period of several hours and the blood levels are cumulative over 2-3 days. The use of these medicinal products in the post-operative phase after routine reversal during the surveillance period of 6 hours (see section 4.4) should be avoided. If administration of flucloxacillin or fusidic acid within this time period can not be avoided, ventilation should be closely observed, in particular during the first 15 minutes after dosing. For re-administration of sugammadex see section 4.2.