er combined or progestogen only). If sugammadex is administered at the same day as an oral contraceptive is taken reference is made to missed dose advice in the package leaflet of the oral contraceptive. In the case of non-oral hormonal contraceptives, the patient must use an additional non hormonal contraceptive method for the next 7 days and refer to the advice in the package leaflet of the product.
Interactions due to the lasting effect of rocuronium or vecuronium:
When medicinal products which potentiate neuromuscular blockade are used in the post-operative period special attention should be paid to the possibility of recurrence of neuromuscular blockade. Please refer to the package leaflet of rocuronium or vecuronium for a list of the specific medicinal products which potentiate neuromuscular blockade. In case recurrence of neuromuscular blockade is observed, the patient may require mechanical ventilation and re-administration of sugammadex (see section (4.2).
Interference with laboratory tests:
In general sugammadex does not interfere with laboratory tests, with the possible exception of the serum progesterone assay. Interference with this test is observed at sugammadex plasma concentrations of 100 microgram/ml (peak plasma level following 8 mg/kg bolus injection).
In a study in volunteers doses of 4 mg/kg and 16 mg/kg of sugammadex resulted in maximum mean prolongations of aPTT by 17 and 22% respectively and of PT(INR) by 11 and 22% respectively. These limited mean aPTT and PT(INR) prolongations were of short duration (≤ 30 minutes).
In in vitro experiments a pharmacodynamic interaction (aPTT and PT prolongation) was noted with vitamin K antagonists, unfractionated heparin, low molecular weight heparinoids, rivaroxaban and dabigatran (see section 4.4).
Paediatric population
No formal interaction studies have been performed. The above mentioned interactions for adults and the warnings in section 4.4 should also be taken into account for the paediatric population.
4.6 Fertility, pregnancy and lactation
Pregnancy
For sugammadex no clinical data on exposed pregnancies are available.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/foetal development, parturition or postnatal development.
Caution should be exercised when administering sugammadex to pregnant women.
Breast-feeding
It is unknown whether sugammadex is excreted in human breast milk. Animal studies have shown excretion of sugammadex in breast milk. Oral absorption of cyclodextrins in general is low and no effect on the suckling child is anticipated following a single dose to the breast-feeding woman.
Sugammadex can be used during breast-feeding.
Fertility
The effects with sugammadex on human fertility have not been investigated. Animal studies to eva luate fertility do not reveal harmful effects.
4.7 Effects on ability to drive and use machines
Bridion has no known influence on the ability to drive and use machines.
4.8 Undesirable effects
Summary of the safety profile
The most commonly reported adverse reactions in surgical patients were anaesthetic complications (Common (≥ 1/100 to < 1/10)).
Tabulated list of adverse reactions
The safety of sugammadex has been eva luated based on an integrated safety database of approximately 1,700 patients and 120 volunteers. The following adverse reactions have been reported for surgical patients in clinical trials:
[Very common (&g |
