Rocuronium B. Braun Solution for Injection/Infusion Use In Pregnancy & Lactation

Pregnancy: There are limited data on the use of rocuronium bromide in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). Rocuronium bromide should only be given to pregnant women when strictly necessary and the attending physician decides that the benefits outweigh the risks.
Cesarean section: In patients undergoing Cesarean section, rocuronium bromide can be used as part of a rapid sequence induction technique, provided no intubation difficulties are anticipated and a sufficient dose of anaesthetic agent is administered or following suxamethonium facilitated intubation. Use of rocuronium bromide during caesarean section has been shown to be safe at doses of 0.6 mg/kg bodyweight. It does not affect the Apgar score, the foetal muscle tone or the cardiorespiratory adaptation.
From umbilical cord blood sampling it is apparent that only limited placental transfer of rocuronium bromide occurs, which does not lead to the observation of clinical adverse reactions in the new-born infant.
Note 1: doses of 1.0 mg/kg have been investigated during rapid sequence induction of anaesthesia, but not in Caesarean section patients.
Note 2: reversal of neuromuscular block induced by neuromuscular blocking agents may be inhibited or unsatisfactory in patients receiving magnesium salts for toxemia of pregnancy because magnesium salts enhance neuromuscular blockade. Therefore, in these patients the dosage of rocuronium bromide should be reduced and be titrated to twitch response.
Breast-feeding: It is unknown whether rocuronium bromide/metabolites are excreted in human milk. Other medicinal products of this class show little excretion into breast milk and low resorption by the suckling child. Animal studies have shown excretion of rocuronium bromide in insignificant amounts in breast milk.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from rocuronium bromide therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility: There are no data with regard to effects of rocuronium bromide on fertility.