Pregnancy & Lactation : הריון/הנקה

4.6 Pregnancy and lactation

Pregnancy
For rocuronium bromide, no clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. Caution should be exercised when prescribing Rocuronium bromide Kalceks to pregnant women.

Caesarean section
In patients undergoing Caesarean section, Rocuronium bromide Kalceks 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. However, Rocuronium bromide Kalceks , administered in doses of 0.6 mg/kg may not produce adequate conditions for intubation until 90 seconds after administration. This dose has been shown to be safe in parturients undergoing Caesarean section. Rocuronium bromide Kalceks does not affect Apgar score, foetal muscle tone or 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 effects in the newborn.

Note 1: doses of 1.0 mg/kg have been investigated during rapid sequence induction of anaesthesia, but not in Caesarean section patients. Therefore, only a dose of 0.6 mg/kg is recommended in this patient group.

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 Kalceks should be reduced and be titrated to twitch response.

Breast-feeding
It is unknown whether rocuronium bromide is excreted in human breast milk. Animal studies have shown insignificant levels of rocuronium bromide in breast milk.
Insignificant levels of rocuronium bromide were found in the milk of lactating rats. There are no human data on the use of Rocuronium bromide Kalceks during lactation. Rocuronium bromide Kalceks should be given to lactating women only when the attending physician decides that the benefits outweigh the risks. After the administration of a single dose, it is recommended to abstain from next breastfeeding for five elimination half-lives of rocuronium, i.e. for about 6 hours.