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PREGNANCY: There are no adequate and well-controlled studies in pregnant women. ULTIVA should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
LABOUR AND DELIVERY: The safety profile of ULTIVA during labour or delivery has not been demonstrated. There are insufficient data to recommend ULTIVA for use during labour and caesarean section.
Remifentanil crosses the placental barrier and fentanyl analogues can cause respiratory depression in the child.
LACTATION: It is not known whether remifentanil is excreted in human milk. However, because fentanyl analogues are excreted in human milk and remifentanil-related material was found in rat milk after dosing with remifentanil, caution should be exercised when ULTIVA is administered to a nursing mother.
