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There are limited clinical study data available from the use of a single dose of Voluven in pregnant women undergoing caesarean section with spinal anesthesia. No negative influence of Voluven on patient safety could be detected; a negative influence on the neonate could also not be detected.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/foetal development, parturition or postnatal development. No evidence of teratogenicity was seen.
Voluven should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Information on the use of Voluven during labour or delivery is unknown with the exception of caesarean section. Use if clearly needed.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Voluven is administered to a nursing woman.
