Volulyte 6% Use In Pregnancy & Lactation

For Volulyte no clinical data on exposed pregnancies are available.
There are limited clinical study data available from the use of a single dose of HES 130/0.4 (6%) in 0.9% sodium chloride in pregnant women undergoing caesarean section with spinal anesthesia. No negative influence of HES on patient safety could be detected; a negative influence on the neonate could also not be detected (see Pharmacology: Pharmacodynamics under Actions).
Animal studies with a similar product containing HES 130/0.4 in 0.9% sodium chloride solution do not indicate harmful effects with respect to pregnancy, embryo/foetal development, parturition or postnatal development (see Pharmacology: Toxicology: Preclinical Safety data under Actions).
No evidence of teratogenicity was seen.
Volulyte should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Information on the use of Volulyte during labour or delivery is unknown with the exception of caesarean section (see above). 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 Volulyte is administered to a nursing woman.