Pregnancy & Lactation : הריון/הנקה

4.6   Fertility, pregnancy and lactation
Pregnancy
There are no or limited amount of data from the use of Gelaspan 4% B.Braun in pregnant women. Animal studies are insufficient with respect to reproductive toxicity: see section 5.3.
Due to limited data available and the possibility of severe anaphylactic/anaphylactoid reactions with consecutive foetal- and neonatal distress caused by maternal hypotension, the use of modified gelatin solutions should be restricted to emergency situations during pregnancy.

Breastfeeding
It is not known whether Gelaspan 4% B.Braun or its metabolites are excreted in human milk. Sodium and chloride are normal constituents of the human body and of food. No significant increase in the content of these electrolytes in breast milk is expected following the use of Gelaspan 4% B.Braun. A decision must be made whether to discontinue breast-feeding or to interrupt/ discontinue Gelaspan 4% B.Braun therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

Fertility
No data are available on the effects of Gelaspan 4% B.Braun on fertility in humans or animals. In view of the nature of its constituents, it is highly improbable, however, that Gelaspan 4% B.Braun has any effect on fertility.