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There is limited clinical experience with NovoMix 30 in pregnancy. NovoMix 30 has not been investigated in pregnant women. However, data from two randomised controlled clinical trials (157 and 14 insulin aspart-exposed pregnancies, respectively, in basal-bolus regimen) do not indicate any adverse effect of insulin aspart on pregnancy or on the health of the foetus/newborn when compared to soluble human insulin.
In general, intensified blood glucose control and monitoring of pregnant women with diabetes are recommended throughout pregnancy and when contemplating pregnancy. Insulin requirements usually fall in the first trimester and increase subsequently during the second and third trimesters. After delivery, insulin requirements normally return rapidly to pre-pregnancy values.
There are no restrictions on treatment with NovoMix 30 during lactation. Insulin treatment of the breast-feeding mother presents no risk to the baby. However, the NovoMix 30 dosage may need to be adjusted.
