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Humalog ® (insulin lispro)
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Humalog Summary of Product Characteristics (SmPC)
Humalog 200 Units/ml (insulin lispro): Fertility pregnancy and lactation
Data on a large number of exposed pregnancies do not indicate any adverse effect of insulin lispro on pregnancy or on the health of the foetus/newborn
Pregnancy
Data on a large number of exposed pregnancies do not indicate any adverse effect of insulin lispro on pregnancy or on the health of the foetus/newborn.
It is essential to maintain good control of the insulin-treated (insulin-dependent or gestational diabetes) patient throughout pregnancy. Insulin requirements usually fall during the first trimester and increase during the second and third trimesters. Patients with diabetes should be advised to inform their doctor if they are pregnant or are contemplating pregnancy. Careful monitoring of glucose control, as well as general health, is essential in pregnant patients with diabetes.
Breast-feeding
Patients with diabetes who are breast-feeding may require adjustments in insulin dose, diet or both.
Fertility
Insulin lispro did not induce fertility impairment in animal studies.
Reference
Humalog 200 Units/ml [Summary of Product Characteristics]. Utrecht, The Netherlands: Eli Lilly Nederland B.V.
Date of Last Review: December 26, 2018
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