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Pregnancy: There is a limited amount of data from the use of Actilyse in pregnant women. Nonclinical studies performed with alteplase in doses higher than human doses exhibited fetal immaturity and/or embryotoxicity, secondary to the known pharmacological activity of the drug. Alteplase is not considered to be teratogenic (see Pharmacology: Toxicology: Preclinical safety data under Actions).
In cases of an acute life-threatening disease the benefit has to be evaluated against the potential risk.
Breast-feeding: It is not known if alteplase is excreted into human milk.
Fertility: Clinical data on fertility are not available for Actilyse. Nonclinical studies performed with alteplase showed no adverse effect on fertility (see Pharmacology: Toxicology: Preclinical safety data under Actions).
