Seebri Breezhaler Use In Pregnancy & Lactation

Women of child-bearing potential: There are no special recommendations for women of child-bearing potential.
Pregnancy: No clinical data on exposed pregnancies in COPD patients are available. SEEBRI BREEZHALER was not teratogenic in rats or rabbits following inhalational administration (see Pharmacology: Toxicology: Non-clinical safety data under Actions). In human parturients undergoing Caesarean section, 86 minutes after a single intramuscular injection of 0.006 mg/kg glycopyrronium bromide, umbilical plasma concentrations were low. As there is no adequate experience in pregnant women, SEEBRI BREEZHALER should only be used during pregnancy if the expected benefit to the patient justifies the potential risk to the fetus.
Breast-feeding: It is not known whether glycopyrronium bromide passes into human breast milk. However, glycopyrronium bromide (including its metabolites) was excreted into the milk of lactating rats. The use of SEEBRI BREEZHALER by breast-feeding women should only be considered if the expected benefit to the woman is greater than any possible risk to the infant (see Pharmacology: Toxicology: Non-clinical safety data under Actions).
Fertility: Reproduction studies and other data in animals did not indicate a concern regarding fertility in either males or females (see Pharmacology: Toxicology: Non-clinical safety data under Actions).