Pantokem/Pantokem IV Use In Pregnancy & Lactation

Pregnancy: Pantokem: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).
Pantokem IV: There are no adequate data from the use of pantoprazole in pregnant women. Studies in animals have shown reproductive toxicity. The potential risk for humans is unknown. Pantoprazole 40 mg should not be used during pregnancy unless clearly necessary.
Breast-feeding: Pantokem IV: Animal studies have shown excretion of pantoprazole in breast milk. Excretion into human milk has been reported. Therefore, a decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Pantoprazole 40 mg should be made taking into account the benefit of breastfeeding to the child and the benefit of Pantoprazole 40 mg therapy to women.