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Women of childbearing potential: Given that the potential risks to the developing foetus are unknown, women of childbearing potential should use effective contraception.
Pregnancy: There are no adequate data from the use of entecavir in pregnant women. Studies in animals have shown reproductive toxicity at high doses. The potential risk for humans is unknown. Entecavir STELLA 0.5 mg film-coated tablet should not be used during pregnancy unless clearly necessary. There are no data on the effect of entecavir on transmission of HBV from mother to newborn infant. Therefore, appropriate interventions should be used to prevent neonatal acquisition of HBV.
Lactation: It is unknown whether entecavir is excreted in human milk. Available toxicological data in animals have shown excretion of entecavir in milk. A risk to the infants cannot be excluded. Lactation should be discontinued during treatment with Entecavir STELLA 0.5 mg film-coated tablet.
