Zisuva 375/Zisuva 625/Zisuva 1G/Zisuva DS/Zisuva 600/Zisuva 1200 Use In Pregnancy & Lactation

Pregnancy: Zisuva 375/Zisuva 625/Zisuva 1G/Zisuva DS: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. Limited data on the use of amoxicillin and clavulanic acid during pregnancy in humans do not indicate an increased risk of congenital malformations. In a single study in women with preterm, premature rupture of the foetal membrane it was reported that prophylactic treatment with amoxicillin and clavulanic acid may be associated with an increased risk of necrotising enterocolitis in neonates. Use should be avoided during pregnancy, unless considered essential by the physician.
Zisuva 600/Zisuva 1200: Limited data on the use of amoxicillin/clavulanic acid during pregnancy in humans do not indicate an Increased risk of congenital malformations. Use should be avoided during pregnancy, unless considered essential by the physician.
Lactation: Zisuva 375/Zisuva 625/Zisuva 1G/Zisuva DS: Both substances are excreted into breast milk (nothing is known of the effects of clavulanic acid on the breast-fed infant). Consequently, diarrhoea and fungus infection of the mucous membranes are possible in the breast-fed infant, so that breast-feeding might have to be discontinued. Amoxicillin and clavulanic acid should only be used during breast-feeding after benefits - risk assessment by the physician in charge.
Zisuva 600/Zisuva 1200: Both substances are excreted into breast milk. Consequently, diarrhea and fungus infection of the mucous membranes are possible in the breast-fed infant, so that breast-feeding might have to be discontinued. The possibility of sensitization should be taken into account. Amoxicillin/clavulanic acid should only be used during breast-feeding after benefit/risk assessment by the physician in charge.