Pregnancy: Clinical experience of intravenous administration of paracetamol is limited. However, epidemiological data from the use of oral therapeutic doses of paracetamol indicate no undesirable effects on the pregnancy or
on the health of the foetus / newborn infant. Prospective data on pregnancies exposed to overdoses did not show an increase in malformation risk.
Reproductive studies with the intravenous form of paracetamol have not been performed in animals. However, studies with the oral route did not show any malformation of foetotoxic effects. Nevertheless, Paracetamol 1 g/100 mL solution for IV infusion should only be used during pregnancy after a careful benefit-risk assessment. In this case, the recommended posology and duration must be strictly observed.
Lactation: After oral administration, paracetamol is excreted into breast milk in small quantities. No undesirable effects on nursing infants have been reported. Consequently, Paracetamol 1 g/100 mL solution for IV infusion may be used in breast-feeding women.
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