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Fresofol 1% MCT/LCT must not be used in patients with known hypersensitivity to propofol or to any of the excipients of the emulsion; in patients who are allergic to soya or peanut; for sedation in children 16 years of age and younger (see Precautions).
Use in Pregnancy & Lactation: The safety of propofol during pregnancy has not been established. Therefore, propofol should not be used in pregnant women unless clearly necessary. Propofol crosses the placenta and may be associated with neonatal depression. High doses (more than 2.5 mg propofol/kg body weight for induction or 6 mg propofol/kg bodyweight/h for maintenance of anaesthesia) should be avoided.
Studies in breast-feeding women showed that propofol is excreted in small amounts into the milk. Therefore, mothers should stop breast-feeding and discard breast milk for 24 hours after administration of propofol.
