Pregnancy & Lactation : הריון/הנקה

4.6      Fertility, pregnancy and lactation

Pregnancy
Ketalar® crosses the placenta. This should be borne in mind during operative obstetric procedures in pregnancy. No controlled clinical studies in pregnancy have been conducted. The use in pregnancy has not been established, and such use is not recommended, with the exception of administration during surgery for abdominal delivery or vaginal delivery.

Some neonates exposed to ketamine at maternal intravenous doses ≥ 1.5 mg/kg during delivery have experienced respiratory depression and low Apgar scores requiring newborn resuscitation.

Marked increases in maternal blood pressure and uterine tone have been observed at intravenous doses greater than 2 mg/kg.

Data are lacking for intramuscular injection and maintenance infusion of ketamine in the parturient population, and recommendations cannot be made. Available data are presented in section 5.2.

Breast-feeding
The safe use of ketamine during lactation has not been established, and such use is not recommended.

Studies in animals have shown reproductive toxicity (see section 5.3).
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