Pregnancy & Lactation : הריון/הנקה

4.6   Fertility, pregnancy and lactation

Pregnancy
There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of glucose solutions in pregnant women. Limited animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity at therapeutic doses (see section 5.3).
The use of Glucose 50% Baxter may be considered during pregnancy, provided that blood glucose and electrolyte and fluid balance are carefully monitored and remain within the physiological range. Glucose 50% Baxter should be administered with particular caution to pregnant women during labour, particularly if administered in combination with oxytocin, due to the risk of hyponatraemia (see sections 4.4, 4.5 and 4.8).

If a medicinal product is added, the type of additive and its use during pregnancy and breastfeeding must be considered separately.

Breast-feeding
Glucose/metabolites are excreted in human milk, but at therapeutic doses of Glucose 50% Baxter, no effects on the breastfed newborns/infants are anticipated.
Glucose 50% Baxter can be used during breast-feeding.

Fertility
No data from humans are available. At therapeutic doses, no effects are anticipated.