Pregnancy & Lactation : הריון/הנקה

4.6 Fertility, pregnancy and lactation
Women of child bearing potential
Preconceptual counselling before programmable baclofen pump placement and in women with intrathecal baclofen pumps already implanted is recommended to ensure proper preparation and management throughout pregnancy and the peripartum period.

Pregnancy
There are limited data on the use of Baclofene Bioindustria L.I.M. 10 mg/5 ml in pregnant women.

Reproductive toxicity has been observed at high oral doses of baclofen (see section 5.3). After intrathecal administration of Baclofene Bioindustria L.I.M. 10 mg/5 ml small amounts of baclofen can be detected in maternal plasma (see section 5.2). Animal data show that baclofen can cross the placental barrier.
Therefore, Baclofene Bioindustria L.I.M. 10 mg/5 ml should not be used during pregnancy unless the expected benefit outweighs the potential risk to the foetus.

Breastfeeding
After oral administration of baclofen at therapeutic doses, baclofen passes into the breast milk, but in quantities so small that no undesirable effects on the infant are to be expected.

After intrathecal administration of Baclofene Bioindustria L.I.M. 10 mg/5 ml small amounts of baclofen can be detected in maternal plasma (see section 5.2). Therefore, no baclofen is expected to be found in the milk of the mother receiving Baclofene Bioindustria L.I.M. 10 mg/5 ml therapy and no special recommendations are given.

Fertility
Animal studies have shown that intrathecal baclofen is unlikely to have an adverse effect on fertility under clinically-relevant conditions (see section 5.3).