Pregnancy & Lactation : הריון/הנקה

4.6 Fertility, pregnancy and lactation
Pregnancy
There is no data from the use of iron sucrose in pregnant women in the first trimester.
Data (303 pregnancy outcomes) from the use of iron sucrose in pregnant women in the second and third trimester showed no safety concerns for the mother or newborn.
A careful risk/benefit evaluation is required before use during pregnancy and FERROVIN should not be used during pregnancy unless clearly necessary (see section 4.4).
Iron deficiency anaemia occurring in the first trimester of pregnancy can in many cases be treated with oral iron. Treatment with FERROVIN should be confined to second and third trimester if the benefit is judged to outweigh the potential risk for both the mother and the fetus.
Foetal bradycardia may occur following administration of parenteral irons. It is usually transient and a consequence of a hypersensitivity reaction in the mother.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Breast-feeding
There is limited information on the excretion of iron in human milk following administration of intravenous iron sucrose. In one clinical study, 10 healthy breast- feeding mothers with iron deficiency received 100 mg iron in the form of iron sucrose.
Four days after treatment, the iron content of the breast milk had not increased and there was no difference from the control group (n=5). It cannot be excluded that newborns/infants may be exposed to iron derived from FERROVIN via the mother's milk, therefore the risk/benefit should be assessed.
Preclinical data do not indicate direct or indirect harmful effects to the nursing child.
In lactating rats treated with 59Fe-labelled iron sucrose, low secretion of iron into the milk and transfer of iron into the offspring was observed. Non metabolised iron sucrose is unlikely to pass into the mother's milk.
Fertility
No effects of iron sucrose treatment were observed on fertility and mating performance in rates.