Pregnancy & Lactation : הריון/הנקה

4.6   Fertility, pregnancy and lactation
Pregnancy
Animal reproduction studies have not been conducted with Haemocomplettan (see section 5.3). Since the active substance is of human blood plasma origin, it is catabolized in the same manner as the patient’s own protein. These physiological constituents of the human blood are not expected to induce adverse effects on reproduction or on the foetus.

The safety of Haemocomplettan for use in human pregnancy has not been established in controlled clinical trials.

Clinical experience with human fibrinogen concentrate in the treatment of obstetric complications suggests that no harmful effects on the course of the pregnancy or health of the foetus or the neonate are to be expected.

Lactation
It is unknown whether Haemocomplettan is excreted in human milk. The safety of Haemocomplettan for use during lactation has not been established in controlled clinical trials.
A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Haemocomplettan therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

Fertility
There are no data on fertility available.