Coagulation factor XIII

Limited data on the clinical use of coagulation factor XIII in pregnancy did not show any negative effects on the course of gestation and the peri- or postnatal development. The use of coagulation factor XIII may be considered during pregnancy, if necessary.

There are no data on the excretion of coagulation factor XIII into human milk. However, based on its large molecular size excretion into milk is unlikely and due to its proteinaceous character, absorption of intact molecules by the infant is also unlikely. Therefore, coagulation factor XIII can be used during breastfeeding.

Fertility

There are no data regarding effects of coagulation factor XIII on fertility.

No studies on the effects on the ability to drive and use machines have been performed.

The following adverse reactions are based on post-marketing experience.

List of adverse reactions

The list presented below is according to the MedDRA system organ classification. Frequencies have been evaluated according to the following convention:

very common: ≥1/10, common: ≥1/100 and <1/10, uncommon: ≥1/1,000 and <1/100, rare: ≥1/10,000 and <1/1,000, very rare: <1/10,000.

Immune System Disorders

Rare: Allergoid-anaphylactoid reactions (like generalised urticaria, rash, fall in blood pressure, dyspnoea)

Very rare: Development of inhibitors to FXIII

General Disorders and Administration Site Conditions

Rare: Rise in temperature

If allergoid-anaphylactoid reactions occur, the administration of coagulation factor XIII has to be discontinued immediately and an appropriate treatment initiated. The current medical standards for shock treatment are to be observed.

Paediatric population

The safety profile for paediatric patients is no different from that of adults in clinical studies.