Fibrogammin

/ Genmedix

1 ml is equivalent to 62.5 IU, and 100 IU are equivalent to 1.6 ml, respectively: Important The amount to be administered and the frequency of administration should always .be oriented towards the clinical efficacy in the individual case. Acute bleeding episodes (including acquired deficiency states) will generally require .considerably higher doses than routine prophylaxis in congenital disease Due to the different pathogenesis of factor-XIII-deficiencies available data on half-lives differ considerably. Thus, it is recommended to monitor the increase in factor-XIII-activity with a factor-XIII-assay. In the case of major surgery and severe .haemorrhages the aim is to obtain normal values. The experience in children is limited.
For full details see prescribing information.

Congenital or acquired factor VIII deficiency, or to promote healing or wounds and bone fractures. Congential deficiency of factor XIII and resultant hemorrhagic syndromes.

Hypersensitivity to the active ingredient or any of the excipients.

In the case of patients with known allergies to the product (with symptoms like generalised urticaria, rash, fall in blood pressure, dyspnoea), antihistaminics and .corticosteroids may be administered prophylactically
In cases of fresh thromboses caution should be exercised due to the fibrin-stabilizing effect.
After repeated Fibrogammin P treatment, patients should be carefully monitored for the development of inhibitors to FXIII by appropriate clinical observation and laboratory tests.
For full details see prescribing information.

Immune system disorders In rare cases allergoid-anaphylactoid reactions (like generalised urticaria, rash, fall .in blood pressure, dyspnoea) are observed .In very rare cases the development of inhibitors to factor XIII may occur General disorders .In rare cases a rise in temperature can be observed If allergoid-anaphylactoid reactions occur, the administration of Fibrogammin P has to be discontinued immediately (e.g. by interruption of the injection) and an appropriate treatment has to be initiated. The current medical standards for shock .treatment are to be observe.
For full details see prescribing information.

No interactions of human plasma coagulation factor XIII concentrate with other medicinal products are known so far.
For full details see prescribing information.

The safety of Fibrogammin P for use in human pregnancy or breastfeeding has not beenestablished in controlled clinical trials. Experimental animal studies are insufficient to,assess the safety with respect to reproduction, development of the embryo or foetus.the course of gestation and peri- and postnatal development.
The clinical use of Fibrogammin P in pregnancy did not show any negative effects on the course of gestation and the peri- or postnatal development. The efficacy of .described Therefore, Fibrogammin P may be used during pregnancy and lactation after careful consideration.

No cases of overdose have been reported.