Haemocomplettan P

/ Genmedix

Posology: The dosage and duration of the substitution therapy depend on the severity of the disorder, location and extent of bleeding and the patient’s clinical condition.
The (functional) fibrinogen level should be determined in order to calculate individual dosage and the amount and frequency of administration should be determined on an individual patient basis by regular measurement of plasma fibrinogen level and continuous monitoring of the clinical condition of the patient and other replacement therapies used.
Normal plasma fibrinogen level is in the range of 1.5 – 4.5 g/l. The critical plasma fibrinogen level below which haemorrhages may occur is approximately 0.5 – 1.0 g/l. In case of major surgical intervention, precise monitoring of replacement therapy by coagulation assays is essential.
Prophylaxis in patients with congenital hypo- or afibrinogenaemia and known bleeding tendency.
To prevent excessive bleeding during surgical procedures, prophylactic treatment is recommended to raise fibrinogen levels to 1 g/l and maintain fibrinogen at this level until haemostasis is secure and above 0.5 g/l until wound healing is complete.
Initial Dose: If the patient’s fibrinogen level is not known, the recommended dose is 70 mg per kg of body weight (bw) administered intravenously.
Subsequent Dose: The target level (1 g/l) for minor events (e.g. epistaxis, intramuscular bleeding or menorrhagia) should be maintained for at least three days. The target level (1.5 g/l) for major events (e.g. head trauma or intracranial haemorrhage) should be maintained for seven days.
Dose of fibrinogen (mg/kg b.w.) = [Target level (g/L) – measured level (g/L)] /
0.017 (g/L per mg/kg b.w.)
Furthermore, the amount to be administered and the frequency of application of
Haemocomplettan P 1g/2g should always be oriented to the degree of bleeding and the clinical efficacy in the individual case.
In case of major surgical intervention, precise monitoring of replacement therapy by coagulation assays is essential.
Treatment of bleeding
Adults: Generally 1-2 g is administered initially with subsequent infusions as required.
In case of severe haemorrhage i.e. obstetric use / abruption placenta, large amounts (4-8 g) of fibrinogen may be required.
Children: Limited data from clinical studies regarding the dosage of Haemocomplettan P1 g/2g in children are available. The dosage should be determined according to the body weight and clinical need but is usually 20-30 mg/kg.
Method of Administration: Intravenous infusion or injection.
Haemocomplettan should be reconstituted according to section 6.6. The reconstituted solution should be warmed to room or body temperature before administration, then injected or infused slowly at a rate which the patient finds comfortable. The injection or infusion rate should not exceed approx. 5 ml per minute.

Treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia. Not indicated for dysfibrinogenemia.

Known hypersensitivity to constituents of the product. Manifest thrombosis or myocardial infarction, except in cases of life threatening hemorrhages.

In the case of patients known to have a tendency towards allergies, antihistaminics and corticosteroids may be administered prophylactically. Patients should be observed closely for signs or symptoms of thrombosis or disseminated intravascular coagulation (DIC). Patients with a history of coronary heart disease or myocardial infarction, patients with liver disease, patients post-operatively, neonates, patients at risk of thromboembolic phenomena. Contains sodium chloride and may therefore be harmful to patients on a low sodium diet.
See prescribing information for full details.

Mostly tolerated without undesirable reactions.
See prescribing information for full details.

No interactions are known so far.

Pregnancy:
Animal reproduction studies have not been conducted with Haemocomplettan. Since the active substance is of human 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 fetus. The safety of human plasma fibrinogen products for use in human pregnancy has not been established in controlled clinical trials.
Clinical experience with fibrinogen products in the treatment of obstetric complications suggests that no harmful effects on the course of the pregnancy or health of the fetus or the neonate are to be expected.
Lactation: It is unknown whether Haemocomplettan is excreted in human milk. The safety of human plasma fibrinogen products 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.

In order to avoid overdosage, regular monitoring of the plasma level of fibrinogen during therapy is indicated.
In case of overdosage, the risk of development of thromboembolic complications is enhanced.