Active Ingredient: Human fibrinogen
Treatment of bleeding in patients with congenital hypo-, or afibrinogenaemia with bleeding tendency.
For this indication, competent medicine agencies globally authorize below treatments:
Intravenous
70 - 70 mg per kg of body weight
From 70 To 70 mg per kg of body weight once every day
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.
If the patient’s fibrinogen level is not known, the recommended dose is 70 mg per kg of body weight (bw) administered intravenously.
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 body weigth) = [Target level (g/l) - measured level (g/l)] / 0.017 (g/l per mg/kg body weigth)
Limited data from clinical studies regarding the dosage of fibrinogen in children are available. Resulting from these studies, as well as from long lasting clinical experience with fibrinogen products, dosage recommendations in the treatment of children are the same as for adults.
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