Posology Only general dosage guidelines are given below. Treatment should be initiated under the supervision of a physician experienced in the treatment of coagulation disorders. The dosage and duration of the substitution therapy depend on the indication for treatment, severity of the disorder, on the location and extent of bleeding and on the patient’s clinical condition.
The amount and the frequency of administration should be calculated on an individual patient basis. 2). Individual dosage requirements can only be identified on the basis of regular determinations of the individual plasma levels of the coagulation factors of interest, or on global tests of the prothrombin complex levels (INR, Quick’s test), and a continuous monitoring of the clinical condition of the patient.
In case of major surgical interventions, precise monitoring of the substitution therapy by means of coagulation assays is essential (specific coagulation factor assays and/or global tests for prothrombin complex levels). - Bleeding and perioperative prophylaxis of bleedings during vitamin K antagonist treatment.
The dose will depend on the INR before treatment and the targeted INR. The pre-treatment INR should be measured as close as possible to the time of dosing in order to calculate the appropriate dose of Beriplex. g. 3) at different initial INR levels are given.
4 2 Approximate dose IU (Factor IX)/kg body weight 25 35 50 Dose is based on body weight up to but not exceeding 100 kg. 0. The correction of the vitamin K antagonist-induced impairment of haemostasis is commonly reached approximately 30 minutes after the injection.
The simultaneous administration of vitamin K should be considered in patients receiving Beriplex for urgent reversal of vitamin K antagonists since vitamin K usually takes effect within 4 - 6 hours. Repeated dosing with Beriplex for patients requiring urgent reversal of vitamin K antagonist treatment is not supported by clinical data and therefore not recommended.
These recommendations are based on data from clinical studies with a limited number of subjects. Recovery and the duration of effect may vary, therefore monitoring of INR during treatment is mandatory. - Bleedings and perioperative prophylaxis in congenital deficiency of any of the vitamin K dependent coagulation factors when specific coagulation factor products are not available.
019 IU/ml) of normal. The dose of a specific factor administered is expressed in International Units (IU), which are related to the current WHO standard for each factor. The activity in the plasma of a specific coagulation factor is expressed either as a percentage (relative to normal plasma) or in International Units (relative to the international standard for the specific coagulation factor).
One International Unit (IU) of a coagulation factor activity is equivalent to the quantity in one ml of the normal human plasma. 019 IU/ml.
The required dosage is determined using the following formula:
Required units = body weight [kg] x desired factor X rise [IU/ml] x 53 where 53 (ml/kg) is the reciprocal of the estimated recovery. Note that the calculation is based upon data from patients receiving vitamin K antagonists. A calculation based upon data from healthy subjects would provide a lower estimate of the required dose.
If the individual recovery is known, that value should be used for calculation. 2). 4). Older population The posology and method of administration in older people (> 65 years) is equivalent to the general recommendations. 6. The reconstituted solution should be administered intravenously (not more than 8 ml/min*).
The solution should be clear or slightly opalescent.