6 ml, respectively.
Important:
The amount to be administered and the frequency of administration should always be orientated towards clinical efficacy in the individual case. Dosage The dosing regimen should be individualised based on body weight, laboratory values, and the patient’s clinical condition.
Routine prophylaxis dosing schedule for treatment of congenital FXIII deficiency Initial dose • 40 International Units (IU) per kg body weight • The injection rate should not exceed 4 ml per minute. Subsequent dosing • Dosing should be guided by the most recent trough FXIII activity level, with dosing every 28 days (4 weeks) to maintain a trough FXIII activity level of approximately 5 to 20%.
• Recommended dosing adjustments of ± 5 IU per kg should be based on trough FXIII activity levels as shown in Table 1 and the patient’s clinical condition. • Dosing adjustments should be made on the basis of a specific, sensitive assay used to determine FXIII levels.
An example of dose adjustment using the standard Berichrom® FXIII activity assay is outlined in Table 1 below.
Table 1:
Dose adjustment using the Berichrom® FXIII activity assay Factor XIII Activity Trough Level (%) Dosage Change One trough level of <5% Increase by 5 units per kg Trough level of 5% to 20% No change Two trough levels of >20% Decrease by 5 units per kg One trough level of >25% Decrease by 5 units per kg The potency expressed in units is determined using the Berichrom® FXIII activity assay, referenced to the current International Standard for Blood Coagulation Factor XIII, Plasma.
Therefore, a unit is equivalent to an International Unit. Prophylaxis prior to surgery After the patient’s last routine prophylactic dose, if a surgery is scheduled: • Between 21 and 28 days later – administer the patient’s full prophylaxis dose immediately prior to surgery and the next prophylactic dose should be given 28 days later.
• Between 8 and 21 days later – an additional dose (full or partial) may be administered prior to surgery. The dose should be guided by the patient’s FXIII activity levels and clinical condition and should be adjusted according to the half- life of Fibrogammin.
• Within 7 days of last dose – additional dosing may not be needed. Adjustments to dosing may be different from these recommendations and should be individualised, based on FXIII activity levels and the patient’s clinical condition.
All patients should be monitored closely during and after surgery. It is recommended to monitor the increase in FXIII-activity with a FXIII assay. e. 4 IU/ml. Paediatric population The posology and method of administration in children and adolescents is based on body weight and is therefore generally based on the same guidelines as for adults.
The dose and/or frequency of administration for each individual should always be guided by the clinical effectiveness and FXIII activity levels. ) Elderly population The posology and method of administration in elderly people (> 65 years) has not been established in clinical studies.
6. After reconstitution the solution should be clear or slightly opalescent. The preparation should be warmed to room or body temperature before administration. Slowly inject or infuse intravenously at a rate which the patient finds comfortable.
The injection or infusion rate should not exceed approximately 4ml per minute. Observe the patient for any immediate reaction. If any reaction takes place that might be related to the administration of Fibrogammin, the rate of infusion should be decreased or the infusion stopped, as required by the clinical condition of the patient.