Beriate 250 IU powder for injection

18 YEARS OLD AND ABOVE
The dosage and duration of the substitution therapy depend on the severity of the factor VIII deficiency, on the location and extent of the bleeding and on the patient’s clinical condition. The number of units of factor VIII administered is expressed in International Units (IU), which are related to the current WHO standard for factor VIII products. Factor VIII activity in plasma is expressed either as a percentage (relative to normal human plasma) or in IU (relative to an International Standard for factor VIII in plasma). One IU of factor VIII activity is equivalent to that quantity of factor VIII in one ml of normal human plasma.

— Prophylaxis
For long term prophylaxis against bleeding in patients with severe haemophilia A, the usual doses are 20 to 40 IU of factor VIII per kg body weight at intervals of 2 to 3 days. In some cases, especially in younger patients, shorter dosage intervals or higher doses may be necessary. During the course of treatment, appropriate determination of factor VIII levels is advised to guide the dose to be administered and the frequency of repeated infusions. In the case of major surgical interventions in particular, aprecise monitoring of the substitution therapy by means of coagulation analysis (plasma factor VIII activity) is indispensable. Individual patients may vary in their response to factor VIII, achieving different levels of in vivo recovery and demonstrating different half-lives. Patients should bemonitored for the development of factor VIII inhibitors.

1 TO 18 YEARS OLD
Dosing in children is based on body weight and is therefore generally based on the same guidelines as for adults. The frequency of administration should always be oriented to the clinical effectiveness in the individual case.

METHOD OF ADMINISTRATION
For intravenous use.
The preparation should be warmed to room or body temperature before administration. Inject or infuse slowly intravenously at a rate which the patient finds comfortable. The injection or infusion rate should not exceed 2 ml per minute. Observe the patient for any immediate reaction. If any reaction takes place that might be related to the administration of Beriate, the rate of infusion should be decreased or the infusion stopped, as required by the clinical condition of the patient.

Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).