<p>Alphanate contains the labeled amount of Factor VIII expressed in International Units (IU) FVIII/vial and Willebrand.<br />
<br />
<strong>Factor</strong>: Ristocetin Cofactor activity in IU VWF:RCo/vial.<br />
<br />
<strong>Hemophilia A</strong>: Control and prevention of bleeding episodes</p>

<ul>
	<li>Dose (units) = body weight (kg) x desired FVIII rise (IU/dL or % of normal) x 0.5 (IU/kg per IU/dL)</li>
	<li>Frequency of intravenous injection of the reconstituted product is determined by the type of bleeding episode and the recommendation of the treating physician</li>
</ul>

<p><strong>Von Willebrand Disease</strong>: Surgical and/or invasive procedure in adult and pediatric patients except Type 3 undergoing major surgery</p>

<ul>
	<li><strong>Adults</strong>: Pre-operative dose of 60 IU VWF:RCo/kg body weight; subsequent doses of 40-60 IU VWF:RCo/kg/body weight at 8-12 hour intervals post-operative as clinically needed.</li>
	<li><strong>Pediatric</strong>: Pre-operative dose of 75 IU VWF:RCo/kg/body weight; subsequent doses of 50-75 IU VWF:RCo/kg body weight at 8-12 hour intervals post-operative as clinically needed.</li>
	<li>Dosage based on protocol used in the Alphanate prospective clinical trial according to judgment of the investigator.</li>
</ul>

<p><strong>Pediatric Use</strong>-</p>

<ul>
	<li><strong>Hemophilia A Indication</strong>: Clinical trials for safety and effectiveness in pediatric hemophilia A patients 16 years of age and younger have not been conducted.</li>
	<li><strong>VWD Indication</strong>: The hemostatic efficacy of Alphanate has been studied in 20 pediatric subjects with VWD 18 years of age and under. Based on the data from a subset of these subjects, age had no effect on the pharmacokinetics of VWF:RCo. There were no clinically important differences between pediatric patients and adults.</li>
</ul>

<p><strong>Geriatric Use</strong>: No human or animal data. Use only if clearly needed.</p>

<p><strong>Administration</strong></p>

<p>Alphanate is for intravenous use only after reconstitution. Use plastic disposable syringes. Do not refrigerate after reconstitution. Reconstituted Alphanate may be stored at room temperature (not to exceed 30&deg; C) prior to administration, but administer intravenously within three hours.<br />
<br />
Discard any unused contents into the appropriate safety container. Do not administer Alphanate at a rate exceeding 10 mL/minute.</p>