Supply: 250 IU(Factor VIII) and 550 IU(von Willebrand factor) / vial                <<IAHM>>

Description: It is a stable, purified, sterile, lyophilized concentrate of Human Antihemophilic Factor and von Willebrand Factor (VWF).

 

Action: The Antihemophilic Factor/VWF complex consists of two different noncovalently bound proteins. Factor VIII is an essential cofactor in activation of Factor X leading ultimately to formation of thrombin and fibrin. The VWF promotes platelet aggregation and platelet adhesion on damaged vascular endothelium; it also serves as a stabilizing carrier protein for the procoagulant protein Factor VIII.

Pharmacokinetics: time to peak conc.: 10 mins to 2 hrs; time to peak effect: 1 to 2 hrs; median half-life:12 to 17 hours (Antihemophilic factor), 10.3 hours (VWF:RCo).

Indication:

 (1). Teatment and prevention of bleeding in hemophilia A patient

(2). Teatment of spontaneous and trauma-induced bleeding episodes in severe von Willebrand disease.

衛生署核准適應症：先天及後天缺乏第八凝血因子。

Dosage and Administration:

1. Prophylaxis of spontaneous hemorrhage
IV, 25 - 40 IU/kg tiw, maintaining the trough factor level above 1% between doses.

2. Treatment of von Willebrand Disease
IV 40 to 80 IU vWF:RCof per kg q 8 - 12 h. Repeat doses are administered for as long as needed based on repeat monitoring of appropriate clinical and laboratory measures. Dosages should be adjusted according to the extent and location of bleeding. The administration of 1 IU of Factor VIII per kg of body weight can be expected to lead to a rise in circulating vWF:RCof of approximately 3.5 - 4 IU per dL.

Adverse drug reaction:

Less frequent: Anaphylaxis or other allergic reaction, hemolytic anemia, thrombosis, burning, stinging, or inflammation at injection site, dizziness or lightheadedness, dry mouth, fatigue, flushing, headache, nausea or vomiting, nosebleed, skin rash, unpleasant taste.

Rare: Hyperfibrinogenemia, paresthesias.

Contraindication: Known hypersensitivity to antihemophilic factor.

Preparation of dosage form: Slowly inject the solution (max:4 mL/min) intravenously with an infusion kit or with a suitable injection needle. Warm both diluent and Haemate P^® in unopened vials to room temperature (20-37℃).

Gently rotate the vial, don’t shake vial.

Storage & Stability:

1.2~8℃, do not freeze.

2.Haemate P^® may be stored at room temperature not to exceed  30°C, for up to six months.

3.After reconstitution, Haemate P should be used within 8 hrs.

Pregnancy Category: C

Reference:

1. USP DI 24^th 2004. 

2. MICROMEDEX(R) Healthcare Series Vol. 128 expires 2006.

3. Drug package Insert.