Following reconstitution with the supplied diluent, Alphanate should be administered IV within 3 hrs after reconstitution to avoid the potential ill effect of any inadvertent bacterial contamination occurring during reconstitution. Alphanate may be administered by injection (plastic disposable syringes are recommended). Administer at room temperature, do not refrigerate after reconstitution and discard any unused contents into the appropriate safety container.
Antihemophilic factor potency (Factor VIII:C activity) is expressed in international units (iu) on the product label. One unit approximates the activity in 1 mL of normal human plasma. Replacement therapy studies have shown a linear dose-response relationship with a 2-2.5% increase in Factor VIII activity for each factor of 0.5 iu/kg can be calculated.
The following formula provides a guide for dosage calculation the plasma Factor VIII may vary depending upon the age, weight, severity of hemorrhage or surgical procedure of the patient:
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Mild to moderate hemorrhages can usually be treated with a single administration of Alphanate sufficient to raise the plasma Factor VIII level to 20-30%. In the event of more serious hemorrhage, the patient's plasma Factor VIII level should be raised to 30-50%. Infusions are generally required at twice daily intervals over several days.
Surgery in patients with Factor VIII requires that postoperatively the Factor VIII level be raised to 50-80% and maintained at or above 30% for approximately 2 weeks. For dental extractions, the Factor VIII level should be raised to 50% immediately prior to the procedure; additional Alphanate may be given if bleeding recurs.
In patients with severe Factor VIII deficiency who experience frequent hemorrhages. Alphanate may be administered prophylactically on a daily or every other day schedule to raise the Factor VIII level to approximately 15%.
Factor VIII levels should be monitored periodically to evaluate individual patient response dose to regime.
Use aseptic technique.
Reconstitution: Warm diluent (Sterile Water for Injection, USP) and concentrate (Alphanate) to at least room temperature (but not above 37°C).
Remove plastic caps from the diluent and concentrate vials.
Swab the exposed stopper surfaces with a cleansing agent eg, alcohol. Do not leave excess cleansing agent on the stoppers.
Remove cover from one end of the double-ended transfer needle. Insert the exposed end of the needle through the center of the stopper in the diluent vial.
Remove plastic cap from the other end of the double-ended transfer needle now seated in the stopper of the diluent vial. To reduce any foaming, invert the vial of diluent and insert the exposed end of the needle through the center of the stopper in the concentrate vial at an angle, making certain that the diluent vial is always above the concentrate vial. The angle of insertion directs the flow of diluent against the side of the concentrate vial. There should be enough vacuums in the vial to transfer all of the diluent.
Disconnect the 2 vials by removing the transfer needle from the diluent vial stopper. Remove the double-ended transfer needle from the concentrate vial and discard the needle into the appropriate safety container.
Let the vial stand contents are in solution, then gently swirl until all concentrate is dissolved. Reconstitution requires <5 min.
Do not shake the contents of the vial. Do not invert the concentrate vial until ready to withdraw contents.
Use as soon as possible after reconstitution.
After reconstitution, parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. When reconstitution procedure is strictly followed, a few small particles may occasionally remain. The microaggregate filter will remove particles and the labeled potency will not be reduced.
Administration by Syringe:
Peel cover from microaggregate filter package and securely install the syringe into the exposed Luer inlet of the filter, using a slight clockwise twisting motion.
Remove filter from packaging. Remove protective cover from the spike end of the filter.
Pull back plunger drawing sufficient air into the syringe to allow reconstituted product to be withdrawn.
Insert the spike end of the filter into the reconstituted concentrate vial. Inject air and withdraw the reconstituted product from the vial into the syringe.
Remove the filter from the syringe; discard the filter and the empty concentrate vial into the appropriate safety container. Attach syringe to an infusion set; expel air from the syringe and infusion set. Perform venipuncture and administer slowly at a rate not exceeding 10 mL/min.
If the patient is to receive >1 vial of concentrate, the infusion set will allow administration of multiple vials to be performed with a single venipuncture.
Discard all administration equipment after use into the appropriate safety container. Do not re-use.