nvert the system upside down and draw the concentrate into the syringe by pulling the plunger back slowly (Fig. 7).
Fig. 7
10.
Now that the concentrate has been transferred into the syringe, firmly grasp the barrel of the syringe (keeping the syringe plunger facing down) and unscrew the syringe from the Mix2Vial set (Fig. 8). Attach the syringe to a suitable intravenous (IV) administration set.
Fig. 8
11.
If the same patient is to receive more than one vial, you may pool the contents of multiple vials. Use a separate unused Mix2Vial for each product vial.
When the reconstitution procedure is followed precisely, it is not uncommon for a few small flakes or particles to remain. The Mix2Vial should remove those particles.
Do not refrigerate Humate-P after reconstitution. Administer within 3 hours after reconstitution.
Slowly infuse the solution (maximally 4 mL/minute) with a suitable IV administration set.
Discard the administration equipment and any unused Humate-P after use.
3DOSAGE FORMS AND STRENGTHS
Humate-P is a sterile, lyophilized powder for intravenous administration. Each vial of Humate-P contains the labeled amount of VWF:RCo and FVIII activity expressed in International Units (IU). The average ratio of VWF:RCo to FVIII is 2.4:1.
Approximate potencies are shown below; check each carton/vial for the actual potency prior to reconstitution:
VWF:RCo/vial FVIII/vial Diluent
* IU = International Units.
600 IU 250 IU 5 mL
1200 IU 500 IU 10 mL
2400 IU 1000 IU 15 mL
4CONTRAINDICATIONS
Humate-P is contraindicated in individuals who have had an anaphylactic or severe systemic reaction to antihemophilic factor or von Willebrand factor preparations.
5WARNINGS AND PRECAUTIONS
5.1Thromboembolic Events (VWD Patients)
Thromboembolic events have been reported in VWD patients receiving Antihemophilic Factor/von Willebrand Factor Complex replacement therapy, especially in the setting of known risk factors for thrombosis.3,4 Early reports indicate a higher incidence may occur in females. Endogenous high levels of FVIII have also been associated with thrombosis, but no causal relationship has been established. Exercise caution and consider antithrombotic measures in all at-risk VWD patients who are receiving coagulation factor replacement therapy.
5.2Monitoring for Intravascular Hemolysis
Humate-P contains blood group isoagglutinins (anti-A and anti-B). When doses are very large or need to be repeated frequently (for example, when inhibitors are present or when pre- and post-surgical care is involved), monitor patients of blood groups A, B, and AB for signs of intravascular hemolysis and decreasing hematocrit values and treat appropriately.
5.3Monitoring VWF:RCo and FVIII Levels
Monitor the VWF:RCo and FVIII levels of VWD patients receiving Humate-P using standard coagulation tests, especially in cases of surgery. It is advisable to monitor trough VWF:RCo and FVIII:C levels at least once a day in order to adjust the dosage of Humate-P as needed to avoid excessive accumulation of coagulation factors (see Dosage and Administration [2.2, 2.3]).
5.4Transmission of Infectious Agents
Humate-P is made from human plasma. Products made from human plasma may contain infectious agents (e.g., viruses and theoretically, the Creutzfeldt-Jakob disease [CJD] agent) that can cause disease (see Description [11] and Patient Counseling Information [17.1]). The risk that s |
