whenever solution and container permit.
Administration
Intravenous Injection
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Plastic disposable syringes are recommended with Mononine® solution. The ground glass surfaces of all-glass syringes tend to stick with solutions of this type. Please note, this concentrate is supplied with a SELF-VENTING filter spike.
Using aseptic technique, attach the vented filter spike to a sterile disposable syringe.
CAUTION: The use of other, non-vented filter needles or spikes without the proper procedure may result in an air lock and prevent the complete transfer of the concentrate.
CAUTION: DO NOT INJECT AIR INTO THE MONONINE® VIAL. The self-venting feature of the vented filter spike precludes the need to inject air in order to facilitate withdrawal of the reconstituted solution. The injection of air could cause partial product loss through the vent filter.
Insert the vented filter spike into the stopper of the Mononine® vial, invert the vial, and position the filter spike so that the orifice is at the inside edge of the stopper.
Withdraw the reconstituted solution into the syringe.
Discard the filter spike. Perform venipuncture using the enclosed winged needle with microbore tubing. Attach the syringe to the luer end of the tubing.
CAUTION: Use of other winged needles without microbore tubing, although compatible with the concentrate, will result in a larger retention of solution within the winged infusion set.
Rate of Administration
The rate of administration should be determined by the response and comfort of the patient; intravenous dosage administration rates of up to 225 IU/minute have been regularly tolerated without incident. When reconstituted as directed, i.e., to approximately 100 IU/mL, Mononine® should be administered at a rate of approximately 2.0 mL per minute.
STORAGE
When stored at refrigerator temperature, 2-8°C (36-46°F), Mononine® is stable for the period indicated by the expiration date on its label. Within this period, Mononine® may be stored at room temperature not to exceed 25°C (77°F), for up to one month.
Avoid freezing, which may damage container for the diluent.
HOW SUPPLIED
Mononine® is supplied in a single dose vial with Sterile Water for Injection, USP, double-ended needle for reconstitution, vented filter spike for withdrawal, winged infusion set and alcohol swabs. Factor IX activity in IU is stated on the label of each vial.
The following strengths are available:
NDC 0053-7668-02 in 10 mL vials containing approximately 500 IU. (Dosage – MID)
NDC 0053-7668-04 in 20 mL vials containing approximately 1,000 IU. (Dosage – HIGH)
REFERENCES
Zauber NP, Levin J. Factor IX levels in patients with hemophilia B (Christmas disease) following transfusion with concentrates of Factor IX or fresh frozen plasma (FFP). Medicine (Baltimore) 56(3):213-24, 1977.
Smith KJ, Thompson AR. Labeled Factor IX Kinetics in Patients with Hemophilia-B. Blood 58(3):625-629, 1981.
Kim HC, McMillan CW, White GC, Bergman GE, Horton MW, Saidi P. Purified Factor IX Using Monoclonal Immunoaffinity Technique: Clinical Trials in Hemophilia B and Comparison to Prothrombin Complex Concentrates. Blood 79(3):568-575, 1992.
Warrier I, Kasper CK, White II GC, Shapiro AD, Bergman GE, the Mononine® Study Group. Sa |
