BEBULIN? VH-Baxter Healthcare

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ADVERSE REACTIONS
As with any other infused plasma derivatives, anaphylactoid or anaphylactic reactions may occur in rare cases. The occurrence of these reactions (e.g. fever, urticarial rashes, nausea, retching, dyspnea, anaphylactic shock) necessitates the interruption of replacement therapy. Mild reactions can be managed with antihistamines; severe hypotensive reactions require immediate intervention using current principles of shock therapy.
DOSAGE AND ADMINISTRATION
General
Bebulin VH, Factor IX Complex, Vapor Heated, is intended for intravenous administration only.
As a general rule, 1 International Unit of Factor IX activity/kg will increase the plasma level of Factor IX by 0.8%.
Accordingly, the following formula is provided for dosage calculations:
Number of Factor IX I.U. required = bodyweight (kg) x desired Factor IX increase (% of normal) x 1.2
It must, however, be emphasized that the response to treatment will vary from patient to patient and that occasionally larger doses than those derived from the above formula will be required, particularly if treatment is delayed.
Exact dosage determination should be based on localization and extent of hemorrhage, and the level of Factor IX to be achieved.
It must be emphasized that particularly with severe hemorrhage and major surgery close laboratory monitoring of the Factor IX level is required to determine proper dosage.
Management of Specific Types of Bleeding (10, 11, 12, 13, 14)
Approximate Factor IX levels, typical initial doses, and the average duration of treatment are suggested in the table below. For minor bleeding a single dose will usually be sufficient, otherwise a second dose may be given after 24 hours. More severe hemorrhage will require the administration of several doses at approximately 24 hour intervals. For maintenance therapy usually two thirds of the initial dose is infused.
{Table: See link}
Management of Surgical Procedures (10, 11, 12, 13, 14)
Dosage guidelines for surgical procedures are suggested below. The preoperative loading dose should be administered one hour prior to surgery. Depending on the type of surgery replacement therapy has to be continued over one to several weeks until adequate wound healing is achieved. The average treatment interval will initially be 12 hours, while in the later postoperative period 24 hours are generally adequate.
{Table:See link}
For tooth extraction the same initial dose as for minor surgery is recommended. Generally, one infusion will be sufficient. In case of extraction of several teeth, replacement therapy for up to one week may be necessary using the same doses as for minor surgery (12, 13, 14).
Long-Term Prophylactic Treatment
Prophylactic doses of 20-30 I.U./kg administered once, or preferably up to twice a week have been shown to significantly reduce the frequency of spontaneous hemorrhage (12, 15). It is however, recommended that prophylactic dosage regimens be tailored to individual needs.
Reconstitution
Bebulin VH, Factor IX Complex, Vapor Heated, should be reconstituted immediately before application. The solution does not contain a preservative and must be used within 3 hours of reconstitution.
For reconstitution proceed as follows:
1. Warm both diluent and concentrate in unopened vials to room temperature (not above 37?C, 98?F).
2. Remove caps from both vials to expose central portions of the rubber stoppers.
3. Cleanse exposed surface of the rubber stoppers with germicidal solution and allow to dry.
4. Using aseptic technique, remove protective covering from one end of the double-ended needle, and insert the exposed end through the diluent vial stopper.
5. Remove protective covering from the other end of the double-ended needle, taking care not to touch the exposed end. Invert diluent vial over the concentrate vial, then insert free end of the needle through the concentrate vial stopper. Diluent will be drawn into the concentrate vial by vacuum.
6. Disconnect the two vials by removing needle from the concentrate vial stopper. Gently agitate or rotate the concentrate vial until all material is dissolved.
Do not refrigerate after reconstitution!
Administration
Parenteral drug products should be inspected for particulate matter and discoloration prior to administration, whenever solution and container permit.
Intravenous Injection:
1. After reconstituting the concentrate as described above attach the enclosed filter needle to a sterile disposable syringe using aseptic technique. Insert filter needle through the concentrate vial stopper.
2. Inject air and withdraw solution into the syringe.
3. Remove and discard filter needle. Attach a suitable intravenous needle or infusion set with winged adapter.
4. Administer the solution intravenously at a rate comfortable to the patient (maximum rate 2 ml per minute).
HOW SUPPLIED
Bebulin VH, Factor IX Complex, Vapor Heated, is supplied in single dose vials with Sterile Water for Injection, U.S.P. (This Product Contains Dry Natural Rubber.), double-ended needle, and filter needle for reconstitution and withdrawal.
Factor IX activity in International Units is stated on the label of each vial.
Rx only
STORAGE
When stored at refrigerated temperature (2?C-8?C, 35?F-46?F),
Bebulin VH, Factor IX Complex, Vapor Heated, is stable for the period indicated by the expiration date on its label.
Avoid freezing, which may damage the diluent vial.