Bebulin Vh

Bebulin Vh Manufacturers

• Baxter Healthcare Corporation
  

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  Bebulin Vh | Baxter Healthcare Corporation

  

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  General

  BEBULIN VH 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 bodyweight desired Factor IX increase x 1.2 IX IU required = (kg) x (% of normal)

  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 14-18

  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 hours intervals. For maintenance therapy, usually two thirds of the initial dose is infused.

  * For patients predisposing to thrombosis see “PRECAUTIONS” section. Type of Bleeding

  Approximate

  Factor IX Level

  (% Normal)

  Typical Initial

  Dose

  (IU/kg)

  Average Duration

  of Treatment

  (Days)

  Minor

  early hemarthrosis,
  minor epistaxis,

  and gingival bleeding,
  mild hematuria 20 25-35 1

  Moderate

  severe joint bleeding,
  early hematoma,

  major open

  bleeding,

  minor trauma,

  minor hemoptysis

  hematemesis,
  and melena,
  major hematuria 40 40-55

  2 or

  until adequate

  wound healing
  

  Major
  severe hematoma major trauma,

  Severe hemoptysis,

  Hematemesis, and
  melena ≥60* 60-70

  2-3 or

  until adequate

  wound healing Management of Surgical Procedures 14-18.

  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 is generally adequate.

  * For patients predisposing to thrombosis see “PRECAUTIONS” section. N/A– Not Applicable.

  Type of

  Surgery

  Day of Operation

  Init. Postop. Period

  (1st to 2nd Week)

  Late Postop. Period

  (from 3rd Week Onwards)

  Approx.

  Level

  F IX

  (% Normal)

  Dose

  (I.U./kg)

  Approx.

  Level

  F IX

  (% Normal)

  Dose

  (I.U./kg)

  Approx.

  Level

  F IX

  (% Normal)

  Dose

  (I.U./kg)
  Major

  ≥60*

  70-95 60-20 70-35 20

  35-25

  Minor 40-60 50-60

  40-20

  55-25

  N/A N/A

  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 13-15

  
  Long-Term Prophylactic Treatment

  Prophylactic doses of 20-30 IU/kg administered once, or preferably up to twice a week have been shown to significantly reduce the frequency of spontaneous hemorrhage 13,16. It is, however, recommended that prophylactic dosage regimens be tailored to individual needs.

  Reconstitution

  BEBULIN VH should be reconstituted immediately before application. The solution does not contain a preservative and must be used within 3 hours after reconstitution.

  For reconstitution proceed as follows:

  Warm both diluent and concentrate in unopened vials to room temperature (not above 37 °C, 98 °F). Remove caps from both vials to expose central portions of the rubber stoppers. Cleanse exposed surface of the rubber stoppers with germicidal solution and allow to dry. Using aseptic technique, remove protective covering from one end of the double-ended needle and insert the exposed end through the diluent vial stopper. 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. 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 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. Inject air and withdraw solution into the syringe. Remove and discard filter needle. Attach a suitable intravenous needle or infusion set with winged adapter. Administer the solution intravenously at a rate comfortable to the patient (maximum rate 2 mL per minute).

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