Profilnine SD Dosage
Generic name: Factor IX Complex 100[iU] in 1mL;
Dosage form: injection
Medically reviewed on August 1, 2017.
For adult usage:
Factor IX Complex, Profilnine SD should be administered intravenously, promptly following reconstitution with the supplied diluent. Although Profilnine SD is stable for at least three (3) hours at room temperature after reconstitution, prompt administration is recommended to avoid the ill effect of any inadvertent bacterial contamination occurring during reconstitution. Profilnine SD may be administered by injection (plastic disposable syringe only) or infusion. Administer at room temperature, do not refrigerate after reconstitution and discard any unused contents.
Each vial of Profilnine SD is labeled with the total units expressed as International Units (IU) which is referenced to the WHO International Standard. One unit approximates the activity in one mL of normal plasma.
A 1.0% increase in Factor IX (0.01 IU)/IU administered/kg can be expected.15 The amount of Profilnine SD required to establish hemostasis will vary with each patient and depend on the circumstances. The following formula may be used as a guide in determining the number of units to be administered:
In normal clinical practice there is variability among patients and their clinical condition.
Therefore, the Factor IX level of each patient should be monitored frequently during replacement therapy.
Mild to moderate hemorrhages may usually be treated with a single administration sufficient to raise the plasma Factor IX level to 20 to 30 percent. In the event of more serious hemorrhage, the patient's plasma Factor IX level should be raised to 30 to 50 percent. Infusions are generally required daily.
Surgery in patients with Factor IX deficiency requires that the Factor IX level should be raised to 30 to 50 percent for at least one week following operation. For dental extractions, the Factor IX level should be raised to 50 percent immediately prior to the procedure; additional Factor IX Complex may be given if bleeding recurs.
For pediatric usage: See PRECAUTIONS
Use Aseptic Technique
- Warm diluent (Sterile Water for Injection, USP) and concentrate (Profilnine SD) to at least room temperature (but not above 37 °C).
- Remove the plastic flip off cap from the diluent vial.
- Gently swab the exposed stopper surface with a cleansing agent such as alcohol trying to avoid leaving any excess cleansing agent on the stopper.
- Open the Mix2Vial® package by peeling away the lid (Figure 1). Leave the Mix2Vial in the clear outer packaging.
- Place the diluent vial upright on an even surface and hold the vial tight and pick up the Mix2Vial in its clear outer packaging. Holding the diluent vial securely, push the blue end of the Mix2Vial vertically down through the diluent vial stopper (Figure 2).
- While holding onto the diluent vial, carefully remove the clear outer packaging from the Mix2Vial set, ensuring the Mix2Vial remains attached to the diluent vial (Figure 3).
- Place the product vial upright on an even surface, invert the diluent vial with the Mix2Vial attached.
- While holding the product vial securely on a flat surface, push the clear end of the Mix2Vial set vertically down through the product vial stopper (Figure 4). The diluent will automatically transfer out of its vial into the product vial. (NOTE: If the Mix2Vial is connected at an angle, the vacuum may be released from the product vial and the diluent will not transfer into the product vial.)
- With the diluent and product vials still attached to the Mix2Vial, gently swirl the product vial to ensure the product is fully dissolved (Figure 5). Reconstitution requires less than 10 minutes. Do not shake the vial.
- Disconnect the Mix2Vial into two separate pieces (Figure 6) by holding each vial adapter and twisting counterclockwise. After separating, discard the diluent vial with the blue end of the Mix2Vial.
- Draw air into an empty, sterile syringe. Keeping the product vial upright with the clear end of the Mix2Vial attached, screw the disposable syringe onto the luer lock portion of the Mix2Vial device by pressing and twisting clockwise. Inject air into the product vial.
- While keeping the syringe plunger depressed, invert the system upside down and draw the reconstituted product into the syringe by pulling the plunger back slowly (Figure 7).
- When the reconstituted product has been transferred into the syringe, firmly hold the barrel of the syringe and the clear vial adapter (keeping the syringe plunger facing down) and unscrew the syringe from the Mix2Vial (Figure 8). Hold the syringe upright and push the plunger until no air is left in the syringe. Attach the syringe to a venipuncture set.
- NOTE: If the same patient is to receive more than one vial of concentrate, the contents of two vials may be drawn into the same syringe through a separate unused Mix2Vial set before attaching to the venipuncture set.
- Use the prepared drug as soon as possible within three hours 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 Mix2Vial set will remove particles and the labeled potency will not be reduced.
- Discard all administration equipment after use into the appropriate safety container. Do not reuse.
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