BAXJECT II needleless transfer device offers safe, fast, and easy mixing.*
*As compared to needles, the BAXJECT II device is needleless and has a one-piece design.
Before you begin the mixing process, bring vials to room temperature. Wash your hands thoroughly, put on gloves, and always work on a clean, flat surface. Remove caps from the ADVATE [Antihemophilic Factor (Recombinant)] concentrate and water vials, then disinfect the stoppers with alcohol swabs and allow to dry.
Without touching the BAXJECT II device, peel away the lid of the package. After placing the vial on a hard, flat surface, invert the device over the water vial and press down until the CLEAR spike pierces the water vial stopper.
Grip the edge of the packaging to remove it from the device. Be sure not to touch the white spike or remove the blue cap. Invert the device with water vial attached, so that the water vial is now on top. Press the device down on the product vial until the white spike pierces the stopper. Wait for the water to enter the ADVATE vial, then swirl gently until the ADVATE is completely dissolved. Do not shake.
It is acceptable for a small amount of water to be left behind. If the water does not transfer successfully, please refer to the troubleshooting guide in the menu.
The ADVATE solution should look clear and colorless. If not, do not use it and notify Shire immediately.
Remove the blue cap from the device. Next, remove the syringe cap and connect the syringe to the device by screwing it onto the device. With the syringe attached, invert the device white side up so that the ADVATE vial is on top.
Now, slowly pull the plunger back on the syringe to withdraw the mixed product. If you find it impossible to withdraw some or all of the mixed product into the syringe, there may be air in the device. Please refer to the troubleshooting guide in the menu.
Finally, disconnect the syringe by unscrewing it. You are now ready to infuse the product. Do not refrigerate after reconstitution.
You should be trained on how to do infusions by your hemophilia treatment center or your healthcare provider. The maximum infusion rate is 10 mL/min.
Rx only. For safe and proper use of this device, please refer to the instructions for use. The BAXJECT II device is intended for use with a single vial of product and is for single use only. Therefore, reconstitution and withdrawing a second vial into the syringe requires a second BAXJECT II device.
ADVATE is a medicine used to replace clotting factor (factor VIII or antihemophilic factor) that is missing in people with hemophilia A (also called "classic" hemophilia).
ADVATE is used to prevent and control bleeding in adults and children (0-16 years) with hemophilia A.
Your healthcare provider may give you ADVATE when you have surgery.
ADVATE can reduce the number of bleeding episodes in adults and children (0-16 years) when used regularly (prophylaxis).
ADVATE is not used to treat von Willebrand disease.
You should not use ADVATE if you:
Tell your healthcare provider if you are pregnant or breastfeeding because ADVATE may not be right for you.
You should tell your healthcare provider if you:
Your body may form inhibitors to factor VIII. An inhibitor is part of the body's normal defense system. If you form inhibitors, it may stop ADVATE from working properly. Consult with your healthcare provider to make sure you are carefully monitored with blood tests for the development of inhibitors to factor VIII.
You can have an allergic reaction to ADVATE.
Call your healthcare provider right away and stop treatment if you get a rash or hives, itching, tightness of the throat, chest pain or tightness, difficulty breathing, lightheadedness, dizziness, nausea or fainting.
Side effects that have been reported with ADVATE include: cough, headache, joint swelling/aching, sore throat, fever, itching, dizziness, hematoma, abdominal pain, hot flashes, swelling of legs, diarrhea, chills, runny nose/congestion, nausea/vomiting, sweating, and rash.
Tell your healthcare provider about any side effects that bother you or do not go away or if your bleeding does not stop after taking ADVATE.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Click here for ADVATE full Prescribing Information.