Let us walk you through the easy2use steps!
CSL Behring is pleased to offer Mix2VialTM—a Needle-Free
device. Mix2VialTM is a simpler way to reconstitute products.
Let us walk you through the process of reconstituting product and filling a syringe
using the Mix2VialTM Needle-free Transfer Device.
Before you start the reconstitution process, make sure you have everything you need,
including alcohol swabs and disposable gloves.
Always wash your hands and make sure to use the disposable gloves.
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Step 1:
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Begin by removing the plastic caps from the two vials and wipe the top of each vial
with an alcohol swab. Then, peel off the top of the Mix2VialTM
package, but don’t take the device out yet!
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Step 2:
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Pick up the Mix2VialTM package and turn it upside down.
Holding the sterile water vial with your other hand, push the blue tip into the
top of the vial.
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Step 3:
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Now you can take the transfer device out of its package. Simply pull off the plastic
and throw it away. Make sure you don’t touch the top of the device with the exposed
tip.
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Step 4:
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Pick up the sterile water vial with the device attached and turn it upside down.
Holding the product vial with your other hand, push the white tip into the top of
the vial. Make sure it goes all the way in!
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Step 5:
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The sterile water will flow into the product vial automatically.
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Step 6:
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When the sterile water vial is empty, you can remove it from the product vial. Simply
hold the product vial in
one hand and, using the other hand, turn the sterile
water vial counterclockwise until the two vials are disconnected.
If necessary, gently swirl the vial to make sure the product is completely dissolved.
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Step 7:
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Now you’re ready to fill the syringe. Pull the plunger back, insert the syringe
and twist it clockwise into the Luer-Lok®. Push air from the syringe
into the vial. Pick up the product vial containing the reconstituted solution and
turn it upside down. Then draw the solution into the syringe.
If you do not get all of the mixed product out of the vial, try this technique--slowly
rotate the vial to get the remaining product into the rubber stopper notch. This
is important medicine, and you want to get the most from the vial.
When you have finished administering the product, make sure to discard the empty
vials, transfer device, and syringe in a sharps container.
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Important Safety Information
Humate-P is indicated for treatment and prevention of bleeding in adult patients
with hemophilia A (classical hemophilia). Humate-P is also indicated in adult and
pediatric patients with von Willebrand disease (VWD) for (1) treatment of spontaneous
and trauma-induced bleeding episodes, and (2) prevention of excessive bleeding during
and after surgery. This applies to patients with severe VWD, and patients with mild
and moderate VWD for whom use of desmopressin is known or suspected to be inadequate.
Humate-P is not indicated for the prophylaxis of spontaneous bleeding episodes.
Humate-P is contraindicated in individuals with a history of anaphylactic or severe
systemic response to antihemophilic factor or von Willebrand factor preparations.
Monitor for intravascular hemolysis and decreasing hematocrit values in patients
with A, B, and AB blood groups who are receiving large or frequent doses. Also monitor
VWF:RCo and FVIII levels in VWD patients, especially those undergoing surgery.
Thromboembolic events have been reported in VWD patients receiving coagulation factor
replacement. Caution should be exercised and antithrombotic measures considered,
particularly in patients with known risk factors for thrombosis.
Humate-P is derived from human plasma. The risk of transmission of infectious agents,
including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent,
cannot be completely eliminated.
In patients receiving Humate-P in clinical studies for treatment of VWD, the most
commonly reported adverse reactions observed by >5% of subjects are allergic-anaphylactic
reactions, including urticaria (hives), chest tightness, rash, pruritus (itching),
and edema (swelling). For patients undergoing surgery, the most common adverse reactions
are postoperative wound or injection-site bleeding, and epistaxis (nosebleed).
Please see full prescribing
information.
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.
© CSL Behring 2010. The product information presented on this site is intended for US residents only.