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Frequently Asked QuestionsQ: Why is ZYVOX® IV Injection (linezolid) transitioning to the new FreeFlex® IV bag?
A: The transition to the new FreeFlex® IV bag is due to the packaging process change at the ZYVOX manufacturer. The current Excel® IV bag can continue to be used until stock runs out. Like the previous bag, the new FreeFlex® IV bag is PVC- and latex-free, is packaged in a laminated foil sleeve to protect product integrity during shelf life, and is compatible with all commercially available, standard IV infusion/transfer sets.
Q: What’s different with the new bag?
A: The new bag offers color-coded, tamper-evident, break-off port caps, with a self-sealing port membrane to reduce spillage of remaining solution.
Q: Why are there two different-colored ports?
A: The FreeFlex® IV bag has two color-coded ports, one blue and one white. The blue port has an arrow pointing downward, signifying liquid flow. This blue port should be used to spike the bag. The white port is not intended to be used for this product as ZYVOX should not be mixed with other drugs.
Q: How is ZYVOX IV Injection administered in the new FreeFlex® IV bag?
A: See accompanying instructions. The key difference is that the new FreeFlex® IV bag has color-coded, tamper-evident, break-off ports.
Q: What should hospitals do with their current stock of ZYVOX IV Injection in Excel® IV bags?
A: Hospitals should continue to use their current stock until it runs out. Any new orders placed after transition will be filled with the new FreeFlex® IV bag.
Q: Are there any cost changes associated with the new FreeFlex® IV bag?
A: No, the cost of ZYVOX IV Injection will not be changing based on the new bag.
Q: Are there any safety/PI changes for ZYVOX IV Injection as a result of the change to the new FreeFlex® IV bag?
A: The ZYVOX IV Injection safety information and PI will remain unchanged. Please refer to the PI for specific information.
Q: What is the timeline for the introduction of ZYVOX IV Injection in the new FreeFlex® IV bag?
A: The new FreeFlex® IV bag will be available in early 2011 in the United States.
Q: Will the new FreeFlex® IV bag be compatible with current tubing?
A: Just like the current Excel® bag, the FreeFlex® IV bag is 100% compatible with all standard infuser sets and infusion pumps.
Q: Will the new FreeFlex® IV bag affect the shelf life of ZYVOX IV Injection?
A: Just like the current Excel® bag, the new FreeFlex® IV bag will not affect the shelf life (36 months) of ZYVOX IV Injection.
If you have any questions about the administration of ZYVOX IV Injection using the new FreeFlex® IV bag, please contact United States Medical Information at 1-800-438-1985, www.pfizermedicalinformation.com, or www.ZYVOX.com.
272747-01 © 2010 Pfizer Inc. All rights reserved. Printed in USA/December 2010
ZYVOX® is a registered trademark of Pfizer Inc.FreeFlex® is registered trademark of Fresenius Kabi.Excel® is a registered trademark of Braun Medical Inc.
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ABUS0X0617_IVBag_PhamrLtr_r21_FSU.indd 3 12/6/10 5:55 PM
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Job Spec SheetMay 2007
XXX Name of HospitalATTN: Hospital Pharmacy DirectorStreet Address XXXCity, State, Zip XXX
Re: ZYVOX® IV Injection (linezolid) announcement of new FreeFlex® IV bag
Dear Valued Customer,
The purpose of this letter is to inform you that ZYVOX IV Injection will transition from the currently used Excel® IV bag to the new FreeFlex® IV bag due to packaging process change. The current Excel IV bags can continue to be used until stock runs out. Like the previous bag, the new FreeFlex® IV bag is PVC- and latex-free, is packaged in a laminated foil sleeve to protect product integrity during shelf life, and is compatible with all commercially available, standard IV infusion/transfer sets.
One important difference is between the ports of the old and new bag.
The new FreeFlex® IV bag has two color-coded, tamper-evident, break-off ports, one blue and one white, which have a self-sealing port membrane to reduce spillage. The blue port has an arrow pointing downward, signifying liquid flow. This blue port should be used to spike the bag. The white port is not intended to be used for this product as ZYVOX should not be mixed with other drugs.
Please refer to the instructions accompanying this letter for administering ZYVOX IV Injection using the new FreeFlex® IV bag.
Depending on your hospital’s current inventory levels, you will begin to see ZYVOX IV Injection in the new FreeFlex® IV bag over the next few months. During this transition, you should continue to use your current inventory of ZYVOX IV Injection in the Excel® IV bags until it is depleted. The formulation of ZYVOX IV Injection and the NDC code will remain unchanged. There will be no changes to the current Product Prescribing Information (PI) or cost as a result of the new IV bag.
If you require further information on the new FreeFlex® IV bag or have any questions, please contact your local Pfizer Institutional Sales Representative or United States Medical Information at 1-800-438-1985 or www.pfizermedicalinformation.com or www.ZYVOX.com.
Sincerely,
David XiaoZYVOX Marketing Team
ZYVOX is a registered trademark of Pfizer Inc.FreeFlex® is registered trademark of Fresenius Kabi.Excel® is a registered trademark of Braun Medical Inc.
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ZYVOX is a registered trademark of Pfizer Inc.FreeFlex® is registered trademark of Fresenius Kabi.
The new FreeFlex® IV bag has two color-coded, tamper-evident, break-off ports, one blue and one white, which have a self-sealing port membrane to reduce spillage. The blue port has an arrow pointing downward, signifying liquid flow.
This blue port should be used to spike the bag. The white port is not intended to be used for this product as ZYVOX should not be mixed with other drugs.
Locate the blue port with the arrow pointing downward. Twist off the cap. Remove the cover of the spike and insert it into the port. It may look like the port is too small for the spike, but this is an optical illusion. The new FreeFlex® IV bag can be used with any standard tubing set.
ZYVOX is indicated for the treatment of nosocomial pneumonia due to known or suspected MRSA and cSSSI, including diabetic foot infections without concomitant osteomyelitis, due to known or suspected MRSA.
ZYVOX Dosing: 600 mg IV or oral q12h
ZYVOX IV Injection should be administered by intravenous infusion over a period of 30 to 120 minutes.
Instructions for spiking the port of ZYVOX® IV Injection (linezolid) in the FreeFlex® IV Bag
If you have any questions about the administration of ZYVOX IV Injectionusing the FreeFlex® IV bag, please contact United States Medical Information at 1-800-438-1985 or www.pfizermedicalinformation.com or www.ZYVOX.com.
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ABUS0X0617_IVBag_PhamrLtr_CB.indd 2 12/3/10 8:26 AM
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Frequently Asked QuestionsQ: Why is ZYVOX transitioning to the new FreeFlex® IV bag?
A: The transition to the new FreeFlex® IV bag is due to the packaging process change at the ZYVOX manufacturer. The current Excel IV bag can continue to be used until stock runs out. Like the previous bag, the new FreeFlex® IV bag is PVC- and latex-free, is packaged in a laminated foil sleeve to protect product integrity during shelf life, and is compatible with all commercially available, standard IV infusion/transfer sets.
Q: What’s different with the new bag?
A: The new bag offers color-coded, tamper-evident, break-off port caps, with a self-sealing port membrane to reduce spillage of remaining solution.
Q: Why are there 2 different-colored ports?
A: The FreeFlex® IV bag has 2 color-coded ports, one blue and one white. The blue port has an arrow pointing downward, signifying liquid flow. This blue port should be used to spike the bag. The white port is not intended to be used for this product as ZYVOX should not be mixed with other drugs.
Q: How is ZYVOX® IV Injection (linezolid) administered in the new FreeFlex® IV bag?
A: See accompanying instructions. The key difference is that the new FreeFlex® IV bag has color-coded, tamper-evident, break-off ports.
Q: What should hospitals do with their current stock of ZYVOX IV Injection in Excel® IV bags?
A: Hospitals should continue to use their current stock until it runs out. Any new orders placed after transition will be filled with the new FreeFlex® IV bag.
Q: Are there any cost changes associated with the new FreeFlex® IV bag?
A: No, the cost of ZYVOX IV Injection will not be changing based on the new bag.
Q: Are there any safety/PI changes for ZYVOX IV Injection as a result of the change to the new FreeFlex® IV bag?
A: The ZYVOX IV Injection safety information and PI will remain unchanged. Please refer to the PI for specific information.
Q: What is the timeline for the introduction of ZYVOX IV Injection in the new FreeFlex® IV bag?
A: The new FreeFlex® IV bag will be available in early 2011 in the United States.
Q: Will the new FreeFlex® IV bag be compatible with current tubing?
A: Just like the current Excel bag, the FreeFlex® IV bag is 100% compatible with all standard infuser sets and infusion pumps.
Q: Will the new FreeFlex® IV bag affect the shelf life of ZYVOX IV Injection?
A: Just like the current Excel bag, the new FreeFlex® IV bag will not affect the shelf life (36 months) of ZYVOX IV Injection.
If you have any questions about the administration of ZYVOX IV Injection using the new FreeFlex® IV bag, please contact United States Medical Information at 1-800-438-1985 or www.pfizermedicalinformation.com or www.ZYVOX.com.
272747-01 © 2010 Pfizer Inc. All rights reserved. Printed in USA/December 2010
ZYVOX is a registered trademark of Pfizer Inc.FreeFlex® is registered trademark of Fresenius Kabi.Excel® is a registered trademark of Braun Medical Inc.
S:8”S:10.5”
T:8.5”T:11”
B:8.5”B:11”
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ABUS0X0617_IVBag_PhamrLtr_CB.indd 3 12/3/10 8:26 AM
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