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Reconstitution Instructions for NUCALA® (mepolizumab)
This is an instructional video for the manual reconstitution of NUCALA® (mepolizumab).
NUCALA should be reconstituted and administered by a healthcare professional.
For additional information, please see full Prescribing Information at www.NUCALAprep.com
ANNOUNCER:
This is an instructional video for the manual reconstitution of NUCALA (mepolizumab).
NUCALA should be reconstituted and administered by a healthcare professional.
For additional information, please see full Prescribing Information at www.NUCALAprep.com.
For the manual reconstitution of NUCALA, you will need the following items:
· alcohol swabs
· a vial of Sterile Water for Injection, USP
· a 2- or 3-milliliter syringe and a 21-gauge needle
· and a 100 milligram vial of NUCALA (mepolizumab)
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[labels for items]
Sterile Water for Injection, USP
NUCALA® (mepolizumab) 100 mg for subcutaneous use
2 or 3 mL syringe and a 21-gauge needle are preferred.
*Syringes, alcohol swabs and Sterile Water for Injection are not provided.
DO NOT MIX WITH OTHER MEDICATIONS.
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Set the vial labeled NUCALA aside and uncap the vial of Sterile Water for Injection. Next, uncap the vial of NUCALA. Remove an alcohol swab from its packet and swab the top of the vial of NUCALA. Do the same for the vial of Sterile Water for Injection. For reconstitution, it is preferred that you use a 2- or 3-milliliter syringe and a 21-gauge needle. Insert the syringe into the vial of Sterile Water for Injection and withdraw 1.2 milliliters of Sterile Water for Injection.
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Withdraw 1.2 mL Sterile Water for Injection.
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Remove excess air from syringe. Verify the amount of Sterile Water for Injection in the syringe before inserting it into the vial of NUCALA.
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1.2 mL Sterile Water for Injection
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Insert the needle into the vial of NUCALA.
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NUCALA 100 mg for subcutaneous use
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Direct the stream of Sterile Water for Injection vertically onto the center of the lyophilized cake.
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Direct the stream of Sterile Water for Injection vertically onto the center of the lyophilized cake.
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Gently swirl the vial for 10 seconds with a circular motion at 15-second intervals until the powder is dissolved.
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Gently swirl the vial for 10 seconds with a circular motion at 15-second intervals until the powder is dissolved.
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Do not shake the reconstituted solution during the procedure as this may lead to product foaming or precipitation.
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Gently swirl the vial for 10 seconds with a circular motion at 15-second intervals until the powder is dissolved.
Do not shake the reconstituted solution during the procedure as this may lead to product foaming or precipitation.
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After swirling the solution for 10 seconds, let it rest for 5 seconds and, if the powder is not completely dissolved, swirl the solution again in a circular motion for 10 seconds. Let the solution rest for another 5 seconds, and repeat the 15-second process until the powder has dissolved.
Manual reconstitution of NUCALA is typically complete within 5 minutes after the Sterile Water for Injection has been added. It can, however, take additional time.
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Reconstitution is typically complete within 5 minutes after the Sterile Water for Injection has been added, but it may take additional time.
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Be sure to visually inspect the reconstituted solution for particulate matter and clarity before use.
The solution should be clear to opalescent, colorless to pale yellow or pale brown, and essentially particulate-free.
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Visually inspect the reconstituted solution for particulate matter and clarity before use.
The solution should be clear to opalescent and colorless to pale yellow or pale brown, essentially particle-free.
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Small air bubbles in the solution are to be expected and acceptable.
If particulate matter remains in the solution, or if the solution appears cloudy or milky, the solution must not be administered.
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Small air bubbles in the solution are to be expected and acceptable.
If particulate matter remains in the solution or if the solution appears cloudy or milky, the solution must not be administered.
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The reconstituted solution will contain a concentration of 100 milligrams/milliliter mepolizumab.
DO NOT mix NUCALA with other medications.
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Small air bubbles in the solution are to be expected and acceptable.
If particulate matter remains in the solution or if the solution appears cloudy or milky, the solution must not be administered.
The reconstituted solution will contain a concentration of 100 mg/mL of NUCALA® (mepolizumab).
DO NOT MIX WITH OTHER MEDICATIONS.
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Once reconstituted, NUCALA can be administered right away.
In line with clinical practice, monitoring of patients after administration of biologic agents is recommended.
If not used immediately after preparation, store the reconstituted solution of NUCALA at a temperature below 30° Celsius (86° Fahrenheit), but DO NOT freeze.
Discard the solution if it has not been used within 8 hours of reconstitution.
For additional information, please see the full Prescribing Information for NUCALA.
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Reconstitution Instructions for NUCALA® (mepolizumab)
In line with clinical practice, monitoring of patients after administration of biologic agents is recommended.
If not used immediately after preparation, store the reconstituted solution of NUCALA at a temperature below 30°C (86°F), but DO NOT freeze.
Discard the solution if it has not been used within 8 hours of reconstitution.
For additional information, please see full Prescribing Information for NUCALA.
©2017 GSK group of companies. All rights reserved. 818564R0 April 2017
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