|
The ENBREL® (etanercept) “Patient Information” insert contains more detailed instructions on the preparation of ENBREL®. Preparation of ENBREL® Using the Single-Use Prefilled Syringe: Before injection, ENBREL® single-use prefilled syringe may be allowed to reach room temperature (approximately 15 to 30 minutes). DO NOT remove the needle shield while allowing the prefilled syringe to reach room temperature. Preparation of ENBREL® Using the Multiple-use Vial: ENBREL® should be reconstituted aseptically with 1 mL of the supplied Sterile Bacteriostatic Water for Injection, USP (0.9% benzyl alcohol) giving a solution of 1.0 mL containing 25 mg ofENBREL®. A vial adapter is supplied for use when reconstituting the lyophilized powder. However, the vialadapter should not be used if multiple doses are going to be withdrawn from the vial. If the vial will be used for multiple doses, a 25-gauge needle should be used for reconstituting and withdrawing ENBREL®, and the supplied “Mixing Date:” sticker should be attached to the vial and the date of reconstitution entered. Reconstitution with the supplied BWFI, using a 25-gaugeneedle, yields a preserved, multiple-use solution that must be used within 14 days. If using the vial adapter, twist the vial adapter onto the diluent syringe. Then, place the vial adapterover the ENBREL® vial and insert the vial adapter into the vial stopper. Push down on the plunger to inject the diluent into the ENBREL® vial. It is normal for some foaming to occur. Keeping the diluent syringe in place, gently swirl the contents of the ENBREL®vial during dissolution. Toavoid excessive foaming, do not shake or vigorously agitate. Text Continues Below
If using a 25-gauge needle to reconstitute and withdraw ENBREL®, the diluent should be injectedvery slowly into the ENBREL® vial. It is normal for some foaming to occur. The contents shouldbe swirled gently during dissolution. To avoid excessive foaming, do not shake or vigorously agitate. Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
|
.gif)
