Handling: Each bag contains no preservative. Once drug has been withdrawn from ready-to-use bag, the bag should be used within 24 hours, with any unused portion discarded.
Visually inspect the container. If the administration port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired.
Do not use plastic containers in series connections. Such use could result in an embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed.
Do not remove unit from overwrap until ready to use. Do not use if overwrap has been previously opened or damaged. The overwrap is a moisture barrier. The inner bag maintains sterility of the solution. Tear overwrap at notch and remove premixed bag. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.
Check for minute leaks by squeezing the inner bag firmly. If leaks are found, discard solution, as sterility may be impaired. Do not use unless the solution is clear (colorless to light yellow) and the seal is intact.
Preparation for intravenous administration: Use aseptic technique.
Suspend premixed bag from eyelet support.
Remove plastic protector from delivery port at bottom of bag.
Attach administration set.
Refer to complete directions accompanying set.
Directions for Use: BREVIBLOC injection is available in a pre-mixed bag and ready-to-use vial. BREVIBLOC injection is not compatible with Sodium Bicarbonate (5%) solution (limited stability) or furosemide (precipitation).
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Premixed Bag: The medication port is to be used solely for withdrawing an initial bolus from the bag.
Use aseptic technique when withdrawing the bolus dose.
Do not add any additional medications to the bag.
Ready-to-Use Vial: The Ready-to-use Vial may be used to administer a loading dosage by hand-held syringe while the maintenance infusion is being prepared [see Handling as previously mentioned].
Compatibility with Commonly Used Intravenous Fluids: BREVIBLOC injection was tested for compatibility with ten commonly used intravenous fluids at a final concentration of 10 mg esmolol hydrochloride per mL. BREVIBLOC injection was found to be compatible with the following solutions and was stable for at least 24 hours at controlled room temperature or under refrigeration: Dextrose (5%) Injection, USP; Dextrose (5%) in Lactated Ringer's Injection; Dextrose (5%) in Ringer's Injection; Dextrose (5%) and Sodium Chloride (0.45%) Injection, USP; Dextrose (5%) and Sodium Chloride (0.9%) Injection, USP; Lactated Ringer's Injection, USP; Potassium Chloride (40 mEq/liter) in Dextrose (5%) Injection, USP; Sodium Chloride (0.45%) Injection, USP; Sodium Chloride (0.9%) Injection, USP.