2.1 Important Administration Instructions

Dextrose Injection (5%) is intended for intravenous use.

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Use a peripheral vein to administer if the final dextrose concentration is 5% or less and the osmolarity is less than 900 mOsm/L.

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To avoid venous irritation, consider using a central vein to administer hypertonic solutions with osmolarity of 900 mOsm/L or greater [see Warnings and Precautions (5.4)].

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Do not administer Dextrose Injection (5%) simultaneously with blood products through the same administration set because of the possibility of pseudoagglutination or hemolysis.

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Use of a final filter is recommended during administration of parenteral solutions, where possible.

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Discard the unused portion.

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Do not use the Dextrose Injection (5%) ADD-VantageTM diluent containers with chemotherapy agents.

2.2 Important Preparation Information

Visually inspect the Dextrose Injection (5%) for particulate matter and discoloration. Do not administer Dextrose Injection (5%) if the solution is cloudy, there are precipitates, and the container is damaged.

To reduce the risk of air embolism, adhere to the following preparation instructions for Dextrose Injection (5%):

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Use a non-vented infusion set or close the vent on a vented set.

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Use a dedicated line without any connections (do not connect flexible containers in series).

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Do not pressurize the flexible container to increase flow rates.

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If using a pumping device to administer Dextrose Injection (5%), turn off the pump before the container is empty.

To Open:

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Peel overwrap at corner and remove solution container.

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Use unit within 30 days of opening overwrap, as long as the use date does not exceed the printed expiration date.

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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.

To Assemble Vial and Flexible Diluent Container:

	1. Remove the protective covers from the top of the vial and the vial port on the diluent container as follows: a. To remove the breakaway vial cap, swing the pull ring over the top of the vial and pull down far enough to start the opening (SEE FIGURE 1.), then pull straight up to remove the cap. (SEE FIGURE 2.) NOTE: Once the breakaway cap has been removed, do not access the vial with the syringe.
	b. To remove the vial port cover, grasp the tab on the pull ring, pull up to break the three tie strings, then pull back to remove the cover. (SEE FIGURE 3.)
	2. Screw the vial into the vial port until it will go no further. THE VIAL MUST BE SCREWED IN TIGHTLY TO ASSURE A SEAL. This occurs approximately 1/2 turn (180°) after the first audible click. (SEE FIGURE 4.) The clicking sound does not assure a seal; the vial must be turned as far as it will go. NOTE: Once vial is seated, do not attempt to remove. (SEE FIGURE 4.) 3. Recheck the vial to assure that it is tight by trying to turn it further in the direction of assembly. 4. Label appropriately.
	To Reconstitute the Drug: 1. Squeeze the bottom of the diluent container gently to inflate the portion of the container surrounding the end of the drug vial. 2. With the other hand, push the drug vial down into the container telescoping the walls of the container. Grasp the inner cap of the vial through the walls of the container. (SEE FIGURE 5.) 3. Pull the inner cap from the drug vial. (SEE FIGURE 6.) Verify that the rubber stopper has been pulled out, allowing the drug and diluent to mix. 4. Mix container contents thoroughly and use within the specified time. 5. Look through the bottom of the vial to verify that the stopper has been removed and complete mixing has occurred. (SEE FIGURE 7.) If the rubber stopper is not removed from the vial, and the medication is not released on the first attempt, the inner cap may be manipulated back into the rubber stopper without removing the drug vial from the diluent container. Repeat steps 3 through 5.

Preparation for Administration:

1.

Confirm the activation and admixture of vial contents.

2.

Check for leaks by squeezing the container firmly. If leaks are found, discard the unit because sterility may be compromised.

3.

Close the flow control clamp of the administration set.

4.

Remove the cover from the outlet port at the bottom of the container.

5.

Insert the piercing pin of the administration set into the port with a twisting motion until the pin is firmly seated. Note: See full directions on the administration set carton.

6.

Lift the free end of the hanger loop on the bottom of the vial, breaking the two tie strings. Bend the loop outward to lock it in the upright position, then suspend the container from the hanger.

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Squeeze and release the drip chamber to establish the proper fluid level in the chamber.

8.

Open the flow control clamp and clear air from set. Close clamp.

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Attach the set to the venipuncture device. If the device is not indwelling, prime and make venipuncture.

10.

Regulate the rate of administration with the flow control clamp. Do not use the flexible container in series connections.

2.3 Dosage Considerations

The choice of dextrose concentration, rate, and volume depends on the age, weight, clinical, and metabolic conditions of the patient and concomitant therapy.

Dextrose Injection (5%) administration rate should be based on the patient’s tolerance of dextrose, especially for preterm neonates with low birth weight.

Increase the infusion rate gradually as needed; frequently monitor blood glucose concentrations to avoid hyperglycemia [see Warnings and Precautions (5.2), Use in Specific Populations (8.4)].