Glycopyrrolate Injection 0.2 mg/mL ANDA209024: Uses, Side Effects and Dosage

INSTRUCTIONS FOR USE

Figure 1: Outer Packaging and Prefilled Syringe

NOTES:

• Do not introduce any other fluid into the syringe at any time.
• Do not dilute for IV push.
• Do not re-sterilize the syringe.
• Do not use this product on a sterile field.
• This product is for single dose only.

1. 1. Inspect the outer packaging (blister pack) to confirm the integrity of the packaging. Do not use if the blister pack or the prefilled syringe has been damaged.
2. 2.

   Remove the syringe from the outer packaging. (See Figure 2)

   Figure 2

   

3. 3. Visually inspect the syringe. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
4. 4.

   Twist off the syringe tip cap. Do not remove the label around the luer lock collar. (See Figure 3)

   Figure 3

   

5. 5. Expel air bubble(s). Adjust the dose (if applicable).
6. 6. Administer the dose ensuring that pressure is maintained on the plunger rod during the entire administration.
7. 7. Discard the used syringe into an appropriate receptacle.

For more information concerning this drug, please call Fresenius Kabi USA, LLC at 1-800-551-7176.

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

The brand names mentioned in this document are the trademarks of their respective owners.

U.S. Patent 9,731,082

www.fresenius-kabi.com/us

451549B

Revised: 09/2020