Anticoagulant Sodium Citrate

ANTICOAGULANT SODIUM CITRATE 4% W/V SOLUTION USP is intended for use only for the anticoagulation of whole blood as part of automated apheresis procedures.

• ANTICOAGULANT SODIUM CITRATE 4% W/V SOLUTION USP is added to tubing sets during apheresis procedures. (
  2. DOSAGE AND ADMINISTRATION

  • ANTICOAGULANT SODIUM CITRATE 4% W/V SOLUTION USP is added to tubing sets during apheresis procedures.
  • ANTICOAGULANT SODIUM CITRATE 4% W/V SOLUTION USP may only be used with apheresis devices. For instructions on the use of the solution see the apheresis device operator's manual.
  • Follow the directions for connecting the ANTICOAGULANT SODIUM CITRATE 4% W/V SOLUTION USP bag to the apheresis system.

  2.1. General Dosing Information

  ANTICOAGULANT SODIUM CITRATE 4% W/V SOLUTION USP is added to tubing sets during apheresis procedures. The solution bag is connected to the tubing set in an apheresis collection. The recommended dose is determined by the apheresis device and metered into the tubing set by the apheresis device. It is not intended for direct intravenous infusion.

  For instructions on the use of the solution with the apheresis device and tubing set, see the device operator's manual.

  2.2. Administration

  • Ensure solution is the ANTICOAGULANT SODIUM CITRATE 4% W/V SOLUTION USP and is within the expiration date
  • Inspect the bag. Do not use if the container is damaged, leaking, or if there is any visible sign of deterioration
  • Use only if solution is clear and free of particulate matter
  • Protect from sharp objects.

  Directions for connecting the

  ANTICOAGULANT SODIUM CITRATE 4% W/V SOLUTION USP

  bag to the apheresis device.

  At the prompt to connect anticoagulant to the apheresis device tubing set:

  • Remove the overwrap by pulling down at the notch, and remove the ANTICOAGULANT SODIUM CITRATE 4% W/V SOLUTION USP bag.
  • Before use, perform the following checks
    [see Warnings and Precautions (5)]
    :
    • Check for leaks by gently squeezing the bag. If leaks are found, discard the bag
    • Ensure that the solution is the ANTICOAGULANT SODIUM CITRATE 4% W/V SOLUTION USP and is within the expiration date
    • Inspect the solution in good light. Bags showing cloudiness, haze, or particulate matter should not be used
  • Remove the twist off port on the bag
  • Connect the bag to the apheresis device tubing set using aseptic technique and hang the solution
  • Proceed according to the apheresis device operator's manual

  Drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit.
  )
• ANTICOAGULANT SODIUM CITRATE 4% W/V SOLUTION USP may only be used with apheresis devices. For instructions on the use of the solution see the apheresis device operator's manual. (
  2.1. General Dosing Information

  ANTICOAGULANT SODIUM CITRATE 4% W/V SOLUTION USP is added to tubing sets during apheresis procedures. The solution bag is connected to the tubing set in an apheresis collection. The recommended dose is determined by the apheresis device and metered into the tubing set by the apheresis device. It is not intended for direct intravenous infusion.

  For instructions on the use of the solution with the apheresis device and tubing set, see the device operator's manual.
  )
• Follow the directions for connecting the ANTICOAGULANT SODIUM CITRATE 4% W/V SOLUTION USP bag to the apheresis system. (
  2.2. Administration

  • Ensure solution is the ANTICOAGULANT SODIUM CITRATE 4% W/V SOLUTION USP and is within the expiration date
  • Inspect the bag. Do not use if the container is damaged, leaking, or if there is any visible sign of deterioration
  • Use only if solution is clear and free of particulate matter
  • Protect from sharp objects.

  Directions for connecting the

  ANTICOAGULANT SODIUM CITRATE 4% W/V SOLUTION USP

  bag to the apheresis device.

  At the prompt to connect anticoagulant to the apheresis device tubing set:

  • Remove the overwrap by pulling down at the notch, and remove the ANTICOAGULANT SODIUM CITRATE 4% W/V SOLUTION USP bag.
  • Before use, perform the following checks
    [see Warnings and Precautions (5)]
    :
    • Check for leaks by gently squeezing the bag. If leaks are found, discard the bag
    • Ensure that the solution is the ANTICOAGULANT SODIUM CITRATE 4% W/V SOLUTION USP and is within the expiration date
    • Inspect the solution in good light. Bags showing cloudiness, haze, or particulate matter should not be used
  • Remove the twist off port on the bag
  • Connect the bag to the apheresis device tubing set using aseptic technique and hang the solution
  • Proceed according to the apheresis device operator's manual

  Drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit.
  )

250 mL ANTICOAGULANT SODIUM CITRATE 4% W/V SOLUTION USP is a sterile solution in a PVC bag. Each 100 mL contains: Sodium Citrate (dihydrate) 4.0 g; Water for Injection to 100 mL, (pH adjusted with citric acid). Approximate millimoles of Sodium Citrate: 13.6.

ANTICOAGULANT SODIUM CITRATE 4% W/V SOLUTION USP has not been adequately studied in controlled clinical trials with specific populations.

• Verify that the ANTICOAGULANT SODIUM CITRATE 4% W/V SOLUTION USP has been securely attached to the anticoagulant (AC) line on the system tubing set. Use aseptic technique throughout all procedures to ensure donor safety and quality.
• Single-use container. Do not reuse. Discard any unused or partially used product.
• Rx only