Sodium Citrate 4% W/v Anticoagulant - Trisodium Citrate Dihydrate injection, Solution

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

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

  • SODIUM CITRATE 4% ANTICOAGULANT SOLUTION USP is added to tubing sets during apheresis procedures.
  • SODIUM CITRATE 4% ANTICOAGULANT 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 SODIUM CITRATE 4% ANTICOAGULANT SOLUTION USP bag to the apheresis system.

  2.1 General Dosing Information

  SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP is added to tubing sets during apheresis procedures. The solution is connected 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 SODIUM CITRATE 4% W/V ANTICOAGULANT 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

  SODIUM CITRATE 4% W/V ANTICOAGULANT 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 SODIUM CITRATE 4% W/V ANTICOAGULANT 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 SODIUM CITRATE 4% W/V ANTICOAGULANT 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 protective cap from the 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.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit.
  )
• SODIUM CITRATE 4% ANTICOAGULANT 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

  SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP is added to tubing sets during apheresis procedures. The solution is connected 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 SODIUM CITRATE 4% ANTICOAGULANT SOLUTION USP bag to the apheresis system. (
  2.2 Administration

  • Ensure solution is the SODIUM CITRATE 4% W/V ANTICOAGULANT 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

  SODIUM CITRATE 4% W/V ANTICOAGULANT 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 SODIUM CITRATE 4% W/V ANTICOAGULANT 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 SODIUM CITRATE 4% W/V ANTICOAGULANT 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 protective cap from the 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.

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

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

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

• Verify that the SODIUM CITRATE 4% W/V ANTICOAGULANT 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.
• Do not reuse. Discard unused or partially used solution bags.