FDA Label for Sodium Citrate 4% W/v Anticoagulant

1 Indications And Usage

SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION is intended for use only for the anticoagulation of whole blood as part of automated apheresis procedures. [See Dosage and Administration (2).]

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.

  
  

3 Dosage Forms And Strengths

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).

4 Contraindications

DO NOT INFUSE SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP DIRECTLY TO THE DONOR.

5 Warnings And Precautions

• 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.

6 Adverse Reactions

Citrate reactions or toxicity may occur with the infusion of blood products to patients and return of blood containing citrate anticoagulant to donors. The recipient of the blood containing citrate should be monitored for the signs and symptoms of citrate toxicity. The signs and symptoms of citrate toxicity begin with paresthesia, a "tingling" sensation around the mouth or in the extremities, followed by severe reactions that are characterized by hypotension and possible cardiac arrhythmia. Citrate toxicity may occur more frequently in patients who are hypothermic, have impaired liver or renal function, or have low calcium levels because of an underlying disease.

8 Use In Specific Populations

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

11 Description

SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP is designed to be metered by an apheresis device in apheresis procedures, to prevent platelet activation and coagulation as blood moves throughout the extracorporeal unit (tubing set) in an apheresis procedure.

The solution is sterile and non-pyrogenic, and it contains no bacteriostatic or antimicrobial agents.

The formulas of the active ingredients are provided in Table 1.

Each 100 mL of SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP contains: Sodium Citrate (dihydrate) 4.0 g; and 100mL Water for Injection (pH adjusted with citric acid).

The PVC bag is not made with natural rubber latex.

The bag is made from a multilayered film. It contains materials that have been tested to demonstrate the suitability of the container for storing pharmaceutical solutions. The bag is nontoxic and biologically inert. The bag-solution unit is a closed system and is not dependent upon entry of external air during administration. The bag is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary.

12.1 Mechanism Of Action

SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP acts as an extracorporeal anticoagulant by binding the free calcium in the blood. Calcium is a necessary co-factor to several steps in the clotting cascade. The following ingredients are key components of the solution:

• Citric acid for pH regulation
• Sodium Citrate anticoagulant

This solution has no pharmacological effect.

16 How Supplied/Storage And Handling

SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP is a clear solution supplied in sterile and non-pyrogenic PVC bags. The bags are packaged 30 bags per case.

Storage And Handling

STORAGE

Up to 25 °C.
Protect from freezing.

Other

Issued: August 2017

Manufactured by
Terumo BCT, Inc.
Lakewood, CO 80215

Principal Display Panel - 250 Ml Bag Carton Label

Sodium Citrate 4% w/v
Anticoagulant Solution USP

Catalog # 40881
30 x 250 mL units
NDC 14537-881-25

For use only with automated apheresis procedures.

See apheresis device operator's manual for complete instructions.
Read the package insert before application.
Sterile. Non-pyrogenic. Sterilized with steam.
Caution: Do not use unless the solution is clear and the container is intact.
Single use container. Discard any unused product. Not for direct
intravenous infusion. Rx Only.

Recommended storage:
Up to 25 °C.
Protect from freezing.

Each 100 mL contains:
Sodium Citrate Dihydrate
4.0 g
Water for Injection to
(pH adjusted with citric acid)
100 mL
Approximate Millimoles:
Sodium Citrate
13.8

Manufactured by Terumo BCT, Inc.
10811 W. Collins Ave., Lakewood CO 80215, USA

777962-240
TERUMOBCT

Lot
Expiry Date

PRINCIPAL DISPLAY PANEL - 250 mL Bag Carton Label - sodium 01