Sodium Citrate 4% w/v Anticoagulant by is a Prescription medication manufactured, distributed, or labeled by Terumo BCT, Ltd. Drug facts, warnings, and ingredients follow.
SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP is intended for use only for the anticoagulation of whole blood as part of automated apheresis procedures. (1)
Citrate reactions or toxicity may occur with the infusion and return of blood containing citrate anticoagulant. The recipient of the blood containing citrate should be monitored for the signs and symptoms of citrate toxicity. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Terumo BCT, Inc. at 1-877-339-4228 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
ANTICOAGULANT SOLUTION has not been studied in controlled clinical trials with specific populations. (7)
Revised: 8/2017
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).]
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.
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:
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit.
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.
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.
Ingredients | Molecular Formula | Molecular Weight |
---|---|---|
Sodium Citrate Dihydrate | C6H9Na3O9 | 294.10 |
Water for Injection | H2O | 18.00 |
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.
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:
This solution has no pharmacological effect.
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
SODIUM CITRATE 4% W/V ANTICOAGULANT
trisodium citrate dihydrate injection, solution |
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Labeler - Terumo BCT, Ltd (233649834) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Terumo BCT, Ltd | 233649834 | MANUFACTURE(14537-881) , ANALYSIS(14537-881) , STERILIZE(14537-881) , LABEL(14537-881) |