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These highlights do not include all the information needed to use SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP safely and effectively. See full prescribing information for SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP. SODIUM CITRATE 4% W/V ANTICOA | Sodium Citrate 4% w/v Anticoagulant [Terumo BCT, Ltd] | BioPortfolio

12:45 EST 27th January 2019 | BioPortfolio

Note: While we endeavour to keep our records up-to-date one should not rely on these details being accurate without first consulting a professional. Click here to read our full medical disclaimer.

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.

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).

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

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 has not been adequately studied in controlled clinical trials with specific populations.

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.

Table 1: Active Ingredients
Ingredients Molecular Formula Molecular Weight
Sodium Citrate Dihydrate C6H9Na3O9 294.10
Water for Injection H2O 18.00

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 is a clear solution supplied in sterile and non-pyrogenic PVC bags. The bags are packaged 30 bags per case.

SIZE CATALOG NUMBER NDC NUMBER
250 mL 40881 14537-881-25

STORAGE

Up to 25 °C.Protect from freezing.

Issued: August 2017

Manufactured by Terumo BCT, Inc. Lakewood, CO 80215

Sodium Citrate 4% w/vAnticoagulant 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 directintravenous 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

Manufacturer

Terumo BCT, Ltd

Active Ingredients

Source

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