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. [See Dosage and Administration (2).]

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.

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

• 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

Citrate reactions or toxicity may occur with the infusion of blood products to patient 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.

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

ANTICOAGULANT SODIUM CITRATE 4% W/V 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. Sterilized with steam.

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

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

Issued: 05/2022

Manufactured By:
CSL Plasma, Inc.
155 Medical Sciences Drive
Union, SC 29379

ANTICOAGULANT SODIUM CITRATE
4% w/v SOLUTION, USP
250mL
NDC 81839-782-01
Product No. 1000782

Rx Only
Intended for use only with automated
apheresis devices

Each 100 mL contains:
Sodium Citrate (Dihydrate), USP 4.0g
(pH adjusted with Citric Acid, Monohydrate
USP)

CAUTION: Not for direct intravenous infusion.
The pouch is a moisture barrier. Do not use
unless solution is clear and no leaks detected.
Single use container. Discard unused portion.

STERILE, nonpyrogenic fluid path.

RECOMMENDED STORAGE: Store at 20° to
25°C (68° to 77°F); excursions permitted
between 15° to 30°C (59° to 86°F) [See USP
Controlled Room Temperature]. Brief exposure
up to 40°C (104°F) does not adversely affect
the product. Protect from freezing.

Manufactured By:
CSL Plasma Inc.
155 Medical Sciences Dr.
Union, SC 29379 USA

Made in USA
62635V01

Anticoagulant Sodium Citrate
4% w/v Solution, USP 250mL
NDC# 81839-782-02
30 UNITS

Rx only
Product Code: 1000782

LOT # 21X000XU

EXP. DATE YYYY MMM

Recommended Storage: Store at 20° to 25°C (68° to 77°F);
excursions permitted between 15° to 30°C (59° to 86°F)
[See USP Controlled Room Temperature]. Brief exposure
up to 40°C (104°F) does not adversely affect the product.
Protect from freezing.

Manufactured By:
CSL Plasma Inc.
155 Medical Sciences Drive
Union, SC 29379

Made in USA

62635V01 000000

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