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FDA Drug information

ANTICOAGULANT SODIUM CITRATE

Read time: 1 mins
Marketing start date: 19 Apr 2025
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Summary of product characteristics


Indications And Usage

INDICATIONS AND USAGE Anticoagulant Sodium Citrate 4% w/v Solution, USP is intended for use only with automated apheresis devices.

Effective Time

20240402

Version

2

Spl Product Data Elements

ANTICOAGULANT SODIUM CITRATE trisodium citrate dihydrate TRISODIUM CITRATE DIHYDRATE ANHYDROUS CITRIC ACID WATER

Application Number

BN980123

Brand Name

ANTICOAGULANT SODIUM CITRATE

Generic Name

trisodium citrate dihydrate

Product Ndc

0338-9669

Product Type

HUMAN PRESCRIPTION DRUG

Route

EXTRACORPOREAL

Package Label Principal Display Panel

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL LOT EXP 2B7867 NDC 0338-9669-01 Anticoagulant Sodium Citrate 4% w/v Solution USP Rx only 250 mL EACH 100 mL CONTAINS 4 g SODIUM CITRATE (DIHYDRATE) USP pH ADJUSTED WITH CITRIC ACID STERILE NONPYROGENIC INTENDED FOR USE ONLY WITH AUTOMATED APHERESIS DEVICES CAUTION — NOT FOR DIRECT INTRAVENOUS INFUSION THE POUCH IS A MOISTURE BARRIER DO NOT USE UNLESS SOLUTION IS CLEAR SQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS ARE FOUND SINGLE USE CONTAINER DISCARD UNUSED PORTION DIRECTIONS FOR USE ARE CONTAINED IN THE OWNERS OPERATING AND MAINTENANCE MANUAL OF THE APHERESIS MACHINE TO BE USED RECOMMENDED STORAGE ROOM TEMPERATURE (25C/77F) AVOID EXCESSIVE HEAT PROTECT FROM FREEZING. FOR PRODUCT INFORMATION 1-800-933-0303 BAXTER IS A TRADEMARK OF BAXTER INTERNATIONAL Baxter Logo BAXTER HEALTHCARE CORPORATION DEERFIELD IL 60015 USA MADE IN USA 07-25-00-4675 Carton Label

Spl Unclassified Section

ADMINISTRATION The pouch is a moisture barrier. Do not remove from pouch until ready to use. Do not use unless solution is clear and no leaks detected. Do not use unless port protector is in place.

How Supplied

HOW SUPPLIED Anticoagulant Sodium Citrate 4% w/v Solution, USP is a clear solution supplied in sterile and nonpyrogenic PVC bags per carton. Storage and Handling Store at room temperature (25C/77F). Avoid excessive heat. Protect from freezing.

Storage And Handling

Storage and Handling Store at room temperature (25C/77F). Avoid excessive heat. Protect from freezing.

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