Anticoagulant Sodium Citrate 4% W/v Solution Usp

Anticoagulant Sodium Citrate 4% W/v Solution Usp
SPL v4
SPL
SPL Set ID 7025a0f9-1a56-4416-a3a4-925d755aed90
Route
EXTRACORPOREAL
Published
Effective Date 2024-07-01
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Anhydrous Citric Acid (40 mg)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
NDA Active Since 2024-04-02

Description

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

Indications and Usage

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

Storage and Handling

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

How Supplied

Anticoagulant Sodium Citrate 4% w/v Solution, USP is a clear solution supplied in sterile and nonpyrogenic PVC bags per carton.


Medication Information

Indications and Usage

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

Dosage Forms and Strengths

Anticoagulant Sodium Citrate 4% w/v Solution, USP in the 250 mL single dose container is a sterile solution that contains 4g Sodium Citrate Dihydrate, USP per 100 mL, pH adjusted with citric acid.

Storage and Handling

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

How Supplied

Anticoagulant Sodium Citrate 4% w/v Solution, USP is a clear solution supplied in sterile and nonpyrogenic PVC bags per carton.

Description

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

Precautions

Not for direct intravenous infusion.

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.

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


Structured Label Content

Precautions (PRECAUTIONS)

Not for direct intravenous infusion.

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.

Administration (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.

Storage and Handling

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

Indications and Usage (INDICATIONS AND USAGE)

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

Dosage Forms and Strengths (DOSAGE FORMS AND STRENGTHS)

Anticoagulant Sodium Citrate 4% w/v Solution, USP in the 250 mL single dose container is a sterile solution that contains 4g Sodium Citrate Dihydrate, USP per 100 mL, pH adjusted with citric acid.

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


Advanced Ingredient Data


Raw Label Data

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