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FDA Drug information

Haemonetics Anticoagulant Sodium Citrate

Read time: 1 mins
Marketing start date: 23 Dec 2024
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Summary of product characteristics


Warnings

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.

Effective Time

20210202

Version

12

Spl Product Data Elements

Haemonetics Anticoagulant Sodium Citrate TRISODIUM CITRATE DIHYDRATE WATER TRISODIUM CITRATE DIHYDRATE ANHYDROUS CITRIC ACID

Application Number

BN980123

Brand Name

Haemonetics Anticoagulant Sodium Citrate

Generic Name

TRISODIUM CITRATE DIHYDRATE

Product Ndc

57826-420

Product Type

HUMAN PRESCRIPTION DRUG

Route

EXTRACORPOREAL

Package Label Principal Display Panel

Product Labeling Label label 2 label 3

Spl Unclassified Section

HAEMONETICS ANTICOAGULANT SODIUM CITRATE 4% w/v SOLUTION USP Rx only 250 mL 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)

Information For Patients

Product code Product Code 420A 117881-00, Rev. AA-XXX Haemonetics Corporation 400 Wood Road Braintree, MA 02184 USA

Storage And Handling

RECOMMENDED STORAGE: Room temperature (25°C/77°F). Avoid excess heat. Protect from freezing.

Drug section

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