FDA Label for Anticoagulant Sodium Citrate
View Indications, Usage & Precautions
Anticoagulant Sodium Citrate Product Label
The following document was submitted to the FDA by the labeler of this product Medsep Corporation. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Anticoagulant Sodium Citrate Solution, Usp
Sterile, non-pyrogenic fluid path. Sterilized by steam.
Rx only.
250 ml volume bag.
Store at room temperature.
Indications And Usage
For use with automated plasmapheresis equipment only. Use according to equipment manufacturer’s instructions. This unit should be used for plasmapheresis only.
Warnings
Not for direct intravenous infusion.
DO NOT VENT.
Avoid excessive heat. Protect from freezing.
General Precautions
Do not use unless solution is clear and no leaks are detected.
Discard unused portion.
How Supplied
Single Use Container.
Information For Patients
Medsep Corporation, A Subsidiary of Pall Corp., Covina, CA 91722, USA
Visit us at www.pall.com/medical
For Pall customer service, call: 1.800.645.6578
Container Text Displayed
ANTICOAGULANT SODIUM CITRATE SOLUTION, USP
250 mL Code 798-60
For use with automated plasmapheresis equipment only. Each 250 mL of anticoagulant contains 10.0 g sodium citrate (dihydrate), USP (pH adjusted with citric acid, USP).
CAUTION: Not for direct intravenous infusion.
Do not use unless anticoagulant is clear. This unit should be used for plasmapheresis only. Sterile, nonpyrogenic fluid path. Sterilized by steam. Rx Only.
DO NOT VENT.
Package Label.Principal Display Panel
Issued August 2010, 147798603
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