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Anticoagulant Sodium Citrate

Medsep Corporation
Medsep Corporation

Anticoagulant Sodium Citrate Solution, USPCode 798-60


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

ANTICOAGULANT SODIUM CITRATE SOLUTION, USP

Sterile, non-pyrogenic fluid path. Sterilized by steam.

Rx only.

250 ml volume bag.

Store at room temperature.

ANTICOAGULANT SODIUM CITRATE 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 Bag Text

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.

Issued August 2010, 147798603

Anticoagulant Sodium Citrate

Sodium Citrate SOLUTION

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:62646-798
Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SODIUM CITRATE 10 g

Inactive Ingredients

Ingredient Name Strength
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:62646-798-60 250 in 1 BAG

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA760305 2011-04-15


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