Anticoagulant Sodium Citrate

ANTICOAGULANT SODIUM CITRATE- sodium citrate solution
Medsep Corporation

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 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 Item Code (Source) NDC:62646-798 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM CITRATE (CITRIC ACID ANHYDROUS) SODIUM CITRATE 10 g in 250 mL

Inactive Ingredients Ingredient Name Strength WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:62646-798-60 250 mL in 1 BAG None

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

Labeler — Medsep Corporation (928224765)

Registrant — Medsep Corporation (928224765)

Establishment
Name	Address	ID/FEI	Operations
Medsep Corporation		928224765	manufacture, relabel, repack

Revised: 05/2011 Medsep Corporation