ANTICOAGULANT SODIUM CITRATE- sodium citrate solution

Anticoagulant Sodium Citrate by

Drug Labeling and Warnings

Anticoagulant Sodium Citrate by is a Prescription medication manufactured, distributed, or labeled by Medsep Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

ANTICOAGULANT SODIUM CITRATE 
sodium citrate solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 62646-798
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM CITRATE (UNII: 1Q73Q2JULR) (CITRIC ACID ANHYDROUS - UNII:XF417D3PSL)	SODIUM CITRATE	10 g  in 250 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

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

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	Business Operations
Medsep Corporation		928224765	manufacture, relabel, repack