HAEMONETICS ANTICOAGULANT SODIUM CITRATE - trisodium citrate dihydrate solution
Haemonetics Corporation

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HAEMONETICS ANTICOAGULANT SODIUM CITRATE 4% w/v SOLUTION U.S.P.

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)

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.

STERILE,

nonpyrogenic fluid path. Rx only.

RECOMMENDED STORAGE:

Room temperature (25 degree C/77 degree F). Avoid excessive heat. Protect from freezing.

Product code

420A 112534-00, Rev. AA / M040, Rev. 01/12 Haemonetics Corporation 400 Wood Road Braintree, MA 02184 USA Made in Mexico Lot No. Exp. Date

HAEMONETICS ANTICOAGULANT SODIUM CITRATE 4% w/v SOLUTION U.S.P. 250 mL Haemonetics Corporation

Product Label

Label

HAEMONETICS ANTICOAGULANT SODIUM CITRATE
trisodium citrate dihydrate solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG LABEL	Item Code (Source)	NDC:57826-420
Route of Administration	EXTRACORPOREAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRISODIUM CITRATE DIHYDRATE (ANHYDROUS CITRIC ACID)	ANHYDROUS CITRIC ACID	40 mg in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER

Packaging
#	Item Code	Package Description
1	NDC:57826-420-02	250 mL in 1 BAG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA980123	01/10/2013

Labeler - Haemonetics Corporation (942344649)

Establishment
Name	Address	ID/FEI	Business Operations
Haemonetics Corporation		942344649	manufacture(57826-420)

Revised: 01/2013

Document Id: d243806a-b588-438e-8c8b-31496eb21ea8

Set id: 447528e6-55cd-4a9b-868e-2a741b2693d3

Version: 3

Effective Time: 20130110

Haemonetics Corporation