Haemonetics Anticoagulant Sodium Citrate Prescribing Information

Package insert / product label
Generic name: trisodium citrate dihydrate
Dosage form: solution

HAEMONETICS ANTICOAGULANT SODIUM CITRATE 4% w/v SOLUTION USP

Rx only 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)

Warnings

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.

Storage and Handling

Room temperature (25°C/77°F). Avoid excess heat. Protect from freezing.

Patient Counseling Information

Product Code 420A
117881-00, Rev. AA-XXX

Haemonetics Corporation
400 Wood Road
Braintree, MA 02184 USA

Product Labeling

Label

label 2

label 3

HAEMONETICS ANTICOAGULANT SODIUM CITRATE
trisodium citrate dihydrate solution

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)	ANHYDROUS CITRIC ACID	40 mg in 1 mL

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:57826-420-02	250 mL in 1 BAG; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	BN980123	01/10/2013

Labeler - Haemonetics Corporation (057827420)

Medical Disclaimer