HAEMONETICS ADDITIVE SOLUTION FORMULA 3 (AS-3)- citric acid monohydrate, sodium phosphate, monobasic, monohydrate, sodium chloride, adenine, anhydrous dextrose, trisodium citrate dihydrate solution
Haemonetics Corporation

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Haemonetics Additive Solution Formula 3 (AS-3)

Additive Solution Formula 3 (AS-3) 300 mL

Intended for use only with automated red cell apheresis devices. See Operator's Manual for additional Information and complete usage instructions.

Each 100 mL contains:

Citric Acid (Monohydrate), USP 0.042 g
Monobasic Sodium Phosphate (Monohydrate), USP 0.276 g
Sodium Chloride, USP 0.410 g
Adenine, USP 0.030 g
Dextrose (Anhydrous), USP 1.000 g
Sodium Citrate (Dihydrate), USP 0.588 g
containing 15 mEq of Sodium.

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,

nonpryogenic fluid path. Rx only.

RECOMMENDED STORAGE:

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

CAUTION:

L322, Rev. E - 01 Product code 462A Haemonatics Corporation Braintree, MA 02184 USA Lot No. Exp. Date.

HAEMONETICS Additive Solution Formula 3 (AS-3) 250 mL Haemonatics Corporation Braintree, MA 02184 USA

Product Label - Package

Label

HAEMONETICS ADDITIVE SOLUTION FORMULA 3 (AS-3)
citric acid monohydrate, sodium phosphate, monobasic, monohydrate, sodium chloride, adenine, anhydrous dextrose, trisodium citrate dihydrate solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:57826-462
Route of Administration	EXTRACORPOREAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)	ANHYDROUS CITRIC ACID	4.2 mg in 1 mL
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN) (PHOSPHATE ION - UNII:NK08V8K8HR)	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	27.6 mg in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698, SODIUM CATION - UNII:LYR4M0NH37)	SODIUM CHLORIDE	41 mg in 1 mL
ADENINE (UNII: JAC85A2161) (ADENINE - UNII:JAC85A2161)	ADENINE	3 mg in 1 mL
ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)	ANHYDROUS DEXTROSE	100 mg in 1 mL
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)	ANHYDROUS CITRIC ACID	58.8 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:57826-462-03	300 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	BN000127	01/07/2013	07/27/2023

Labeler - Haemonetics Corporation (057827420)

Name	Address	ID/FEI	Business Operations
Establishment
Haemonetics Corporation		057827420	label(57826-462)

Name	Address	ID/FEI	Business Operations
Establishment
Haemonetics Manufacturing Inc.		078598396	manufacture(57826-462)

Revised: 7/2023

Document Id: 018dd6d5-a3f9-b024-e063-6394a90a6ed2

Set id: e6775fa2-9f23-4d71-be07-1e9e4d6265d0

Version: 10

Effective Time: 20230728

Haemonetics Corporation