Haemonetics Additive Solution Formula 3 (AS-3)

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

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

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 DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CITRIC ACID MONOHYDRATE (ANHYDROUS CITRIC ACID) ANHYDROUS CITRIC ACID 4.2 mg in 1 mL SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (PHOSPHATE ION) SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 27.6 mg in 1 mL SODIUM CHLORIDE (CHLORIDE ION and SODIUM CATION) SODIUM CHLORIDE 41 mg in 1 mL ADENINE (ADENINE) ADENINE 3 mg in 1 mL ANHYDROUS DEXTROSE (ANHYDROUS DEXTROSE) ANHYDROUS DEXTROSE 100 mg in 1 mL TRISODIUM CITRATE DIHYDRATE (ANHYDROUS CITRIC ACID) ANHYDROUS CITRIC ACID 58.8 mg in 1 mL

Inactive Ingredients Ingredient Name Strength WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:57826-462-03 300 mL in 1 BAG None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA BN000127 01/07/2013

Labeler — Haemonetics Corporation (057827420)

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

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

Revised: 09/2020 Haemonetics Corporation