AS 3

AS 3- dextrose monohydrate, sodium citrate, unspecified form, sodium chloride, sodium phosphate, monobasic, monohydrate, citric acid monohydrate and adenine injection, solution
Terumo BCT Ltd

Catalog # 777965-000
6 x 6 x 100 mL units

NDC 14537-966-10Canada DIN 02324393

Intended for use only with Trima and Trima Accel automated red blood cell apheresis devices and Atreus Whole Blood Processing System. See Operator’s Manuals for additional information and complete usage instructions.

Sterile. Non-pyrogenic. Do not use unless the solution is clear and the container is intact. Rx only.

Single use container.

Caution: Not for direct intravenous infusion.

Recommended storage

Room temperature.

Avoid excessive heat. Protect from freezing.

Each 100 mL contains:

Dextrose Monohydrate USP	1.10 g
Sodium Citrate Dihydrate USP	0.588 g
Sodium Chloride USP	0.410 g
Monobasic Sodium Phosphate Monohydrate USP	0.276 g
Citric Acid Monohydrate USP	0.042 g
Adenine USP	0.030 g
In Water for Injection USP

Manufactured by Terumo BCT, Inc.
10811 W. Collins Ave., Lakewood CO 80215, USA

Dist in Canada: Terumo BCT (Canada), Inc., 4 Robert Speck Pkwy,
Ste. 1500, Mississauga, ON, Canada L4Z1S1

777965-065

Lot
Expiry Date

PRINCIPAL DISPLAY PANEL — 100 mL Label

Additive Solution Formula 3 AS-3

Catalog # 777965-000
6 x 6 x 100 mL units

NDC 14537-966-10
Canada DIN 02324393

Intended for use only with Trima and Trima Accel automated red blood cell
apheresis devices and Atreus Whole Blood Processing System. See Operator’s
Manuals for additional information and complete usage instructions.
Sterile. Non-pyrogenic. Do not use unless the solution is clear and
the container is intact. Rx only. Single use
container.

Caution: Not for direct intravenous infusion.

Recommended storage: Room temperature.Avoid excessive heat. Protect from freezing.

Each 100 mL contains:

Dextrose Monohydrate USP	1.10 g
Sodium Citrate Dihydrate USP	0.588 g
Sodium Chloride USP	0.410 g
Monobasic Sodium Phosphate Monohydrate USP	0.276 g
Citric Acid Monohydrate USP	0.042 g
Adenine USP	0.030 g
In Water for Injection USP

Manufactured by Terumo BCT, Inc.
10811 W. Collins Ave., Lakewood CO 80215, USA
Dist in Canada: Terumo BCT (Canada), Inc., 4 Robert Speck Pkwy,
Ste. 1500, Mississauga, ON, Canada L4Z1S1

TERUMO BCT
777965-065

LotExpiry Date

AS 3 dextrose monohydrate, sodium citrate, sodium chloride, sodium phosphate, monobasic, monohydrate, citric acid monohydrate and adenine injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:14537-966 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dextrose Monohydrate (Anhydrous Dextrose) Dextrose Monohydrate 1.1 g in 100 mL SODIUM CITRATE, UNSPECIFIED FORM (Anhydrous Citric Acid) SODIUM CITRATE, UNSPECIFIED FORM 0.588 g in 100 mL Sodium Chloride (Chloride Ion) Sodium Chloride 0.41 g in 100 mL Sodium Phosphate, Monobasic, Monohydrate (Phosphate Ion) Sodium Phosphate, Monobasic, Monohydrate 0.276 g in 100 mL Citric Acid Monohydrate (Anhydrous Citric Acid) Anhydrous Citric Acid 0.042 g in 100 mL Adenine (Adenine) Adenine 0.03 g in 100 mL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:14537-966-10 6 POUCH in 1 CASE contains a POUCH 1 6 BAG in 1 POUCH This package is contained within the CASE (14537-966-10) and contains a BAG 1 100 mL in 1 BAG This package is contained within a POUCH and a CASE (14537-966-10) 2 NDC:14537-966-20 30 BAG in 1 CASE contains a BAG 2 200 mL in 1 BAG This package is contained within the CASE (14537-966-20)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA BN001214 05/29/2002

Labeler — Terumo BCT Ltd (233649834)

Establishment
Name	Address	ID/FEI	Operations
Terumo BCT Ltd.		233649834	MANUFACTURE (14537-966), STERILIZE (14537-966), LABEL (14537-966), ANALYSIS (14537-966)

Revised: 12/2018 Terumo BCT Ltd