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AS

Terumo BCT Ltd

Additive Solution Formula 3


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

AS
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

TERUMOBCT
777965-065

Lot
Expiry Date

AS

AS

Dextrose Monohydrate, Sodium Citrate, Sodium Chloride, Sodium Phosphate, Monobasic, Monohydrate, Citric Acid Monohydrate and Adenine INJECTION, SOLUTION

Product Information

Product Type Human prescription drug label 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 1.1 g
SODIUM CITRATE 0.588 g
SODIUM CHLORIDE 0.41 g
Sodium Phosphate, Monobasic, Monohydrate 0.276 g
CITRIC ACID MONOHYDRATE 0.042 g
Adenine ADENINE 0.03 g

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 100 in 1 BAG
2 200 in 1 BAG
3 NDC:14537-966-20 30 in 1 CASE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BN BN001214 2002-05-29


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