AS 3

Generic Name: dextrose monohydrate, sodium citrate, sodium chloride, sodium phosphate, monobasic, monohydrate, citric acid monohydrate and adenine
Dosage Form: injection, solution

Additive Solution Formula 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


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   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 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) Dextrose Monohydrate 1.1 g  in 100 mL
Sodium Citrate (Anhydrous Citric Acid) Sodium Citrate 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
1 NDC:14537-966-10 6 POUCH in 1 CASE
1 6 BAG in 1 POUCH
1 100 mL in 1 BAG
2 NDC:14537-966-20 30 BAG in 1 CASE
2 200 mL in 1 BAG
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: 09/2013
 
Terumo BCT Ltd



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