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AS 3 Prescribing Information

Package insert / product label
Generic name: dextrose monohydrate, sodium citrate, sodium chloride, sodium phosphate, monobasic, monohydrate, citric acid monohydrate and adenine
Dosage form: injection, solution

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.

Storage and Handling

Room temperature.

Avoid excessive heat. Protect from freezing.

Each 100 mL contains:

Dextrose Monohydrate USP1.10 g
Sodium Citrate Dihydrate USP0.588 g
Sodium Chloride USP0.410 g
Monobasic Sodium Phosphate Monohydrate USP0.276 g
Citric Acid Monohydrate USP0.042 g
Adenine USP0.030 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

Logo
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 USP1.10 g
Sodium Citrate Dihydrate USP0.588 g
Sodium Chloride USP0.410 g
Monobasic Sodium Phosphate Monohydrate USP0.276 g
Citric Acid Monohydrate USP0.042 g
Adenine USP0.030 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

Principal Display Panel - 100 mL Label
AS 3
dextrose monohydrate, sodium citrate, sodium chloride, sodium phosphate, monobasic, monohydrate, citric acid monohydrate and adenine injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:14537-966
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dextrose Monohydrate (UNII: LX22YL083G) (Anhydrous Dextrose - UNII:5SL0G7R0OK) Dextrose Monohydrate1.1 g in 100 mL
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) (Anhydrous Citric Acid - UNII:XF417D3PSL) SODIUM CITRATE, UNSPECIFIED FORM0.588 g in 100 mL
Sodium Chloride (UNII: 451W47IQ8X) (Chloride Ion - UNII:Q32ZN48698) Sodium Chloride0.41 g in 100 mL
Sodium Phosphate, Monobasic, Monohydrate (UNII: 593YOG76RN) (Phosphate Ion - UNII:NK08V8K8HR) Sodium Phosphate, Monobasic, Monohydrate0.276 g in 100 mL
Citric Acid Monohydrate (UNII: 2968PHW8QP) (Anhydrous Citric Acid - UNII:XF417D3PSL) Anhydrous Citric Acid0.042 g in 100 mL
Adenine (UNII: JAC85A2161) (Adenine - UNII:JAC85A2161) Adenine0.03 g in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14537-966-106 in 1 CASE
16 in 1 POUCH
1100 mL in 1 BAG; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
2NDC:14537-966-2030 in 1 CASE
2200 mL in 1 BAG; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDABN00121405/29/2002
Labeler - Terumo BCT Ltd (233649834)
Establishment
NameAddressID/FEIBusiness Operations
Terumo BCT Ltd.233649834MANUFACTURE(14537-966) , STERILIZE(14537-966) , LABEL(14537-966) , ANALYSIS(14537-966)