As 3 injection, solution

Spl unclassified section

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

NDC 14537-966-10
Canada DIN 02324393

Description section

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.

Spl unclassified section

Caution:Not for direct intravenous infusion.

Recommended storage

Room temperature.

Avoid excessive heat. Protect from freezing.

How supplied section

Each 100 mL contains:

Dextrose Monohydrate USP 1.10g
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

Spl unclassified section

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

Ingredients and appearance - Product information

As 3 injection, solution- Dextrose monohydrate, sodium citrate, sodium chloride, sodium phosphate, monobasic, monohydrate, citric acid monohydrate and adenine

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 14537-966
Route of Administration Intravenous

Active Ingredient/Active Moiety

Ingredient Name Strength
Dextrose monohydrate ( UNII: LX22YL083G)( Anhydrous dextrose - UNII: 5SL0G7R0OK ) 1.1 gin 100 mL
Sodium citrate, unspecified form ( UNII: 1Q73Q2JULR)( Anhydrous citric acid - UNII: XF417D3PSL ) 0.588 gin 100 mL
Sodium chloride ( UNII: 451W47IQ8X)( Chloride ion - UNII: Q32ZN48698 ) 0.41 gin 100 mL
Sodium phosphate, monobasic, monohydrate ( UNII: 593YOG76RN)( Phosphate ion - UNII: NK08V8K8HR ) 0.276 gin 100 mL
Citric acid monohydrate ( UNII: 2968PHW8QP)( Anhydrous citric acid - UNII: XF417D3PSL ) 0.042 gin 100 mL
Adenine ( UNII: JAC85A2161)( Adenine - UNII: JAC85A2161 ) 0.03 gin 100 mL

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
NDA BN001214 USA

Labeler - Terumo BCT Ltd( 233649834)

Establishment

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

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