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Name:As 3
Manufacturer:Caridianbct, Inc.
Category:Prescription Marketed Drugs


Additive Solution Formula 3

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

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Additive Solution Formula 3

AS-3 100 mL Catalog # 777965-000

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 and undamaged. Rx only.

Single use container.

Caution: Not for direct intravenous infusion.

Recommended storage

Room temperature.

Avoid excessive heat. Protect from freezing.

Each 100mL 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

Lot
Expiry Date

Manufactured for CaridianBCT, Inc., Lakewood CO 80215
by Ivex Pharmaceuticals, Larne, BT40 2SH, UK.

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

777965-054

PRINCIPAL DISPLAY PANEL - 100 mL Label

Additive Solution Formula 3 AS-3

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

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 and undamaged. Rx only. Single use
container.

Caution: Not for direct intravenous infusion.

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

Each 100mL 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

Lot
Expiry Date

Manufactured for CaridianBCT, Inc., Lakewood CO 80215
by Ivex Pharmaceuticals, Larne, BT40 2SH, UK.

Dist in Canada: CaridianBCT (Canada), Inc., 4 Robert Speck Pkwy,
Ste. 1500, Mississauga, ON, Canada L4Z1S1
Canada DIN 02324393
777965-064

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 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 (Dextrose) Dextrose Monohydrate 1.1 g  in 100 mL
Sodium Citrate (Sodium Cation) Sodium Citrate 0.588 g  in 100 mL
Sodium Chloride (Sodium Cation) Sodium Chloride 0.41 g  in 100 mL
Sodium Phosphate, Monobasic, Monohydrate (Sodium Cation) Sodium Phosphate, Monobasic, Monohydrate 0.276 g  in 100 mL
Citric Acid Monohydrate (Ascorbic Acid) Citric Acid Monohydrate 0.042 g  in 100 mL
Adenine (Adenine) Adenine 0.03 g  in 100 mL
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:14537-966-10 100 mL in 1 BAG None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA001214 05/29/2002

Labeler - CaridianBCT, Inc. (233649834)
Establishment
Name Address ID/FEI Operations
CaridianBCT, Northern Ireland, Ltd. (dba Ivex Pharmaceuticals) 233649834 MANUFACTURE, STERILIZE, LABEL, ANALYSIS

Revised: 04/2010 CaridianBCT, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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