ACD A

Dosage Form: injection, solution
Anticoagulant Citrate Dextrose

Solution USP (ACD)

Solution A 750 ml

Catalog # 777967-000

Sterile. Non-pyrogenic.

Do not use unless the solution is clear and the container is intact and undamaged.

Rx Only.

Single use container. Discard unused portion.

Not for direct intravenous infusion.

For use only with automated apheresis devices. See operator's manual for additional information and complete usage instructions.

Recommended storage:

room temperature (25°C). Avoid excessive heat. Protect from freezing.

Each 100ml contains:

 

Dextrose Monohydrate USP        2.45g

 

Sodium Citrate Dihydrate USP    2.2g

 

Citric Acid Anhydrous USP        0.73g

 

in Water for Injection USP

Lot

Expiry Date

Manufactured exclusively for CaridianBCT, Inc.

10811 W Collins Avenue, Lakewood CO 80215, USA

by Ivex Pharmaceuticals, Larne, BT40 2SH, UK.

777967-052 BC3v2

PRINCIPAL DISPLAY PANEL - 750mL Label

Anticoagulant Citrate Dextrose

Solution USP (ACD) Solution A

Catalog # 777967-000

12 x 750ml units

Sterile. Non-pyrogenic. Do not use unless the solution is clear and

the container is intact and undamaged. Rx Only. Single use

container. Discard unused portion. Not for direct intravenous

infusion. For use only with automated apheresis devices. See

operator's manual for additional information and complete usage

instructions. Recommended storage: room temperature (25°C).

Avoid excessive heat. Protect from freezing.

Each 100ml contains:

Dextrose Monohydrate USP	2.45g
Sodium Citrate Dihydrate USP	2.2g
Citric Acid Anhydrous USP	0.73g
in Water for Injection USP

Lot

Expiry Date

Manufactured exclusively for CaridianBCT, Inc.,

10811 W Collins Avenue, Lakewood CO 80215, USA

by Ivex Pharmaceuticals, Larne, BT40 2SH, UK.

777967-062

ACD   A dextrose monohydrate, sodium citrate, and anhydrous citric acid  injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 14537-967 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dextrose Monohydrate (Dextrose) Dextrose Monohydrate 2.45 g  in 100 mL Sodium Citrate (Sodium Cation) Sodium Citrate 2.2 g  in 100 mL Anhydrous Citric Acid (Ascorbic Acid) Anhydrous Citric Acid 0.73 g  in 100 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 14537-967-75 750 mL In 1 BAG None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA010228	02/25/2002

Labeler - CaridianBCT, Inc. (233649834)

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

Revised: 04/2010CaridianBCT, Inc.