ANTICOAGULANT CITRATE DEXTROSE A ACD-A injection, solution

Anticoagulant Citrate Dextrose A ACD-A by

Drug Labeling and Warnings

Anticoagulant Citrate Dextrose A ACD-A by is a Prescription medication manufactured, distributed, or labeled by Arteriocyte Medical Systems, Inc., Terumo BCT, Inc., Terumo BCT, Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

ACD-A 50 mL
Catalog # AMSACD-A

Anticoagulant intended for use only with devices that prepare Platelet Rich Plasma (PRP) products for extracorporeal use. 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 preparation of blood products for transfusion or for direct intravenous infusion.

Recommended storage

Room temperature (68° to 77°F, 20° to 25°C)

Avoid excessive heat. Protect from freezing.

Each 10mL contains

• Citric Acid Monohydrate USP: 0.08 g
• Sodium Citrate Dihydrate USP: 0.220 g
• Dextrose Monohydrate USP: 0.245 g

SPL UNCLASSIFIED SECTION

Manufactured for Arteriocyte Medical Systems, Inc.
45 South Street, Hopkinton, MA., 01748
by Ivex Pharmaceuticals, Larne, BT40 2SH, UK.

ARTERIOCYTE
CELLULAR THERAPIES
MEDICAL SYSTEMS

Lot
Expiry Date

PRINCIPAL DISPLAY PANEL - 50 Pouch Case Label

Anticoagulant Citrate Dextrose Solution,
Solution A USP ACD-A

50 mL
50 x 50 mL

Catalog # AMSACD-A

Anticoagulant intended for use only with devices that prepare Platelet Rich
Plasma (PRP) products for extracorporeal use. 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 preparation of blood products for transfusion or for direct
intravenous infusion.

Storage Conditions: Room temperature (68° to 77°F, 20° to 25°C)
Avoid excessive heat. Protect from freezing. Protect from direct sunlight.

Each 10mL contains:

Citric Acid Monohydrate USP
0.08 g
Sodium Citrate Dihydrate USP
0.220 g
Dextrose Monohydrate USP
0.245 g
In Water for Injection USP

Manufactured for Arteriocyte Medical Systems, Inc.
45 South Street, Hopkinton, MA., 01748
by Ivex Pharmaceuticals, Larne, BT40 2SH, UK.

ARTERIOCYTE
CELLULAR THERAPIES
MEDICAL SYSTEMS

Lot
Expiry Date

INGREDIENTS AND APPEARANCE

ANTICOAGULANT CITRATE DEXTROSE A ACD-A 
anticoagulant citrate dextrose a acd-a injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 43203-852
Route of Administration	EXTRACORPOREAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)	ANHYDROUS CITRIC ACID	0.08 g  in 10 mL
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM CITRATE, UNSPECIFIED FORM	0.220 g  in 10 mL
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)	DEXTROSE MONOHYDRATE	0.245 g  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)	9.76 g  in 10 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43203-852-47	50 in 1 CASE
1		1 in 1 POUCH
1		50 mL in 1 BAG; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	BA110057	05/11/2011

Labeler - Arteriocyte Medical Systems, Inc. (809012870)

Registrant - Terumo BCT, Inc. (801679200)

Establishment
Name	Address	ID/FEI	Business Operations
Terumo BCT, Ltd.		233649834	MANUFACTURE(43203-852) , ANALYSIS(43203-852) , STERILIZE(43203-852) , LABEL(43203-852)