Leukotrap WB Sytem

CP2D Anticoagulant Solution and AS-3 Solution may be used with Haemonetics

apheresis devices. See the Haemonetics Operation Manual for full operating

instructions.

Prior to use of the solutions, check the solutions for leaks by squeezing each of the

bags firmly. If leaks are found, discard the solution.

Envelope Label

LEUKOTRAP WB SYSTEM
leukotrap wb system kit

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:53157-262

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53157-262-01	1 in 1 KIT; Type 1: Convenience Kit of Co-Package

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	0 BAG	1 mL in 63
Part 2	0 BAG	1 mL in 100

Part 1 of 2

ANTICOAGULANT CITRATE PHOSPHATE DOUBLE DEXTROSE
anticoagulant citrate phosphate double dextrose injection, solution

Product Information
Route of Administration	INTRAVENOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DEXTROSE (UNII: IY9XDZ35W2) (DEXTROSE - UNII:IY9XDZ35W2)	DEXTROSE	3.21 g in 63 mL

Ingredient Name	Strength
Inactive Ingredients
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)	0.206 g in 63 mL
SODIUM CITRATE (UNII: 1Q73Q2JULR)	1.66 g in 63 mL
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)	0.14 g in 63 mL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		63 mL in 1 BAG; Type 1: Convenience Kit of Co-Package

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	BN820915

Part 2 of 2

ADDITIVE SOLUTION - 3
additive solution - 3 injection, solution

Product Information
Route of Administration	INTRAVENOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ADENINE (UNII: JAC85A2161) (ADENINE - UNII:JAC85A2161)	ADENINE	0.03 g in 100 mL
DEXTROSE (UNII: IY9XDZ35W2) (DEXTROSE, UNSPECIFIED FORM - UNII:IY9XDZ35W2)	DEXTROSE	1.1 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)	0.276 g in 100 mL
SODIUM CITRATE (UNII: 1Q73Q2JULR)	0.588 g in 100 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X)	0.41 g in 100 mL
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)	0.042 g in 100 mL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		100 mL in 1 BAG; Type 1: Convenience Kit of Co-Package

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	BN820915	09/23/1983

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	BN820915	09/22/1983

Labeler - Haemonetics Corporation (057827420)

Name	Address	ID/FEI	Business Operations
Establishment
Haemonetics Manufacturing Inc		078598396	manufacture(53157-262)