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ACD-A- anticoagulant citrate dextrose solution a solution


  1. Description
  2. Indications And Usage
  3. Contraindications
  4. Warnings
  5. Precautions
  6. How Supplied
  7. Package/label Principal Display Panel
  8. References

Description 

Re-Order Product Code: 796-08

750 mL volume. Single use container.

Sterile, nonpyrogenic fluid path. Sterilized by steam.

Store at room temperature.

Indications And Usage 

For use with automated pheresis equipment only. Use according to equipment manufacturer s instructions. This unit should be used for pheresis only.

Contraindications 

Not for direct intravenous infusion.

Warnings 

Avoid excessive heat. Protect from freezing.

Precautions 

Do not use unless solution is clear and no leaks detected.

General

Rx only. Discard unused portion.

Recommended Storage: Store at room temperature (25 C / 77 F).

How Supplied 

750 mL volume bag.

Each 100 ml contains:

0.73 g citric acid (anhydrous), USP

2.20 g sodium citrate (dihydrate), USP

2.45 g dextrose (monohydrate), USP

Package/label Principal Display Panel 

Hot Stamped Bag

796-08 Hot Stamped Bag

Envelope Label

796-08 Envelope Label

References 

HAEMONETICS and THE Blood Management Company are trademarks of Haemonetics Corporation.

Manufactured for:

Haemonetics Corporation

400 Wood Road

Braintree, MA 02184, USA

By: Haemonetics Manufacturing Inc.

1630 Industrial Park Street

Covina, CA 91722, USA

ACD-A
anticoagulant citrate dextrose solution a solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53157-796
Route of Administration INTRAVENOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE 2.45 g in 100 mL
SODIUM CITRATE (UNII: 1Q73Q2JULR) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) SODIUM CITRATE 2.20 g in 100 mL
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID 0.73 g in 100 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:53157-796-08 12 in 1 CARTON
1 750 mL in 1 BAG; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA710497 11/06/1987
Labeler - Haemonetics Manufacturing Inc (078598396)
Registrant - Haemonetics Manufacturing Inc (078598396)
Establishment
Name Address ID/FEI Business Operations
Haemonetics Manufacturing Inc 078598396 MANUFACTURE(53157-796)

Revised: 2/2015 Haemonetics Manufacturing Inc



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