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ACD-A

Fenwal Inc


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Anticoagulant Citrate Dextrose Solution USP (ACD) Formula A

CAUTION —

DO NOT REMOVE UNIT FROM OVERWRAP UNTIL READY FOR USE

THE OVERWRAP IS A MOISTURE BARRIER
THE INNER BAG MAINTAINS THE STERILITY OF THE PRODUCT

RECOMMENDED STORAGE–STORE AT CONTROLLED ROOM TEMPERATURE.

CODE 4B7891X
NDC 0942-0641-04

1000 mL

Fenwal™

Anticoagulant Citrate Dextrose Solution USP (ACD) Formula A

EACH 100 mL CONTAINS 2.45 g DEXTROSE (MONOHYDRATE) USP 2.2 g SODIUM CITRATE (DIHYDRATE) USP 730 mg CITRIC ACID (ANHYDROUS) USP

STERILE

NONPYROGENIC

SINGLE USE CONTAINER

DISCARD UNUSED PORTION

FOR USE WITH CYTAPHERESIS DEVICE ONLY

NOT FOR DIRECT INTRAVENOUS INFUSION

DO NOT USE UNLESS SOLUTION IS CLEAR AND NO LEAKS ARE DETECTED

AFTER REMOVING OVERWRAP CHECK FOR MINUTE LEAKS BY SQUEEZING INNER BAG FIRMLY. IF LEAKS ARE FOUND DISCARD SOLUTION AS STERILITY MAY BE IMPAIRED

Rx only

PL 146 PLASTIC

Manufactured by:
Baxter Healthcare Corporation
Deerfield, IL 60015 USA

Manufactured for:
Fenwal, Inc.
Lake Zurich, IL 60047 USA

07-25-58-006         Made in USA

LABEL ISSUE DATE    05/2008

PACKAGE/LABEL DISPLAY PANEL

ACD-A

Anticoagulant Citrate Dextrose Solution Formula A SOLUTION

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:0942-0641
Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Dextrose monohydrate ANHYDROUS DEXTROSE 24.5 g
SODIUM CITRATE 22 g
ANHYDROUS CITRIC ACID ANHYDROUS CITRIC ACID 7.3 g

Inactive Ingredients

Ingredient Name Strength
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0942-0641-04 1000 in 1 BAG

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BN BN160918 2007-03-01


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