FDA Label for Sodium Citrate Blood-pack Units, (pl 146 Plastic)
View Indications, Usage & Precautions
Sodium Citrate Blood-pack Units, (pl 146 Plastic) Product Label
The following document was submitted to the FDA by the labeler of this product Fenwal, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Package/Label Principal Display Panel
CODE 6B7801
NDC 0942-9506-25
250mL
Fresenius Kabi Rx only
ANTICOAGULANT SODIUM CITRATE SOLUTION USP
NOT FOR DIRECT INTRAVENOUS INFUSION
EACH 100 mL CONTAINS 4 g SODIUM CITRATE (DIHYDRATE) USP
pH ADJUSTED WITH CITRIC ACID
STERILE NONPYROGENIC FOR USE WITH APHERESIS DEVICE ONLY
SINGLE USE CONTAINER DISCARD UNUSED PORTION 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
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 STORE AT CONTROLLED
ROOM TEMPERATURE
FRESENIUS KABI AG
61346 BAD HOMBURG / GERMANY
TEL.: +49 (0)6172 686-0
www.fresenius-kabi.com
Made in MX 47-25-13-348 REV: A
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