ignee) determines that the product in a ruptured bag should be used, the HEMACORD product may be recovered as follows:
1.Place the ruptured bag into the sterile zipper-locked plastic bag to prevent further loss and/or contamination of the product during the thawing process.
2.Thaw the product according to the Section 3 above. Small leaks or tears of the ruptured bag can be blocked off with hemostat clips.
3.Withdraw the thawed product from the freezing bag and any product from the zipper-locked bag into one or more 60 mL syringe(s) with sterile tubing attached.
4.Inside a biological safety cabinet, transfer the product into a new bag using a sterile syringe. (This new bag could be either the sterile transplant bag that is provided with the HEMACORD product or a bag of a stocked salvage kit that should be readily available in the thawing laboratory for use in these situations.)
5.Save an aliquot of the product to send for gram stain and bacterial and fungal cultures.
6.Dilute (reconstitute) the thawed HEMACORD and remove the cryoprotectant according to the procedure described above or administer the diluted product to the patient as per transplant physician’s instructions.
7.It is the transplant physician’s (or designee’s) responsibility to determine whether to treat the patient with broad-spectrum antibiotic coverage and the necessity for an infectious disease consultation.
8.If possible, place the ruptured bag (with or without the product) into a biohazard bag and save for reference when notifying the National Cord Blood Program at the New York Blood Center. This staff will notify the manufacturer and provide information for returning the bag to the manufacturer for eva luation.
9.Notify the National Cord Blood Program at the New York Blood Center [phone number: 718-706-5211 or 1-866-767-NCBP (1-866-767-6227)].
Distributed by:
New York Blood Center, Inc.
45-01 Vernon Boulevard
Long Island City, NY 11101
License No. 0465
Issued:
Package Label - Principal Display Panel - 25 mL Bag
Package Label - Principal Display Panel - 25 mL Canister
HEMACORD
human cord blood hematopoietic progenitor cell injection
Product Information
Product Type CELLULAR THERAPY Item Code (Source) NDC:76489-001
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HUMAN CORD BLOOD HEMATOPOIETIC PROGENITOR CELL (HUMAN CORD BLOOD HEMATOPOIETIC PROGENITOR CELL) HUMAN CORD BLOOD HEMATOPOIETIC PROGENITOR CELL 500000000 in 25 mL
Inactive Ingredients
Ingredient Name Strength
DIMETHYL SULFOXIDE
Packaging
Item Code Package Description
1 NDC:76489-001-02 1 in 1 CANISTER
1 NDC:76489-001-01 25 mL in 1 BAG
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125397 11/10/2011
Labeler - New York Blood Center (073271827)
Establishment
Name Address ID/FEI Business Operations
New York Blood Center, Inc. 026299340 ANALYSIS(76489-001), API MANUFACTURE(76489-001), LABEL(76489-001), MANUFACTURE(76489-001), PACK(76489-001)
Revised: 02/2012
Document Id: a2ac1115-42a8-11e1-b86c-0800200c9a66Set id: bd9a5180-1773-11e0-980a-0002a5d5c51bVersion: 2Effective Time: 20120216
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