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Name:Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1)
Manufacturer:Terumo Corporation
Category:Prescription Marketed Drugs


TERUFLEX® BLOOD BAG SYSTEM with Blood Sampling Arm CPDA-1 SOLUTION

TERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1)  - anhydrous citric acid, trisodium citrate dihydrate, sodium phosphate, monobasic, dextrose monohydrate and adenine solution 
Terumo Corporation

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TERUFLEX® BLOOD BAG SYSTEM with Blood Sampling Arm CPDA-1 SOLUTION

Revised 8/96 N-BB-CA-A(SP) 3

TERUFLEX® BLOOD BAG SYSTEM with Blood Sampling Arm
CPDA-1 SOLUTION

Read these instructions before use.


INSTRUCTIONS FOR BLOOD COLLECTION: Use aseptic technique.


Materials Needed:     VENOJECT® II Tube Holder (code P-1316R)
                                VENOJECT® II Multi-Sample Luer Adapter
                                (code MN*2000)
                                VENOJECT® II Plastic Blood Collection Tubes
                                (or equivalent glass or plastic
                                evacuated blood collection tube)

1. Confirm that all numbered tubing of each blood bag unit contains segment numbers.
2. Make a loose knot in donor tubing below "Y" unless alternate methods are used to seal tubing.
3. Clamp donor tubing.
4. Suspend primary bag as far as possible below the donor's arm.
5. Apply blood pressure cuff or tourniquet to donor's arm. Disinfect site of phlebotomy. If blood pressure cuff is used, inflate cuff to approximately 60 mmHg.
6. Remove needle protector and perform phlebotomy. Remove clamp to permit blood flow into primary bag.

CAUTION Do not touch needle after removing the needle protector.

7. Appropriately secure donor tubing to donor's arm.
8. MIX BLOOD WITH ANTICOAGULANT AT SEVERAL INTERVALS DURING COLLECTION.
9. Collect labeled volume of blood (+/-10%).
10. Tighten knot firmly after collection. Clamp between knot and "Y". Sever donor tubing between the knot and clamp. Alternate methods may be used to seal tubing.

CAUTION Do not use the dielectric tube sealer while the needle is connected to the donor's body.

Anytime before Step #13 below, sever donor tubing between the two seals.
Collect blood samples as follows:
a) Connect VENOJECT II Multi-Sample Luer Adapter to VENOJECT II Tube Holder (Fig. 1).
Image of Fig. 1 (attach luer adapter to tube holder)
b) Remove covers and connect multi-sample luer adapter to female luer at end of donor sampling tubing (Fig. 2).
Image of Fig. 2 (attach adapter/holder to Blood Sampling Arm)
c) Snap CLIKTIP in donor sampling tubing to open blood pathway.
d) Insert blood collection tube (VENOJECT II or equivalent) firmly into VENOJECT II Tube Holder; when full, remove sample tube from holder. Repeat to collect additional samples.
11. Reapply clamp to donor tubing between phlebotomy needle and "Y"; release pressure on donor's arm and remove needle.

CAUTION Discard tubing/phlebotomy needle unit according to institutional procedures.

12. Immediately after collection, invert bag several times to assure blood and anticoagulant are well mixed.
13. Strip blood from donor tubing into bag, mix well, and allow tubing to refill. Seal on or near X marks on donor tubing to provide numbered aliquots of anticoagulated blood for testing.
14. If components are prepared, centrifuge unit and separate cells from plasma within 8 hours of blood collection.
NOTE: Final hematocrit should be 75% or less.
15. Snap CLIKTIP (inline closure device) of primary collection bag and transfer plasma into satellite bag. Clamp transfer tubing of satellite bag.
16. Seal tubing of primary bag in two places, cut between seals and separate from satellite bag(s).
17. Store CPDA-1 Red Blood Cells (or whole blood) between 1-6o C.
18. Infuse CPDA-1 Red Blood Cells within 35 days of collection.

For further processing, use standard component processing techniques.

To open blister package, peel cover film back 4/5 of its length.

After opening, unused blood bags may be stored for 30 days by returning cover film to original position and sealing with tape to prevent possible loss of moisture.
(See Figure)
Image of Figure Sealing with tape

CAUTIONS
• THE PACKET OF AGELESS CONTAINED IN THIS PACKAGE ABSORBS OXYGEN AND GENERATES HEAT ON REMOVAL AND SHOULD BE HANDLED WITH CARE.
• DISPOSE WITH PACKET IN TRAY.
• DO NOTE DISPOSE WITH WASTES CONTAINING VOLATILE OR FLAMMABLE MATERIALS.
• DISCARD AGELESS PACKET WITHOUT OPENING.

TERUMO CORPORATION
44-1, 2-CHOME, HATAGAYA, SHIBUYA-KU, TOKYO, JAPAN
®: Registered Trademark




Tray/Case Label

TERUFLEX® BLOOD BAG SYSTEM with Blood Sampling ArmTM

ANTICOAGULANT CITRATE PHOSPHATE
DEXTROSE ADENINE SOLUTION (CPDA-1) USP
FOR COLLECTION OF 500mL OF BLOOD


Each unit consists of a primary bag containing 70 mL of solution with
209 mg Citric Acid (anhydrous) USP, 1.84 9 Sodium Citrate (dihydrate)
USP, 155 mg Monobasic Sodium Phosphate (monohydrate) USP, 2.23 9
Dextrose (monohydrate) USP, 19.3 mg Adenine USP.

STERILE, NON-PYROGENIC FLUID PATH.
DO NOT USE UNLESS ANTICOAGULANT IS CLEAR.

CODE

LOT NO.

EXPIRY

UNITS

DONOR NEEDLE 16G X 1 1/2" (1.60 X 38mm)
RxONLY

RECOMMENDED STORAGE: Room Temperature (15-30°C/59-86°F).
Avoid excessive heat. Protect from freezing.

After opening, unused bags may be stored for 30 days by returning cover film to original
position and sealing with tape to prevent possible loss of moisture.
See InstrucUons For Blood Collection.

Manufactured by: TERUMO CORPORATION Tokyo, Japan
®: Registered Trademark Blood Sampling Arm is a trademark of TERUMO CORPORATION.
Rev. 01/03

B-2-H6-A4-2

Image of Representative Tray/Case Label CPDA-1 500mL w/BSA




TERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1) 
anticoagulant citrate phosphate dextrose adenine (cpda-1) solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53877-001
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Anhydrous Citric Acid (Citric Acid) Anhydrous Citric Acid 2.99 g  in 1000 mL
Trisodium Citrate Dihydrate (Citric Acid) Trisodium Citrate Dihydrate 26.3 g  in 1000 mL
Sodium Phosphate, Monobasic (Phosphoric Acid) Sodium Phosphate, Monobasic 2.22 g  in 1000 mL
Dextrose Monohydrate (Dextrose) Dextrose Monohydrate 31.9 g  in 1000 mL
Adenine (Adenine) Adenine 0.275 g  in 1000 mL
Inactive Ingredients
Ingredient Name Strength
Water  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53877-001-04 48 BAG ( BAG) in 1 CASE contains a BAG
1 63 mL in 1 BAG This package is contained within the CASE (53877-001-04)
2 NDC:53877-001-05 30 BAG ( BAG) in 1 CASE contains a BAG
2 63 mL in 1 BAG This package is contained within the CASE (53877-001-05)
3 NDC:53877-001-06 36 BAG ( BAG) in 1 CASE contains a BAG
3 70 mL in 1 BAG This package is contained within the CASE (53877-001-06)
4 NDC:53877-001-07 30 BAG ( BAG) in 1 CASE contains a BAG
4 70 mL in 1 BAG This package is contained within the CASE (53877-001-07)
5 NDC:53877-001-08 24 BAG ( BAG) in 1 CASE contains a BAG
5 70 mL in 1 BAG This package is contained within the CASE (53877-001-08)
6 NDC:53877-001-09 24 BAG ( BAG) in 1 CASE contains a BAG
6 63 mL in 1 BAG This package is contained within the CASE (53877-001-09)
7 NDC:53877-001-10 36 BAG ( BAG) in 1 CASE contains a BAG
7 63 mL in 1 BAG This package is contained within the CASE (53877-001-10)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA820528 12/14/2009

Labeler - Terumo Corporation (690543319)
Establishment
Name Address ID/FEI Operations
Terumo Corp. - Fujinomiya Factory 695214015 manufacture

Revised: 12/2009 Terumo Corporation



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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