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Name:Teruflex Blood Bag System Anticoagulant Citrate Phosphate Dextrose (cpd) And Optisol Red Cell Preservative
Manufacturer:Terumo Corporation
Category:Prescription Marketed Drugs


TERUFLEX® BLOOD BAG SYSTEM CPD/OPTISOL® SOLUTION BLOOD BAG SYSTEM

TERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL RED CELL PRESERVATIVE   - anticoagulant citrate phosphate dextrose (cpd) and as-5 red cell preservative   
Terumo Corporation

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TERUFLEX® BLOOD BAG SYSTEM CPD/OPTISOL® SOLUTION BLOOD BAG SYSTEM

Revised 8/96

TERUFLEX® BLOOD BAG SYSTEM
CPD/OPTISOL® SOLUTION

Read these instructions before use.

INSTRUCTIONS FOR BLOOD COLLECTION: Use aseptic technique
1. Confirm that all numbered tubing of each blood bag unit contains segment numbers.
2. Make a loose knot in the donor tubing approximately 10 cm from needle 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 tourniquiet to donor's arm. Disinfect site of phlebotomy. If blood pressure cuff is used, inflate cuff to 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 needle. Sever donor tubing between knot and clamp. Collect blood samples.
11. Reapply clamp to donor tubing; release pressure on donor's arm and remove needle. Seal donor tubing.
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. Centrifuge unit to separate red cells from plasma.
15.The time of addition of OPTISOL Solution may vary depending on the processing option selected. Add solution under one of the following conditions.
a) After removal of plasma from freshly collected blood.
b) Within 8 hours of blood collection if components are prepared.
c) Within 72 hours of collection if blood is refrigerated immediately following collection.
16. Snap CLIKTIP (incline closure device) of primary collection bag and transfer plasma into satellite bag. Clamp transfer tubing of satellite bag.
17. Snap CLIKTIP of OPTISOL Solution bag and drain contents into primary bag containing red blood cells. Seal tubing of primary bag in two places, and cut between seals and separate from satellite bag(s).
NOTE: For TERUFLEX double bags, seal OPTISOL Solution bag tubing in two places, and cut between seals. Discard OPTISOL Solution container.
18. Invert the red cell- OPTISOL mixture several times to insure that the final AS-5 red cell product is well suspended.
19. Store AS-5 Red Blood Cells between 1-6oC.
20. Infuse AS-5 Red Blood Cells within 42 days of collection.

For further processing, use standard component processing techniques.

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

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.
Image 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 NOT 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

N-BB-OP-A (4)



Tray/Case Label

TERUFLEX® BLOOD BAG SYSTEM

CPD WITH OPTISOL® RED CELL PRESERVATIVE SOLUTION
FOR COLLECTION OF 450mL OF BLOOD

Each unit consists of a primary bag containing 63mL of Anticoagulant
CPD solution, with a  satellite bag containing 100mL of OPTISOL Red
Cell Preservative Solution.

Each 63mL Anticoagulant CPD solution USP contains 1.61g Dextrose
(monohydrate) USP, 1.66g Sodium Citrate (dihydrate) USP,188mg Citric
Acid (anhydrous) USP, 144mg Monobasic Sodium Phosphate
(monohydrate) USP.

Each 100mL OPTISOL Red Cell Preservative Solution contains 877mg
Sodium Chloride USP, 900mg Dextrose (monohydrate) USP, 525mg
Mannitol USP, 30mg 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)
Rx ONLY

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 Instructions For Blood Collection.

Manufactured by : TERUMO CORPORATION Tokyo, Japan
® : Registered Trademark of TERUMO CORPORATION

Rev. 01/03
B-4-G6-A (4)
Image of Representative Tray/Case Label CPD-OPTISOL w/o BSA




TERUFLEX BLOOD BAG SYSTEM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL RED CELL PRESERVATIVE  
anticoagulant citrate phosphate dextrose (cpd) and as-5 red cell preservative kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53877-005
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53877-005-21 24 BAG ( BAG) in 1 CASE contains a BAG
1 1 KIT ( KIT) in 1 BAG This package is contained within the CASE (53877-005-21)
QUANTITY OF PARTS
Part # Package Quantity Total Product Quantity
Part 1 1 BAG   63 mL
Part 2 1 BAG   100 mL
Part 1 of 2
ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD)  
anticoagulant citrate phosphate dextrose (cpd) solution
Product Information
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
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 25.5 g  in 1000 mL
Anhydrous Citric Acid (Citric Acid) Anhydrous Citric Acid 2.99 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 63 mL in 1 BAG None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA880217 01/13/2010

Part 2 of 2
OPTISOL RED CELL PRESERVATIVE  
as-5 red cell preservative solution
Product Information
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Sodium Chloride (SODIUM CATION) Sodium Chloride 877 mg  in 100 mL
Dextrose Monohydrate (Dextrose) Dextrose Monohydrate 818 mg  in 100 mL
Mannitol (Mannitol) Mannitol 525 mg  in 100 mL
Adenine (Adenine) Adenine 30 mg  in 100 mL
Inactive Ingredients
Ingredient Name Strength
Water  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 100 mL in 1 BAG None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA880217 01/13/2010


Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA880217 01/13/2010

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

Revised: 01/2010 Terumo Corporation



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


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