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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 CPDA-1 SOLUTION Collection of 250 mL Whole Blood

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 CPDA-1 SOLUTION Collection of 250 mL Whole Blood

Issued 2009-10 N-BB-A 1

TERUFLEX® BLOOD BAG SYSTEM CPDA-1 SOLUTION
Collection of 250 mL Whole Blood

Read these instructions carefully before use. Rx ONLY.

INTENDED USE

Intended for the collection, processing and preservation of human blood and blood components.
Collection of 250 mL Whole Blood:
• From elderly, pediatric, or smaller autologous donors who may not tolerate larger blood collections.
• For blood collections as directed by a patient’s physician.
• For single use only. Sterile and non-pyrogenic fluid path.
Sterilized by steam.

NOTE: Production of Platelets and Plasma is not intended with this product.

PRECAUTIONS
• Do not use unless the solution is clear.
• Avoid excessive heat and direct sunlight. Protect from freezing.
• Recommended storage conditions: Room Temperature (15-30oC/59-86oF).

CAUTION
Do not use a dielectric tube sealer to seal the tubing while the needle is connected to the donor’s body unless it is approved for such a purpose.

INSTRUCTIONS FOR BLOOD COLLECTION: Use aseptic technique
1. Prepare the blood bag following your institution’s standard operating procedures.
2. Make a loose knot in the donor tubing approximately 10 cm from the needle unless alternate methods are used to seal the tubing at the end of collection.
3. Temporarily clamp the donor tubing.
4. Suspend the collection 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 to approximately 60 mmHg.
6. Remove the needle cover and perform phlebotomy. Remove the temporary clamp on the donor tubing to permit blood flow into the collection bag.

CAUTION Do not touch the needle after removing the needle protector.

7. Secure donor tubing to donor’s arm.
8. Mix blood with anticoagulant in the collection bag and continue to mix at several intervals during collection and immediately after collection. If using an automated mixer, follow manufacturer’s instructions.
9. Collect labeled volume of blood (+ / - 10%).
10. When the desired amount of blood has been collected,seal the tubing or tighten the loose knot (white knot) prepared in Step 2. Make a second seal between the first seal or knot and the needle. Various methods may be used to seal tubing.
11. Release pressure on the donor’s arm and remove the needle. Sever the donor tubing between the two seals.

CAUTION Discard the phlebotomy needle/donor tubing according to institutional procedures.

12. Strip blood from donor tubing into collection bag, mix well, and allow tubing to refill; repeat once. Make an appropriate number of segments for testing by sealing near the segment numbers. Leave segments attached to the whole blood unit.
13. Store CPDA-1 Whole Blood between 1-6oC for up to 35 days.

For further processing, use standard component processing techniques.

BLISTER PACKAGE
(See Fig. 1)
To open the blister package, peel the cover film back 4/5 of its length. After opening, unused blood bags may be stored at room temperature for 96 hours, or they may be stored for 30 days in the blister package after returning the cover film to the original position and sealing with tape to prevent possible loss of moisture.

Image of Fig. 1 Sealing with tape

CAUTION
• The AGELESS packet contained in this package absorbs oxygen and generates heat on removal. Do not open and handle it with care.
• Dispose of the AGELESS packet with the blister tray.
• Do not dispose with wastes containing volatile or flammable materials.


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

©TERUMO CORPORATION 2009 09J22



Tray/Case Label

TERUFLEX® BLOOD BAG SYSTEM

ANTICOAGULANT CITRATE PHOSPHATE
DEXTROSE ADENINE SOLUTION (CPDA-1) USP
FOR COLLECTION OF 250mL OF BLOOD

Each unit consists of a primary bag containing 35 mL of solution with
105 mg Citric Acid (anhydrous) USP, 921 mg Sodium Citrate (dihydrate)
USP, 77.7 mg Monobasic Sodium Phosphate (monohydrate) USP, 1.12 g
Dextrose (monohydrate) USP, 9.63 mg Adenine USP.

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

DONOR NEEDLE 16G 11 2˝ (1.60 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 at room temperature for 96 hours, or they may be
stored for 30 days in the blister package after returning the 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
Issued 2009 -10

Image of Representative Tray/Case Label CPDA-1 250mL




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:53877-001-01 30 BAG ( BAG) in 1 CASE contains a BAG
1 35 mL in 1 BAG This package is contained within the CASE (53877-001-01)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA820528 11/18/2009

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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