TERUFLEX BLOOD BAG SYSTEM WITH DIVERSION BLOOD SAMPLING ARM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL (AS-5) RE

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Trisodium Citrate Dihydrate (UNII: B22547B95K) (Anhydrous Citric Acid - UNII:XF417D3PSL), Sodium Phosphate, Monobasic (UNII: 3980JIH2SW) (Phosphate Ion - UNII:NK08V8K8HR, Sodium Cation - UNII:LYR4M0NH37), Dextrose Monohydrate (UNII: LX22YL083G) (Anhydrous Dextrose - UNII:5SL0G7R0OK), Anhydrous Citric Acid (UNII: XF417D3PSL) (Anhydrous Citric Acid - UNII:XF417D3PSL)

Available from:

Terumo Corporation

INN (International Name):

Trisodium Citrate Dihydrate

Composition:

Trisodium Citrate Dihydrate 26.3 g in 1000 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

1.1. Read these instructions carefully before use. 1.2. Rx ONLY. 1.3. Intended for the collection, processing and preservation of Whole Blood and blood components. Not intended for direct intravenous infusion. 1.4. For the collection of 450 mL ±10% or 500 mL ±10% Whole Blood. 1.5. Integral Diversion Blood Sampling Arm is intended to divert and obtain donor samples for laboratory testing prior to collection of the Whole Blood unit. 1.6. For further processing, use standard component processing techniques. This device is for use by trained individuals. Intended Use The DonorCare® Needle Guard is incorporated onto the donor tubing to shield the needle immediately after withdrawal from the donor. Single Use Only. Preparation 1. Move the DonorCare on the tubing ensuring that it slides easily and the arrow is pointing toward the needle hub. 2. Ensure that the three lock points on the DonorCare are locked closed. Whole Blood Collection 3. Perform the phlebotomy as per your institution's standard operating procedures

Product summary:

16.1. Single use only. 16.2. Sterile and non-pyrogenic fluid path. Sterilized by steam. Opacity of the blood bag system may be observed. This is due to moisture absorption during the sterilization process. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. 16.3. A Material Safety Data Sheet (MSDS) is not required for this product. 16.4. Recommended storage conditions: Room Temperature (15-30°C/59-86°F). 16.5. Avoid excessive heat and direct sunlight. Protect from freezing. 16.6. To open blister package, peel cover film back 4/5 of its length. 16.7. After opening the blister package, unused blood bags may be stored at room temperature for 96 hours or they may be stored for 30 days by returning cover film to original position and sealing with tape to prevent evaporation of solutions. 16.8. Blood bags in the unopened blister package may be used through the last day of the month and year as indicated on the original manufacturer's packaging. 16.9. The AGELESS packet contained in this package absorbs oxygen and generates heat on removal. Do not open and handle it with care. 16.10. Dispose of the AGELESS packet with the blister tray. 16.11. Do not dispose the AGELESS packet with wastes containing volatile or flammable materials. 16.12. For the Double blood bag sets, Codes BB *AGD456A2 and BB *AGD506A2 are supplied 24/case. 16.13. For the Triple blood bag sets, Codes BB *AGT456A2 and BB *AGT506A2 are supplied 24/case. 16.14. For the Quadruple blood bag sets, Codes BB *AGQ456A2 and BB *AGQ506A2 are supplied 18/case.

Authorization status:

New Drug Application

Summary of Product characteristics

TERUFLEX BLOOD BAG SYSTEM WITH DIVERSION BLOOD SAMPLING ARM
ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL (AS-5)
RED CELL PRESERVATIVE - ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD)
AND AS-5 RED CELL
PRESERVATIVE
TERUMO CORPORATION
----------
TERUFLEX BLOOD BAG SYSTEM WITH DIVERSION BLOOD SAMPLING ARM
CPD/OPTISOL SOLUTION
For the collection of 450 mL or 500 mL of Whole Blood
Revised 2015-12 N-BB-OP-A2-DB-DCNG
FULL PRESCRIBING INFORMATION
*Sections or subsections omitted from the Full Prescribing Information
are not listed [includes sections
4, 6, 7, 8, 9, 10, 12, 13, 14, 15 and 17].
1. INDICATIONS AND USAGE
1.1. Read these instructions carefully before use.
1.2. Rx ONLY.
1.3. Intended for the collection, processing and preservation of Whole
Blood and blood components.
Not intended for direct intravenous infusion.
1.4. For the collection of 450 mL ±10% or 500 mL ±10% Whole Blood.
1.5. Integral Diversion Blood Sampling Arm is intended to divert and
obtain donor samples for
laboratory testing prior to collection of the Whole Blood unit.
1.6. For further processing, use standard component processing
techniques.
2. DOSAGE AND ADMINISTRATION
2.1. To open blister package, peel cover film back 4/5 of its length.
2.2. Prepare the blood bag following your institution's standard
operating procedures.
2.2.1. Materials Needed:
VENOJECT®@Tube Holder (code P-1316R) or equivalent
VENOJECT@Multi-Sample Luer Adapter (code MN*2000T) or equivalent
Evacuated blood collection tubes (glass or plastic)
2.3. Make a loose knot in the donor tubing below the "Y" and CLIKTIP®
(inline closure device) unless
alternate methods are used to seal the tubing at the end of
collection.
2.4. Temporarily clamp donor tubing between the phlebotomy needle and
the "Y".
2.5. Close the White Clamp below the diversion pouch.
2.6. Assemble the luer adapter and the tube holder.
2.6.1. Connect the VENOJECT@Multi-Sample Luer Adapter to the
VENOJECT@Tube Holder (or
equivalent) (Fig. 1).
2.6.2. Twist and snap to remove the blue port cap at the en