IMUFLEX WB-RP BLOOD BAG SYSTEM WITH INTEGRAL WHOLE BLOOD LEUKOCYTE REDUCTION FILTER (REMOVING PLATELETS) 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 kit

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

Trisodium Citrate Dihydrate (UNII: B22547B95K) (Anhydrous Citric Acid - UNII:XF417D3PSL), Sodium Phosphate, Monobasic, Unspecified form (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)

Disponible depuis:

Terumo Corporation

DCI (Dénomination commune internationale):

Trisodium Citrate Dihydrate

Composition:

Trisodium Citrate Dihydrate 26.3 g in 1000 mL

Mode d'administration:

INTRAVENOUS

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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 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. Integral filter unit intended for leukocyte reduction of Whole Blood up to 8 hours after blood collection when Whole Blood is stored at ambient temperature or cooled towards 1-10°C (transport temperature). 1.7. 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 - Move the DonorCare on the tubing ensuring that it slides easily and the arrow is pointing toward the needle hub. - Ensure that the three lock points on the DonorCare are locked closed. Whole Blood Collection Whole Blood Collection - Perform the phlebotomy as per your institution's standard operating procedures. - Slide the DonorCare over the needle hub so that it covers approximately one half to two thirds of the needle hub. - Stabilize the DonorCare to the arm by placing a piece of tape over the front end so that the tape does not extend over the front of the DonorCare. Withdrawal of Needle Important The DonorCare must be held stationary while the needle is withdrawn into it. Caution The needle must be fully shielded by DonorCare to prevent accidental injury. Withdrawal of Needle Important The DonorCare must be held stationary while the needle is withdrawn into it. Caution The needle must be fully shielded by DonorCare to prevent accidental injury. - Hold gauze over the venipuncture site with finger tips without exerting pressure. Hold the sides of the DonorCare near the front with the index finger and thumb of the same hand. - With the other hand, hold the donor tubing close behind the DonorCare. Note: A hemostat may be placed on the tubing behind the DonorCare when the blood collection is complete. This will help to prevent blood drops from forming. Note: A hemostat may be placed on the tubing behind the DonorCare when the blood collection is complete. This will help to prevent blood drops from forming. - Pull tubing smoothly and swiftly with one motion until the needle is locked in place inside the DonorCare. - Confirm that the needle is locked by: Listening for two 'clicks' as the needle is drawn into DonorCare. If the clicks are not heard as the needle is drawn into the DonorCare, continue to pull firmly on the tubing to assure needle is fully withdrawn into DonorCare. - Listening for two 'clicks' as the needle is drawn into DonorCare. - If the clicks are not heard as the needle is drawn into the DonorCare, continue to pull firmly on the tubing to assure needle is fully withdrawn into DonorCare. - Visually check that the needle is fully shielded by DonorCare before removing from the donor's arm. - Remove the tape from the DonorCare and arm. - Apply pressure to the gauze covering the venipuncture site. Warning Do not place fingers at the opening of DonorCare after removal from the donor's arm. Difficult Phlebotomy (Examples may include: Slow blood flow, deep or fine vein, steep angle) Warning Do not place fingers at the opening of DonorCare after removal from the donor's arm. Difficult Phlebotomy (Examples may include: Slow blood flow, deep or fine vein, steep angle) It may be necessary to delay placing the DonorCare over the needle hub until the end of the blood collection. In such situations: Leave the DonorCare on the tubing behind the needle hub. At the end of the blood collection carefully remove the tape from the needle hub and slide the DonorCare over the hub so that it covers approximately one half to two thirds of the needle hub. Withdraw the needle into the DonorCare as stated in steps 6. through 12. above. Rx ONLY DonorCare is manufactured by ITL Corporation, Melbourne, Australia. TERUMO CORPORATION 44-1, 2-CHOME, HATAGAYA, SHIBUYA-KU, TOKYO 151-0072, JAPAN © TERUMO CORPORATION December, 2015

Descriptif du produit:

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 Quadruple blood bag set, Code BB ＊WGQ506A2 is supplied 18/case.

Statut de autorisation:

New Drug Application

Résumé des caractéristiques du produit

IMUFLEX WB-RP BLOOD BAG SYSTEM WITH INTEGRAL WHOLE BLOOD
LEUKOCYTE REDUCTION FILTER (REMOVING PLATELETS) 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
----------
IMUFLEX WB-RP BLOOD BAG SYSTEM WITH INTEGRAL WHOLE BLOOD LEUKOCYTE
REDUCTION FILTER (REMOVING PLATELETS) WITH DIVERSION BLOOD SAMPLING
ARM
Revised 2015-12 N-WR-OP-A-DB 2
CPD/OPTISOL® SOLUTION
For the collection of 500 mL of Whole Blood
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 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. Integral filter unit intended for leukocyte reduction of Whole
Blood up to 8 hours
after blood collection when Whole Blood is stored at ambient
temperature or cooled
towards 1-10°C (transport temperature).
1.7. 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.