IMUFLEX WB-SP BLOOD BAG SYSTEM WITH INTEGRAL WHOLE BLOOD LEUKOCYTE REDUCTION FILTER (SAVING PLATELETS) WITH DIVERSION BLOOD SAMP

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. 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 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

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 blood bag system may be stored at room temperature for 7 days, or it 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. 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*LGQ506A6 is supplied 15/case.

Statut de autorisation:

New Drug Application

Résumé des caractéristiques du produit

IMUFLEX WB-SP BLOOD BAG SYSTEM WITH INTEGRAL WHOLE BLOOD LEUKOCYTE
REDUCTION FILTER (SAVING 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-SP BLOOD BAG SYSTEM WITH INTEGRAL WHOLE BLOOD LEUKOCYTE
REDUCTION
FILTER (SAVING PLATELETS) WITH DIVERSION BLOOD SAMPLING ARM
CPD/OPTISOL SOLUTION
For the collection of 500 mL of Whole Blood
Revised 2015-12 N-SP-OP-A-DB
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.
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 : 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
2.5. Suspend the collection bag as far as possible below the donor's
arm.
2.6. Apply blood pre