CPD/ADSOL RED CELL PRESERVATION SOLUTION SYSTEM (PL 2209) (anticoagulant citrate phosphate dextrose- cpd solution and adsol pres

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

Trisodium Citrate Dihydrate (UNII: B22547B95K) (Anhydrous Citric Acid - UNII:XF417D3PSL), DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK), ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL), SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN) (PHOSPHATE ION - UNII:NK08V8K8HR)

Tillgänglig från:

Fenwal, Inc.

INN (International namn):

Trisodium Citrate Dihydrate

Sammansättning:

Anhydrous Citric Acid 1.84 g in 70 mL

Receptbelagda typ:

PRESCRIPTION DRUG

Bemyndigande status:

New Drug Application

Produktens egenskaper

CPD/ADSOL RED CELL PRESERVATION SOLUTION SYSTEM (PL 2209)-
ANTICOAGULANT
CITRATE PHOSPHATE DEXTROSE (CPD) SOLUTION AND ADSOL PRESERVATION
SOLUTION
FENWAL, INC.
----------
BLOOD-PACK UNIT WITH AN INTEGRAL SEPACELL FLEX-EXCEL LEUKOCYTE
REDUCTION FILTER USING
CPD/ADSOL RED CELL PRESERVATION SOLUTION FOR WHOLE BLOOD COLLECTION
AND FILTRATION OF RED
BLOOD CELLS
RX ONLY
Contains Y-Sampling Site for the collection of unanticoagulated whole
blood samples for laboratory
testing and the Donor_Care_ Needle Guard.
Integral filter unit intended for leukocyte reduction of AS-1 Red
Blood Cells:
The leukocyte reduced Red Blood Cells may then be stored for the
maximum allowable dating period.
THIS PRODUCT CONTAINS DRY NATURAL RUBBER.
INSTRUCTIONS FOR USE
COLLECTION PROCEDURE:
USE ASEPTIC TECHNIQUE.
NOTE: Nominal tubing dimensions of product are 0.118" inner diameter x
0.025" wall thickness.
NOTE: If the Y-Sampling Site is not used, donor samples may be
collected using an alternate method
following standard procedures.
PRECAUTIONS :
1.
2.
3.
4.
5.
6.
7.
8.
At ambient temperature up to 8 hours after blood collection.
At refrigerated temperature up to 3 days after blood collection if
AS-1 Red Blood Cells are
prepared within 3 days after whole blood collection.
DO NOT USE UNLESS THE SOLUTIONS ARE CLEAR.
BEFORE BEGINNING PROCEDURE, OBTAIN ONE ACCESS DEVICE FOR EACH
BLOOD-PACK UNIT WITH Y-
SAMPLING SITE TO BE PROCESSED.
Identify Blood-Pack Unit using appropriate donor identification
system.
Adjust donor scale to desired collection weight and position primary
container on the donor scale
as far as possible below donor arm.
Clamp donor tubing between needle and Y-Sampling Site with hemostat.
This step may be
performed prior to step 1 or 2.
Apply pressure to donor’s arm and disinfect site of venipuncture.
If blood pressure cuff is used, inflate to approximately 60 mmHg.
Remove needle cover per instructions below:
a)
b)
Holding the hub and cover near the tamper-evident seal, twist cover
1/4 turn to break seal.
Remove needle cover, being