ADSOL RED CELL PRESERVATION (anticoagulant citrate phosphate dextrose- cpd and adsol preservation kit

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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)

Boleh didapati daripada:

Fenwal, Inc.

Jenis preskripsi:

PRESCRIPTION DRUG

Status kebenaran:

New Drug Application

Ciri produk

ADSOL RED CELL PRESERVATION- ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE
(CPD) AND ADSOL PRESERVATION
FENWAL, INC.
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CODE 6R1783, 6R1787 (20X) CODE 6R1790 (18X) RX ONLY
FRESENIUS KABI
BLOOD-PACK UNIT WITH AN INTEGRAL FENWAL BIOFLEX RC LEUKOCYTE REDUCTION
FILTER USING CPD/ADSOL RED CELL PRESERVATION SOLUTION FOR WHOLE BLOOD
COLLECTION AND FILTRATION OF RED BLOOD CELLS AND FENWAL HIGHFLO NEEDLE
Contains Sample Diversion System for the collection of
unanticoagulated whole blood
samples for laboratory testing.
Store at Controlled Room Temperature. Protect from freezing. Avoid
excessive heat.
Definition of “Controlled Room Temperature”:
“A temperature maintained thermostatically that encompasses the
usual and customary
working environment of 20° to 25° C (68° to 77° F); that results
in a mean kinetic
temperature calculated to be not more than 25° C; and that allows for
excursions
between 15° C and 30° C (59° and 86° F) that are experienced in
pharmacies, hospitals,
and warehouses. Provided the mean kinetic temperature remains in the
allowed range,
transient spikes up to 40°C are permitted as long as they do not
exceed 24 hours ...
The mean kinetic temperature is a calculated value that may be used as
an isothermal
storage temperature that simulates the non isothermal effects of
storage temperature
variations.”
Reference: United States Pharmacopeia, General Notices. United States
Pharmacopeial
Convention, Inc.
12601 Twinbrook Parkway, Rockville, MD.
Integral filter unit intended for leukocyte reduction of AS-1 red
blood cells:
• At ambient temperature up to 8 hours after blood collection.
• At refrigerated temperature (1° to 6° C) up to 3 days after
blood collection if AS-1 red
blood cells are prepared within 3 days after whole blood collection.
The leukocyte reduced red blood cells may then be stored for up to 42
days after
collection.
INSTRUCTIONS FOR USE
COLLECTION PROCEDURE:
USE ASEPTIC TECHNIQUE.
NOTES:
•
•
If sample diversion system is not used, donor samples may be collected
usi