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 6R1782, 6R1784 20X 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 Y-Sampling Site 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, MO.
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 the Y-Sampling Site is not used, donor samples may be collected
using an
alternative method following stan