REJUVESOL- sodium pyruvate, inosine, adenine, sodium phosphate, dibasic, and sodium phosphate, monobasic, monohydrate solution

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

SODIUM PYRUVATE (UNII: POD38AIF08) (PYRUVIC ACID - UNII:8558G7RUTR), INOSINE (UNII: 5A614L51CT) (INOSINE - UNII:5A614L51CT), ADENINE (UNII: JAC85A2161) (ADENINE - UNII:JAC85A2161), SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37), SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37)

Διαθέσιμο από:

Citra Labs, LLC

INN (Διεθνής Όνομα):

SODIUM PYRUVATE

Σύνθεση:

SODIUM PYRUVATE 0.55 g in 50 mL

Οδός χορήγησης:

EXTRACORPOREAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Rejuvesol ® Solution is intended only for the extracorporeal rejuvenation of a RBC. It should never be directly administered to Humans. Rejuvesol ® Solution must not be added to whole blood because the additional plasma may reduce the effectiveness of the rejuvenation process. Immediately after rejuvenation, RBC must either be washed via an approved protocol prior to transfusion or glycerolized and frozen. RBC which have been rejuvenated, glycerolized, and frozen must be deglycerolized via an approved protocol prior to transfusion. RBC rejuvenated before 6 days of storage may achieve 2,3-DPG levels in excess of 2 times normal and ATP levels in excess of 1.5 times normal. 5,6 In patients with reduced arterial blood p0 2 of less than 40 torr, the use of RBC rejuvenated before 6 days of storage are contraindicated because their high 2,3-DPG levels and low oxygen affinity may impair proper oxygenation of the red blood cells in the lung. 7 Rej

Περίληψη προϊόντος:

PN 7012: 50 mL vial; 12 vials per case

Καθεστώς αδειοδότησης:

New Drug Application

Αρχείο Π.Χ.Π.

REJUVESOL- SODIUM PYRUVATE, INOSINE, ADENINE, SODIUM PHOSPHATE,
DIBASIC,
AND SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE SOLUTION
CITRA LABS, LLC
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REJUVESOL
RED BLOOD CELL PROCESSING SOLUTION
_FOR USE IN THE EXTRACORPOREAL REJUVENATION OF RED BLOOD CELLS_
_50 ML GLASS VIAL _
_NDC 23731-7000-5 _
_PN 7012 12 VIALS/CASE_
DESCRIPTION
_Rejuvesol _
Red Blood Cell Processing Solution ( _rejuvesol _
Solution) is a sterile, non-
pyrogenic solution of sodium pyruvate, inosine, adenine, dibasic
sodium phosphate, and
monobasic sodium phosphate in water for injection intended only for
use in the
extracorporeal rejuvenation of a unit of red blood cell concentrate
(RBC). Each 50 mL of
_rejuvesol _
Solution contains sodium pyruvate 0.550 g, inosine 1.34 g, adenine
0.034 g,
dibasic sodium phosphate (heptahydrate) 0.730 g, and monobasic sodium
phosphate
(monohydrate) 0.311 g, in water for injection, pH 6.7-7.4.
CLINICAL PHARMACOLOGY
A gradual depletion of red blood cell adenosine triphosphate (ATP) and
2,3
diphosphoglycerate (2,3-DPG) occurs with storage of RBC at 1-6 °C.
The level of 2,3-
DPG in RBC stored for greater than 14 days is less than 10% of normal
.
Rejuvenation of RBC with _rejuvesol _
Solution increases the levels of ATP and 2,3-DPG.
An in vitro loss of red blood cells occurs with the preservation and
processing of RBC.
Thus, the effectiveness of a transfusion is influenced by both the
total number of red
blood cells transfused and the number of those cells which remain in
circulation.
Therefore, the "dose" of a transfusion is defined as the percentage of
pre-transfusion
recovered red blood cells multiplied by the 24 hour post-transfusion
survival value.
Rejuvenation is accomplished by incubating the contents of one 50 mL
vial of _rejuvesol _
Solution with one unit of RBC (prepared from up to 550 mL of whole
blood) for sixty
(60) minutes at 37 °C. Citra recommends that the entire 50 mL of
_rejuvesol _
Solution
be added to a "smaller than normal" RBC as long as the prerejuvenation
net packed cell
weight is gre