SODIUM CHLORIDE injection solution

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)

Pieejams no:

Baxter Healthcare Corporation

SNN (starptautisko nepatentēto nosaukumu):

SODIUM CHLORIDE

Kompozīcija:

SODIUM CHLORIDE 9 g in 1000 mL

Receptes veids:

PRESCRIPTION DRUG

Autorizācija statuss:

Unapproved drug for use in drug shortage

Produkta apraksts

SODIUM CHLORIDE- SODIUM CHLORIDE INJECTION, SOLUTION
BAXTER HEALTHCARE CORPORATION
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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SODIUM CHLORIDE 0.9% W/V INTRAVENOUS INFUSION BP
IMPORTANT DRUG INFORMATION
March 2014
SUBJECT: TEMPORARY IMPORTATION OF 0.9% SODIUM CHLORIDE INJECTION IN
VIAFLO (NON-PVC)
CONTAINERS
Dear Healthcare Professional,
Due to current critical shortage of 0.9% Sodium Chloride Injection in
the U.S. market, Baxter
Healthcare Corporation (Baxter) is coordinating with the Food and Drug
Administration (FDA) to
increase the availability of the drug. Baxter has initiated temporary
importation of a foreign Sodium
Chloride 0.9% Injection Solution for Intravenous Infusion in VIAFLO
non-polyvinyl chloride (non-
PVC) containers manufactured at Baxter’s Bieffe Medital, Sabinanigo,
Spain facility and marketed within
the European Union.
At this time, FDA is not objecting to the importation and distribution
of Baxter’s Sodium Chloride 0.9%
Injection Solution for Intravenous Infusion to address the critical
shortage of Sodium Chloride 0.9%
Injection. Importation or distribution of Baxter’s Sodium Chloride
0.9% Injection Solution for
Intravenous Infusion by any entity other than Baxter is not within the
scope of this decision and may be
subject to enforcement action by the FDA. FDA has not approved this
product in the United States.
Effective immediately, Baxter will offer the Sodium Chloride 0.9%
Intravenous Infusion in VIAFLO
(non-PVC) containers in the following volumes and quantities:
PRODUCT
VIAFLO (NON-PVC)
CONTAINER
Sodium Chloride 0.9% Intravenous
Infusion, 250 mL
30 bags per carton
Sodium Chloride 0.9% Intravenous
Infusion, 500 mL
20 bags per carton
Sodium Chloride 0.9% Intravenous
Infusion, 1000 mL (1L)
10 bags per carton
INDICATIONS AND USAGE AND DOSAGE ADMINISTRATION
Baxter’s Sodium Chloride 0.9% Intravenous Infusion in the VIAFLO
(non-PVC) co