SODIUM CHLORIDE injection

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

B. Braun Medical Inc.

INN (Isem Internazzjonali):

SODIUM CHLORIDE

Kompożizzjoni:

SODIUM CHLORIDE 450 mg in 500 mL

Rotta amministrattiva:

INTRAVENOUS

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

L-istatus ta 'awtorizzazzjoni:

Unapproved drug for use in drug shortage

Karatteristiċi tal-prodott

SODIUM CHLORIDE- SODIUM CHLORIDE INJECTION
B. BRAUN MEDICAL INC.
_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
IMPORTANT PRESCRIBING INFORMATION
B. BRAUN MEDICAL INC.
824 12th Avenue
Bethlehem, PA 18018
610-691-5400
August 29, 2014
SUBJECT: TEMPORARY IMPORTATION OF 0.9% SODIUM CHLORIDE W/V INTRAVENOUS
INFUSION IN ECOFLAC®
PLUS CONTAINERS
Dear Health Care Provider,
The purpose of this letter is to inform you of an additional foreign
product that B. Braun Medical Inc.
(B. Braun) will be providing in the United States (U.S.) to address
the critical drug shortage of 0.9%
Sodium Chloride for Injection. Due to the shortage of 0.9% Sodium
Chloride Injection products in the
U.S., B. Braun is coordinating with the U.S. Food and Drug
Administration (FDA) to temporarily import
foreign Sodium Chloride 0.9% w/v Intravenous Infusion BP in the
Ecoflac® plus container into the U.S.
market. The foreign product is manufactured at an FDA inspected B.
Braun sterile injectable facility in
Melsungen, Germany which is currently in compliance with FDA
regulations.
At this time, FDA is not objecting to the importation and distribution
of Sodium Chloride 0.9% w/v
Intravenous Infusion BP in the Ecoflac® plus container product by B.
Braun to address the critical U.S.
shortage of 0.9% Sodium Chloride Injection. Importation or
distribution of B. Braun’s Sodium Chloride
0.9% w/v Intravenous Infusion BP in the Ecoflac® plus container by
any entity other than B. Braun and
its authorized distributor(s), is not within the scope of this
decision and may be subject to enforcement
action by the FDA. FDA has not approved B. Braun’s Sodium Chloride
0.9% w/v Intravenous Infusion
BP in the Ecoflac® plus container in the United States.
Effective immediately and during this temporary period, B. Braun will
offer the following presentations
of B. Braun’s