SODIUM CHLORIDE injection, solution

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Vedd Meg Most

Letöltés Termékjellemzők (SPC)
08-10-2019

Aktív összetevők:

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

Beszerezhető a:

Fresenius Kabi USA, LLC

Az alkalmazás módja:

INTRAVENOUS

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Sodium Chloride Injection, USP is indicated for parenteral restoration of sodium ion in patients with restricted oral intake.  Sodium replacement is specifically indicated in patients with hyponatremia or low salt syndrome.  Sodium chloride injection may also be added to compatible carbohydrate solutions such as dextrose in water to provide electrolytes. Sodium chloride injection is contraindicated in patients with hypernatremia or fluid retention.

Termék összefoglaló:

Sodium Chloride Injection, USP is available in flip-top glass vials. Product  No. NDC No. % NaCl Na + mEq/mL Cl - mEq/mL mOsmol/ mL Fill Volume mL 13920 63323-139-20   14.6      2.5             2.5 5 20 13940 63323-139-40 14.6 2.5 2.5 5 40 These vials are Single Dose Vials; packaged 25 vials per tray. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].  Do not permit to freeze.

Engedélyezési státusz:

unapproved drug other

Termékjellemzők

                                SODIUM CHLORIDE- SODIUM CHLORIDE INJECTION, SOLUTION
FRESENIUS KABI USA, LLC
_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 INJECTION USP
14.6% (2.5 mEq/mL)
CONCENTRATED SOLUTIONS FOR USE ONLY AFTER DILUTION WITH COMPATIBLE
IV FLUIDS TO CORRECT SODIUM DEFICIENCY WHEN ORAL REPLACEMENT IS NOT
FEASIBLE.
DESCRIPTION
Sodium Chloride Injection, USP is a sterile, nonpyrogenic,
concentrated solution for intravenous
administration ONLY AFTER DILUTION to replenish electrolytes. The
preparation contains 2.5
mEq/mL (14.6%) sodium chloride, in Water for Injection. The solution
contains no bacteriostat,
antimicrobial agent or added buffer; pH of the solution ranges from
4.5 to 7.0. Each mL contains:
Sodium chloride 146 mg; Water for Injection q.s. pH may have been
adjusted with hydrochloric acid.
The osmolar concentration of the 2.5 mEq/mL solution is 5 mOsmol/mL.
Sodium chloride is chemically
designated NaCI, a white crystalline compound freely soluble in water.
CLINICAL PHARMACOLOGY
Sodium chloride in water dissociates to provide sodium (Na
) and chloride (CI
) ions. These ions
are normal constituents of the body fluids (principally extracellular)
and are essential for maintaining
electrolyte balance.
Sodium is the principal cation of extracellular fluid. It comprises
more than 90% of the total cations at
its normal plasma concentration of approximately 142 mEq/L. While the
sodium ion can diffuse across
cell membranes, intracellular sodium is maintained at a much lower
concentration than extracellular
sodium through the expenditure of energy by the cell (so-called
‘‘sodium cation pump’’). Loss of
intracellular potassium ion is usually accompanied by an increase in
intracellular sodium ion.
When serum sodium concentration is low, the secretion of antidiuretic
hormone (ADH) by the pituitary
is inhibited, thereby preventing water reabsorption by the distal

                                
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