NORMOSOL-R- sodium chloride, sodium acetate anhydrous, sodium gluconate, potassium chloride, and magnesium chloride injection, s

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698), SODIUM ACETATE ANHYDROUS (UNII: NVG71ZZ7P0) (SODIUM CATION - UNII:LYR4M0NH37), SODIUM GLUCONATE (UNII: R6Q3791S76) (SODIUM CATION - UNII:LYR4M0NH37), POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698), MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698)

Dostępny od:

ICU Medical Inc.

Droga podania:

INTRAVENOUS

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Normosol-R is indicated for replacement of acute extracellular fluid volume losses in surgery, trauma, burns or shock. Normosol-R also can be used as an adjunct to restore a decrease in circulatory volume in patients with moderate blood loss. Normosol-R is not intended to supplant transfusion of whole blood or packed red cells in the presence of uncontrolled hemorrhage or severe reductions of red cell volume. None known.

Podsumowanie produktu:

Normosol-R (Multiple Electrolytes Injection Type 1, USP) is supplied in single-dose flexible plastic containers. ICU Medical is transitioning NDC codes from the "0409" to a "0990" labeler code. Both NDC codes are expected to be in the market for a period of time. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. Revised: October, 2018 EN-4693 ICU Medical, Inc., Lake Forest, IL Illinois, 60045, USA

Status autoryzacji:

New Drug Application

Charakterystyka produktu

NORMOSOL-R- SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM
GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE INJECTION,
SOLUTION
ICU MEDICAL INC.
----------
NORMOSOL -R
_MULTIPLE ELECTROLYTES INJECTION TYPE 1, USP_
FOR REPLACING ACUTE LOSSES OF EXTRACELLULAR FLUID
FLEXIBLE PLASTIC CONTAINER
R only
DESCRIPTION
Normosol-R is a sterile, nonpyrogenic isotonic solution of balanced
electrolytes in water
for injection. The solution is administered by intravenous infusion
for parenteral
replacement of acute losses of extracellular fluid.
Each 100 mL of Normosol-R contains sodium chloride, 526 mg; sodium
acetate, 222
mg; sodium gluconate, 502 mg; potassium chloride, 37 mg; magnesium
chloride
hexahydrate, 30 mg. May contain HCl and/or NaOH for pH adjustment. pH
6.6 (4.0 to
8.0); 294 mOsmol/liter (calc.).
Electrolytes per 1000 mL (not including pH adjustment): Sodium 140
mEq; potassium 5
mEq; magnesium 3 mEq; chloride 98 mEq; acetate 27 mEq; gluconate 23
mEq.
The solution contains no bacteriostat, antimicrobial agent or added
buffer (except for pH
adjustment) and is intended only for use as a single-dose injection.
When smaller doses
are required the unused portion should be discarded.
Normosol-R is a parenteral fluid and electrolyte replenisher.
Sodium Chloride, USP is chemically designated NaCl, a white
crystalline powder freely
soluble in water.
Potassium Chloride, USP is chemically designated KCl, a white granular
powder freely
soluble in water.
Magnesium Chloride, USP is chemically designated magnesium chloride
hexahydrate
(MgCl
• 6H O) deliquescent crystals very soluble in water.
Sodium Acetate, USP, is chemically designated sodium acetate anhydrous
(C H NaO ), a
hygroscopic powder soluble in water. It has the following structural
formula:
®
x
2
2
2
3
2
Sodium gluconate is chemically designated C H
NaO , the normal sodium salt of
gluconic acid soluble in water. It has the following structural
formula:
Water for Injection, USP is chemically designated H O.
The flexible plastic container is fabricated from a s