SODIUM CHLORIDE injection, solution

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

B. Braun Medical Inc.

INN (Internationale Bezeichnung):

SODIUM CHLORIDE

Zusammensetzung:

SODIUM CHLORIDE 3 g in 100 mL

Verabreichungsweg:

INTRAVENOUS

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

These intravenous solutions are indicated for use in adults and pediatric patients as sources of electrolytes and water for hydration. 3% and 5% Sodium Chloride Injections USP are of particular value in severe salt depletion when rapid electrolyte restoration is of paramount importance. The low salt syndrome may occur in the presence of heart failure, renal impairment, during surgery, and postoperatively. In these conditions, chloride loss frequently exceeds sodium loss. These hypertonic sodium chloride solutions are also indicated for the following clinical conditions. -  Hyponatremia and hypochloremia due to electrolyte and fluid loss replaced with sodium-free fluids. -  Drastic dilution of extracellular body fluid following excessive water intake sometimes resulting from multiple enemas or perfusion of irrigating fluids into open venous sinuses during transurethral prostatic resections. -  Emergency treatment of severe salt depletion due to excess sweating, vomiting, diarrhea and other conditions. 3% and 5

Produktbesonderheiten:

3% and 5% Sodium Chloride Injections USP are supplied sterile and nonpyrogenic in EXCEL® Containers packaged 24 per case. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product. Storage in automated dispensing machines: Brief exposure up to 2 weeks to ultraviolet or fluorescent light does not adversely affect the product labeling legibility; prolonged exposure can cause fading of the red label. Rotate stock frequently.

Berechtigungsstatus:

New Drug Application

Fachinformation

SODIUM CHLORIDE- SODIUM CHLORIDE INJECTION, SOLUTION
B. BRAUN MEDICAL INC.
----------
3% AND 5% SODIUM CHLORIDE
INJECTIONS USP, (HYPERTONIC)
THESE ARE CONCENTRATED SODIUM CHLORIDE SOLUTIONS. INFUSE SLOWLY WITH
CONSTANT OBSERVATION OF PATIENT TO AVOID PULMONARY EDEMA.
DESCRIPTION
Each 100 mL of 3% SODIUM CHLORIDE INJECTION USP contains:
Sodium Chloride USP 3 g; Water for Injection USP qs
pH: 5.8 (4.5–7.0) Calculated Osmolarity: 1030 mOsmol/liter
pH may be adjusted with Hydrochloric Acid NF
Concentration of Electrolytes (mEq/liter): Sodium 513 Chloride 513
Each 100 mL of 5% SODIUM CHLORIDE INJECTION USP contains:
Sodium Chloride USP 5 g; Water for Injection USP qs
pH: 5.8 (4.5–7.0) Calculated Osmolarity: 1710 mOsmol/liter
pH may be adjusted with Hydrochloric Acid NF
Concentration of Electrolytes (mEq/liter): Sodium 856 Chloride 856
3% and 5% Sodium Chloride Injections USP are sterile, nonpyrogenic and
contain no
bacteriostatic or antimicrobial agents.
The formula of the active ingredient is:
INGREDIENT
MOLECULAR FORMULAMOLECULAR WEIGHT
Sodium Chloride USP
NaCl
58.44
Not made with natural rubber latex, PVC or DEHP.
The plastic container is made from a multilayered film specifically
developed for
parenteral drugs. It contains no plasticizers and exhibits virtually
no leachables. The
solution contact layer is a rubberized copolymer of ethylene and
propylene. The
container is nontoxic and biologically inert. The container-solution
unit is a closed system
and is not dependent upon entry of external air during administration.
The container is
overwrapped to provide protection from the physical environment and to
provide an
additional moisture barrier when necessary.
Addition of medication should be accomplished using complete aseptic
technique.
The closure system has two ports; the one for the administration set
has a tamper
evident plastic protector and the other is a medication addition site.
Refer to the
Directions for Use of the container.
CLINICAL PHARMACOLOGY
3% and 5% Sodium Chloride Injections USP provide ele