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:

B. Braun Medical Inc.

Ievadīšanas:

INTRAVENOUS

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

This intravenous solution is indicated for use in adults and pediatric patients as a source of electrolytes and water for hydration. 0.9% Sodium Chloride Injection USP is indicated for extracellular fluid replacement, treatment of metabolic alkalosis in the presence of fluid loss and mild sodium depletion. 0.9% Sodium Chloride Injection USP is also indicated for use as a priming solution in hemodialysis procedures and may be used to initiate and terminate blood transfusions without hemolyzing red blood cells. Sodium Chloride Injection USP is also indicated as a pharmaceutic aid and diluent for the infusion of compatible drug additives. Refer to prescribing information accompanying additive drugs. This solution is contraindicated where the administration of sodium or chloride could be clinically detrimental. Directions for Use of Plastic Container Caution: Do not use plastic container in series connection. To Open Check for minute leaks by squeezing solution container firmly. If leaks are found, discard solut

Produktu pārskats:

Sodium Chloride Injection USP is supplied sterile and nonpyrogenic in Plastic Containers packaged 12 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.

Autorizācija statuss:

New Drug Application

Produkta apraksts

SODIUM CHLORIDE- SODIUM CHLORIDE INJECTION, SOLUTION
B. BRAUN MEDICAL INC.
----------
0.9% SODIUM CHLORIDE INJECTION USP
DESCRIPTION
Each 100 mL of 0.9% SODIUM CHLORIDE INJECTION USP contains:
Sodium Chloride USP 0.9 g; Water for Injection USP qs
pH: 5.6 (4.5-7.0)
Calculated Osmolarity: 308 mOsmol/liter
pH adjusted with Hydrochloric Acid NF
Concentration of Electrolytes (mEq/liter): Sodium 154; Chloride 154
Sodium Chloride Injection USP is sterile, nonpyrogenic, isotonic and
contains no
bacteriostatic or antimicrobial agents.
The formula of the active ingredient is:
INGREDIENT
MOLECULAR FORMULA MOLECULAR WEIGHT
Sodium Chloride USP
NaCl
58.44
Not made with natural rubber latex, PVC, or DEHP.
The plastic container is made from a homogenous blend of polypropylene
and
thermoplastic modifier specifically developed for parenteral drugs.
The container is
nontoxic and biologically inert. The container is a closed system and
is not dependent
upon entry of external air during administration.
Addition of medication should be accomplished using complete aseptic
technique.
The closure system has two ports; one for the administration set and
the other is a
medication addition site. Each port has a tamper evident cover. Refer
to the Directions
for Use of the container.
CLINICAL PHARMACOLOGY
Sodium Chloride Injection USP provides electrolytes and is a source of
water for
hydration. It is capable of inducing diuresis depending on the
clinical condition of the
patient.
Sodium, the major cation of the extracellular fluid, functions
primarily in the control of
water distribution, fluid balance, and osmotic pressure of body
fluids. Sodium is also
associated with chloride and bicarbonate in the regulation of the
acid-base equilibrium of
body fluid.
Chloride, the major extracellular anion, closely follows the
metabolism of sodium, and
changes in the acid-base balance of the body are reflected by changes
in the chloride
concentration.
INDICATIONS AND USAGE
This intravenous solution is indicated for use in adults and pediatric
patients a