SODIUM CHLORIDE injection

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Fresenius Medical Care North America

INN (International Name):

SODIUM CHLORIDE

Sammensetning:

SODIUM CHLORIDE 900 mg in 100 mL

Administreringsrute:

INTRAVENOUS

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Intravenous solutions containing sodium chloride are indicated for parenteral replenishment of fluid and sodium chloride as required by the clinical condition of the patient. None known.

Produkt oppsummering:

0.9% Sodium Chloride Injection, USP is supplied in a 1000 mL single-dose flexible plastic container. (US manufactured NDC number 49230-300-10) (Mexico manufactured DNC number 46163-300-10) Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. Fresenius Medical Care North America Waltham, MA  02451 1-800-323-5188 89-900-74 Rev. 03/15

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

SODIUM CHLORIDE- SODIUM CHLORIDE INJECTION
FRESENIUS MEDICAL CARE NORTH AMERICA
----------
0.9% SODIUM CHLORIDE INJECTION, USP
FLEXIBLE PLASTIC CONTAINER
DESCRIPTION
0.9% Sodium Chloride Injection, USP is sterile and nonpyrogenic. It is
a parenteral
solution containing 0.9% sodium chloride in water for injection
intended for intravenous
administration.
Each 100 mL of 0.9% Sodium Chloride Injection, USP contains 900 mg
sodium chloride
in water for injection. Electrolytes per 1000 mL: sodium 154 mEq;
chloride 154 mEq.
The osmolarity is 308 mOsmol/L (calc.).
The pH is 5.6. The pH range is 4.5 - 7.0.
The solution contains no bacteriostat, antimicrobial agent or added
buffer and is
intended only as a single-dose injection. When smaller doses are
required the unused
portion should be discarded.
The solution is a parenteral fluid and electrolyte replenisher.
Sodium Chloride, USP is chemically designated NaCl, a white
crystalline powder freely
soluble in water.
Water for Injection, USP is chemically designed H
O.
The flexible plastic container is fabricated from a specially
formulated polyvinylchloride.
Water can permeate from inside the container into the overwrap but not
in amounts
sufficient to affect the solution significantly. Solutions in contact
with the plastic
container may leach out certain chemical components from the plastic
in very small
amounts; however, biological testing was supportive of the safety of
the plastic
container materials. Exposure to temperatures above 25°C (77°F)
during transport and
storage will lead to minor losses in moisture content. Higher
temperatures lead to
greater losses. It is unlikely that these minor losses will lead to
clinically significant
changes within the expiration period.
CLINICAL PHARMACOLOGY
When administered intravenously, this solution provides a source of
water and
electrolytes.
Solutions which provide combinations of hypotonic or isotonic
concentrations of sodium
chloride are suitable for parenteral maintenance or replacement of
water and electrolyte
requirements.