SODIUM CHLORIDE- sodium chloride injection, solution

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Hospira, Inc.

Toedieningsweg:

INTRAVENOUS

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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. To Open Tear outer wrap at notch and remove solution container. If supplemental medication is desired, follow directions below before preparing for administration. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. To Add Medication (Use aseptic technique) Preparation for Administration (Use aseptic technique) NOTE: See appropriate IV administration set Instructions for Use. WARNING: Do not use flexible container in series connections.

Product samenvatting:

0.45% Sodium Chloride Injection, USP is supplied in single-dose flexible plastic containers as follows: NDC No. Product Fill Volume/Container size mL 0409-7985-25 0409-7985-30 0409-7985-48 0.45% Sodium Chloride Inj., USP 0.45% Sodium Chloride Inj., USP 0.45% Sodium Chloride Inj., USP 250/250 500/500 1000/1000 Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. Revised: 6/2014                                                                                 EN- 3566 Hospira, Inc., Lake Forest, IL 60045 USA                                                                           

Autorisatie-status:

New Drug Application

Productkenmerken

SODIUM CHLORIDE- SODIUM CHLORIDE INJECTION, SOLUTION
HOSPIRA, INC.
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0.45% SODIUM CHLORIDE INJECTION, USP
_VISIV_
CONTAINER Rx only
DESCRIPTION
0.45% Sodium Chloride Injection, USP is sterile and nonpyrogenic. It
is a parenteral solution containing
sodium chloride in water for injection intended for intravenous
administration.
Each 100 mL of 0.45% Sodium Chloride Injection, USP contains 450 mg
sodium chloride in water for
injection. Electrolytes per 1000 mL: sodium (Na ) 77 mEq; chloride (Cl
) 77 mEq. The osmolarity is
154 mOsmol/L (calc.).
The pH is 5.6 (4.5 to 7.0).
This 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.
0.45% Sodium Chloride Injection, USP 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 designated H O.
The flexible plastic container is fabricated from a clear multilayer
polyolefin plastic film. 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, these solutions provide 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.
Isotonic concentrations of sodium chloride are suitable for parenteral
replacement of chloride losses
that exceed or equal the sodium loss. Hypotonic concentrations of
sodium chloride are suited for
parenteral maintenance of water requirements when only small
quantities of salt are desired. A
hypertonic concentration of sodium chloride may