SODIUM CHLORIDE injection, solution

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

Hospira, Inc.

Rotta amministrattiva:

INTRAVENOUS

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

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 Preparation for Administration (Use aseptic technique) WARNING: Do not use flexible container in series connections.

Sommarju tal-prodott:

Sodium Chloride Injection, USP is supplied in single-dose flexible plastic containers in various sizes and concentrations as shown in the accompanying Table. 0409-7730-20 0.45% Sodium Chloride Inj., USP 25 0409-7730-36 0.45% Sodium Chloride Inj., USP 50 0409-7730-37 0.45% Sodium Chloride Inj., USP 100 0409-7985-02 0.45% Sodium Chloride Inj., USP 250 0409-7985-03 0.45% Sodium Chloride Inj., USP 500 0409-7985-09 0.45% Sodium Chloride Inj., USP 1000 0409-7984-20 0.9% Sodium Chloride Inj., USP 25 0409-7984-36 0.9% Sodium Chloride Inj., USP 50 0409-7984-13 0.9% Sodium Chloride Inj., USP 50 0409-7984-37 0.9% Sodium Chloride Inj., USP 100 0409-7984-23 0.9% Sodium Chloride Inj., USP 100 0409-7983-61 0.9% Sodium Chloride Inj., USP 150 0409-7983-02 0.9% Sodium Chloride Inj., USP 250 0409-7983-53 0.9% Sodium Chloride Inj., USP 250 0409-7983-03 0.9% Sodium Chloride Inj., USP 500 0409-7983-55 0.9% Sodium Chloride Inj., USP 500 0409-7983-09 0.9% Sodium Chloride Inj., USP 1000 Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. Revised: 6/2014                                                                                       EN-3569 Hospira, Inc., Lake Forest, IL 60045 USA                                                                             

L-istatus ta 'awtorizzazzjoni:

New Drug Application

Karatteristiċi tal-prodott

SODIUM CHLORIDE- SODIUM CHLORIDE INJECTION, SOLUTION
HOSPIRA, INC.
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SODIUM CHLORIDE INJECTION, USP
FLEXIBLE PLASTIC CONTAINER Rx only
DESCRIPTION
Sodium Chloride Injection, USP solutions are sterile and nonpyrogenic.
They are parenteral solutions
containing various concentrations of sodium chloride in water for
injection intended for intravenous
administration.
For 0.45% Sodium Chloride Injection, USP, each 100 mL contains 450 mg
sodium chloride in water for
injection. Electrolytes per 1000 mL: sodium 77 mEq; chloride 77 mEq.
The osmolarity is 154
mOsmol/L (calc.).
For 0.9% Sodium Chloride Injection, USP, each 100 mL 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 for both concentrations in the 100 mL and smaller containers is
6.0; for the 250 mL and larger
containers, the pH is 5.6. The pH range is 4.5 to 7.0 for all
containers.
The solutions contain no bacteriostat, antimicrobial agent or added
buffer and each is intended only as a
single-dose injection. When smaller doses are required the unused
portion should be discarded.
The solutions are parenteral fluid and electrolyte replenishers.
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 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 l