SODIUM CHLORIDE injection, solution

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Hospira, Inc.

INN (nemzetközi neve):

SODIUM CHLORIDE

Összetétel:

SODIUM CHLORIDE 900 mg in 100 mL

Az alkalmazás módja:

INTRAVENOUS

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Intravenous solutions containing sodium chloride are indicated for parenteral replenishment of fluid and sodium chloride as required by the clinical condition of the patient. In this dosage form, Sodium Chloride Injection, USP is intended to be used as a diluent for the contents of an ADD-Vantage vial, or single-dose vials with 20 mm closure using the ADD-Vantage ADDAPTOR™. None known.

Termék összefoglaló:

Unit of Sale Concentration Each NDC 0409-7132-66 Case of 50 0.45% NDC 0409-7132-68 50 mL bags NDC 0409-7132-67 Case of 50 0.45% NDC 0409-7132-69 100 mL bags NDC 0409-7132-02 Case of 24 0.45% NDC 0409-7132-04 250 mL bags NDC 0409-7101-66 Case of 50 0.9% NDC 0409-7101-68 50 mL bags NDC 0409-7101-67 Case of 50 0.9% NDC 0409-7101-69 100 mL bags NDC 0409-7101-02 Case of 24 0.9% NDC 0409-7101-04 250 mL bags Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. INSTRUCTIONS FOR USE WITH ADD-VANTAGE VIAL These instructions for use should be made available to the individuals who perform the reconstitution steps. To Open: Peel overwrap at corner and remove solution container. Use unit within 30 days of opening overwrap, as long as the use date does not exceed the printed expiration date. 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 Assemble Vial and Flexible Diluent Container: (Use Aseptic Technique)                                                                                                                                        Fig. 1                                                     Fig. 2                                                                                                                                    Fig. 3                                                          Fig. 4 To Reconstitute the Drug: If the rubber stopper is not removed from the vial and medication is not released on the first attempt, the inner cap may be manipulated back into the rubber stopper without removing the drug vial from the diluent container. Repeat steps 3 through 5.                                                                                                        Fig. 5                                             Fig. 6                                                 Fig. 7                  Preparation for Administration: (Use Aseptic Technique) WARNING: Do not use flexible container in series connections. INSTRUCTIONS FOR USE WITH ADD-VANTAGE ADDAPTOR ™ The instructions for use provided with the ADD-Vantage ADDAPTOR™ should be made available to the individuals who perform the reconstitution steps. Distributed by Hospira, Inc., Lake Forest, IL 60045 USA                                                                              LAB-1103-2.0 Revised: 11/2018

Engedélyezési státusz:

New Drug Application

Termékjellemzők

SODIUM CHLORIDE- SODIUM CHLORIDE INJECTION, SOLUTION
HOSPIRA, INC.
----------
SODIUM CHLORIDE
INJECTION,
USP Rx
only
ADD-Vantage™ Diluent
Flexible Plastic Container
_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 after admixing with
an ADD-Vantage
vial, or single-dose powdered drug vials with 20 mm closure using the
ADD-Vantage
ADDAPTOR™ (WARNING: DO NOT USE WITH CHEMOTHERAPY AGENTS).
Each 100 mL of 0.45% Sodium Chloride Injection, USP 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.), which is hypotonic.
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.), which is isotonic.
The pH for both concentrations is 5.6 (4.5 to 7.0).
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