PHYSIOSOL- sodium chloride, sodium acetate anhydrous, sodium gluconate, potassium chloride, and magnesium chloride irrigant

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Nopērc to tagad

Lejuplādēt Produkta apraksts (SPC)
14-02-2011

Aktīvā sastāvdaļa:

SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698), SODIUM ACETATE ANHYDROUS (UNII: NVG71ZZ7P0) (SODIUM CATION - UNII:LYR4M0NH37), SODIUM GLUCONATE (UNII: R6Q3791S76) (SODIUM CATION - UNII:LYR4M0NH37), POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698), MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698)

Pieejams no:

Hospira, Inc.

SNN (starptautisko nepatentēto nosaukumu):

SODIUM CHLORIDE

Kompozīcija:

SODIUM CHLORIDE 526 mg in 100 mL

Ievadīšanas:

IRRIGATION

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

PhysioSol™ is indicated for all general irrigation, washing and rinsing purposes which permit use of a sterile, nonpyrogenic electrolyte solution. NOT FOR INJECTION BY USUAL PARENTERAL ROUTES. An electrolyte solution should not be used for irrigation during electrosurgical procedures.

Produktu pārskats:

PhysioSolTM Irrigation is supplied in a 1000 mL single-dose semi-rigid irrigation container. (NDC No. 0409-6141-09) Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. Revised: May, 2010                                                                                                                             Printed in USA                           EN-2512 Hospira, Inc., Lake Forest, IL 60045 USA

Autorizācija statuss:

New Drug Application

Produkta apraksts

                                PHYSIOSOL- SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM
GLUCONATE, POTASSIUM
CHLORIDE, AND MAGNESIUM CHLORIDE IRRIGANT
HOSPIRA, INC.
----------
PHYSIOSOL IRRIGATION
Balanced Electrolyte Solution for Irrigation
For All General Irrigation, Washing and Rinsing Purposes
NOT FOR INJECTION BY USUAL PARENTERAL ROUTES
SEMI-RIGID IRRIGATION CONTAINER
Rx only
DESCRIPTION
PhysioSol™ is a sterile, nonpyrogenic solution of electrolytes in
water for injection intended only for
sterile irrigation, washing and rinsing purposes.
Each 100 mL of PhysioSol™ Irrigation contains sodium chloride 526
mg, sodium acetate 222 mg,
sodium gluconate 502 mg, potassium chloride 37 mg, magnesium chloride
hexahydrate 30 mg. The pH
is 6.0 (5.0 to 6.5) adjusted with hydrochloric acid. The solution is
isotonic (294 mOsmol/liter, calc.)
and has the following electrolyte content (mEq/liter): Na 140, K 5, Mg
3, Cl
98, HCO 50
alternates (27 as acetate and 23 as gluconate).
It contains no bacteriostat, antimicrobial agent or added buffer
(except for pH adjustment) and is intended
only for use as single-dose or short procedure irrigation. When
smaller volumes are required the
unused portion should be discarded.
PhysioSol
may be classified as a sterile irrigant, wash, rinse and
pharmaceutical vehicle.
Magnesium Chloride, USP is chemically designated magnesium chloride
hexahydrate (MgCl
• 6H O),
colorless, odorless flakes or crystals very soluble in water.
Potassium Chloride, USP is chemically designated KCl, a white granular
powder freely soluble in
water.
Sodium Chloride, USP is chemically designated NaCl, a white
crystalline powder freely soluble in
water.
Sodium Acetate, USP is chemically designated sodium acetate (C H O
Na), colorless crystals or white
crystalline powder or flakes very soluble in water. It has the
following structural formula:
TM
+
+
++
−
3
−
™
2
2
2
3
2
Sodium gluconate is chemically designated C H NaO , the normal sodium
salt of gluconic acid
soluble in water. It has the following structural formula:
Water for Inject
                                
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