LACTATED RINGERS AND DEXTROSE- sodium chloride, sodium lactate, potassium chloride, calcium chloride, and dextrose monohydrate i

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698), SODIUM LACTATE (UNII: TU7HW0W0QT) (SODIUM CATION - UNII:LYR4M0NH37, LACTIC ACID, UNSPECIFIED FORM - UNII:33X04XA5AT), POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698), CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698), DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0

Disponible depuis:

Hospira, Inc.

DCI (Dénomination commune internationale):

SODIUM CHLORIDE

Composition:

SODIUM CHLORIDE 600 mg in 100 mL

Mode d'administration:

INTRAVENOUS

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

These solutions are indicated for parenteral replacement of extracellular losses of fluid and electrolytes, with or without minimal carbohydrate calories, as required by the clinical condition of the patient. Solutions containing lactate are NOT FOR USE IN THE TREATMENT OF LACTIC ACIDOSIS. 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   - Prepare additive port. - Using aseptic technique and an additive delivery needle of appropriate length, puncture resealable additive port at target area, inner diaphragm and inject. Withdraw needle after injecting medication. - The additive port may be protected by covering with an additive cap. - Mix container contents thoroughly.

Descriptif du produit:

These solutions are supplied in single-dose flexible plastic containers as follows: 0409-7953-02 Lactated Ringer's Inj., USP 250 Lactated Ringer's Inj., USP Lactated Ringer's Inj., USP 0409-7929-03 Lactated Ringer's and 5% Dextrose Inj., USP 500 Lactated Ringer's and 5% Dextrose Inj., USP Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. Revised: July, 2009   Printed in USA                            EN-2203 Hospira, Inc., Lake Forest, IL 60045 USA

Statut de autorisation:

New Drug Application

Résumé des caractéristiques du produit

LACTATED RINGERS AND DEXTROSE- SODIUM CHLORIDE, SODIUM LACTATE,
POTASSIUM
CHLORIDE, CALCIUM CHLORIDE, AND DEXTROSE MONOHYDRATE INJECTION,
SOLUTION
LACTATED RINGERS- SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE,
AND CALCIUM
CHLORIDE INJECTION, SOLUTION
HOSPIRA, INC.
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LACTATED RINGER'S INJECTION, USP
LACTATED RINGER'S AND 5% DEXTROSE INJECTION, USP
FLEXIBLE PLASTIC CONTAINER
R only
DESCRIPTION
These products are sterile, nonpyrogenic solutions each containing
isotonic concentrations of
electrolytes (with or without dextrose) in water for injection. The
solutions containing dextrose and
electrolytes are hypertonic; those containing only electrolytes are
isotonic. They are administered by
intravenous infusion for parenteral replacement of extracellular
losses of fluid and electrolytes, with or
without minimal carbohydrate calories.
Each 100 mL of Lactated Ringer's Injection, USP contains sodium
chloride 600 mg, sodium lactate,
anhydrous 310 mg, potassium chloride 30 mg and calcium chloride,
dihydrate 20 mg. May contain
hydrochloric acid and/or sodium hydroxide for pH adjustment. A liter
provides 9 calories (from
lactate), sodium (Na ), 130 mEq, potassium (K ) 4 mEq, calcium (Ca
) 3 mEq, chloride (Cl
) 109 mEq
and lactate [CH CH(OH) COO ] 28 mEq. The electrolyte content is
isotonic (273 mOsmol/liter, calc.)
in relation to the extracellular fluid (approx. 280 mOsmol/liter). The
pH of the solution is 6.6 (6.0 −
7.5).
Each 100 mL of Lactated Ringer's and 5% Dextrose Injection, USP
contains dextrose, hydrous 5 g
plus the same ingredients and mEq values as Lactated Ringer's
Injection, USP (contains only
hydrochloric acid for pH adjustment). A liter provides 179 calories
(from dextrose and lactate) and has
a hypertonic osmolar concentration of 525 mOsmol (calc.). The pH is
4.9 (4.0 − 6.5).
The solutions contain no bacteriostat, antimicrobial agent or added
buffer (except for pH adjustment)
and each is intended only for use as a single-dose injection. When
smaller doses are required the
unused portion sh