NEUT SODIUM BICARBONATE- sodium bicarbonate injection, solution

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20)

Disponibil de la:

Cardinal Health

INN (nume internaţional):

SODIUM BICARBONATE

Compoziție:

SODIUM BICARBONATE 0.2 g in 5 mL

Calea de administrare:

INTRAVENOUS

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Neut (4% sodium bicarbonate additive solution) is indicated for use as an additive to raise the pH of acid solutions administered intravenously to reduce the incidence of chemical phlebitis and patient discomfort due to vein irritation at or near the site of infusion. Not for use as a systemic alkalizer. None known.

Rezumat produs:

Neut (4% sodium bicarbonate additive solution) is supplied in partial-fill single-dose containers. 5 mL fliptop vial (List No. 6609). Available overbagged with 5 x 5 mL Single-Dose Vials, NDC 55154-7829-5 Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]   Revised: November, 2004     ©Hospira 2004                                               EN-0545                                                 Printed in USA Repackaged By: Cardinal Health Zanesville, Oh 43701 L51706260216

Statutul autorizaţiei:

unapproved drug other

Caracteristicilor produsului

NEUT SODIUM BICARBONATE- SODIUM BICARBONATE INJECTION, SOLUTION
CARDINAL HEALTH
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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NEUT
_4% SODIUM BICARBONATE ADDITIVE_
_SOLUTION_
TO ADJUST ACIDIC PARENTERAL SOLUTIONS TO A
MORE NEARLY NEUTRAL PH.
FLIPTOP VIAL RX ONLY
(0.2 G IN 5 ML)
DESCRIPTION
Neut (4% sodium bicarbonate additive solution) is a sterile,
nonpyrogenic solution of sodium
bicarbonate in water for injection. It is administered by the
intravenous route only after addition as a
neutralizing agent to an acidic large volume parenteral solution. Each
5 mL contains sodium bicarbonate
0.2 g (2.4 mEq each of Na and HCO ‾ ); edetate disodium, anhydrous
10 mg added as a stabilizer. Total
sodium (Na ) content of each 5 mL is 56.1 mg (11.2 mg/mL).
The solutions contain no bacteriostat, antimicrobial agent or added
buffer; pH 8.0 (7.0 to 8.5).
Sodium Bicarbonate, USP is chemically designated as NaHCO , a white
crystalline powder soluble in
water.
CLINICAL PHARMACOLOGY
The acid pH of most intravenous solutions has been implicated as a
factor in the production of
postinfusion (chemical) phlebitis not caused by obvious infection.
Vein irritation, with local redness and
tenderness near the site of venipuncture or along the course of a
vein, appears to be related to the nature
of the substances in the infusion and the speed (insufficient dilution
by the bloodstream) as well as the
duration (prolonged exposure of the intima) of infusion. Other
contributing factors include the size of
the vein used for venipuncture, shape or method of insertion of the
venipuncture needle, the use or type
of indwelling catheter, infection at the infusion site and the age of
the patient (children and females seem
to be more susceptible).
The pH of commonly used dextrose infusion solutions ranges from 3.5 to
6.5. Other commonly used
solutions also may have an acid pH. Since non-neutral parenter