PRALIDOXIME CHLORIDE- pralidoxime chloride injection

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

Pralidoxime chloride (UNII: 38X7XS076H) (Pralidoxime - UNII:P7MU9UTP52)

Beszerezhető a:

Meridian Medical Technologies, Inc.

INN (nemzetközi neve):

Pralidoxime chloride

Összetétel:

Pralidoxime chloride 600 mg in 2 mL

Az alkalmazás módja:

INTRAMUSCULAR

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

This auto-injector for pralidoxime chloride is specifically indicated for intramuscular use as an adjunct to atropine in the treatment of poisoning by nerve agents having anticholinesterase activity. The pralidoxime chloride auto-injector is contraindicated in patients who are hypersensitive to any component of the product. Pralidoxime chloride is not subject to abuse and possesses no known potential for dependence.

Termék összefoglaló:

Pralidoxime chloride is supplied in aqueous solution prefilled in the auto-injector (600 mg, 2 mL) for military use and for use by qualified civilian emergency responders. Auto-injectors are supplied through the Directorate of Medical Materiel, Defense Supply Center Philadelphia or other analogous local, state or federal agency. When activated, each auto-injector dispenses 600 mg of pralidoxime chloride in 2 mL of a sterile solution containing 20 mg/mL benzyl alcohol, 11.26 mg/mL glycine in Water for Injection, USP. The pH is adjusted with hydrochloric acid. The pH is 2.0-3.0 The product is pyrogen free. Store at 25°C (77°F); Excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature] Keep from freezing. Meridian Medical Technologies, Inc. Columbia, MD 21046 A Pfizer Company 00001976 08/16 Printed in U.S.A.

Engedélyezési státusz:

New Drug Application

Termékjellemzők

PRALIDOXIME CHLORIDE- PRALIDOXIME CHLORIDE INJECTION
MERIDIAN MEDICAL TECHNOLOGIES, INC.
----------
PRALIDOXIME CHLORIDE INJECTION
(AUTO-INJECTOR)
FOR USE IN NERVE AGENT POISONING ONLY
A Sterile Solution For Intramuscular Use Only
RX ONLY
DESCRIPTION
Pralidoxime Chloride Injection (auto-injector) provides pralidoxime
chloride in a sterile solution for
intramuscular injection.
Each prefilled auto-injector provides a dose of the antidote,
pralidoxime chloride in a self-contained
unit, specially designed for automatic self- or buddy-administration
by military personnel. Pralidoxime
in the auto-injector may also be administered by qualified civilian
emergency responders who have had
adequate training in the on-site recognition and treatment of nerve
agent intoxication in the event of an
accidental release of nerve agent. The recommended procedure (see
DOSAGE AND
ADMINISTRATION) is to inject the contents of the auto-injector into
the muscles of an outer thigh.
After an auto-injector has been activated, the empty container should
be disposed of properly (see
DOSAGE AND ADMINISTRATION), it cannot be refilled nor can the
protruding needle be
retracted.
When activated, each auto-injector dispenses 600 mg of pralidoxime
chloride in 2 mL of a sterile
solution containing 20 mg/mL benzyl alcohol, 11.26 mg/mL glycine in
Water for Injection, USP. The pH
is adjusted with hydrochloric acid. The pH range is 2.0-3.0. The
product is pyrogen free.
Pralidoxime chloride is a cholinesterase reactivator.
CHEMICAL NAME: 2-formyl-1 methylpyridinium chloride oxime
(pyridine-2-aldoxime methochloride).
Also referred to as 2-PAM Chloride.
STRUCTURAL FORMULA:
Pralidoxime chloride occurs as an odorless, white, nonhygroscopic,
crystalline powder which is
soluble in water to the extent of 1 g in less than 1 mL. Stable in
air, it melts between 215°C and 225°C,
with decomposition.
The specific activity of the drug resides in the 2-formyl-1
methylpyridinium ion and is independent of
the particular salt employed. The chloride is preferred because of