KETAMINE HYDROCHLORIDE INJECTION USP SOLUTION

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

KETAMINE (KETAMINE HYDROCHLORIDE)

זמין מ:

STERIMAX INC

קוד ATC:

N01AX03

INN (שם בינלאומי):

KETAMINE

כמות:

500MG

טופס פרצבטיות:

SOLUTION

הרכב:

KETAMINE (KETAMINE HYDROCHLORIDE) 500MG

מסלול נתינה (של תרופות):

INTRAMUSCULAR

יחידות באריזה:

100

סוג מרשם:

Narcotic (CDSA I)

איזור תרפויטי:

MISCELLANEOUS GENERAL ANESTHETICS

leaflet_short:

Active ingredient group (AIG) number: 0131360003; AHFS:

מצב אישור:

APPROVED

תאריך אישור:

2017-12-21

מאפייני מוצר

PRESCRIBING INFORMATION
N
KETAMINE HYDROCHLORIDE INJECTION USP
50 mg/mL
Sterile Solution
Parenteral General Anesthetic
SteriMax Inc.
Date of Revision:
2770 Portland Drive
September 27, 2021
Oakville, ON
Canada, L6H 6R4
Control No. 255551
_Ketamine Hydrochloride Injection USP _
_ _
_Page 2 of 14 _
NAME OF DRUG
N
KETAMINE HYDROCHLORIDE INJECTION USP
50 mg/mL
PHARMACOLOGICAL CLASSIFICATION
Parenteral General Anesthetic
STRUCTURAL FORMULA AND CHEMISTRY
MOLECULAR FORMULA: C
13
H
16
ClNO · HCl
MOLECULAR MASS: 274.19 g/mol
Ketamine
Hydrochloride
Injection
USP,(±)-2-(o-Chlorophenyl)-2-(methylamino)cyclohexanone
hydrochloride, is a white crystalline compound, soluble in water to
20% clear and colorless solution.
Aqueous solutions in use have pH range from 3.5 to 5.5. The base
component is 86.7% of the salt. It is
supplied as a slightly
acidic (pH 3.5 - 5.5) solution for intravenous or intramuscular
injection in
concentration containing the equivalent of 50 mg ketamine base per mL
and contains 0.01% benzethonium
chloride as a preservative.
ACTION
Ketamine Hydrochloride Injection USP is a rapid-acting,
non-barbiturate general anesthetic. It produces an
anesthetic state characterized by profound analgesia, normal
pharyngeal-laryngeal reflexes and normal or
slightly enhanced skeletal muscle tone. Mild cardiac stimulation and
occasionally respiratory depression
occur.
The anesthetic state produced by Ketamine Hydrochloride Injection USP
has been termed “dissociative
anesthesia” in that it appears to selectively interrupt association
pathways of the brain before producing
somesthetic sensory blockage. Ketamine
Hydrochloride Injection USP decreases the activity of the
neocortex and subcortical structures (thalamus) and increases the
activity in the limbic system and reticular
substance.
_Ketamine Hydrochloride Injection USP _
_ _
_Page 3 of 14 _
Following administration of recommended doses of Ketamine
Hydrochloride Injection USP, blood pressure
and pulse rate are usually moderately and temporarily increased. In
12,283 pro