KETAMINE HYDROCHLORIDE INJECTION SDZ SOLUTION

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

KETAMINE (KETAMINE HYDROCHLORIDE)

Dostupné z:

SANDOZ CANADA INCORPORATED

ATC kód:

N01AX03

INN (Medzinárodný Name):

KETAMINE

Dávkovanie:

10MG

Forma lieku:

SOLUTION

Zloženie:

KETAMINE (KETAMINE HYDROCHLORIDE) 10MG

Spôsob podávania:

INTRAMUSCULAR

Počet v balení:

100

Typ predpisu:

Narcotic (CDSA I)

Terapeutické oblasti:

MISCELLANEOUS GENERAL ANESTHETICS

Prehľad produktov:

Active ingredient group (AIG) number: 0131360002; AHFS:

Stav Autorizácia:

CANCELLED PRE MARKET

Dátum Autorizácia:

2017-08-21

Súhrn charakteristických

_Ketamine Hydrochloride Injection USP &_ _Ketamine Hydrochloride
Injection SDZ _
_Page 1 of 17 _
PRODUCT MONOGRAPH
N
KETAMINE HYDROCHLORIDE INJECTION USP
(KETAMINE HYDROCHLORIDE)
10 MG/ML
50 MG/ML
N
KETAMINE HYDROCHLORIDE INJECTION SDZ
10 MG/ML KETAMINE (AS KETAMINE HYDROCHLORIDE)
50 MG/ML KETAMINE (AS KETAMINE HYDROCHLORIDE)
MANUFACTURER’S STANDARD
PARENTERAL GENERAL ANESTHETIC
Sandoz Canada Inc.
Date of revision: May 6, 2015
145 Jules-Léger Street
QC, Canada
J4B 7K8
Submission Control No.: 183296
_Ketamine Hydrochloride Injection USP &_ _Ketamine Hydrochloride
Injection SDZ _
_Page 2 of 17 _
N
KETAMINE HYDROCHLORIDE INJECTION USP
Ketamine hydrochloride
10 mg/mL
50 mg/mL
N
KETAMINE HYDROCHLORIDE INJECTION SDZ
10 mg/mL ketamine (as ketamine hydrochloride)
50 mg/mL ketamine (as ketamine hydrochloride)
THERAPEUTIC CLASSIFICATION
Parenteral General Anesthetic
ACTION AND CLINICAL PHARMACOLOGY
Ketamine hydrochloride is a rapid-acting, nonbarbiturate 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 has been
termed "dissociative
anesthesia" in that it appears to selectively interrupt association
pathways of the brain before
producing somesthetic sensory blockage. Ketamine hydrochloride
decreases the activity of the
neocortex and subcortical structures (thalamus) and increases the
activity in the limbic system
and reticular substance.
Following administration of recommended doses of ketamine
hydrochloride, blood pressure and
pulse rate are usually moderately and temporarily increased. In 12,283
procedures, the median
systolic rise was 24% and the median diastolic rise was 22%.
Respiration is usually unaffected. Mild stimulation occasionally
occurs. However, transient
respiratory depression (rate and tidal volume) may occur and is
generally associated with rapid
(le