KETAMINE HYDROCHLORIDE INJECTION SDZ SOLUTION

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

KETAMINE (KETAMINE HYDROCHLORIDE)

Dostopno od:

SANDOZ CANADA INCORPORATED

Koda artikla:

N01AX03

INN (mednarodno ime):

KETAMINE

Odmerek:

50MG

Farmacevtska oblika:

SOLUTION

Sestava:

KETAMINE (KETAMINE HYDROCHLORIDE) 50MG

Pot uporabe:

INTRAMUSCULAR

Enote v paketu:

100

Tip zastaranja:

Narcotic (CDSA I)

Terapevtsko območje:

MISCELLANEOUS GENERAL ANESTHETICS

Povzetek izdelek:

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

Status dovoljenje:

CANCELLED PRE MARKET

Datum dovoljenje:

2017-08-21

Lastnosti izdelka

_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