KETAMINE INJECTION, BP SOLUTION

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

KETAMINE (KETAMINE HYDROCHLORIDE)

Fáanlegur frá:

STERIMAX INC

ATC númer:

N01AX03

INN (Alþjóðlegt nafn):

KETAMINE

Skammtar:

50MG

Lyfjaform:

SOLUTION

Samsetning:

KETAMINE (KETAMINE HYDROCHLORIDE) 50MG

Stjórnsýsluleið:

INTRAMUSCULAR

Einingar í pakka:

15G/50G

Gerð lyfseðils:

Narcotic (CDSA I)

Vörulýsing:

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

Leyfisstaða:

APPROVED

Leyfisdagur:

2023-02-21

Vara einkenni

KETAMINE INJECTION, BP (ketamine hydrochloride) Product Monograph
Page 1 of 15
PRODUCT MONOGRAPH
N
KETAMINE INJECTION, BP
50 mg / mL Ketamine (as Ketamine hydrochloride)
2 mL (100 mg / 2 mL) and 10 mL (500 mg / 10 mL) vials
Sterile solution for intravenous or intramuscular administration
Parenteral General Anesthetic
SteriMax Inc.
Date of Preparation:
2770 Portland Drive
FEB 20, 2023
Oakville, Ontario
L6H 6R4
Submission Control No. 271307
KETAMINE INJECTION, BP (ketamine hydrochloride) Product Monograph
Page 2 of 15
NAME OF DRUG
N
KETAMINE INJECTION, BP
50 mg / mL Ketamine (as Ketamine hydrochloride)
2 mL (100 mg / 2 mL) and 10 mL (500 mg / 10 mL) vials
PHARMACOLOGICAL CLASSIFICATION
Parenteral General Anesthetic
ACTION AND CLINICAL PHARMACOLOGY
Ketamine Injection, BP (ketamine hydrochloride) 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 has been termed
“dissociative anesthesia” in that it appears to
selectively interrupt association pathways of the brain before
producing somesthetic sensory blockage.
ketamine 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 Injection,
BP, 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 (less than 60 seconds)
intravenous administration. Blood gas tensions (PO
2
and PCO
2
) are relatively unaffected.
A patent airway is maintained part