KETALAR SOLUTION

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

KETAMINE (KETAMINE HYDROCHLORIDE)

Disponible des:

SEARCHLIGHT PHARMA INC

Codi ATC:

N01AX03

Designació comuna internacional (DCI):

KETAMINE

Dosis:

50MG

formulario farmacéutico:

SOLUTION

Composición:

KETAMINE (KETAMINE HYDROCHLORIDE) 50MG

Vía de administración:

INTRAMUSCULAR

Unidades en paquete:

15G/50G

tipo de receta:

Narcotic (CDSA I)

Área terapéutica:

MISCELLANEOUS GENERAL ANESTHETICS

Resumen del producto:

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

Estat d'Autorització:

APPROVED

Data d'autorització:

2001-01-05

Fitxa tècnica

500 MG/10 ML
200 MG/20 ML
PRODUCT MONOGRAPH
N
KETALAR
®
KETAMINE HYDROCHLORIDE INJECTION, U.S.P.
10 ML VIAL
20 ML VIAL
50 MG/ML
10 MG/ML
PARENTERAL GENERAL ANESTHETIC
Searchlight Pharma Inc.
1600 Notre-Dame West, suite 312
Montreal, QC
H3J 1M1
Date of Preparation:
MAY 24, 2023
Submission Control No.: 274911
2
500 MG/10 ML
200 MG/20 ML
NAME OF DRUG
N
KETALAR
®
KETAMINE HYDROCHLORIDE INJECTION, U.S.P.
10 ML VIAL
20 ML VIAL
50 MG/ML
10 MG/ML
PHARMACOLOGICAL CLASSIFICATION
Parenteral General Anesthetic
STRUCTURAL FORMULA AND CHEMISTRY
KETALAR, dl 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 concentrations containing the equivalent of either 10 to
50 mg ketamine base per mL and contains 0.01%
Phemerol (benzethonium chloride) as a preservative. The 10 mg per mL
solution has been made isotonic with sodium
chloride.
ACTION
KETALAR 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 KETALAR has been termed
“dissociative anesthesia” in that it appears to selectively
interrupt association pathways of the brain before producing
somesthetic sensory blockage. KETALAR decreases the
activity of the neocortex and subcortical structures (thalamus) and
increases the activity in the limbic system and reticular
substance.
3
Following administration of recommended doses of KETALAR, 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%.
Respiratio