Krajina: Kanada
Jazyk: angličtina
Zdroj: Health Canada
KETAMINE (KETAMINE HYDROCHLORIDE)
SANDOZ CANADA INCORPORATED
N01AX03
KETAMINE
50MG
SOLUTION
KETAMINE (KETAMINE HYDROCHLORIDE) 50MG
INTRAMUSCULAR
10ML
Narcotic (CDSA I)
MISCELLANEOUS GENERAL ANESTHETICS
Active ingredient group (AIG) number: 0131360003; AHFS:
APPROVED
2005-08-12
_Ketamine Hydrochloride Injection USP _ _Page 1 of 17 _ PRODUCT MONOGRAPH N KETAMINE HYDROCHLORIDE INJECTION USP (KETAMINE HYDROCHLORIDE) 10 MG/ML 50 MG/ML PARENTERAL GENERAL ANESTHETIC Sandoz Canada Inc. Date of revision: February 11, 2021 110 Rue de Lauzon QC, Canada J4B 1E6 Submission Control No.: 247495 _Ketamine Hydrochloride Injection USP _ _Page 2 of 17 _ N KETAMINE HYDROCHLORIDE INJECTION USP Ketamine hydrochloride 10 mg/mL 50 mg/mL 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 (less than 60 seconds) intravenous administration. Blood gas tensions (PO 2 and PCO 2 ) are relatively unaffected. A patent airway is maintained partly by virtue of unimpaired pharyngeal and laryngeal reflexes. Ketamine undergoes N-demethylation and hydroxylation of the cyclohexanone ring, with the formation of water-soluble conjugates which are excreted in the urine. Fu Prečítajte si celý dokument