Kraj: Kanada
Język: angielski
Źródło: Health Canada
KETAMINE (KETAMINE HYDROCHLORIDE)
BAXTER CORPORATION
N01AX03
KETAMINE
50MG
SOLUTION
KETAMINE (KETAMINE HYDROCHLORIDE) 50MG
INTRAVENOUS
100
Narcotic (CDSA I)
Active ingredient group (AIG) number: 0131360003; AHFS:
APPROVED
2022-03-08
KETAMINE INJECTION, BP (ketamine hydrochloride) Product Monograph Page 1 of 16 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 BAXTER CORPORATION Date of Revision: 7125 Mississauga Road March 4, 2022 Mississauga, ON L5N 0C2 Submission Control No. 242642 KETAMINE INJECTION, BP (ketamine hydrochloride) Product Monograph Page 2 of 16 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 p Przeczytaj cały dokument