Country: Kanada
Bahasa: Inggeris
Sumber: Health Canada
KETAMINE (KETAMINE HYDROCHLORIDE)
STERIMAX INC
N01AX03
KETAMINE
500MG
SOLUTION
KETAMINE (KETAMINE HYDROCHLORIDE) 500MG
INTRAMUSCULAR
100
Narcotic (CDSA I)
MISCELLANEOUS GENERAL ANESTHETICS
Active ingredient group (AIG) number: 0131360003; AHFS:
APPROVED
2017-12-21
PRESCRIBING INFORMATION N KETAMINE HYDROCHLORIDE INJECTION USP 50 mg/mL Sterile Solution Parenteral General Anesthetic SteriMax Inc. Date of Revision: 2770 Portland Drive September 27, 2021 Oakville, ON Canada, L6H 6R4 Control No. 255551 _Ketamine Hydrochloride Injection USP _ _ _ _Page 2 of 14 _ NAME OF DRUG N KETAMINE HYDROCHLORIDE INJECTION USP 50 mg/mL PHARMACOLOGICAL CLASSIFICATION Parenteral General Anesthetic STRUCTURAL FORMULA AND CHEMISTRY MOLECULAR FORMULA: C 13 H 16 ClNO · HCl MOLECULAR MASS: 274.19 g/mol Ketamine Hydrochloride Injection USP,(±)-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 concentration containing the equivalent of 50 mg ketamine base per mL and contains 0.01% benzethonium chloride as a preservative. ACTION Ketamine Hydrochloride Injection USP 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 Hydrochloride Injection USP has been termed “dissociative anesthesia” in that it appears to selectively interrupt association pathways of the brain before producing somesthetic sensory blockage. Ketamine Hydrochloride Injection USP decreases the activity of the neocortex and subcortical structures (thalamus) and increases the activity in the limbic system and reticular substance. _Ketamine Hydrochloride Injection USP _ _ _ _Page 3 of 14 _ Following administration of recommended doses of Ketamine Hydrochloride Injection USP, blood pressure and pulse rate are usually moderately and temporarily increased. In 12,283 pro Baca dokumen lengkap