Država: Kanada
Jezik: angleščina
Source: Health Canada
KETAMINE (KETAMINE HYDROCHLORIDE)
SEARCHLIGHT PHARMA INC
N01AX03
KETAMINE
50MG
SOLUTION
KETAMINE (KETAMINE HYDROCHLORIDE) 50MG
INTRAMUSCULAR
15G/50G
Narcotic (CDSA I)
MISCELLANEOUS GENERAL ANESTHETICS
Active ingredient group (AIG) number: 0131360003; AHFS:
APPROVED
2001-01-05
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 Preberite celoten dokument