국가: 캐나다
언어: 영어
출처: Health Canada
MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE)
MYLAN PHARMACEUTICALS ULC
N05CD08
MIDAZOLAM
1MG
SOLUTION
MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) 1MG
INTRAMUSCULAR
1/2/5/10ML
Targeted (CDSA IV)
BENZODIAZEPINES
Active ingredient group (AIG) number: 0119935002; AHFS:
CANCELLED PRE MARKET
2017-05-09
_Page 1 of 49 _ PRODUCT MONOGRAPH PR MIDAZOLAM INJECTION 1 MG/ML AND 5 MG/ML BENZODIAZEPINE PREMEDICANT/SEDATIVE/ANESTHETIC AGENT MYLAN PHARMACEUTICALS ULC DATE OF PREPARATION: JULY 16, 2014 85 ADVANCE ROAD ETOBICOKE, ON M8Z 2S6 SUBMISSION CONTROL NO: 175409 _Page 2 of 49 _ PRODUCT MONOGRAPH Pr Midazolam Injection 1 mg/mL and 5 mg/mL THERAPEUTIC CLASSIFICATION Benzodiazepine Premedicant/Sedative/Anesthetic Agent GENERAL ADULT AND PEDIATRIC Intravenous Midazolam Injection has been associated with respiratory depression and respiratory arrest, especially when used for sedation in noncritical care settings. In some cases, where this was not recognized promptly and treated effectively, death or hypoxic encephalopathy has resulted. Intravenous midazolam should be used only in hospital or ambulatory care settings, that provide for continuous monitoring of respiratory and cardiac function, i.e., pulse oximetry. Immediate availability of resuscitative drugs and age- and size-appropriate equipment for bag/valve/mask ventilation and intubation, and personnel trained in their use and skilled in airway management should be assured (see WARNINGS). For deeply sedated patients, a dedicated individual, other than the practitioner performing the procedure, should monitor the patient throughout the procedure. The initial intravenous dose for sedation in adult patients may be as little as 1 mg, but should not exceed 2.5 mg in a normal healthy adult. Lower doses are necessary for older (over 60 years) or debilitated patients and in patients receiving concomitant narcotics or other central nervous system depressants. The initial dose and all subsequent doses should always be titrated slowly; administered over 2-3 minutes and allow about 2 minutes to fully evaluate the sedative effect. The use of the 1 mg/mL formulation or dilution of the 1 mg/mL or 5 mg/mL formulation is recommended to facilitate slower injection. Doses of sedative medications in pediatric patients _Page 3 of 49 _ must be calculated on a mg/kg basis, and initial dose 전체 문서 읽기