מדינה: קנדה
שפה: אנגלית
מקור: Health Canada
MIVACURIUM (MIVACURIUM CHLORIDE)
ABBVIE CORPORATION
M03AC10
MIVACURIUM CHLORIDE
2MG
LIQUID
MIVACURIUM (MIVACURIUM CHLORIDE) 2MG
INTRAVENOUS
10/20ML
Prescription
MISCELLANEOUS SKELETAL MUSCLE RELAXANTS
Active ingredient group (AIG) number: 0139961001; AHFS:
CANCELLED POST MARKET
2012-11-03
PRODUCT MONOGRAPH PR MIVACRON ® (Mivacurium Chloride) 2 mg/mL Injection _Nondepolarising Skeletal Neuromuscular Blocking Agent_ AbbVie Corporation DATE OF PREPARATION: 8401 Trans Canada Highway November 1, 2012 St-Laurent (QC) CANADA H4S 1Z1 DATE OF LATEST REVISION: DATE OF REVISION: Control No. 158345 NOTE: MIVACRON is a trademark of the Glaxo group of companies, AbbVie Corporation licensed use - 2 - PRODUCT MONOGRAPH NAME OF DRUG PR MIVACRON ® Mivacurium Chloride Injection THERAPEUTIC CLASSIFICATION Nondepolarising Skeletal Neuromuscular Blocking Agent THIS DRUG SHOULD BE ADMINISTERED BY, OR UNDER THE SUPERVISION OF, EXPERIENCED CLINICIANS WHO ARE FAMILIAR WITH ITS ACTIONS, CHARACTERISTICS, OR HAZARDS. ACTION AND CLINICAL PHARMACOLOGY MIVACRON (mivacurium chloride) is a short-acting, nondepolarising skeletal neuromuscular blocking agent which is hydrolyzed by plasma cholinesterase. Mivacurium chloride results in a blockade of neuromuscular transmission by binding competitively with cholinergic receptors on the motor end-plate to antagonize the action of acetylcholine. PHARMACODYNAMICS The time to maximum neuromuscular block is similar for mivacurium and intermediate-acting agents (e.g., atracurium), but longer than for the ultra-short-acting agent, succinylcholine. The clinically effective duration of action of mivacurium is one-third to one-half that of intermediate-acting agents and 2 to 2.5 times that of succinylcholine. The average ED 95 (dose required to produce 95% suppression of the adductor pollicis muscle response to ulnar nerve stimulation) of MIVACRON is 0.07 mg/kg (range: 0.06 to 0.09 mg/kg) in adults receiving opioid/nitrous oxide/oxygen anesthesia. The pharmacodynamics of various doses of $ ED 95 administered over 5 to 15 seconds during stable-state opioid/nitrous oxide/oxygen anesthesia are summarized in Table 1. Administration of MIVACRON over 60 seconds does not alter the time to maximum neuromuscular block or the duration of action. - 3 - TABLE 1 THE PHARMACODYNAMIC DOSE-RESPONSE OF MIVACRON קרא את המסמך השלם