MIVACRON LIQUID

Land: Canada

Sprog: engelsk

Kilde: Health Canada

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Hent Produktets egenskaber (SPC)
01-11-2012

Aktiv bestanddel:

MIVACURIUM (MIVACURIUM CHLORIDE)

Tilgængelig fra:

ABBVIE CORPORATION

ATC-kode:

M03AC10

INN (International Name):

MIVACURIUM CHLORIDE

Dosering:

2MG

Lægemiddelform:

LIQUID

Sammensætning:

MIVACURIUM (MIVACURIUM CHLORIDE) 2MG

Indgivelsesvej:

INTRAVENOUS

Enheder i pakken:

10/20ML

Recept type:

Prescription

Terapeutisk område:

MISCELLANEOUS SKELETAL MUSCLE RELAXANTS

Produkt oversigt:

Active ingredient group (AIG) number: 0139961001; AHFS:

Autorisation status:

CANCELLED POST MARKET

Autorisation dato:

2012-11-03

Produktets egenskaber

                                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
                                
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