MIVACRON INJECTION 10 mg5 ml

Land: Singapore

Sprog: engelsk

Kilde: HSA (Health Sciences Authority)

Aktiv bestanddel:

MIVACURIUM CHLORIDE

Tilgængelig fra:

DCH AURIGA SINGAPORE

ATC-kode:

M03AC10

Dosering:

10 mg/5 ml

Lægemiddelform:

INJECTION

Sammensætning:

MIVACURIUM CHLORIDE 10 mg/5 ml

Indgivelsesvej:

INTRAVENOUS

Recept type:

Prescription Only

Fremstillet af:

GLAXOSMITHKLINE MANUFACTURING SPA

Autorisation status:

ACTIVE

Autorisation dato:

1994-01-26

Indlægsseddel

CONFIDENTIAL 

MIVACRON™ 
MIVACURIUM CHLORIDE 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
_INJECTION: _
Sterile solution containing 2
mg mivacurium_ _per ml as mivacurium chloride, without an 
antimicrobial preservative, supplied in ampoules.  
PHARMACEUTICAL FORM 
Solution for injection or infusion. 
CLINICAL PARTICULARS 
INDICATIONS_ _
_MIVACRON_ is a highly selective, short-acting,
non-depolarising neuromuscular blocking 
agent with a fast recovery profile. 
_MIVACRON_ is used as an adjunct to general anaesthesia to
relax skeletal muscles and to 
facilitate tracheal intubation and mechanical ventilation. 
The injection formulation contains no
antimicrobial preservative and is intended for 
single patient use. 
DOSAGE AND ADMINISTRATION 
In common with all neuromuscular blocking agents,
monitoring of neuromuscular 
function is recommended during the use of_ MIVACRON_ in
order to individualise dosage 
requirements. 
With _MIVACRON_, significant train-of-four fade is not seen
during onset.  It is often 
possible to intubate the trachea before complete abolition
of the train-of-four response of 
the adductor pollicis muscle has occurred. 
POPULATIONS 
•  ADULTS 
_MIVACRON_ is administered by intravenous (i.v.) injection.
The mean dose required to 
produce 95% suppression of the adductor pollicis single twitch
response to ulnar nerve 
CONFIDENTIAL 

stimulation (ED95) is 0.07 mg/kg (range 0.06 to 0.09) in
adults receiving narcotic 
anaesthesia. 
The following dose regimens are recommended
for tracheal intubation: 
I. A dose of 0.2 mg/kg, administered over 30 seconds,
produces good to excellent 
conditions for tracheal intubation within 2.0 to 2.5 minutes. 
II. A dose of 0.25 mg/kg, administered as a divided dose (0.15
mg/kg followed 
30 seconds later by 0.1 mg/kg), produces good to
excellent conditions for tracheal 
intubation within 1.5 t

Produktets egenskaber

MIVACRON
Mivacurium chloride
QUALITATIVE AND
QUANTITATIVE COMPOSITION
Injection:
Sterile solution containing 2 mg
mivacurium per ml as mivacurium chloride,
without an antimicrobial preservative,
supplied in ampoules.
PHARMACEUTICAL FORM
Solution for injection or infusion.
CLINICAL PARTICULARS
Indications
MIVACRON
is a highly selective, short-acting, non-depolarising neuromuscular
blocking agent with a fast recovery profile.
MIVACRON
is used as an adjunct to general anaesthesia to relax skeletal
muscles and to facilitate tracheal intubation and mechanical
ventilation.
The injection formulation contains no antimicrobial preservative and
is intended
for single patient use.
Dosage and Administration
In common with all neuromuscular blocking agents, monitoring of
neuromuscular function is recommended during the use of
MIVACRON
in order
to individualise dosage requirements.
With
MIVACRON
, significant train-of-four fade is not seen during onset. It is
often possible to intubate the trachea before complete abolition of
the train-of-
four response of the adductor pollicis muscle has occurred.
Populations
•
Adults
MIVACRON
is administered by intravenous (i.v.) injection. The mean dose
required to produce 95% suppression of the adductor pollicis single
twitch
response to ulnar nerve stimulation (ED
95
) is 0.07 mg/kg (range 0.06 to 0.09) in
adults receiving narcotic anaesthesia.
The following dose regimens are recommended for tracheal intubation:
I.
A dose of 0.2 mg/kg, administered over 30 seconds, produces good to
excellent conditions for tracheal intubation within 2.0 to 2.5
minutes.
II.
A dose of 0.25 mg/kg, administered as a divided dose (0.15 mg/
kg followed 30 seconds later by 0.1 mg/kg), produces good to excellent
conditions for tracheal intubation within 1.5 to 2.0 minutes of
completion
of administration of the first dose portion.
The recommended bolus dose range for healthy adults is 0.07 to 0.25
mg/kg. The
duration of neuromuscular block is related to the dose. Doses of 0.07,
0.15, 0.20
and 0.25 mg/kg produce