Nimbex Forte Injection 150 mg30 ml

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

cisatracurium (bis-cation) (as besylate) 201.0 mg/30 ml eqv cisatracurium

Available from:

DCH AURIGA SINGAPORE

ATC code:

M03AC11

Dosage:

150 mg/30 ml

Pharmaceutical form:

INJECTION, SOLUTION

Composition:

cisatracurium (bis-cation) (as besylate) 201.0 mg/30 ml eqv cisatracurium 150 mg/30 ml

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

GlaxoSmithKline Manufacturing S.p.A.

Authorization status:

ACTIVE

Authorization date:

2013-02-05

Patient Information leaflet

 
NIMBEX™ INJECTION 5 MG/2.5 ML 
NIMBEX™ FORTE INJECTION 150 MG/30 ML 
CISATRACURIUM  
QUALITATIVE AND QUANTITATIVE COMPOSITION 
_AMPOULES:_ 
A sterile solution containing cisatracurium (bis-cation) (as
besylate) 6.7 mg per 2.5 ml 
equivalent to 5 mg cisatracurium per 2.5 ml, without an
antimicrobial preservative, 
supplied in an ampoule. 
_VIALS: _
A sterile solution containing cisatracurium (bis-cation) (as
besylate) 201.0 mg per 30 ml 
equivalent to 150 mg cisatracurium per 30 ml, without an
antimicrobial preservative, 
supplied in a vial. 
PHARMACEUTICAL FORM 
Solution for injection or infusion. 
Colourless to pale yellow or greenish yellow solution. Practically
free from visible 
particulate matter. 
CLINICAL PARTICULARS 
INDICATIONS 
_NIMBEX _is an intermediate-duration, non-depolarising neuromuscular
blocking agent for 
i.v. administration. _NIMBEX _is indicated for use during surgical
and other procedures and 
in intensive care. It is used as an adjunct to general anaesthesia,
or sedation in the 
Intensive Care Unit (ICU), to relax skeletal muscles, and to
facilitate tracheal intubation 
and mechanical ventilation. 
_NIMBEX _contains no antimicrobial preservative and is intended
for single patient use. 
DOSAGE AND ADMINISTRATION 
As with other neuromuscular blocking agents, monitoring of
neuromuscular function is 
recommended during the use of _NIMBEX_ in order to
individualise dosage requirements. 
  USE BY I.V. BOLUS INJECTION IN ADULTS 

TRACHEAL INTUBATION: The recommended intubation dose of _NIMBEX_ for
adults is 
0.15 mg/kg administered rapidly over 5 to 10 seconds.  This dose
produces good to 
excellent conditions for tracheal intubation 120 seconds
following injection. 
Higher doses will shorten the time to onset of neuromuscular
block. The following table 
summarises mean pharmacodynamic data when _NIMBEX _injection was
administered at 
doses of 0.1 to 0.4 mg/kg to healthy adult patients during opio

Summary of Product characteristics

NIMBEX™ INJECTION 2 MG/ML
NIMBEX™ FORTE INJECTION 150 MG/30 ML
CISATRACURIUM
QUALITATIVE AND QUANTITATIVE COMPOSITION
_AMPOULES:_
A sterile solution containing cisatracurium (bis-cation) (as besylate)
2.68 mg per mL
equivalent to 2 mg cisatracurium per ml, without an antimicrobial
preservative, supplied
in an ampoule.
_VIALS: _
A sterile solution containing cisatracurium (bis-cation) (as besylate)
201.0 mg per 30 mL
equivalent to 150 mg cisatracurium per 30 ml, without an antimicrobial
preservative,
supplied in a vial.
PHARMACEUTICAL FORM
Solution for injection or infusion.
Colourless to pale yellow or greenish yellow solution. Practically
free from visible
particulate matter.
CLINICAL PARTICULARS
INDICATIONS
_NIMBEX _is an intermediate-duration, non-depolarising neuromuscular
blocking agent for
intravenous (i.v.) administration. _NIMBEX _is indicated for use
during surgical and other
procedures and in intensive care. It is used as an adjunct to general
anaesthesia, or
sedation in the Intensive Care Unit (ICU), to relax skeletal muscles,
and to facilitate
tracheal intubation and mechanical ventilation.
_NIMBEX _contains no antimicrobial preservative and is intended for
single patient use.
DOSAGE AND ADMINISTRATION
As with other neuromuscular blocking agents, monitoring of
neuromuscular function is
recommended during the use of _NIMBEX_ in order to individualise
dosage requirements.

USE BY I.V. BOLUS INJECTION IN ADULTS
TRACHEAL INTUBATION: The recommended intubation dose of _NIMBEX_ for
adults is
0.15 mg/kg administered rapidly over 5 to 10 seconds. This dose
produces good to
excellent conditions for tracheal intubation 120 seconds following
injection.
Higher doses will shorten the time to onset of neuromuscular block.
Table 1 summarises
mean pharmacodynamic data when _NIMBEX _injection was administered at
doses of 0.1 to
0.4 mg/kg to healthy adult patients during opioid
(thiopentone/fentanyl/midazolam) or
propofol anaesthesia.
TABLE 1: MEAN PHARMACODYNAMIC DATA FOLLOWING A RANGE OF _NIMBEX _DOSES
Initial