ROCON rocuronium bromide 100 mg/10 mL solution for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

rocuronium bromide, Quantity: 100 mg

Available from:

Medis Pharma Pty Ltd

INN (International Name):

Rocuronium bromide

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: acetic acid; sodium hydroxide; sodium chloride; water for injections; sodium acetate trihydrate

Administration route:

Intravenous

Units in package:

vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Adjunct to general anaesthesia to facilitate endotracheal intubation during routine induction, to provide muscle relaxation and to facilitate mechanical ventilation in adults, children and infants over 1 month of age.. Adjunct to general anaesthesia to facilitate endotracheal intubation during rapid sequence induction when suxamethonium is contraindicated, however, this has not been studied in infants and children. Rocuronium is also indicated as an adjunct in the intensive care unit (ICU) to facilitate mechanical ventilation.

Product summary:

Visual Identification: Clear colourless to yellowish solution in glass vial; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2011-10-18

Patient Information leaflet

Product Information
Medis Pharmaceuticals
Page 1 of 19
Nov 2017
_ROCON, ROCURONIUM BROMIDE, 10MG/ML, INJECTION, SOLUTION _
_ _
NAME OF MEDICINE
Rocuronium bromide.
Chemical name: 1-(17 beta-acetoxy-3alpha- hydroxy-2 beta- morpholino-5
alpha- androstan- 16beta-yl)-1-allylpyrrolidinium bromide.
Molecular formula: C
32
H
53
BrN
2
O
4
.
CAS: 119302-91-9.
Molecular weight:
609.70
DESCRIPTION
Rocuronium bromide is a quaternary aminosteroid and an analogue of
vecuronium bromide.
It is an off white to pale yellow or slightly pink
amorphous powder which is readily soluble in water (> 200 mg/mL). A 1%
w/v solution in water has a pH of 8.9 to 9.5. In aqueous solution
rocuronium
bromide is more stable at acidic pH.
Rocon contains rocuronium bromide 10mg/mL,
sodium acetate trihydrate,
sodium chloride, sodium hydroxide, acetic acid and water for
injections
in a
clear, colourless to faintly yellow solution with a pH of 3.5 - 4.5.
Rocuronium
bromide is administered by intravenous bolus or infusion.
PHARMACOLOGY
_PHARMACODYNAMICS._
Rocuronium is a fast onset (relative to vecuronium), intermediate
acting
nondepolarising neuromuscular blocking agent. It acts by competing
with
the natural transmitter acetylcholine and blocking the cholinoceptors
located at the motor endplate of the striated muscle. This is unlike
suxamethonium which causes depolarisation and renders the endplate,
after
initial contraction, unresponsive to stimuli, thus producing paralysis
of the
striated muscle. The action of rocuronium is antagonised by
acetylcholinesterase inhibitors, e.g. neostigmine, edrophonium and
pyridostigmine. The neuromuscular block can also be reversed by
sugammadex, a Selective Relaxant Binding Agent. Rocuronium does not
produce clinically significant autonomic and cardiovascular effects
within
the recommended dose range and is not expected to modulate
cardiovascular effects of anaesthetics or other drugs used during
surgery.
Product Information
Medis Pharmaceuticals
Page 2 of 19
Nov 2017
The ED
90
(dose required to produce 90% depressio

Summary of Product characteristics

Product Information
Spirit Pharmaceuticals
Page 1 of 19
January 2012
_ROCON, ROCURONIUM BROMIDE, 10MG/ML, INJECTION, SOLUTION _
_ _
NAME OF MEDICINE
Rocuronium bromide.
Chemical name: 1-(17 beta-acetoxy-3alpha- hydroxy-2 beta- morpholino-5
alpha- androstan- 16beta-yl)-1-allylpyrrolidinium bromide.
Molecular formula: C
32
H
53
BrN
2
O
4
.
CAS: 119302-91-9.
Molecular weight:
609.70
DESCRIPTION
Rocuronium bromide is a quaternary aminosteroid and an analogue of
vecuronium bromide.
It is an off white to pale yellow or slightly pink
amorphous powder which is readily soluble in water (> 200 mg/mL). A 1%
w/v solution in water has a pH of 8.9 to 9.5. In aqueous solution
rocuronium
bromide is more stable at acidic pH.
Rocon contains rocuronium bromide 10mg/mL,
sodium acetate trihydrate,
sodium chloride, sodium hydroxide, acetic acid and water for
injections
in a
clear, colourless to faintly yellow solution with a pH of 3.5 - 4.5.
Rocuronium
bromide is administered by intravenous bolus or infusion.
PHARMACOLOGY
_PHARMACODYNAMICS._
Rocuronium is a fast onset (relative to vecuronium), intermediate
acting
nondepolarising neuromuscular blocking agent. It acts by competing
with
the natural transmitter acetylcholine and blocking the cholinoceptors
located at the motor endplate of the striated muscle. This is unlike
suxamethonium which causes depolarisation and renders the endplate,
after
initial contraction, unresponsive to stimuli, thus producing paralysis
of the
striated muscle. The action of rocuronium is antagonised by
acetylcholinesterase inhibitors, e.g. neostigmine, edrophonium and
pyridostigmine. The neuromuscular block can also be reversed by
sugammadex, a Selective Relaxant Binding Agent. Rocuronium does not
produce clinically significant autonomic and cardiovascular effects
within
the recommended dose range and is not expected to modulate
cardiovascular effects of anaesthetics or other drugs used during
surgery.
Product Information
Spirit Pharmaceuticals
Page 2 of 19
January 2012
The ED
90
(dose required to produce 90%