ROCURONIUM SANDOZ rocuronium bromide 100mg/10ml solution for injection

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

rocuronium bromide, Quantity: 100 mg

Available from:

Sandoz Pty Ltd

INN (International Name):

Rocuronium bromide

Pharmaceutical form:

Injection, solution

Composition:

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

Administration route:

Intravenous

Units in package:

10 vials

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.. Adjunct in the intensive care unit (ICU) to facilitate mechanical ventilation.

Product summary:

Visual Identification: Clear, colourless to yellow/orange solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2010-03-31

Summary of Product characteristics

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_Rocuronium Sandoz 50mg/5ml and 100mg/10ml solution for injection _
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PRODUCT INFORMATION
ROCURONIUM SANDOZ
50MG/5ML AND 100MG/10ML
SOLUTION FOR INJECTION
NAME OF THE MEDICINE
Generic name: Rocuronium bromide
Chemical name:
1-(17β-acetoxy-3α-hydroxy-2β-morpholino-5α-androstan-16β-yl)-1-
allylpyrrolidinium bromide
Chemical structure:
CAS: 119302-91-9
Empirical formula: C
32
H
53
BrN
2
O
4
MW: 609.696
DESCRIPTION
Rocuronium bromide is an off-white to pale yellow or slightly pink
amorphous
powder which is readily soluble in water (> 200mg/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. Rocuronium bromide is administered by intravenous bolus or
infusion.
As well as the active ingredient Rocuronium Sandoz contains the
following inactive
ingredients: sodium acetate trihydrate, sodium chloride, sodium
hydroxide, acetic acid
- glacial, water for injections.
PHARMACOLOGY
Pharmacodynamics
Rocuronium
is
a
fast
onset
(relative
to
vecuronium),
intermediate
acting
non-
depolarising 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
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_Rocuronium Sandoz 50mg/5ml and 100mg/10ml solution for injection _
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_Sandoz Pty Ltd _
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_Version 05 _
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 cardiovasc