ROCURONIUM MYLAN rocuronium bromide 100mg/10mL solution for injection vial

Krajina: Austrália

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktívna zložka:

rocuronium bromide, Quantity: 100 mg

Dostupné z:

Alphapharm Pty Ltd

INN (Medzinárodný Name):

Rocuronium bromide

Forma lieku:

Injection, solution

Zloženie:

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

Spôsob podávania:

Intravenous

Počet v balení:

10 vials per carton, 5 vials per carton

Typ predpisu:

(S4) Prescription Only Medicine

Terapeutické indikácie:

Rocuronium bromide injection is indicated as an 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.,Rocuronium is also indicated as an 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.

Prehľad produktov:

Visual Identification: clear, colorless to yellow or orange solution free from visible particles; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 18 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Stav Autorizácia:

Licence status A

Dátum Autorizácia:

2011-11-29

Príbalový leták

ROCURONIUM MYLAN
_contains the active ingredient Rocuronium bromide_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ROCURONIUM
MYLAN. It does not contain all the
available information. It does not
take the place of talking to your
pharmacist or doctor.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you having Rocuronium
Mylan against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT ROCURONIUM
MYLAN IS USED FOR?
Rocuronium Mylan is one of a group
of medicines called muscle relaxants.
Muscle relaxants are used during an
operation as part of the general
anaesthetic. When you have an
operation, your muscles must be
completely relaxed. This makes it
easier for the surgeon to perform the
operation.
Normally the nerves send messages
to the muscles by impulses.
Rocuronium Mylan acts by blocking
these impulses so the muscles are
relaxed. Because the muscles needed
for breathing also become relaxed
you will need help with your
breathing (artificial respiration)
during and after your operation until
you can breathe on your own. During
the operation the effect of the muscle
relaxant is constantly checked and if
necessary some more drug is given.
At the end of the operation the
effects of Rocuronium Mylan are
allowed to wear off and you can start
breathing on your own. Sometimes
another drug is given to help speed
this up. Rocuronium Mylan can also
be used in Intensive Care to keep
your muscles relaxed.
Ask your doctor if you want any
more information about this
medicine.
Rocuronium Mylan is not addictive.
BEFORE YOU ARE GIVEN
ROCURONIUM MYLAN
_WHEN YOU MUST NOT BE GIVEN_
_IT_
YOU MUST NOT BE GIVEN
ROCURONIUM MYLAN IF YOU HAVE AN
ALLERGY TO:
•
any medicine containing
rocuronium bromide
•
any of the ingredients listed at the
end of this leaflet
Some of the symptoms of an allergic
rea

Súhrn charakteristických

PRODUCT INFORMATION
ROCURONIUM MYLAN
_Rocuronium bromide _
NAME OF THE MEDICINE
Active Ingredient:
Rocuronium bromide
Chemical Name:
1-(17β-Acetoxy-3α-hydroxy-2 β-morpholino-5α-androstan-16β-yl)-1-
allylpyrrolidinium bromide.
Structural Formula:
Molecular Formula : C
32
H
53
BrN
2
O
4
CAS No. : 119302-91-9
DESCRIPTION
Rocuronium bromide is a quaternary aminosteroid and analogue of
vecuronium bromide. It 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 - 9.5. In
aqueous solution rocuronium
bromide is more stable at acidic pH.
Rocuronium
Mylan
contains
rocuronium
bromide
10mg/mL,
sodium
acetate
trihydrate,
sodium
chloride, acetic acid and water for injections in a clear, colorless
to yellow or orange solution free
from visible particles.Rocuronium bromide is administered by
intravenous bolus or infusion.
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
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 dosage range and is not expected to modulate
cardiovascular effects of anaesthetics or
other drugs used during surgery.
ROCURONIUM MYLAN – PRODUCT INFORMATION
2
The ED90 (dose required to produce 90% of depression of the twitch
response of the thumb to
stimulation of the ulnar nerve) during balanced ana