Bridion

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Aktiva substanser:

Sugammadex

Tillgänglig från:

Merck Sharp & Dohme Australia Pty Ltd

Klass:

Medicine Registered

Bipacksedel

BRIDION
®

_100 MG/ML_
_Sugammadex_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about BRIDION.
It does not contain all the available
information. It does not take the
place of talking to your doctor.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you being given
BRIDION against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, TELL YOUR
DOCTOR.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT BRIDION IS USED
FOR
BRIDION belongs to a group of
medicines called Selective Relaxant
Binding Agents. It is used to speed
up recovery of your muscles after an
operation.
During some operations, your
muscles must be completely relaxed.
This makes it easier for the surgeon
to perform the operation. To make
your muscles relax, the general
anaesthetic includes muscle relaxants
such as Esmeron and Norcuron.
Because the muscles needed for
breathing also become relaxed, you
will need help with your breathing
(artificial ventilation) during and
after your operation until you can
breathe on your own again.
BRIDION is used to stop the muscle
relaxants working. It does this by
combining with Esmeron or
Norcuron in your body.
BRIDION is given to speed up your
recovery from the muscle relaxant -
for example, at the end of an
operation to allow you to breathe
normally earlier.
Your doctor will have explained why
you are being treated with BRIDION.
ASK YOUR DOCTOR IF YOU WANT ANY
MORE INFORMATION ABOUT THIS
MEDICINE.
BRIDION is not addictive.
BEFORE YOU ARE GIVEN
BRIDION
You may already have been given
BRIDION Injection. Your doctor
will have considered the situation
carefully and decided to use it.
_WHEN YOU MUST NOT BE GIVEN_
_IT_
YOU MUST NOT BE GIVEN BRIDION
IF:
•
you are allergic to sugammadex
or have an allergy to any of the
ingredients listed at the end of
this leaflet
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficult

Produktens egenskaper

A20130725 RA 8700 OS S9 REF 9.0 
1 
BRIDION
®

_sugammadex (as sodium salt) _

(I) 
NAME OF THE MEDICINE 
_ _
BRIDION 100 MG/ML Solution for Injection _ _

_ _
_Molecular Formula: _C
72
H
104
O
48
S
8
Na
8

_ _
_Molecular mass: _2178.01_ _
_ _
_ _
_Cas. Registry No:_ 343306-79-6 
_ _
_Chemical Name:_ octakis(6-S-(2-carboxyethyl)-6-thio)cyclomaltooctaose
octasodium salt_ _ 

(II) 
DESCRIPTION 

Sugammadex is a white to off-white powder. It is soluble at
room temperature in water, normal saline 
and 5% mannitol in water.  

Bridion solution
for injection contains sugammadex 100 mg/mL, hydrochloric acid and sodium 
hydrochloride for pH adjustment and Water for Injections. It
is a clear and colourless to slightly yellow 
solution in 2 mL or 5 mL vials. The pH is between 7 and
8 and osmolality is between 300 and 500 
mOsm/kg.  

(III)  PHARMACOLOGY 

PHARMACODYNAMICS  
_Pharmacotherapeutic Group_: all other therapeutic products, ATC
code: V03AB35 
_ _
_Mechanism of action _
Sugammadex is a modified gamma
cyclodextrin which is a Selective Relaxant Binding
Agent (SRBA). 
It forms a complex with the neuromuscular blocking
agents rocuronium or vecuronium and it reduces 
the amount of neuromuscular
blocking agent available to bind to nicotinic receptors in
the 
A20130725 RA 8700 OS S9 REF 9.0 
2 
neuromuscular junction. This results in the
reversal of neuromuscular blockade induced by rocuronium 
or vecuronium.  

_Pharmacodynamic effects_ 
Sugammadex has been administered
in doses ranging from 0.5 mg/kg to 16 mg/kg in dose-response 
studies of rocuronium-induced

blockade (0.6, 0.9, 1.0 and 1.2 mg/kg
rocuronium bromide with and 
without maintenance doses) and vecuronium-induced blockade
(0.1 mg/kg vecuronium bromide with 
or without maintenance doses) at different time
points/depths