Dysport

Krajina: Austrália

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktívna zložka:

Clostridium botulinum type a toxin - haemagglutinin complex

Dostupné z:

Ipsen Pty Ltd

Trieda:

Medicine Registered

Príbalový leták

DYSPORT
®

_(Clostridium botulinum type A toxin-haemagglutinin complex)_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Dysport. It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Dysport
against the benefits he/she expects it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST. KEEP THIS
LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT IS DYSPORT
Dysport is a muscle relaxant
produced by Clostridium botulinum
bacteria. It acts on the junctions
between the nerves and muscles,
preventing the release of one of the
chemical messengers called
acetylcholine from the nerve endings
that would normally cause the
muscle to contract. If the messenger
is prevented from being released this
results in a weakened muscle and
helps to reduce some of the abnormal
muscle contractions.
WHAT DYSPORT IS USED
FOR
Dysport is used for the treatment of
•
arm spasticity in adults following
a stroke. Arm spasticity is an
increased stiffness in the arm
muscles that develops in many
patients after a stroke and can
lead to restricted use of the arm
•
spasmodic torticollis in adults.
Spasmodic torticollis is where
there is a turning movement of
the neck leading to an unusual
head and shoulder position
•
equinus foot deformity due to
spasticity in children (2 years of
age or older) with cerebral palsy.
Equinus foot deformity is a
condition where an unnatural
ankle position and walking gait
occur due to spasticity in patients
with cerebral palsy. Cerebral
palsy spasticity is a disorder in
which some muscles become stiff
and movement is difficult
•
blepharospasm or hemifacial
spasm in adults. Blepharospasm
is a condition affecting the eye lid
muscles causing uncontrollable
blinking and closure of the
eyelids. Hemifacial spasm is a
condition that causes t

Súhrn charakteristických

Dysport Product Information: Version 2.3 17 Sept 2013

1 

DYSPORT: PRODUCT INFORMATION    

NAME OF THE MEDICINE:-   
_Clostridium botulinum_ type A toxin-haemagglutinin complex 

DESCRIPTION:- 
Dysport  Powder  for  Injection  contains  300  or  500  IPSEN  UNITS*  per  vial  of  _Clostridium _
_botulinum_ type A toxin-haemagglutinin complex, 125 microgram human serum albumin and 
2.5 mg lactose in a
sterile, lyophilised form without a preservative.  
*One Ipsen unit (U) is defined as the median lethal intra-peritoneal dose (LD
50
) in mice of the 
reconstituted Dysport Powder for Injection.  

ONE IPSEN UNIT is not equivalent to ONE
UNIT of another botulinum toxin preparation. 
From now on in this Product Information the term Ipsen unit will simply be replaced by the 
term unit.  

_Clostridium botulinum_ type A toxin-haemagglutinin complex has a molecular weight of about 
900,000D and is a complex of proteins. 

PHARMACOLOGY:- 

PHARMACODYNAMICS: 
_Clostridium  botulinum_  type  A  toxin-haemagglutinin  complex  blocks  peripheral  cholinergic 
transmission  at  the  neuromuscular junction  by  a  presynaptic action at a  site  proximal  to the 
release  of  acetylcholine.  The  toxin  acts  within  the  nerve  ending  to  antagonise  those  events 
that  are  triggered  by  Ca
2+
  which  culminate  in  transmitter  release.  It  does  not  affect 
postganglionic cholinergic transmission or postganglionic
sympathetic transmission. 

The  action  of  toxin  involves  an  initial  binding  step  whereby  the  toxin  attaches  rapidly  and 
avidly to the presynaptic nerve membrane. Secondly, there is an internalisation step in which 
toxin crosses the presynaptic membrane, without causing onset of par