Botox

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

Botulinum toxin - type a; botulinum toxin, type A; Botulinum toxin, type A

Tilgjengelig fra:

Allergan Australia Pty Ltd

Klasse:

Medicine Registered

Informasjon til brukeren

BOTOX
®
 BOTULINUM TOXIN TYPE A- CMI      VERSION 9.0 

PAGE 1 OF 7  

CONSUMER MEDICINE INFORMATION 

BOTOX
®
 (botulinum toxin, type A) purified neurotoxin complex 

_The information in this leaflet is ONLY a summary
and is not a complete statement about BOTOX_
_®_
_ injection. Your _
_doctor has more detailed information relating
to you, your medical history and the product and should be
consulted _
_so that you will be informed about all aspects of BOTOX_
_®_
_ injection as it relates to you. _

PLEASE READ THIS LEAFLET CAREFULLY BEFORE RECEIVING BOTOX

 INJECTION AND KEEP THIS LEAFLET HANDY AS 
YOU MAY WANT TO REFER TO IT IN THE FUTURE.  IF YOU HAVE ANY CONCERNS
ABOUT RECEIVING THIS MEDICINE, 
ASK YOUR DOCTOR. 

All medicines have benefits and risks. Your doctor has weighed the
risks of using BOTOX

 injection 
against the benefits expected from using it for you. 

1. PRODUCT DESCRIPTION 

WHAT IS BOTOX

 INJECTION? 
The injection contains a muscle relaxant obtained from the
bacterium _Clostridium botulinum._ 

WHAT IS IN BOTOX

 INJECTION? 
Each vial contains either 50 units (U), 100 units (U) or
200U of _Clostridium botulinum_ toxin type A-
haemagglutin complex as the active ingredient.  It also contains
human albumin and sodium chloride.   

WHAT IT LOOKS LIKE 
The injection is supplied as a sterile white vacuum-dried powder
in a clear glass vial.  It is diluted before 
use with sterile 0.9% sodium chloride injection. 

2. WHAT BOTOX
®
 INJECTION IS USED FOR 

HOW BOTOX

 INJECTION WORKS 
BOTOX

 works by temporarily relaxing overactive or spastic (contracting)
muscles.  BOTOX

 can also 
block signals to the sweat glands thus reducing excessive sweating
(hyperhidrosis), and can also block the 
release of chemicals in the brain associated with the cause of pain
(chronic migraine). When injected into 
the bl

Preparatomtale

 
BOTOX
®
 Botulinum Toxin Product Information Version 10.0      

Page 1 of 51 

NAME OF THE MEDICINE 
BOTOX® PURIFIED NEUROTOXIN COMPLEX INJECTION (50U, 100 U
OR 200 U) 
(botulinum toxin, type A) 

DESCRIPTION 
COMPOSITION 

Active ingredient: 
Each vial of BOTOX
®
 contains either 50 units (U), 100 units (U) or 200 units (U)
of 
botulinum toxin, type A, as a haemagglutinin complex. 

Excipients: 
Human albumin: 0.25 mg for 50 U, 0.5 mg for 100 U or 1.0
mg for 200 U 
Sodium chloride: 0.45 mg for 50U, 0.9 mg for 100 U or 1.8
mg for 200 U 

BOTOX
®
 (botulinum toxin type A) Neurotoxin complex is produced from
the fermentation 
of _Clostridium botulinum_ type A (Hall strain) and is purified
from the culture solution as an 
approximately 900 kD molecular weight complex consisting of
the neurotoxin and several 
accessory proteins.  The complex is dissolved in sterile sodium
chloride solution containing 
human serum albumin and is sterile filtered (0.2 microns) prior to
filling and vacuum-drying. 

One unit (U) of BOTOX
®
 corresponds to the calculated median intraperitoneal lethal dose 
(LD
50
) in mice, performed in a mouse potency assay.
 This assay method is specific to 
Allergan‟s product, BOTOX
®
.  Due to specific method details such as the vehicle, dilution 
scheme and laboratory protocols for the various mouse LD
50
 assays, units of biological 
activity of BOTOX
®
 cannot be compared to or converted into units of
any other botulinum 
toxin activity. 

PHARMACOLOGY 
PHARMACODYNAMICS 

Therapeutic class:  neuromuscular blocking agent. 

_Clostridium botulinum_ type A neurotoxin blocks peripheral
acetylcholine release at 
presynaptic cholinergic nerve terminals by cleaving SNAP-25,
a protein integral to the 
docking and release of acetylcholine from vesicles located within
the nerve terminals.   

After inje