BOTOX botulinum toxin, type A purified neurotoxin complex 50U injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Patient Information leaflet (PIL)

24-08-2020

Summary of Product characteristics (SPC)

24-08-2020

Public Assessment Report (PAR)

28-11-2017

Active ingredient:

Botulinim toxin type a, Quantity: 50 U

Available from:

Abbvie Pty Ltd

INN (International Name):

Botulinim toxin type a

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: Albumin; sodium chloride

Administration route:

Intramuscular, Intradermal, Subcutaneous

Units in package:

1 x 50U vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

BOTOX (Botulinum toxin type A) purified neurotoxin complex is indicated for the following therapeutic indications: Treatment of overactive bladder with symptoms of urinary incontinence, urgency, and frequency, in adult patients who have an inadequate response to or are intolerant of an anticholinergic medication. Treatment of urinary incontinence due to neurogenic detrusor overactivity resulting from a defined neurological illness (such as spinal cord injury or multiple sclerosis) and not controlled adequately by anticholinergic agents. Prophylaxis of headaches in adults with chronic migraine (headaches on at least 15 days per month of which at least 8 days are with migraine). Treatment of strabismus in children and adults.Treatment of blepharospasm associated with dystonia, including benign blepharospasm and VIIth nerve disorders (specifically hemifacial spasm) in patients twelve years and older. Treatment of cervical dystonia (spasmodic torticollis). Treatment of focal spasticity of the upper and lower limbs, including dynamic equinus foot deformity, due to juvenile cerebral palsy in patients two years and older. Treatment of severe primary hyperhidrosis of the axillae. Treatment of focal spasticity in adults. Treatment of spasmodic dysphonia. BOTOX (botulinum toxin type A) purified neurotoxin complex is indicated for the following cosmetic indications: temporary improvement in the appearance of upper facial rhytides (glabellar lines, crow's feet and forehead lines) in adults.

Product summary:

Visual Identification: White powder; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2013-07-01

Patient Information leaflet

BOTOX
® BOTULINUM TOXIN TYPE A CMI V13 PI V17.0.
PAGE 1 OF 9
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 U or 200 U of
_Clostridium botulinum_
toxin type A-haemagglutinin
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 non-preserved, sterile 0.9% w/w 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 bladder
wall, BOTOX

works on the bladder muscle to prevent leakage of urine (urinary
incontinence).
It is used to treat medical conditions associated with overactive
muscles:
-
causing excessive eyelid blinking (blep

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Summary of Product characteristics

BOTOX
®
injection PI v17.0 CCDS v20.0
Page 1 of 58
AUSTRALIAN PRODUCT INFORMATION – BOTOX
® (BOTULINUM
TOXIN TYPE A) POWDER FOR INJECTION
1
NAME OF THE MEDICINE
Botulinum toxin type A purified neurotoxin complex
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of BOTOX
®
injection contains either 50 units (U), 100 units (U) or 200 units (U)
of
botulinum toxin type A, as a haemagglutinin complex.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Powder for injection
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
BOTOX

(botulinum toxin type A) purified neurotoxin complex is indicated for
the
following therapeutic indications:
•
treatment of overactive bladder with symptoms of urinary incontinence,
urgency and
frequency, in adult patients who have an inadequate response to or are
intolerant of an
anticholinergic medication
•
treatment of urinary incontinence due to neurogenic detrusor
overactivity resulting
from a defined neurological illness (such as spinal cord injury or
multiple sclerosis) in
adult patients who have an inadequate response to or are intolerant of
an anticholinergic
medication
•
prophylaxis of headaches in adults with chronic migraine (headaches on
at least 15
days per month of which at least 8 days are with migraine)
•
treatment of strabismus in patients twelve years and over
•
treatment of blepharospasm associated with dystonia, including benign
blepharospasm and VIIth nerve disorders (specifically hemifacial
spasm) in patients
twelve years and over
•
treatment of cervical dystonia (spasmodic torticollis)
•
treatment of focal spasticity of the upper and lower limbs, including
dynamic equinus
foot deformity, due to juvenile cerebral palsy in patients two years
and older
_ _
•
treatment of severe primary hyperhidrosis of the axillae
•
treatment of focal spasticity in adults
_ _
•
treatment of spasmodic dysphonia.
BOTOX

(botulinum toxin type A) purified neurotoxin complex is indicated for
the
BOTOX
®
injection PI v17.

Read the complete document