XEOMIN, incobotulinumtoxinA, 50 units; purified neurotoxin, free from complexing proteins

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

incobotulinumtoxinA, Quantity: 50 U

Available from:

Merz Australia Pty Ltd

INN (International Name):

incobotulinumtoxinA

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: Albumin; sucrose

Administration route:

Intramuscular

Units in package:

50 LD50 Units

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Xeomin is indicated in adults for the treatment of:,? Cervical dystonia (spasmodic torticollis),? Blepharospasm,? Spasticity of the upper limb,? Chronic sialorrhea due to neurological disorders,? Upper facial lines,- Glabellar frown lines,- Lateral periorbital lines (crow?s feet),- Horizontal forehead lines,Xeomin is indicated in children and adolescents aged 2 years to 17 years for the symptomatic treatment of:,? Chronic sialorrhea due to neurological/neurodevelopmental disorders,? Spasticity of the lower and/or upper limbs

Product summary:

Visual Identification: Powder for injection, white to off-white solid, supplied in a glass vial closed with a rubber stopper and sealed with an aluminium cap; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2014-03-21

Patient Information leaflet

Xeomin CMI
February 2019
Page 1 of 4
XEOMIN
®
(ZEE-oh-min)
_incobotulinumtoxinA _
_Purified Botulinum toxin type A free from complexing proteins _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Xeomin.
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 using
this medicine against the
benefits they expect it will
have for you.
IF' YOU HAVE ANY CONCERNS
ABOUT USING THIS MEDICINE,
ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT XEOMIN IS USED
FOR
The medicine is used:
•
To treat the abnormal head
position and neck pain that
happens with cervical
dystonia in adults,
•
To treat abnormal spasm
of the eyelids
(blepharospasm) in adults,
•
Spasticity of the upper
limbs in adults,
•
To improve the look of
upper facial lines including
frown lines between the
eyebrows (glabellar lines),
wrinkles at the side of eyes
(crow’s feet) and
horizontal forehead lines
in adults.
The medicine contains
incobotulinumtoxinA, purified
neurotoxin free from
complexing proteins. This
belongs to a family of
medicines called peripheral
muscle relaxants.
Xeomin is injected into the
muscles where it blocks
passage of signals from nerves
to the muscle. This causes a
reduction in the ability of the
muscle to contract.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN
PRESCRIBED FOR YOU.
Your doctor may have
prescribed it for another
reason.
This medicine is not addictive.
This medicine is available
only with a doctor's
prescription.
XEOMIN HAS ONLY BEEN
EXAMINED FOR SAFETY AND
EFFECTIVENESS IN ADULTS. IT IS
NOT RECOMMENDED FOR USE IN
CHILDREN.
BEFORE YOU ARE GIVEN
XEOMIN
_WHEN YOU MUST NOT USE IT _
DO NOT USE THE MEDICINE IF
YOU HAVE AN ALLERGY TO:
•
any medicine containing
incobotulinumtoxinA,
•
any of the ingredients
listed at the end of this
leaflet.
DO NOT USE THE MED

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – XEOMIN®
(INCOBOTULINUMTOXINA)
powder for solution for injection
1
NAME OF THE MEDICINE
XEOMIN® 50 Units or 100 Units powder for solution for injection
IncobotulinumtoxinA, purified Botulinum toxin type A, free from
complexing proteins
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of Xeomin powder for solution for injection contains 50 or
100 units of
incobotulinumtoxinA.
Native Botulinum toxin type A is a high molecular weight complex,
which, in addition to the toxin
(150 kD), contains other bacterial non-toxic proteins, like
haemagglutinins and non-haemagglutinins.
In contrast to conventional preparations containing the botulinum
toxin A complex, Xeomin contains
pure (150 kD) toxin since it is free from complexing proteins and thus
has a low foreign protein
content. The foreign protein content administered is considered as one
of the factors for secondary
therapy failure.
IncobotulinumtoxinA is produced from the fermentation of Clostridium
botulinum and is subsequently
purified to remove complexing proteins. It consists of the purified
neurotoxin which has been
separated from complexing proteins (haemagglutinins and a non-toxic
non-haemagglutinating protein)
during production.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Powder for solution for injection
White to off-white powder
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Xeomin is indicated in adults for the treatment of:
•
Cervical dystonia
•
Blepharospasm
•
Spasticity of the upper limb
•
Upper facial lines
o
Glabellar frown lines
o
Lateral periorbital lines (crow’s feet)
o
Horizontal forehead lines
2
4.2
D
OSE AND METHOD OF ADMINISTRATION
Xeomin may only be administered by medical practitioners with suitable
qualifications and proven
experience in the application of botulinum toxin and in the use of the
necessary equipment.
Due to unit differences in the potency assay, Xeomin units are
specific to Xeomin. Therefore, unit
doses recommended for Xeomin