Xeomin

Страна: Нова Зеландія

мова: англійська

Джерело: Medsafe (Medicines Safety Authority)

Активний інгредієнт:

Botulinum toxin type A 100 Units equivalent to incobotulinumtoxinA (USAN), purified botulinum toxin type A

Доступна з:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

ІПН (Міжнародна Ім'я):

Botulinum toxin type A 100 Units (= incobotulinumtoxinA (USAN), purified botulinum toxin type A)

Дозування:

100 Units

Фармацевтична форма:

Powder for injection

Склад:

Active: Botulinum toxin type A 100 Units equivalent to incobotulinumtoxinA (USAN), purified botulinum toxin type A Excipient: Albumin Sucrose

Тип рецепту:

Prescription

Виробник:

Merz Pharma GmbH & Co KGaA

Терапевтичні свідчення:

Xeomin is indicated in adults for the treatment of: · Cervical dystonia · Blepharospasm · Spasticity of the upper limb · Upper facial lines -Glabellar frown lines -Lateral periorbital lines (crow's feet) - Horizontal forehead lines

Огляд продуктів:

Package - Contents - Shelf Life: Vial, glass, single dose, Type 1 clear, with West bromobutyl rubber stopper - 1 dose units - 36 months from date of manufacture stored at or below 30°C

Дата Авторизація:

2014-05-06

інформаційний буклет

Xeomin New Zealand Consumer Medicine Information
July 2023
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 o

Характеристики продукта

Version 4.0, May 2021
Page 1 of 29
NEW ZEALAND DATA SHEET
1. XEOMIN (POWDER FOR INJECTION)
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.
3. PHARMACEUTICAL FORM
Powder for solution for injection.
White to off-white powder.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC 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
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSE
Xeomin may only be administered by health care professionals with
suitable qualifications and proven
experience in the application of botulinum toxin and in the use of the
necessary equipment
Version 4.0, May 2021
Page 2 of 29
DUE TO UNIT DIFFERENCES IN THE POTENCY ASSAY, XEOMIN UNITS ARE
SPECIFIC TO XEOMIN. THEREFORE,
UNIT DOSES RECOMMENDED FOR XEOMIN ARE NOT