Botox

Land: Neuseeland

Sprache: Englisch

Quelle: Medsafe (Medicines Safety Authority)

Wirkstoff:

Botulinum toxin type A 50 U

Verfügbar ab:

AbbVie Limited

INN (Internationale Bezeichnung):

Botulinum toxin type A 50 U

Dosierung:

50 U

Darreichungsform:

Powder for injection

Zusammensetzung:

Active: Botulinum toxin type A 50 U Excipient: Albumin Sodium chloride

Einheiten im Paket:

Vial, glass, 50 U

Klasse:

Prescription

Verschreibungstyp:

Prescription

Hergestellt von:

Allergan Inc

Anwendungsgebiete:

· For the prophylaxis of headaches in adults with chronic migraine (headaches on at least 15 days per month with headache lasting 4 hours a day or longer, of which at least 8 days are with migraine)

Produktbesonderheiten:

Package - Contents - Shelf Life: Vial, glass, - 50 U - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze). Single use only

Berechtigungsdatum:

2012-01-31

Gebrauchsinformation

BOTOX
® BOTULINUM TOXIN TYPE A INJECTION NZ CMI V14.0, DS V16.0 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 units (U) or 200 units (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 0.9% sterile non-preserved 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
®
injection 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 exc

Fachinformation

BOTOX
®
Botulinum Toxin Type A Data Sheet Version 16 CCDS Version 22.0
Page
1
of
37
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
BOTOX
®
(botulinum toxin type A) purified neurotoxin complex 50 units (U), 100
units (U) or 200 units
(U) powder for injection.
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.
3.
PHARMACEUTICAL FORM
A sterile, vacuum-dried preparation. Powder for injection.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
BOTOX
®
(botulinum toxin type A) purified neurotoxin complex is indicated:
•
for the treatment of overactive bladder with symptoms of urinary
incontinence, urgency and
frequency, in adults who have an inadequate response to or are
intolerant of an anticholinergic
medication
•
for the treatment of urinary incontinence due to neurogenic detrusor
overactivity (e.g. spinal
cord injury or multiple sclerosis) in adults who have an inadequate
response to or are intolerant
of an anticholinergic medication
•
for the prophylaxis of headaches in adults with chronic migraine
(headaches on at least 15 days
per month with headache lasting 4 hours a day or longer, of which at
least 8 days are with
migraine)
•
for the treatment of strabismus and blepharospasm associated with
dystonia, including benign
essential blepharospasm or VIIth nerve disorders in patients 12 years
of age and above
•
to reduce the subjective symptoms and objective signs of spasmodic
torticollis (cervical
dystonia) in adults
•
treatment of focal spasticity in children two years and older
•
for the treatment of primary hyperhidrosis of the axillae
•
for the treatment of focal spasticity in adults
•
for the treatment of upper facial rhytides, including forehead,
crow’s feet and glabellar lines._ _
_ _
4.2 DOSE AND METHOD OF ADMINISTRATION
ROUTE OF ADMINISTRATION
Intramuscular injection.
BOTOX
®
Botulinum Toxin Type A Data