Botox 50 Allergan Units Powder for solution for injection

Страна: Мальта

Язык: английский

Источник: Medicines Authority

Доступна с:

AbbVie Limited Citywest Business Campus, Dublin 24, Ireland

код АТС:

M03AX01

ИНН (Международная Имя):

BOTULINUM TOXIN TYPE A 50 Allergan units/0.1 millilitre

Фармацевтическая форма:

POWDER FOR SOLUTION FOR INJECTION

состав:

BOTULINUM TOXIN TYPE A 50 Allergan units/0.1 millilitre

Тип рецепта:

POM

Терапевтические области:

MUSCLE RELAXANTS

Статус Авторизация:

Authorised

Дата Авторизация:

2009-03-03

тонкая брошюра

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
BOTOX,
50 Allergan Units, Powder for Solution for Injection
BOTOX,
100 Allergan Units, Powder for Solution for Injection
BOTOX,
200 Allergan Units, Powder for Solution for Injection
Botulinum toxin type A
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What BOTOX is and what it is used for
2.
What you need to know before you use BOTOX
3.
How to use BOTOX
4.
Possible side effects
5.
How to store BOTOX
6.
Contents of the pack and other information
1.
WHAT BOTOX IS AND WHAT IT IS USED FOR
BOTOX is a muscle relaxant used to treat a number of conditions within
the body. It contains the
active substance Botulinum toxin type A and is injected into either
the muscles, the bladder wall or
deep into the skin. It works by partially blocking the nerve impulses
to any muscles that have been
injected and reduces excessive contractions of these muscles.
When injected into the skin, BOTOX works on sweat glands to reduce the
amount of sweat produced.
When injected into the bladder wall, BOTOX works on the bladder muscle
to reduce leakage of urine
(urinary incontinence). In the case of chronic migraine, it is thought
that BOTOX may block pain
signals which indirectly block the development of a migraine. However,
the way BOTOX works in
chronic migraine is not fully established.
1)
BOTOX can be injected directly into the muscles, and can be used to
treat the following
conditions:
•
PERSISTENT MUSCLE SPASMS
in the
ANKLE AND FOOT
in
CHILDREN
aged two years or older wit

Характеристики продукта

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
BOTOX
50 Allergan Units
Powder for Solution for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Botulinum toxin
*
type A, 50 Allergan Units/vial.
*
from
_Clostridium botulinum_
Botulinum toxin units are not interchangeable from one product to
another.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for injection.
White powder.
BOTOX product appears as a thin white deposit that may be difficult to
see on the base of the vial.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
BOTOX is indicated for the management of:
NEUROLOGIC DISORDERS:
BOTOX is indicated for the symptomatic treatment of:
-
FOCAL SPASTICITY
of the ankle and foot in ambulant
PAEDIATRIC CEREBRAL PALSY
patients, two
years of age or older as an adjunct to rehabilitative therapy.
-
FOCAL SPASTICITY
of the wrist and hand in
ADULT POST STROKE
patients.
-
FOCAL SPASTICITY
of the ankle and foot in
ADULT POST STROKE
patients (see section 4.4).
-
BLEPHAROSPASM, HEMIFACIAL SPASM
and associated focal dystonias.
-
CERVICAL DYSTONIA
(spasmodic torticollis).
•
Symptom relief in adults fulfilling criteria for
CHRONIC MIGRAINE
(headaches on ≥15 days per
month of which at least 8 days with migraine) in patients who have
responded inadequately or are
intolerant of prophylactic migraine medications (see section 4.4).
BLADDER DISORDERS:
•
IDIOPATHIC OVERACTIVE BLADDER
with symptoms of urinary incontinence, urgency and frequency
in adult patients who have an inadequate response to, or are
intolerant of, anticholinergic
medication.
•
Urinary incontinence in adults with
NEUROGENIC DETRUSOR OVERACTIVITY
resulting from neurogenic
bladder due to stable sub-cervical spinal cord injury, or multiple
sclerosis.
SKIN AND SKIN APPENDAGE DISORDER:
•
Persistent severe primary
HYPERHIDROSIS OF THE AXILLAE
, which interferes with the activities of
daily living and is resistant to topical treatment.
3
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Bot