BOTOX 200 Allergan Units Powder for solution for injection

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

BOTULINUM TOXIN, TYPE A

Available from:

Allergan Pharmaceuticals Ireland Castlebar Road, Westport, County Mayo, Ireland

ATC code:

M03AX01

INN (International Name):

BOTULINUM TOXIN TYPE A 200 Allergan units/0.1 millilitre

Pharmaceutical form:

POWDER FOR SOLUTION FOR INJECTION

Composition:

BOTULINUM TOXIN TYPE A 200 Allergan units/0.1 millilitre

Prescription type:

POM

Therapeutic area:

MUSCLE RELAXANTS

Authorization status:

Authorised

Authorization date:

2010-09-01

Patient Information leaflet

Page 1 of 17
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 o

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
BOTOX
200 Allergan Units
Powder for Solution for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Botulinum toxin
*
type A, 200 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 ankleand 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.
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4.2
POSOLOGY AND MET