BOTOX50 Allergan Units Powder for solution for injection

Country: Ирска

Језик: Енглески

Извор: HPRA (Health Products Regulatory Authority)

Активни састојак:

Botulinum toxin type a

Доступно од:

Allergan Pharmaceuticals Ireland

АТЦ код:

M03AX; M03AX01

INN (Међународно име):

Botulinum toxin type a

Дозирање:

50 Allergan Units

Фармацеутски облик:

Powder for solution for injection

Тип рецептора:

Product subject to prescription which may not be renewed (A)

Терапеутска област:

Other muscle relaxants, peripherally acting agents; botulinum toxin

Статус ауторизације:

Marketed

Датум одобрења:

2008-01-18

Информативни летак

BOTOX
®
50/100/200 Allergan Units, Powder for Solution for Injection
1/18
IE/H/xxxx/WS/150
HPRPACKAGE 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
condition

Карактеристике производа

Health Products Regulatory Authority
28 January 2022
CRN00C7R3
Page 1 of 31
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
BOTOX50 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
to