BOTOX 100

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

BOTULINUM TOXIN TYPE A

متاح من:

ABBVIE BIOPHARMACEUTICALS LTD, ISRAEL

ATC رمز:

M03AX01

الشكل الصيدلاني:

POWDER FOR SOLUTION FOR INJECTION

تركيب:

BOTULINUM TOXIN TYPE A 100 U/VIAL

طريقة التعاطي:

INTRADERMAL, I.M

نوع الوصفة الطبية :

Required

المصنعة من قبل:

ALLERGAN PHARMACEUTICALS IRELAND

المجموعة العلاجية:

BOTULINUM TOXIN

المجال العلاجي:

BOTULINUM TOXIN

الخصائص العلاجية:

Neurologic disorders:• •Focal spasticity associated with dynamic equinus foot deformity due to spasticity in ambulant paediatric cerebral palsy patients two years of age or older. • • Focal spasticity of the wrist and hand in adult • Focal spasticity of the lower limb, including ankle and foot in adult. • •Blepharospasm or VII nerve disorders in patients over 12 years, hemifacial spasm and associated focal dystonias as well as the correction of strabismus in patients 12 years of age and above. • •Reduction of the signs and symptoms of Cervical dystonia (spasmodic torticollis) in adults. • •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. Bladder disorders: •Management of 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: •Management of primary axillary hyperhidrosis in patients who failed other medical symptomatic treatment. •For the temporary improvement in the appearance of: - moderate to severe vertical lines between the eyebrows seen at maximum frown (glabellar lines) and/or, - moderate to severe lateral canthal lines (crow’s feet lines) seen at maximum smile and/or, - moderate to severe forehead lines seen at maximum eyebrow elevation when the severity of the facial lines has an important psychological impact in adult patients.

تاريخ الترخيص:

2022-07-31

نشرة المعلومات

Patient leaflet in accordance with the Pharmacists' Regulations
(Preparations) - 1986
THIS MEDICINE IS DISPENSED WITH A DOCTOR’S PRESCRIPTION ONLY
BOTOX
® 50 / BOTOX
® 100 / BOTOX
® 200
POWDER FOR SOLUTION FOR INJECTION
NAME AND QUANTITY OF ACTIVE INGREDIENT:
botulinum toxin type A
Each vial of BOTOX 50 contains:
50 Allergan units of botulinum toxin type A
Each vial of BOTOX 100 contains:
100 Allergan units of botulinum toxin type A
Each vial of BOTOX 200 contains:
200 Allergan units of botulinum toxin type A
INACTIVE INGREDIENTS AND ALLERGENS:
Please see section 6 ‘Additional
information’ and section 2 under ‘Important information about some
of this
medicine’s ingredients’.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
This leaflet contains concise information about this medicine. If you
have any
further questions, consult your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may
harm them, even if it seems to you that their medical condition is
similar to
yours.
1. WHAT IS THIS MEDICINE INTENDED FOR?
_NERVOUS SYSTEM DISORDERS _
-
BOTOX is indicated for the treatment of CHILDREN aged two years or
older with
cerebral palsy who can walk and who have a FOOT DEFORMITY, caused by
persistent muscle spasms in the legs.
-
ADULTS AND CHILDREN AGED 12 YEARS OR OLDER
o
persistent muscle spasms in the eyelid and half of the face
.
o
crossed eyes
. - ADULTS
o
persistent muscle spasms in the wrist and hand.
o
persistent muscle spasms in the lower limb including ankle and foot
.
o
persistent muscle spasms in the neck and in the shoulders
(torticollis)
.
o
reducing the symptoms of chronic migraine in adults who have headaches
on 15 or more days each month of which at least 8 days are with
migraine,
and who have not responded well to other preventative migraine
medications.
Page 2 of 17
_BLADDER DISORDERS _
BOTOX is indicated for treatment of the following conditions in
ADULTS:
o
overactive bladder with leakage of urine, sudden urge to empty

خصائص المنتج

BOT API MAR23 CL-2
1/44
BOTOX
®
1.
NAME OF THE MEDICINAL PRODUCT
BOTOX 50/ BOTOX 100/ BOTOX 200
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Botulinum toxin
*
type A, 50 Allergan Units/vial, 100 Allergan Units/vial and 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
Neurologic disorders:
•
Focal spasticity associated with dynamic equinus foot deformity due to
spasticity in ambulant
paediatric cerebral palsy patients two years of age or older.
•
Focal spasticity of the wrist and hand in adults.
•
Focal spasticity of the lower limb, including ankle and foot in
adults.
•
Blepharospasm or VII nerve disorders in patients over 12 years,
hemifacial spasm and
associated focal dystonias as well as the correction of strabismus in
patients 12 years of age
and above.
•
Reduction of the signs and symptoms of Cervical dystonia (spasmodic
torticollis) in adults.
•
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.
Bladder disorders
•
Management of 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:
•
Management
of
primary
axillary
hyperhidrosis
in
patients
who
failed
other
medical
symptomatic treatment.
For the temporary improvement in the ap