XEOMIN 50

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

BOTULINUM TOXIN TYPE A

Available from:

ALPHAMEDIX LTD, ISRAEL

ATC code:

M03AX01

Pharmaceutical form:

POWDER FOR SOLUTION FOR INJECTION

Composition:

BOTULINUM TOXIN TYPE A 0.2 - 0.4 NG 50 LD50 UNITS / VIAL

Administration route:

I.M

Prescription type:

Required

Manufactured by:

MERZ PHARMA GMBH & CO. KGAA, GERMANY

Therapeutic area:

BOTULINUM TOXIN

Therapeutic indications:

Xeomin is indicated for the symptomatic treatment of blepharospasm, cervical dystonia of a predominantly rotational form (spasmodic torticollis) and of post-stroke spasticity of the upper limb presenting with flexed wrist and clenched fist in adult. Xeomin is indicated for the temporary improvement in the appearance of moderate to severe vertical lines between eyebrows seen at frown (glabellar frown lines) in adults below 65 years when the severity of these lines has an important psychological impact for the patient

Authorization date:

2019-03-20

Patient Information leaflet

ودبت يتلا نيبجاحلا نيب ةيقفلأا
ديعاجتلا صقانت
مايأ 3 ىتح 2 للاخ بلغلأا ىلع لصحت
سوبعلاك
.
ً
اموي 30 للاخ يمظعلأا ريثأتلاب روعشلا
متي ثيح
.نقحلا دعب رهشأ 4 ىتح ريثأتلا رمتسي
ءاطعلإا ةقيرط
نقح( لضعلا لخاد نقحلل صصخ
ُ
م باذ
ُ
ملا نيمويسك
يبطلا مقاطلل ةبسنلاب تامولعملا ةيؤر
ناكملإاب ؛يلضع
.)ةرشنلا ةياهن يف
.هب ىصوملا يئاودلا رادقملا زواجت زوجي
لا نم ناك امم رثكأ نيمويسك أطخلاب تيقلت
اذإ
هاقلتت نأ ضرتفملا
:يئاودلا رادقملا طرف ضارعأ
نقحلا دعب
ً
لااح رهظت لا يئاودلا رادقملا طرف ضارعأ
جاودزإ ،نفجلا يلدت ،ماع فعض لمشت نأ
اهنأش نمو
للشو قطنلا يف ةبوعص ،سفنتلا يف تابوعص
،ةيؤرلا
اهنأش نم يتلا علبلا يف ةبوعص وأ
ةيسفنتلا تلاضعلا
.نيتئرلا باهتللإ يدؤت نأ
:يئاودلا رادقملا طرف ةلاح يف فرصتلا
اذإ وأ ،يئاودلا رادقملا طرف ضارعأب
رعشت تنك اذإ
ةيبط ةدعاسم
ً
لااح بلطأ ءاودلا نم أطخلاب لفط علب
ةفرغ ىلإ
ً
لااح هجوت ،كلذ لعف كبراقأ نم بلطأ وأ
.ءاودلا ةبلع كعم رضحأو ىفشتسملا يف
ئراوطلا
مايأ ةدع ىتح يبط فارشإ رملأا بلطتي نأ
زئاجلا نم
.سفنتلا ىلع ةدعاسم عم
.بيبطلا تايصوت بسحب جلاعلا ىلع
ةبظاوملا بجي بجي !ةمتعلا يف ةيودلأا لامعتسإ زوجي لا يئاودلا رادقملا نم دكأتلاو ءاودلا
عباط صيخشت تاراظنلا عض .ءاود اهيف لمعتست ةرم لك
يف
.كلذ رملأا مزل اذإ ةيبطلا لا�

Summary of Product characteristics

DISTANT SPREAD OF TOXIN EFFECT
Post marketing reports indicate that the effects of xeomin and all
botulinum toxin products may spread from
the area of injection to produce symptoms consistent with botulinum
toxin effects. These may include
asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia,
dysphonia, dysarthria, urinary
incontinence, and breathing difficulties. These symptoms have been
reported hours to weeks after injection.
Swallowing and breathing difficulties can be life threatening and
there have been reports of death. The risk of
symptoms is probably greatest in children treated for spasticity but
symptoms can also occur in adults treated
for spasticity and other conditions, particularly in those patients
who have underlying conditions that would
predispose them to these symptoms. In unapproved uses, and in approved
indications, cases of spread of
effect have been reported at doses comparable to those used to treat
cervical dystonia and at lower doses.
1.
NAME OF THE MEDICINAL PRODUCT
XEOMIN 50
XEOMIN 100
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial contains 50 Units of (Botulinum toxin type A (150 kDa), free
from complexing proteins.*
One vial contains 100 Units of (Botulinum toxin type A (150 kDa), free
from complexing proteins.*
_* Botulinum neurotoxin type A, purified from cultures of Clostridium
Botulinum (Hall strain)_
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for injection
White to off white powder
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Xeomin is indicated for the symptomatic treatment of blepharospasm,
cervical dystonia of a
predominantly rotational form (spasmodic torticollis) and of
post-stroke spasticity of the upper limb
presenting with flexed wrist and clenched fist in adults.
Xeomin is indicated for the temporary improvement in the appearance of
moderate to severe
vertical lines between eyebrows seen at frown (glabellar frown lines)
in adults below 65 years when
the severity of these lines has an important