国: イスラエル
言語: 英語
ソース: Ministry of Health
BOTULINUM TOXIN TYPE A
ALPHAMEDIX LTD, ISRAEL
M03AX01
POWDER FOR SOLUTION FOR INJECTION
BOTULINUM TOXIN TYPE A 0.8 NG 100 LD50 UNITS / VIAL
I.M
Required
MERZ PHARMA GMBH & CO. KGAA, GERMANY
BOTULINUM TOXIN
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
2019-03-20
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 完全なドキュメントを読む
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 完全なドキュメントを読む