Pays: Israël
Langue: anglais
Source: Ministry of Health
ERENUMAB
NOVARTIS ISRAEL LTD
N02CX07
SOLUTION FOR INJECTION
ERENUMAB 140 MG / 1 ML
S.C
Required
AMGEN MANUFACTURING LIMITED, USA
ERENUMAB
Aimovig is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month when initiating treatment with Aimovig
2020-03-29
يلاقترب ءاطغ ،يدامر ليغشت رز ،نكاد قرزأ نولب مسج وذ( لامعتسلإل زهاج ملق غلم 140 ﭻﯿﭬوميأ ـل ةروص )نوللا رفصأ ناملأل مامصو :ماع لكشب :ةماهلا تامولعملا هذه أرقإ ،لامعتسلإل زهاج ملق ﭻﯿﭬوميأ لامعتسإ لبق ريضحتلا :1 ةلحرملا ىوتحم نقح كيلع ،غلم 70 هردق يئاود رادقمل ةبسنلاب يأ .غلم 140 وأ غلم 70 وه ﭻﯿﭬوميأ ـل فوصوملا يئاودلا رادقملا :هبتنإ غلم 140 وذ دحاو ملق ىوتحم نقح كيلع ،غلم 140 هردق يئاود رادقمل ةبسنلاب .ةدحاو ةرمل لامعتسلإل غلم 70 وذ دحاو ملق .ةفلتخم نقح قطانم يفو رخلآا ولت ً ادحاو ،ةدحاو ةرمل لامعتسلإل غلم 70 رايع نم نيملق ىوتحم وأ ةدحاو ةرمل لامعتسلإل )أ( نينثإ وأ دحاو ملق لامعتسإ كيلع بجوتيس .ةيجراخلا ةبلعلا نم لامعتسلإل ةزهاج/زهاج ﭻﯿﭬوميأ نم ملاقأ/ملق رذحب جرخأ .ضخلا زوجي لا .كل فص ُ و يذلا يئاودلا رادقملا بسحب .نقحلا لبق لقلأا ىلع ةقيقد 30 ةدمل ةفرغلا ةرارح ةجردب ملاقلأا/ملقلا عد ،نقحلا ةقطنم يف جاعزنإ ثودح بنجتل .ڤيووركيملا وأ نخاسلا ءاملا لثم يرارح ردصم ةطساوب ملاقلأا/ملقلا نيخست لواحت لا :هبتنإ )ب( .حتاف رفصأ نول ىتح نوللا ميدعو ً لايلق يبيلح ىتح قئار ةذفانلا يف هارت يذلا لولحملا نأ نم دكأت .ملاقلأا/ملقلا صحفإ :هبتنإ .روسكم وأ ققشتم ودبي ءزج يأ ناك اذإ ملاقلأا/ملقلا لمعتست لا ∙ .طقس يذلا ملقلا لمعتست لا ∙ .ديج لكشب لوصوم ريغ Lire le document complet
AIM API Aug23 V8 Page 1 of 14 EU SmPC July23 1. NAME OF THE MEDICINAL PRODUCT Aimovig 70 mg Aimovig 140 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Aimovig 70 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 70 mg erenumab. Aimovig 140 mg solution for injection in pre-filled syringe _ _ Each pre-filled syringe contains 140 mg erenumab. Aimovig 70 mg solution for injection in pre-filled pen Each pre-filled pen contains 70 mg erenumab. Aimovig 140 mg solution for injection in pre-filled pen Each pre-filled pen contains 140 mg erenumab. Erenumab is a fully human IgG2 monoclonal antibody produced using recombinant DNA technology in Chinese hamster ovary (CHO) cells. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. The solution is clear to opalescent, colourless to light yellow and practically free from particles. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Aimovig is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month when initiating treatment with Aimovig. 4.2 Posology and method of administration Treatment should be initiated by physicians experienced in the diagnosis and treatment of migraine. Posology Treatment is intended for patients with at least 4 migraine days per month when initiating treatment with erenumab. The recommended dose is 70 mg erenumab every 4 weeks. Some patients may benefit from a dose of 140 mg every 4 weeks (see section 5.1). Each 140 mg dose is given either as one subcutaneous injection of 140 mg or as two subcutaneous injections of 70 mg. AIM API Aug23 V8 Page 2 of 14 EU SmPC July23 Clinical studies have demonstrated that the majority of patients responding to therapy showed clinical benefit within 3 months. Consideration should be given to discontinuing treatment in patients who have shown no response after 3 months of treatment. Evaluation of the need to continue treatment is recommended regularly thereafter. _Special populations _ _Elderly (aged 65 years and Lire le document complet