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توضيح من "الغذاء والدواء" بشأن مستحضر "ريبلسس" لإنقاص الوزن: يحتوي على ادعاءات غير دقيقة وجاري اتخاذ الإجراءات النظامية بحق الشركة

توضيح من "الغذاء والدواء" بشأن مستحضر "ريبلسس" لإنقاص الوزن: يحتوي على ادعاءات غير دقيقة وجاري اتخاذ الإجراءات النظامية بحق الشركة
صحيفة المرصد: أوضحت هيئة الغذاء والدواء أنه المقطع المتداول حول مستحضر ريبلسس (Rybelsus®️) والذي ورد فيه تعليق أحد الممارسين الصحيين بتعدد منافع المستحضر غير دقيق ، حيث يحتوي مستحضر ريبلسس (Rybelsus®️) على المادة الفعالة سيماجلوتايد (المسجل منها مستحضرات عدة .

وتابعت أنه قد تم الترخيص له لعلاج البالغين (أكثر من ١٨ عامًا) المصابين بمرض داء السكري من النوع الثاني ، ويتم صرفه في حال وجود مانع لاستخدام علاج الميتافورمين، أو يتم إعطاؤه كعلاج إضافي مع أدوية التحكم بمستوى السكري في الدم عندما لا تكون كافية. وأكدت "الغذاء والدواء" أن هذا الدواء يعتبر من الأدوية الوصفية والتي يجب عدم تناولها إلا بوصفة طبية .


استخدامات الدواء المرخصة
وشددت "الهيئة" على أنه قد تم الترخيص لهذا المستحضر لدواعي الاستخدام المذكورة سابقًا فقط، وعلى المريض الاستمرار في الالتزام بالحمية الغذائية وممارسة الرياضة للتحكم بمستوى السكر في الدم لما له من أثر في السيطرة على مضاعفات المرض ، كما توصي الهيئة بعدم الانسياق خلف الشائعات والادعاءات الطبية غير الدقيقة وضرورة مراجعة واستشارة الطبيب المختص والاطلاع على النشرة الداخلية للدواء قبل تناوله.
وبينت "الغذاء والدواء" أنه جاري اتخاذ الإجراءات النظامية بحق الشركة المعلنة إذ أن تسجيل الدواء في أنظمة الهيئة لا يتضمن الإعلان عنه، كما أنَّ أنظمة الهيئة تمنع إقامة المحاضرات العلمية الموجهة للممارسين الصحيين والإعلان للمستحضرات من خلالها دون موافقة مسبقة منها .
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SettingsRequest history319msRequest Duration47MBMemory Usage10.x
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PHP Version
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        • vendor/laravel/framework/src/Illuminate/Cache/Repository.php:396
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      App\Models\Article
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