Раствор методжект для подкожного введения - 50 мг/мл - по 17... Инструкция
Показания к применению
Ревматоидный артрит у взрослых, полиартрит у пациентов с тяжелым ювенильным хроническим артритом в активной форме, тяжелые генерализованные формы псориаза и псориатического артрита у взрослых при неэффективности стандартной терапии.
1мл препарата содержит: активное вещество: метотрексат динатрия 54,84 мг (эквивалентно 50 мг метотрексата). Приготовлено по прописи: метотрексат 50 мг, натрия гидроксид 9,6 мг. Вспомогательные вещества: натрия хлорид 4 мг, натрия гидроксид QS (до pH 8,5-8,9), вода для инъекций до 1 мл.
Описание
Раствор методжект для подкожного введения - 50 мг/мл - по 17,5мг/0,35мл в шприце - противоопухолевый препарат. Антагонист фолиевой кислоты, цитотоксический препарат - антиметаболит. Конкурентно ингибирует фермент дигидрофолатредуктазу, участвующую в восстановлении дигидрофолиевой кислоты в тетрагидрофолиевую кислоту (переносчик углеродных фрагментов, необходимых для синтеза пуриновых нуклеотидов и их производных), и таким образом ингибирует синтез ДНК. Наряду с противоопухолевым обладает иммунодепрессивным действием. Остается невыясненным, чем обусловлена эффективность метотрексата в лечении псориаза, псориатического артрита и ревматоидного артрита (в том числе ювенильного хронического артрита): его противовоспалительным или иммуносупрессивным действием. Также не установлено в какой степени эффективность терапии объясняется вызванным метотрексатом увеличением экстрацеллюлярной концентрации аденозина в местах воспаления.
Показания к применению
Ревматоидный артрит у взрослых, полиартрит у пациентов с тяжелым ювенильным хроническим артритом в активной форме, тяжелые генерализованные формы псориаза и псориатического артрита у взрослых при неэффективности стандартной терапии.
Применение при беременности и в период грудного вскармливания
Противопоказано.
Способ применения и дозы
Методжект назначают подкожно. Интегрированная в шприц игла предназначена только для подкожного введения Методжекта ! Методжект не следует смешивать с другими лекарственными препаратами. Препарат должен назначаться врачом, имеющим опыт применения метотрексата и знакомым со свойствами метотрексата и особенностями его действия. Препарат предназначен только для однократного применения. Методжект применяют один раз в неделю. Пациент должен быть ясно проинформирован об однократном еженедельном режиме введения. Рекомендуется назначить для введения конкретный день недели. У пациентов с дополнительным объемом распределения (наличие асцита, плеврального выпота) скорость выведения метотретсата из организма снижена. У таких пациентов необходимо особенно тщательно проводить контроль токсичности, снизить дозу препарата, а в некоторых случаях, при необходимости, прервать лечение. Применение Методжекта проводится под контролем врача. По решению врача препарат может применяться больными самостоятельно. В этом случае больной перед применением препарата должен быть обучен врачом технике выполнения подкожных инъекций. В любом случае первое самостоятельное применение препарата больным должно проводиться в присутствии врача. В случае появления первых признаков нежелательных явлений пациент должен без промедления информировать лечащего врача.
Побочное действие
Наиболее частыми побочными эффектами при применении Методжекта являются реакции со стороны системы кроветворения и пищеварительной системы. Определение частоты побочных эффектов: очень часто (≥ 1/10), часто (≥ 1/100, < 1/10), иногда (≥ 1/1000, < 1/100), редко (≥ 1/10 000, < 1/1000), очень редко (< 1/10 000). Со стороны пищеварительной системы: очень часто - стоматит, диспепсия, тошнота, потеря аппетита, повышение активности трансаминаз, часто - язвы в полости рта, диарея, иногда - энтерит, рвота, цирроз, фиброз и жировое перерождение печени, гепатотоксичность (острый гепатит, печеночная недостаточность), редко - эрозивно-язвенные поражения ЖКТ, очень редко - рвота с примесью крови, кровотечение из ЖКТ (в т.ч. мелена, гематемезис), возможно - панкреатит. Со стороны системы кроветворения: часто - лейкопения, анемия (в т.ч. апластическая), нейтропения, тромбоцитопения, иногда - панцитопения, очень редко - агранулоцитоз, тяжелое угнетение функции костного мозга. Дерматологические реакции: часто - экзантема, эритема, дерматит, кожный зуд, иногда - фотосенсибилизация, облысение, увеличение ревматических узлов, васкулит, инфекции, вызванные Herpes zoster, герпетиформные высыпания на коже, крапивница, редко - повышенная пигментация, очень редко - изменения пигментации ногтей, острые паронихии, синдром Стивенса-Джонсона, токсический эпидермальный некролиз (синдром Лайелла). При лечении псориаза - ощущение жжения кожи, редко - болезненные эрозивные бляшки на коже. Аллергические реакции: различные проявления вплоть до анафилактического шока, аллергический васкулит, лихорадка. Со стороны сердечно-сосудистой системы: перикардит, перикардиальный выпот, перикардиальная тампонада, снижение АД, тромбоэмболия (в т.ч. артериальный тромбоз, тромбоз церебральных сосудов, тромбоз глубоких вен, тромбоз вен сетчатки, тромбофлебит, легочная эмболия). Со стороны ЦНС и периферической нервной системы: часто - головная боль, чувство усталости, сонливость, иногда - головокружение, чувство смятения, депрессия, очень редко - боль, мышечная слабость или парестезия конечностей, нарушение вкусовых ощущений (металлический привкус), судороги, менингизм, паралич. Со стороны эндокринной системы: возможно - сахарный диабет. Со стороны органов чувств: конъюнктивит, очень редко - нарушение зрения, (в т.ч. преходящая слепота), возможно - звон в ушах. Со стороны органов дыхания: часто - интерстициальный альвеолит/пневмония, симптомы потенциально серьезной интерстициальной пневмонии (сухой непродуктивный кашель, одышка и лихорадка), иногда - фарингит, редко - легочный фиброз, легочный пневмоцистоз, легочная недостаточность и бронхиальная астма, возможно - плевральный выпот, носовое кровотечение. Со стороны мочевыделительной системы: иногда - воспаление и язвенное поражение мочевого пузыря, болезненное мочеиспускание, гематурия, гиперурикемия, почечная недостаточность, редко - тяжелая почечная недостаточность, олигурия, анурия, азотемия. Со стороны половой системы: реже - воспаление и язвенное поражение влагалища, очень редко - вагинальные выделения, утрата полового влечения, импотенция, олигоспермия, нарушения менструального цикла, бесплодие. Со стороны костно-мышечной системы: редко - артралгия, миалгия, остеопороз, остеонекроз, повышенный риск возникновения переломов, возможно - некроз мягких тканей. Со стороны обмена веществ: повышенная потливость, гипогаммаглобулинемия, редко - нарушения электролитного баланса. Инфекции: возможно - угрожающие жизни оппортунистические инфекции (в т.ч. пневмоцистная пневмония), цитомегаловирусные инфекции (ЦМВ) (в т.ч. ЦМВ-пневмония), сепсис (в т.ч. фатальный), нокардиоз, гистоплазмоз, криптококкоз, инфекции, вызванные Herpes zoster и Herpes simplex (в т.ч. диссеминированный), ухудшение заживления ран. Новообразования: в отдельных случаях - возникновение лимфом. В недавнем исследовании не было установлено, что терапия метотрексатом увеличивает частоту случаев лимфом. Местные реакции: при применении в/м введении - чувство жжения в месте введения, формирование асептического абсцесса, разрушение жировой клетчатки. Частота и тяжесть побочных эффектов лечения метотрексатом зависит от дозы и частоты применения. Однако тяжелые побочные эффекты могут возникать и при применении метотрексата в низких дозах, поэтому необходимо, чтобы пациенты, получающие метотрексат, регулярно с короткими интервалами проходили медицинское обследование.
Особые указания
Противопоказания к применению:— выраженное нарушение функции печени,— алкоголизм,— почечная недостаточность тяжелой степени (КК менее 20 мл/мин),— нарушения кроветворения в анамнезе, такие как гипоплазия костного мозга, лейкопения, тромбоцитопения, выраженная анемия,— тяжелые острые или хронические инфекционные заболевания, такие как туберкулез, ВИЧ-инфекция,— язвенные поражения ротовой полости,— язвенное поражение ЖКТ в активной фазе,— выраженный иммунодефицит,— беременность,— период лактации (грудного вскармливания),— одновременная вакцинация живыми вакцинами,— повышенная чувствительность к компонентам препарата. С осторожностью следует применять препарат у пациентов с асцитом, дегидратацией, обструктивными заболеваниями ЖКТ, плевральным или перитонеальном выпотом, с хронической почечной недостаточностью, при паразитарных и инфекционных заболеваниях вирусной, грибковой или бактериальной природы (в настоящее время или недавно перенесенные, включая недавний контакт с больным) - простой герпес, опоясывающий герпес в виремической фазе, ветряная оспа, корь, амебиаз, стронгилоидоз установленный или подозреваемый (риск развития тяжелого генерализованного заболевания), при подагре (в т.ч. в анамнезе) или уратном нефроуролитиазе (в т.ч. в анамнезе), инфекции и воспалении слизистой оболочки полости рта, при рвоте и диарее (потеря жидкости вследствие выраженной рвоты и диареи может привести к усилению токсичности метотрексата), язвенной болезни желудка и двенадцатиперстной кишки, язвенном колите, при предшествующей химио- или лучевой терапии, астении, у пациентов пожилого возраста.
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препарата содержит: активное вещество: метотрексат динатрия 54,84 мг (эквивалентно 50 мг метотрексата). Приготовлено по прописи: метотрексат 50 мг, натрия гидроксид 9,6 мг. Вспомогательные вещества: натрия хлорид 4 мг, натрия гидроксид QS (до pH 8,5-8,9), вода для инъекций до 1 мл."}}]},{"id":2,"name":"Описание","slug":"common_description","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Раствор методжект для подкожного введения - 50 мг/мл - по 17,5мг/0,35мл в шприце - противоопухолевый препарат. Антагонист фолиевой кислоты, цитотоксический препарат - антиметаболит. Конкурентно ингибирует фермент дигидрофолатредуктазу, участвующую в восстановлении дигидрофолиевой кислоты в тетрагидрофолиевую кислоту (переносчик углеродных фрагментов, необходимых для синтеза пуриновых нуклеотидов и их производных), и таким образом ингибирует синтез ДНК. Наряду с противоопухолевым обладает иммунодепрессивным действием. Остается невыясненным, чем обусловлена эффективность метотрексата в лечении псориаза, псориатического артрита и ревматоидного артрита (в том числе ювенильного хронического артрита): его противовоспалительным или иммуносупрессивным действием. Также не установлено в какой степени эффективность терапии объясняется вызванным метотрексатом увеличением экстрацеллюлярной концентрации аденозина в местах воспаления."}}]},{"id":3,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Ревматоидный артрит у взрослых, полиартрит у пациентов с тяжелым ювенильным хроническим артритом в активной форме, тяжелые генерализованные формы псориаза и псориатического артрита у взрослых при неэффективности стандартной терапии."}}]},{"id":4,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Противопоказано."}}]},{"id":5,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Методжект назначают подкожно. Интегрированная в шприц игла предназначена только для подкожного введения Методжекта ! Методжект не следует смешивать с другими лекарственными препаратами. Препарат должен назначаться врачом, имеющим опыт применения метотрексата и знакомым со свойствами метотрексата и особенностями его действия. Препарат предназначен только для однократного применения. Методжект применяют один раз в неделю. Пациент должен быть ясно проинформирован об однократном еженедельном режиме введения. Рекомендуется назначить для введения конкретный день недели. У пациентов с дополнительным объемом распределения (наличие асцита, плеврального выпота) скорость выведения метотретсата из организма снижена. У таких пациентов необходимо особенно тщательно проводить контроль токсичности, снизить дозу препарата, а в некоторых случаях, при необходимости, прервать лечение. Применение Методжекта проводится под контролем врача. По решению врача препарат может применяться больными самостоятельно. В этом случае больной перед применением препарата должен быть обучен врачом технике выполнения подкожных инъекций. В любом случае первое самостоятельное применение препарата больным должно проводиться в присутствии врача. В случае появления первых признаков нежелательных явлений пациент должен без промедления информировать лечащего врача."}}]},{"id":6,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Наиболее частыми побочными эффектами при применении Методжекта являются реакции со стороны системы кроветворения и пищеварительной системы. Определение частоты побочных эффектов: очень часто (≥ 1/10), часто (≥ 1/100, \u003c 1/10), иногда (≥ 1/1000, \u003c 1/100), редко (≥ 1/10 000, \u003c 1/1000), очень редко (\u003c 1/10 000). Со стороны пищеварительной системы: очень часто - стоматит, диспепсия, тошнота, потеря аппетита, повышение активности трансаминаз, часто - язвы в полости рта, диарея, иногда - энтерит, рвота, цирроз, фиброз и жировое перерождение печени, гепатотоксичность (острый гепатит, печеночная недостаточность), редко - эрозивно-язвенные поражения ЖКТ, очень редко - рвота с примесью крови, кровотечение из ЖКТ (в т.ч. мелена, гематемезис), возможно - панкреатит. Со стороны системы кроветворения: часто - лейкопения, анемия (в т.ч. апластическая), нейтропения, тромбоцитопения, иногда - панцитопения, очень редко - агранулоцитоз, тяжелое угнетение функции костного мозга. Дерматологические реакции: часто - экзантема, эритема, дерматит, кожный зуд, иногда - фотосенсибилизация, облысение, увеличение ревматических узлов, васкулит, инфекции, вызванные Herpes zoster, герпетиформные высыпания на коже, крапивница, редко - повышенная пигментация, очень редко - изменения пигментации ногтей, острые паронихии, синдром Стивенса-Джонсона, токсический эпидермальный некролиз (синдром Лайелла). При лечении псориаза - ощущение жжения кожи, редко - болезненные эрозивные бляшки на коже. Аллергические реакции: различные проявления вплоть до анафилактического шока, аллергический васкулит, лихорадка. Со стороны сердечно-сосудистой системы: перикардит, перикардиальный выпот, перикардиальная тампонада, снижение АД, тромбоэмболия (в т.ч. артериальный тромбоз, тромбоз церебральных сосудов, тромбоз глубоких вен, тромбоз вен сетчатки, тромбофлебит, легочная эмболия). Со стороны ЦНС и периферической нервной системы: часто - головная боль, чувство усталости, сонливость, иногда - головокружение, чувство смятения, депрессия, очень редко - боль, мышечная слабость или парестезия конечностей, нарушение вкусовых ощущений (металлический привкус), судороги, менингизм, паралич. Со стороны эндокринной системы: возможно - сахарный диабет. Со стороны органов чувств: конъюнктивит, очень редко - нарушение зрения, (в т.ч. преходящая слепота), возможно - звон в ушах. Со стороны органов дыхания: часто - интерстициальный альвеолит/пневмония, симптомы потенциально серьезной интерстициальной пневмонии (сухой непродуктивный кашель, одышка и лихорадка), иногда - фарингит, редко - легочный фиброз, легочный пневмоцистоз, легочная недостаточность и бронхиальная астма, возможно - плевральный выпот, носовое кровотечение. Со стороны мочевыделительной системы: иногда - воспаление и язвенное поражение мочевого пузыря, болезненное мочеиспускание, гематурия, гиперурикемия, почечная недостаточность, редко - тяжелая почечная недостаточность, олигурия, анурия, азотемия. Со стороны половой системы: реже - воспаление и язвенное поражение влагалища, очень редко - вагинальные выделения, утрата полового влечения, импотенция, олигоспермия, нарушения менструального цикла, бесплодие. Со стороны костно-мышечной системы: редко - артралгия, миалгия, остеопороз, остеонекроз, повышенный риск возникновения переломов, возможно - некроз мягких тканей. Со стороны обмена веществ: повышенная потливость, гипогаммаглобулинемия, редко - нарушения электролитного баланса. Инфекции: возможно - угрожающие жизни оппортунистические инфекции (в т.ч. пневмоцистная пневмония), цитомегаловирусные инфекции (ЦМВ) (в т.ч. ЦМВ-пневмония), сепсис (в т.ч. фатальный), нокардиоз, гистоплазмоз, криптококкоз, инфекции, вызванные Herpes zoster и Herpes simplex (в т.ч. диссеминированный), ухудшение заживления ран. Новообразования: в отдельных случаях - возникновение лимфом. В недавнем исследовании не было установлено, что терапия метотрексатом увеличивает частоту случаев лимфом. Местные реакции: при применении в/м введении - чувство жжения в месте введения, формирование асептического абсцесса, разрушение жировой клетчатки. Частота и тяжесть побочных эффектов лечения метотрексатом зависит от дозы и частоты применения. Однако тяжелые побочные эффекты могут возникать и при применении метотрексата в низких дозах, поэтому необходимо, чтобы пациенты, получающие метотрексат, регулярно с короткими интервалами проходили медицинское обследование."}}]},{"id":7,"name":"Особые указания","slug":"cautions","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Противопоказания к применению:— выраженное нарушение функции печени,— алкоголизм,— почечная недостаточность тяжелой степени (КК менее 20 мл/мин),— нарушения кроветворения в анамнезе, такие как гипоплазия костного мозга, лейкопения, тромбоцитопения, выраженная анемия,— тяжелые острые или хронические инфекционные заболевания, такие как туберкулез, ВИЧ-инфекция,— язвенные поражения ротовой полости,— язвенное поражение ЖКТ в активной фазе,— выраженный иммунодефицит,— беременность,— период лактации (грудного вскармливания),— одновременная вакцинация живыми вакцинами,— повышенная чувствительность к компонентам препарата. С осторожностью следует применять препарат у пациентов с асцитом, дегидратацией, обструктивными заболеваниями ЖКТ, плевральным или перитонеальном выпотом, с хронической почечной недостаточностью, при паразитарных и инфекционных заболеваниях вирусной, грибковой или бактериальной природы (в настоящее время или недавно перенесенные, включая недавний контакт с больным) - простой герпес, опоясывающий герпес в виремической фазе, ветряная оспа, корь, амебиаз, стронгилоидоз установленный или подозреваемый (риск развития тяжелого генерализованного заболевания), при подагре (в т.ч. в анамнезе) или уратном нефроуролитиазе (в т.ч. в анамнезе), инфекции и воспалении слизистой оболочки полости рта, при рвоте и диарее (потеря жидкости вследствие выраженной рвоты и диареи может привести к усилению токсичности метотрексата), язвенной болезни желудка и двенадцатиперстной кишки, язвенном колите, при предшествующей химио- или лучевой терапии, астении, у пациентов пожилого возраста."}}]}],"source":{"title":"36.6","url":"https://366.ru"}},"description_toggle":false,"short_description":"Раствор методжект для подкожного введения - 50 мг/мл - по 17,5мг/0,35мл в шприце - противоопухолевый препарат. 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