Энплейт Порошок, 1 шт, 5 мл, 250 мкг

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Одну контурную ячейковую упаковку помещают в картонную пачку вместе с листком-вкладышем. На каждую пачку наклеивают две прозрачные защитные этикетки для контроля первого вскрытия, имеющие продольную цветную полосу."}}]},{"id":7,"name":"Фармакологические свойства","slug":"pharmacologic_effects","body":[{"type":"paragraph","data":{"text":"Действующим веществом препарата Энплейт является ромиплостим. Ромиплостим относится к гемостатическим средствам, и его действие основано на стимуляции производства тромбоцитов – специфических клеток, работа которых необходима для остановки кровотечений. Ромиплостим применяется при низком количестве тромбоцитов у пациентов с первичной иммунной тромбоцитопенией (ИТП). ИТП — это заболевание, при котором иммунная система организма уничтожает собственные тромбоциты. Тромбоциты представляют собой клетки крови, способствующие устранению повреждений тканей и формирующие тромбы. Значительное снижение количества тромбоцитов может привести к появлению кровоподтеков и стать причиной серьезного кровотечения."}},{"type":"paragraph","data":{"text":"Принцип работы препарата Энплейт заключается в стимуляции костного мозга (кроветворного органа внутри костей, вырабатывающего клетки крови) с целью увеличения количества тромбоцитов. Такая стимуляция должна способствовать предотвращению появления гематом и предупреждать кровотечения на фоне ИТП."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"Препарат Энплейт применяется для лечения взрослых пациентов с ИТП с сохраненной селезенкой или без нее, которые не ответили на предыдущую терапию кортикостероидами или иммуноглобулинами. "}},{"type":"paragraph","data":{"text":"Препарат Энплейт также применяется для лечения детей в возрасте от 1 года с хронической ИТП с сохраненной селезенкой или без нее, которые не ответили на предыдущую терапию кортикостероидами или иммуноглобулинами."}},{"type":"paragraph","data":{"text":"Если улучшение не наступило или Вы чувствуете ухудшение, необходимо обратиться к врачу."}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"paragraph","data":{"text":"Не применяйте препарат Энплейт:"}},{"type":"list","data":{"style":"ordered","items":["если у Вас аллергия на ромиплостим или любые другие компоненты препарата (перечисленные в разделе 6 листка-вкладыша);","если у Вас аллергия на другие лекарственные препараты, которые производятся по ДНК-технологии с применением бактерии Escherichia coli (E. coli)."]}},{"type":"paragraph","data":{"text":"\u003cb\u003eПрепарат Энплейт не рекомендован для применения у детей в возрасте до 1 года.\u003c/b\u003e"}}]},{"id":11,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"Беременность и грудное вскармливание"}},{"type":"paragraph","data":{"text":"Если Вы беременны или кормите грудью, думаете, что можете быть беременны, или планируете беременность, перед началом применения лекарственного препарата проконсультируйтесь с Вашим лечащим врачом или работником аптеки. Препарат Энплейт не рекомендован для применения во время беременности, за исключением случаев, когда он назначен Вам лечащим врачом."}},{"type":"paragraph","data":{"text":"Неизвестно, проникает ли ромиплостим в грудное молоко. Препарат Энплейт не рекомендован для применения в период грудного вскармливания. При принятии решения о прекращении грудного вскармливания или терапии ромиплостимом следует учитывать пользу грудного вскармливания для ребенка и пользу терапии ромиплостимом для матери."}},{"type":"paragraph","data":{"text":"Прежде чем применять какой-либо лекарственный препарат, проконсультируйтесь с Вашим лечащим врачом."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Всегда применяйте препарат в полном соответствии с рекомендациями лечащего врача."}},{"type":"paragraph","data":{"text":"При появлении сомнений посоветуйтесь с лечащим врачом."}},{"type":"paragraph","data":{"text":"Применение у взрослых и детей (в возрасте от 1 года до 17 лет)"}},{"type":"paragraph","data":{"text":"Рекомендуемая доза"}},{"type":"paragraph","data":{"text":"Начальная доза составляет 1 микрограмм препарата Энплейт на килограмм массы тела (один раз в неделю). Ваш лечащий врач сообщит Вам, какое количество препарата необходимо получать. Для повышения количества тромбоцитов инъекции препарата Энплейт следует выполнять один раз в неделю. Ваш лечащий врач будет регулярно брать образцы крови для оценки тромбоцитарного ответа. При необходимости доза будет корректироваться."}},{"type":"paragraph","data":{"text":"Когда количество тромбоцитов будет под контролем, лечащий врач продолжит регулярно проверять Вашу кровь. Доза может быть скорректирована в целях поддержания необходимого количества тромбоцитов на протяжении длительного времени."}},{"type":"paragraph","data":{"text":"Применение у детей (в возрасте от 1 года до 17 лет)"}},{"type":"paragraph","data":{"text":"Помимо определения количества тромбоцитов, для корректировки дозы лечащий врач также будет регулярно измерять массу тела."}},{"type":"paragraph","data":{"text":"Путь и (или) способ введения"}},{"type":"paragraph","data":{"text":"Препарат Энплейт применяется под непосредственным наблюдением лечащего врача, тщательно следящего за тем, какую дозу Вы получаете."}},{"type":"paragraph","data":{"text":"Препарат Энплейт вводится один раз в неделю в виде подкожной инъекции."}},{"type":"paragraph","data":{"text":"Если Вы применили препарата Энплейт больше, чем следовало"}},{"type":"paragraph","data":{"text":"Лечащий врач убедится, что Вы получаете правильную дозу препарата Энплейт. В случае применения большей дозы препарата Энплейт у Вас может не возникнуть каких-либо физических симптомов, однако количество тромбоцитов может стать очень высоким, что приведет к увеличению риска образования тромбов. Таким образом, при возникновении у лечащего врача подозрения на применение большей дозы препарата Энплейт рекомендуется следить за появлением любых признаков или симптомов нежелательных реакций и незамедлительно получить соответствующее лечение."}},{"type":"paragraph","data":{"text":"Если Вы применили препарата Энплейт меньше, чем следовало"}},{"type":"paragraph","data":{"text":"Лечащий врач убедится, что Вы получаете правильную дозу препарата Энплейт. В случае применения меньшей дозы препарата Энплейт у Вас может не возникнуть каких-либо физических симптомов, однако количество тромбоцитов может снизиться, что приведет к увеличению риска кровотечения. Таким образом, при возникновении у лечащего врача подозрения на применение меньшей дозы препарата Энплейт рекомендуется следить за появлением любых признаков и симптомов нежелательных реакций и незамедлительно получить соответствующее лечение."}},{"type":"paragraph","data":{"text":"Если Вы забыли применить препарат Энплейт"}},{"type":"paragraph","data":{"text":"Если Вы пропустили дозу препарата Энплейт, Ваш лечащий врач договорится с Вами о времени введения следующей дозы."}},{"type":"paragraph","data":{"text":"Если Вы прекратили применение препарата Энплейт"}},{"type":"paragraph","data":{"text":"При прекращении применения препарата Энплейт возможен рецидив тромбоцитопении (снижение количества тромбоцитов). Ваш лечащий врач решит, можете ли Вы прекратить применение препарата Энплейт."}},{"type":"paragraph","data":{"text":"При наличии вопросов по применению препарата обратитесь к Вашему лечащему врачу."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"Подобно всем лекарственным препаратам данный препарат может вызвать нежелательные реакции, однако они возникают не у всех."}},{"type":"paragraph","data":{"text":"Наиболее серьезные нежелательные реакции, которые могут возникать при применении препарата Энплейт, перечислены ниже:"}},{"type":"paragraph","data":{"text":"Частые — могут возникать не более чем у 1 из 10 человек (могут выявляться при проведении анализов крови и мочи):"}},{"type":"list","data":{"style":"ordered","items":["низкое количество тромбоцитов в крови (рецидив тромбоцитопении и кровотечения после прекращения лечения);","повышенное количество тромбоцитов в крови, которое может увеличить риск свертывания крови (тромботические/тромбоэмболические осложнения);"]}},{"type":"paragraph","data":{"text":"Частые — могут возникать не более чем у 1 из 10 человек"}},{"type":"list","data":{"style":"ordered","items":["нарушения со стороны костного мозга, в том числе увеличение количества волокон костного мозга (увеличение уровня отложений ретикулина);"]}},{"type":"paragraph","data":{"text":"Нечастые — могут возникать не более чем у 1 из 10 человек (могут выявляться при проведении анализов крови и мочи):"}},{"type":"list","data":{"style":"ordered","items":["количество тромбоцитов в крови может подняться до очень высокого уровня (передозировка), что может увеличить риск свертывания крови; или количество тромбоцитов может снизиться (недостаточная доза), что может увеличить риск кровотечения (ошибки при применении препарата);"]}},{"type":"paragraph","data":{"text":"Частота неизвестна — исходя из имеющихся данных частоту возникновения определить невозможно: "}},{"type":"list","data":{"style":"ordered","items":["увеличение количества бластных клеток и ухудшение миелодисплатического синдрома до острого миелоидного лейкоза, который является типом злокачественного заболевания крови (прогрессирование имеющегося миелодисплатического синдрома до острого миелоидного лейкоза)."]}},{"type":"paragraph","data":{"text":"Если у вас развился какой-либо из перечисленных выше симптомов, немедленно прекратите применение препарата Энплейт и обратитесь к врачу, или обратитесь за медицинской помощью."}},{"type":"paragraph","data":{"text":"Возможные нежелательные реакции у взрослых пациентов с ИТП"}},{"type":"paragraph","data":{"text":"Очень частые — могут возникать более чем у 1 из 10 человек:"}},{"type":"list","data":{"style":"ordered","items":["головная боль;","гиперчувствительность (аллергическая реакция);","инфекция верхних дыхательных путей."]}},{"type":"paragraph","data":{"text":"Частые — могут возникать не более чем у 1 из 10 человек:"}},{"type":"list","data":{"style":"ordered","items":["нарушение сна (бессонница);","головокружение;","ощущение покалывания или онемения в кистях и стопах (парестезия);","мигрень;","покраснение кожи (приливы крови);","тромбоз легочной артерии (легочная эмболия);","тошнота;","диарея;","боль в животе;","нарушенное пищеварение (диспепсия);","запор;","кожный зуд (зуд);","подкожное кровоизлияние (экхимоз);","кровоподтеки (ушибы);","сыпь;","боль в суставах (артралгия);","боль или слабость в мышцах (миалгия);","боль в кистях и стопах;","мышечные спазмы;","боль в спине;","боль в костях;","утомляемость (усталость);","реакции в месте инъекции;","отек кистей и стоп (периферический отек);","гриппоподобные симптомы (гриппоподобное заболевание);","боль;","слабость (астения);","повышение температуры тела (пирексия);","озноб;","ушибы;","отек лица, губ, рта, языка или горла, который может препятствовать глотанию или дыханию (ангионевротический отек);","гастроэнтерит;","ощущение сильного сердцебиения;","воспаление придаточных пазух носа (синусит);","воспаление путей, по которым воздух попадает в легкие (бронхит)."]}},{"type":"paragraph","data":{"text":"Частые — могут возникать не более чем у 1 из 10 человек (могут выявляться при проведении анализов крови и мочи):"}},{"type":"list","data":{"style":"ordered","items":["анемия."]}},{"type":"paragraph","data":{"text":"Нечастые — могут возникать не более чем у 1 из 100 человек:"}},{"type":"list","data":{"style":"ordered","items":["недостаточность костного мозга, заболевание костного мозга, приводящее к образованию рубцов (миелофиброз), увеличение селезенки (спленомегалия), вагинальное кровотечение, ректальное кровотечение, кровотечение в ротовой полости, кровоизлияние в месте инъекции;","сердечный приступ (инфаркт миокарда), повышенная частота сердечных сокращений;","головокружение или ощущение головокружения (вертиго);","проблемы с глазами, в том числе глазное кровоизлияние (кровоизлияние в конъюнктиву), затрудненная фокусировка или помутнение в поле зрения (нарушение аккомодации, застойный диск или нарушения со стороны глаз), слепота, зуд в глазу, повышенное слезотечение, расстройство зрения;","проблемы с пищеварительной системой, в том числе рвота, запах изо рта, затрудненное глотание (дисфагия), нарушеное пищеварение или изжога (гастроэзофагеальная рефлюксная болезнь), кровь в кале (гематохезия), дискомфорт в области живота, язвы или волдыри в полости рта (стоматит), изменение окраски зубов;","снижение массы тела, увеличение массы тела, непереносимость алкоголя, потеря аппетита (анорексия или снижение аппетита), обезвоживание;","общее чувство недомогания, боль в грудной клетке, раздражительность, отечность лица (отек лица), ощущение жара, повышенная температура тела, ощущение тревоги;","грипп, местная инфекция, воспаление носовых ходов и горла (назофарингит);","проблемы с носом и горлом, в том числе кашель, насморк (ринорея), сухость в горле, одышка или затрудненное дыхание (диспноэ), заложенность носа, боль при дыхании;","болезненность и отечность суставов вследствие воздействия мочевой кислоты, которая образуется при реакциях распада в процессе пищеварения (подагра);","напряженность мышц, мышечная слабость, боль в области плеча, подергивание мышц;","проблемы с нервной системой, в том числе непроизвольные сокращения мышц (клонус), расстройство вкуса (дисгевзия), ослабление вкусового восприятия (гипогевзия), снижение чувствительности, в особенности кожи (гипестезия), нарушения функционирования нервов в руках и ногах (периферическая нейропатия), попадание тромба в поперечный синус (тромбоз поперечного синуса);","депрессия, необычные сновидения;","выпадение волос (алопеция), чувствительность к свету (реакция фоточувствительности), угри, кожная аллергическая реакция при контакте с аллергеном (контактный дерматит), сыпь и волдыри на коже (экзема), сухая кожа, покраснение на коже (эритема), усиленное шелушение кожи (эксфолиативная сыпь), аномальный рост волос, утолщение и зуд кожи из-за расчесывания (пруриго), подкожное кровоизлияние или кровотечение (пурпура), папулезная сыпь, зудящая кожная сыпь, генерализованная зудящая сыпь (крапивница), кожные узелки, необычный запах тела;","проблемы с циркуляцией крови, в том числе образование тромбов в вене внутри печени (тромбоз воротной вены), тромбоз глубоких вен, низкое артериальное давление (гипотензия), высокое артериальное давление, закупорка кровеносных сосудов (эмболия периферической артерии), снижение кровотока в кистях, голеностопах или стопах (периферическая ишемия), отечность вен и образование в них тромбов, что иногда сопровождается особой болезненностью при касании вен (флебит или поверхностных тромбофлебит), образование тромбов (тромбоз);","редкий синдром, при котором периодически возникает жгучая боль в стопах и кистях, сопровождаемая покраснением и повышением их температуры (эритромелалгия)."]}},{"type":"paragraph","data":{"text":"Нечастые — могут возникать не более чем у 1 из 10 человек (могут выявляться при проведении анализов крови и мочи):"}},{"type":"list","data":{"style":"ordered","items":["редкий тип анемии, при котором снижается уровень эритроцитов, лейкоцитов и тромбоцитов (апластическая анемия);","повышенное количество лейкоцитов (лейкоцитоз);","изменения результатов некоторых анализов крови (повышение уровня трансаминаз, повышение уровня лактатдегидрогеназы в крови);","рак лейкоцитов (множественная миелома);","белок в моче."]}},{"type":"paragraph","data":{"text":"Возможные нежелательные реакции у детей с ИТП"}},{"type":"paragraph","data":{"text":"Очень частые — могут возникать более чем у 1 из 10 человек:"}},{"type":"list","data":{"style":"ordered","items":["инфекция верхних дыхательных путей;","боль во рту и горле (боль в ротоглотке);","ринит (зуд, насморк или заложенность носа);","кашель;","боль в верхних отделах живота;","диарея;","сыпь;","повышение температуры тела (пирексия);","кровоподтеки (ушибы)."]}},{"type":"paragraph","data":{"text":"Частые — могут возникать не более чем у 1 из 10 человек:"}},{"type":"list","data":{"style":"ordered","items":["гастроэнтерит;","боль и дискомфорт в горле при глотании (фарингит);","воспаление глаза (конъюнктивит);","ушная инфекция;","воспаление придаточных пазух носа (синусит);","отек конечностей, кистей или стоп;","подкожное кровоизлияние или кровотечение (пурпура);","зудящая сыпь (крапивница)."]}},{"type":"paragraph","data":{"text":"Нечастые — могут возникать не более чем у 1 из 100 человек:"}},{"type":"list","data":{"style":"ordered","items":["повышенное количество тромбоцитов (тромбоцитоз)."]}},{"type":"paragraph","data":{"text":"Сообщение о нежелательных реакциях"}},{"type":"paragraph","data":{"text":"Если у Вас возникают какие-либо нежелательные реакции, проконсультируйтесь с лечащим врачом, работником аптеки или медицинской сестрой/медицинским братом. Данная рекомендация распространяется на любые возможные нежелательные реакции, в том числе на не перечисленные в листке-вкладыше. Вы также можете напрямую сообщить о нежелательных реакциях в информационную базу данных по нежелательным реакциям (действиям) на лекарственные препараты, включая сообщения о неэффективности лекарственных препаратов, выявленные на территории государства–члена. Сообщая о нежелательных реакциях, Вы помогаете получить больше сведений о безопасности препарата."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"Перед применением препарата Энплейт проконсультируйтесь с Вашим лечащим врачом, работником аптеки или медицинской сестрой:"}},{"type":"list","data":{"style":"ordered","items":["Если у Вас повышен риск образования тромбов или это явление распространено в Вашей семье. "]}},{"type":"paragraph","data":{"text":"Следующие факторы также повышают риск образования тромбов:"}},{"type":"list","data":{"style":"ordered","items":["проблемы с печенью;","пожилой возраст (≥ 65 лет);","прикованность к постели;","злокачественные новообразования;","прием противозачаточных таблеток или получение заместительной гормональной терапии;","недавнее оперативное вмешательство или получение травмы;","ожирение (избыточная масса тела);","курение."]}},{"type":"paragraph","data":{"text":"При очень высоком количестве тромбоцитов эти факторы могут увеличить риск образования тромбов. Ваш лечащий врач скорректирует дозу препарата Энплейт, чтобы исключить чрезмерное повышение количества тромбоцитов."}},{"type":"list","data":{"style":"ordered","items":["При прекращении применения препарата Энплейт возможен рецидив тромбоцитопении (снижение количества тромбоцитов). В случае отмены препарата Энплейт потребуется следить за уровнем тромбоцитов. Кроме того, Ваш лечащий врач обсудит с Вами меры предосторожности, которые необходимо соблюдать."]}},{"type":"paragraph","data":{"text":"Прослеживаемость"}},{"type":"paragraph","data":{"text":"Для улучшения прослеживаемости биологических лекарственных препаратов необходимо точно документировать наименование и номер серии применяемого препарата."}},{"type":"paragraph","data":{"text":"Изменения в костном мозге (повышение концентрации ретикулина и возможный фиброз костного мозга)"}},{"type":"paragraph","data":{"text":"Длительное применение препарата Энплейт может стать причиной изменений в костном мозге. Эти изменения могут привести к появлению аномальных клеток крови или снижению продукции клеток крови. Легкая форма этих изменений в костном мозге, характеризуемая повышением концентрации ретикулина, отмечалась в клинических исследованиях препарата Энплейт. Неизвестно, прогрессируют ли эти изменения до более тяжелой формы (фиброза). Признаками изменений в костном мозге могут быть отклонения, выявленные при проведении анализов крови. Ваш лечащий врач определит, означают ли отклонения в результатах анализов крови, что требуется провести исследования костного мозга или прекратить применение препарата Энплейт."}},{"type":"paragraph","data":{"text":"Ошибки при применении препарата"}},{"type":"paragraph","data":{"text":"Медицинские ошибки при применении препарата Энплейт могут заключаться во введении слишком большой или недостаточной дозы. Необходимо соблюдать рекомендации по расчету и коррекции дозы. "}},{"type":"paragraph","data":{"text":"Введение слишком высоких доз препарата может привести к чрезмерному увеличению количества тромбоцитов, которое может вызвать тромботические/тромбоэмболические осложнения. При чрезмерном увеличении количества тромбоцитов необходимо прекратить применение препарата Энплейт, необходимо контролировать количество тромбоцитов. "}},{"type":"paragraph","data":{"text":"Введение недостаточной дозы может привести к образованию меньшего, чем ожидалось, количества тромбоцитов и вероятности возникновения кровотечения. Рекомендуется контролировать количество тромбоцитов при применении препарата Энплейт."}},{"type":"paragraph","data":{"text":"Прогрессирование злокачественных заболеваний крови"}},{"type":"paragraph","data":{"text":"Ваш лечащий врач может решить провести биопсию костного мозга, если посчитает это необходимым для подтверждения диагноза ИТП и исключения других заболеваний, таких как миелодиспластический синдром (МДС). 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Лечащий врач может рекомендовать Вам регулярно сдавать кровь для контроля данных параметров. "}}]},{"id":17,"name":"Влияние на способность управлять автомобилем и движущимися механизмами","slug":"","body":[{"type":"paragraph","data":{"text":"Прежде чем начать управление транспортными средствами и работу с механизмами, поговорите с Вашим лечащим врачом, поскольку некоторые нежелательные реакции на препарат (например, приступы головокружения) могут влиять на способность выполнять соответствующие действия безопасным образом."}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"Храните препарат в недоступном для ребенка месте так, чтобы ребенок не мог его увидеть."}},{"type":"paragraph","data":{"text":"Не применяйте препарат после истечения срока годности, указанного на картонной пачке и этикетке флакона после фразы «Годен до:». Датой истечения срока годности является последний день указанного месяца."}},{"type":"paragraph","data":{"text":"Храните при температуре от 2 до 8 °C. "}},{"type":"paragraph","data":{"text":"Не замораживать."}},{"type":"paragraph","data":{"text":"Храните в оригинальной упаковке (картонной пачке) для защиты от света."}},{"type":"paragraph","data":{"text":"Препарат может храниться вне холодильника в течение 30 дней при температуре не выше 25 °C в оригинальной упаковке (пачке картонной)."}},{"type":"paragraph","data":{"text":"После разведения: в течение 24 часов при температуре 25 °С или в течение 24 часов при температуре от 2 до 8 °С в оригинальной упаковке (пачке картонной) для защиты от света."}},{"type":"paragraph","data":{"text":"Не выбрасывайте никакие лекарственные препараты в канализацию или вместе с бытовыми отходами. Уточните у работника аптеки как избавиться от препаратов, которые больше не потребуются. 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