Липофундин МСТ/ЛСТ эмульс. 10 шт, 250 мл, для инфузий

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При применении согласно инструкции по применению с соблюдением дозы концентрация триглицеридов в плазме крови обычно не превышает 4 ммоль/л."}},{"type":"paragraph","data":{"text":"Распределение"}},{"type":"paragraph","data":{"text":"Сродство среднецепочечных жирных кислот к альбумину несколько меньше чем у длинноцепочечных жирных кислот тем не менее при соблюдении рекомендаций по дозированию препарата среднецепочечные и длинноцепочечные жирные кислоты практически полностью связываются с альбумином плазмы."}},{"type":"paragraph","data":{"text":"При соблюдении дозы среднецепочечные и длинноцепочечные жирные кислоты не проникают через гематоэнцефалический барьер и следовательно не попадают в спинномозговую жидкость."}},{"type":"paragraph","data":{"text":"Данные о проникновении через плацентарный барьер и в грудное молоко отсутствуют."}},{"type":"paragraph","data":{"text":"Метаболизм"}},{"type":"paragraph","data":{"text":"После введения триглицериды гидролизуются до глицерола и жирных кислот. Оба компонента метаболизируются с образованием энергии или используются для синтеза биологически активных веществ глюконеогенеза и ресинтеза липидов."}},{"type":"paragraph","data":{"text":"Выведение"}},{"type":"paragraph","data":{"text":"Период полувыведения компонентов препарата Липофундин МСТ/ЛСТ 20% из плазмы составляет приблизительно 9 минут. Выведения почками триглицеридов или свободных жирных кислот не происходит. Форсированный диурез или гемодиализ не приводят к выведению компонентов препарата Липофундин МСТ/ЛСТ 20%. При передозировке препарата Липофундин МСТ/ЛСТ 20% не возникает интоксикации требующей форсированного диуреза или гемодиализа."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"- Источник энергии включающий легко утилизируемый липидный компонент (среднецепочечные триглицериды);"}},{"type":"paragraph","data":{"text":"- обеспечение организма незаменимыми жирными кислотами в составе парентерального питания."}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"paragraph","data":{"text":"Препарат нельзя назначать при следующих состояниях:"}},{"type":"paragraph","data":{"text":"- гиперчувствительность к яичному белку или белку соевых бобов арахисовому маслу или к любому из действующих или вспомогательных веществ;"}},{"type":"paragraph","data":{"text":"- тяжелая гиперлипидемия;"}},{"type":"paragraph","data":{"text":"- выраженные нарушения свертывания крови;"}},{"type":"paragraph","data":{"text":"- тяжелая печеночная недостаточность;"}},{"type":"paragraph","data":{"text":"- внутрипеченочный холестаз;"}},{"type":"paragraph","data":{"text":"- острая фаза инфаркта миокарда или инсульта;"}},{"type":"paragraph","data":{"text":"- острая тромбоэмболия;"}},{"type":"paragraph","data":{"text":"- жировая эмболия."}},{"type":"paragraph","data":{"text":"Общие противопоказания для парентерального питания:"}},{"type":"paragraph","data":{"text":"- нестабильное угрожающее жизни нарушение кровообращения (коллапс и шок);"}},{"type":"paragraph","data":{"text":"- нестабильный метаболизм (например тяжелый посттравматический синдром декомпенсированный сахарный диабет тяжелый сепсис метаболический ацидоз);"}},{"type":"paragraph","data":{"text":"- тяжелая почечная недостаточность (олиго- или анурия) при отсутствии возможности заместительной почечной терапии;"}},{"type":"paragraph","data":{"text":"- некорригированные нарушения водно-электролитного баланса такие как гипокалиемия и гипотоническая дегидратация;"}},{"type":"paragraph","data":{"text":"- декомпенсированная сердечная недостаточность;"}},{"type":"paragraph","data":{"text":"- острый отек легких;"}},{"type":"paragraph","data":{"text":"- гипергидратация."}}]},{"id":10,"name":"С осторожностью","slug":"cautions","body":[{"type":"paragraph","data":{"text":"Необходимо соблюдать осторожность при назначении препарата пациентам с нарушением жирового метаболизма (например при почечной недостаточности компенсированном сахарном диабете панкреатите нарушении функции печени легкой и средней степени гипотиреозе с гипертриглицеридемией и сепсисе легкой и средней степени)."}}]},{"id":11,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"Беременность"}},{"type":"paragraph","data":{"text":"Данные о применении препарата Липофундин МСТ/ЛСТ 20% во время беременности и возможности проникновения через плацентарный барьер недостаточны. Имеющиеся данные не указывают на прямое или косвенное вредное воздействие на течение беременности и внутриутробное развитие плода роды и послеродовый период. Применение препарата во время беременности возможно если ожидаемая польза для матери превышает риск для плода."}},{"type":"paragraph","data":{"text":"Период грудного вскармливания"}},{"type":"paragraph","data":{"text":"Опыт применения препарата Липофундин МСТ/ЛСТ 20% в период грудного вскармливания отсутствует. В настоящее время недостаточно информации о возможности выделения препарата Липофундин МСТ/ЛСТ 20% с грудным молоком. Как правило кормление грудью во время парентерального питания не рекомендуется."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Способ применения"}},{"type":"paragraph","data":{"text":"Предназначен для внутривенного введения в периферические и центральные вены."}},{"type":"paragraph","data":{"text":"Температура вводимой эмульсии должна соответствовать комнатной."}},{"type":"paragraph","data":{"text":"Жировая эмульсия может вводиться отдельно как одна из составляющих частей полного парентерального питания."}},{"type":"paragraph","data":{"text":"Максимальная суточная доза может быть введена только путем ступенчатого увеличения под тщательным контролем переносимости инфузии."}},{"type":"paragraph","data":{"text":"В зависимости от энергетических потребностей пациента рекомендованы следующие дозы:"}},{"type":"paragraph","data":{"text":"Взрослые и дети с 6 лет"}},{"type":"paragraph","data":{"text":"1-2 г липидов/кг массы тела/сутки что соответствует 5-10 мл/кг массы тела/сутки."}},{"type":"paragraph","data":{"text":"Новорожденные (до 28 дней)"}},{"type":"paragraph","data":{"text":"2-3 г (до 4 г) липидов/кг массы тела/сутки что соответствует 10-15 мл (до 20 мл)/кг массы тела/сутки."}},{"type":"paragraph","data":{"text":"Способность к выведению липидов у недоношенных и новорожденных с низкой массой тела недостаточно развита. Поэтому дозы должны подбираться индивидуально а концентрации триглицеридов и жирных кислот в плазме крови должны тщательно контролироваться."}},{"type":"paragraph","data":{"text":"Дети с 29 дней до 5 лет включительно"}},{"type":"paragraph","data":{"text":"1-3 г липидов/кг массы тела/сутки что соответствует 5-15 мл/кг массы тела/сутки."}},{"type":"paragraph","data":{"text":"Скорость инфузии"}},{"type":"paragraph","data":{"text":"Скорость инфузии жировых эмульсий должна быть максимально низкой и в первые 15 минут инфузии не должна превышать 005-01 г липидов/кг массы тела/ч что соответствует 025-05 мл/кг массы тела/ч."}},{"type":"paragraph","data":{"text":"Максимальная скорость инфузии"}},{"type":"paragraph","data":{"text":"До 015 г липидов/кг массы тела/ч что составляет до 075 мл/кг массы тела/ч. Соответственно скорость введения не должна превышать 025 капли/кг массы тела/мин. Это означает что для пациента с массой тела 70 кг максимальная скорость инфузии составляет приблизительно 50 мл/ч или 18 капель/мин."}},{"type":"paragraph","data":{"text":"Скорость инфузии должна быть снижена у истощенных пациентов и у детей. Рекомендуется выбрать такую скорость инфузии при которой рассчитанная суточная доза вводится в течение около 24 ч но не менее чем за 16 ч."}},{"type":"paragraph","data":{"text":"Продолжительность применения"}},{"type":"paragraph","data":{"text":"В рамках полного парентерального питания Липофундин МСТ/ЛСТ 20% назначается как правило в течение 1-2 недель. Если парентеральное питание с применением жировых эмульсий показано на более длительный период то срок введения препарата Липофундин МСТ/ЛСТ 20% может быть увеличен при проведении соответствующего лабораторного контроля."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"Ниже указаны системные неблагоприятные побочные реакции которые могут быть связаны с применением препарата Липофундин МСТ/ЛСТ 20%. При соблюдении рекомендаций по применению они развиваются очень редко (<1/10000)."}},{"type":"paragraph","data":{"text":"Нарушения со стороны крови и лимфатической системы"}},{"type":"paragraph","data":{"text":"Очень редкие: гиперкоагуляция."}},{"type":"paragraph","data":{"text":"Нарушения со стороны иммунной системы"}},{"type":"paragraph","data":{"text":"Очень редкие: аллергические реакции."}},{"type":"paragraph","data":{"text":"Нарушения со стороны обмена веществ и питания"}},{"type":"paragraph","data":{"text":"Очень редкие: гиперлипидемия гипергликемия метаболический ацидоз."}},{"type":"paragraph","data":{"text":"Эти неблагоприятные побочные реакции являются дозозависимыми и поэтому чаще возникают при относительной или абсолютной передозировке препарата. Частота возникновения этих неблагоприятных побочных реакций менее 1/10000 при применении препарата в строгом соответствии с инструкцией соблюдении режима дозирования и контроля за правильным и безопасным введением препарата."}},{"type":"paragraph","data":{"text":"Нарушения со стороны нервной системы"}},{"type":"paragraph","data":{"text":"Очень редкие: сонливость."}},{"type":"paragraph","data":{"text":"Нарушения со стороны сосудов"}},{"type":"paragraph","data":{"text":"Очень редкие: повышение или снижение артериального давления."}},{"type":"paragraph","data":{"text":"Нарушения со стороны дыхательной системы органов грудной клетки и средостения"}},{"type":"paragraph","data":{"text":"Очень редкие: одышка цианоз."}},{"type":"paragraph","data":{"text":"Нарушения со стороны желудочно-кишечного тракта"}},{"type":"paragraph","data":{"text":"Очень редкие: тошнота рвота."}},{"type":"paragraph","data":{"text":"Общие расстройства и нарушения в месте введения"}},{"type":"paragraph","data":{"text":"Очень редкие: головная боль приливы/эритема повышение температуры тела потливость озноб боль в спине и грудной клетке синдром жировой перегрузки."}},{"type":"paragraph","data":{"text":"В случае развития неблагоприятных побочных реакций или повышения концентрации триглицеридов в плазме крови выше 3 ммоль/л у взрослых и 17 ммоль/л у детей необходимо снизить дозу или прекратить инфузию."}},{"type":"paragraph","data":{"text":"При повторном введении особенно в начале инфузии требуется тщательное наблюдение за состоянием пациента. Триглицериды плазмы крови должны контролироваться с повышенной периодичностью."}},{"type":"paragraph","data":{"text":"Синдром жировой перегрузки"}},{"type":"paragraph","data":{"text":"Нарушение способности к утилизации триглицеридов которое может быть вызвано передозировкой может привести к синдрому “жировой перегрузки”. Необходимо проводить мониторинг с целью раннего выявления симптомов метаболической перегрузки. Синдром жировой перегрузки может быть генетической этиологии (индивидуальные различия в метаболизме) кроме того на жировой обмен могут влиять имеющиеся или перенесенные заболевания. Этот синдром может также развиться на фоне тяжелой гипертриглицеридемии даже при соблюдении рекомендуемой скорости инфузии а также на фоне развития тяжелых осложнений таких как почечная недостаточность или инфекция. Синдром жировой перегрузки характеризуется гиперлипидемией лихорадкой жировой инфильтрацией гепатомегалией (с желтухой или без неё) спленомегалией болями в животе слабостью анемией лейкоцитопенией тромбоцитопенией нарушением свертывания крови гемолизом и ретикулоцитозом не соответствующими норме функциональными пробами печени и комой. Симптомы имеют обратимый характер и обычно исчезают после прекращения инфузии."}},{"type":"paragraph","data":{"text":"В случае появления признаков синдрома жировой перегрузки введение препарата Липофундин МСТ/ЛСТ 20% должно быть немедленно прекращено."}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"Симптомы"}},{"type":"paragraph","data":{"text":"Синдром жировой перегрузки может быть результатом длительного введения жировой эмульсии у пациентов с нарушением выведения триглицеридов."}},{"type":"paragraph","data":{"text":"Передозировка жировой эмульсии содержащей триглицериды средней цепи особенно без сопутствующего введения растворов углеводов может привести к метаболическому ацидозу."}},{"type":"paragraph","data":{"text":"Лечение"}},{"type":"paragraph","data":{"text":"При передозировке показано немедленное прекращение инфузии. Дальнейшие терапевтические меры зависят от конкретных симптомов и их тяжести. В случае возобновлении инфузии после устранения симптомов скорость введения должна увеличиваться постепенно под постоянным наблюдением состояния пациента."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Гепарин вызывает временное повышение активности липопротеинлипазы в плазме крови. Вначале это может привести к усиленному липолизу в плазме за которым следует временное снижение концентрации триглицеридов."}},{"type":"paragraph","data":{"text":"Соевых бобов масло содержит в своем составе витамин К\u003csub\u003e1\u003c/sub\u003e. Однако его содержание в препарате Липофундин МСТ/ЛСТ 20% настолько низкое что значительного влияния на процессы свертывания крови у пациентов получающих непрямые антикоагулянты - производные кумарина не оказывается. Тем не менее у пациентов получающих антикоагулянты необходим контроль коагулограммы."}},{"type":"paragraph","data":{"text":"Липофундин МСТ/ЛСТ 20% нельзя применять как носитель растворов электролитов или других лекарственных препаратов нельзя смешивать с другими растворами для инфузий без предварительной проверки совместимости так как в этом случае не может быть гарантирована стабильность жировой эмульсии."}},{"type":"paragraph","data":{"text":"Нельзя допускать смешивания препарата Липофундин М6Т/ЛСТ 20% со спиртосодержащими инъекционными или инфузионными растворами."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"Липофундин МСТ/ЛСТ 20% всегда должен быть частью режима парентерального питания включающего назначение препаратов аминокислот и растворов углеводов. Тошнота рвота отсутствие аппетита и гипергликемия - симптомы которые являются основанием для назначения парентерального питания или часто имеются у пациентов которым показано парентеральное питание."}},{"type":"paragraph","data":{"text":"При введении препарата Липофундин МСТ/ЛСТ 20% необходимо контролировать концентрацию триглицеридов в плазме крови. При подозрении наличия у пациента нарушений жирового метаболизма исходная гиперлипидемия с концентрацией триглицеридов плазмы крови выше 3 ммоль/л у взрослых и выше 17 ммоль/л у детей должна быть устранена до начала инфузии. Гипертриглицеридемия спустя 12 ч после введения препарата указывает на нарушение метаболизма жиров."}},{"type":"paragraph","data":{"text":"В зависимости от состояния метаболизма пациента может развиться преходящая гипертриглицеридемия или повышение концентрации глюкозы в плазме крови. Если концентрация триглицеридов в плазме во время введения жировой эмульсии превышает указанные выше предельные значения для взрослых и детей рекомендовано снизить скорость инфузии. Если концентрация триглицеридов в плазме остается выше 3 ммоль/л введение должно быть приостановлено до нормализации концентрации триглицеридов в плазме крови."}},{"type":"paragraph","data":{"text":"При назначении жировых эмульсий новорожденным и детям до 1 года билирубин может вытесняться из связи с альбумином. Этот эффект обусловлен триглицеридами длинной цепи."}},{"type":"paragraph","data":{"text":"Нарушения водно-электролитного баланса такие как гипокалиемия и гипотоническая дегидратация должны быть скорригированы путем введения жидкости и электролитов в необходимых количествах до начала парентерального питания."}},{"type":"paragraph","data":{"text":"Необходим контроль электролитов баланса жидкости или массы тела кислотно-основного равновесия концентрации глюкозы в плазме крови а при длительном применении - клеточного состава крови коагулограммы и функций печени."}},{"type":"paragraph","data":{"text":"Реакции гиперчувствительности на любой компонент препарата Липофундин МСТ/ЛСТ 20% (например на следы белка в соевых бобов масле или на лецитин яичный) проявляются крайне редко но не могут быть полностью исключены у сенсибилизированных пациентов. При любом из симптомов аллергической реакции (например высокой температуре ознобе сыпи или одышке) необходимо немедленно прекратить инфузию препарата Липофундин МСТ/ЛСТ 20% (или любой другой жировой эмульсии)."}},{"type":"paragraph","data":{"text":"Передозировка может привести к синдрому жировой перегрузки."}},{"type":"paragraph","data":{"text":"Жировая эмульсия может снизить точность лабораторных исследований (например билирубин лактатдегидрогеназа степень насыщения крови кислородом гемоглобин) если образцы крови взяты во время или сразу после окончания инфузии препарата. У большинства пациентов липиды исчезают из кровотока через 5-6 ч после завершения инфузии."}},{"type":"paragraph","data":{"text":"Применение жировых эмульсий в качестве единственного источника энергии может спровоцировать возникновение метаболического ацидоза. Одновременное применение растворов углеводов предупреждает развитие этого осложнения. Таким образом инфузия жировой эмульсии всегда должна сочетаться с введением в достаточных количествах углеводных растворов или препаратов содержащих аминокислоты и углеводы."}},{"type":"paragraph","data":{"text":"Входящий в состав препарата витамин Е влияет на эффективность витамина К участвующего в синтезе факторов свертывания крови. Это необходимо принимать во внимание при назначении препарата пациентам с нарушениями свертывания крови или подозрением на дефицит витамина К."}},{"type":"paragraph","data":{"text":"Липофундин МСТ/ЛСТ 20% содержит 26 ммоль натрия/л. Это необходимо учитывать у пациентов находящихся на бессолевой диете."}},{"type":"paragraph","data":{"text":"Если при введении препарата используются фильтры они должны быть жиропроницаемыми."}},{"type":"paragraph","data":{"text":"При введении эмульсии одновременно с аминокислотами и растворами углеводов Y-образный или обходной коннекторы должны быть расположены максимально близко к пациенту."}},{"type":"paragraph","data":{"text":"Перед введением жировой эмульсии вместе с другими растворам через Y-образный или обходной коннекторы необходимо проверить совместимость этих препаратов."}},{"type":"paragraph","data":{"text":"Особую осторожность следует проявлять при совместном введении с растворами которые содержат двухвалентные электролиты (например кальций)."}},{"type":"paragraph","data":{"text":"Бутылка для одноразового применения."}},{"type":"paragraph","data":{"text":"Оставшиеся неиспользованными объемы препарата выбрасывать."}},{"type":"paragraph","data":{"text":"Перед применением аккуратно взболтать."}},{"type":"paragraph","data":{"text":"Эмульсию использовать только в том случае если после взбалтывания она однородна и бутылка не повреждена."}},{"type":"paragraph","data":{"text":"Перед применением визуально оценить однородность эмульсии."}},{"type":"paragraph","data":{"text":"После случайного замораживания препарат не подлежит использованию."}}]},{"id":17,"name":"Влияние на способность управлять автомобилем и движущимися механизмами","slug":"","body":[{"type":"paragraph","data":{"text":"Препарат не оказывает влияния на способность управлять транспортными средствами механизмами а также заниматься потенциально опасными видами деятельности требующими повышенной концентрации внимания и быстроты психомоторных реакций."}}]},{"id":18,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"Эмульсия для инфузий 20%."}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"Хранить при температуре не выше 25 °С. Не замораживать."}},{"type":"paragraph","data":{"text":"Хранить в местах недоступных для детей."}}]},{"id":20,"name":"Срок годности","slug":"expiry_date","body":[{"type":"paragraph","data":{"text":"2 года."}},{"type":"paragraph","data":{"text":"Не применять по истечении срока годности указанного на упаковке."}}]},{"id":21,"name":"Условия отпуска","slug":"release_condition","body":[{"type":"paragraph","data":{"text":"По рецепту"}}]},{"id":22,"name":"Производитель","slug":"","body":[{"type":"paragraph","data":{"text":"Б.Браун Мельзунген АГ"}}]},{"id":23,"name":"Организация, принимающая претензии потребителей","body":[{"type":"paragraph","data":{"text":"Б.Браун Мельзунген АГ"}}]}],"source":null},"description_toggle":false,"short_description":"Липофундин МСТ/ЛСТ 20% как часть режима парентерального питания является источником энергии и полиненасыщенных (\"незаменимых\") жирных кислот. С этой целью Липофундин МСТ/ЛСТ 20% содержит триглицериды средней цепи триглицериды длинной цепи (соевых бобов масло) фосфолипиды (лецитин яичный) и глицерол. Триглицериды средней цепипо сравнению с триглицеридами длинной цепи быстрее гидролизуются выводятся и полностью окисляются. Они являются более предпочтительным источником энергии особенно при нарушении процессов метаболизма и/или выведения триглицеридов длинной цепи например в случае дефицита липопротеинлипазы кофакторов липопротеинлипазы карнитина и нарушения карнитинзависимой транспортной системы. Ненасыщенные жирные кислоты входящие в состав триглицеридов длинной цепи используются в организме главным образом для профилактики и лечения недостатка незаменимых жирных кислот и лишь во вторую очередь в качестве источника энергии. Фосфолипиды помимо их функции в качестве эмульгатора триглицеридов являются компонентами клеточных мембран и необходимы для их текучести и выполнения биологических функций. Глицерол добавляемый для придания эмульсии изотоничности является промежуточным веществом метаболизма глюкозы и липидов: он метаболизируется в процессе гликолиза с образованием энергии или используется для синтеза глюкозы гликогена и триглицеридов. В ходе фармакологических исследовании безопасности было выявлено только нутритивное терапевтическое действие препарата сходное с терапевтическим действием оказываемым при пероральном введении компонентов препарата. Всасывание Биодоступность. Поскольку Липофундин МСТ/ЛСТ 20% вводится внутривенно биодоступность всех его компонентов составляет 100%. Максимальная индивидуальная концентрация триглицеридов в плазме крови зависит от дозы скорости введения состояния метаболизма и состояния пациента (степени истощения). При применении согласно инструкции по применению с соблюдением дозы концентрация триглицеридов в плазме крови обычно не превышает 4 ммоль/л. Распределение Сродство среднецепочечных жирных кислот к альбумину несколько меньше чем у длинноцепочечных жирных кислот тем не менее при соблюдении рекомендаций по дозированию препарата среднецепочечные и длинноцепочечные жирные кислоты практически полностью связываются с альбумином плазмы. При соблюдении дозы среднецепочечные и длинноцепочечные жирные кислоты не проникают через гематоэнцефалический барьер и следовательно не попадают в спинномозговую жидкость. Данные о проникновении через плацентарный барьер и в грудное молоко отсутствуют. Метаболизм После введения триглицериды гидролизуются до глицерола и жирных кислот. Оба компонента метаболизируются с образованием энергии или используются для синтеза биологически активных веществ глюконеогенеза и ресинтеза липидов. Выведение Период полувыведения компонентов препарата Липофундин МСТ/ЛСТ 20% из плазмы составляет приблизительно 9 минут. Выведения почками триглицеридов или свободных жирных кислот не происходит. 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