У взрослых: блефароспазм; гемифациальный спазм; спастическая кривошея; спастичность мышц руки после инсульта; гиперкинетические складки (мимические морщины) лица. У детей старше 2 лет: динамическая деформация стопы, вызванная спастичностью при ДЦП.
Противопоказания
– беременность; – острая фаза сопутствующих заболеваний.
Инструкция
Состав
В 100 мл содержится: 28,6 мл воды Атлантического океана, 71,4 мл воды очищенной и 0,05 г экстракта Aloe vera. Концентрация соли в КВИКС алоэ соответствует прибл. 9 г NaCl на литр (изотоническая). Не содержит химических добавок и консервантов
Описание
Отпуск иммунобиологического лекарственного препарата ОСУЩЕСТВЛЯЕТСЯ ПО РЕЦЕПТУ ВРАЧА и ПРИ НАЛИЧИИ У ПОКУПАТЕЛЯ ТЕРМОКОНТЕЙНЕРА, в который помещается лекарственный препарат, доставка данного лекарственного препарата в медицинскую организацию при условии хранения в специальном термоконтейнере не должна превышать срок 48 часов после его приобретения.
Фармакологические свойства
Миорелаксирующее.
Показания к применению
У взрослых: блефароспазм; гемифациальный спазм; спастическая кривошея; спастичность мышц руки после инсульта; гиперкинетические складки (мимические морщины) лица. У детей старше 2 лет: динамическая деформация стопы, вызванная спастичностью при ДЦП.
Противопоказания
– беременность; – острая фаза сопутствующих заболеваний.
Применение при беременности и в период грудного вскармливания
Противопоказано при беременности
Способ применения и дозы
Для взрослых и пожилых пациентов суммарная начальная доза для лечения двустороннего блефароспазма составляет 120 ЕД на каждый глаз. Препарат вводят п/к в объеме 0.1 мл (20 ЕД) медиально, в объеме 0.2 мл (40 ЕД) - латерально в соединение между пресептальной и глазничными частями как нижней, так и верхней орбитальной мышцами каждого глаза. Для проведения инъекций в верхнее веко иглу следует направлять в сторону от центра, чтобы не задеть мышцу, поднимающую верхнее веко. Проявление клинического эффекта можно ожидать в течение 2-4 дней, максимальный лечебный эффект развивается в течение 2 недель. Для профилактики рецидивов введение препарата следует повторять каждые 8 недель или в зависимости от клинической ситуации. При каждом последующем введении дозу следует уменьшать до 80 ЕД на глаз (например, 0.1 мл (20 ЕД) медиально и 0.1 мл (20 ЕД) латерально выше и ниже глаза по способу, представленному выше). В дальнейшем доза препарата может быть снижена до 60 ЕД на глаз, за счет исключения введения медиально в нижнее веко. Последующие дозы определяются в зависимости от полученного эффекта. При одностороннем блефароспазме лечение ограничивается областью пораженного глаза. Аналогичное лечение проводят при гемифациальном спазме. Дозы, рекомендуемые для лечения кривошеи, применяют у взрослых, имеющих нормальную массу тела и удовлетворительное развитие мышц шеи. Снижение дозы препарата возможно при выраженном похудании или у лиц пожилого возраста, со сниженной массой тела. Начальная разовая доза для лечения спастической кривошеи составляет 500 ЕД, препарат вводят частями в 2 или 3 наиболее активные мышцы шеи. При ротационной кривошее 500 ЕД препарата вводят следующим образом: 350 ЕД в ременную мышцу головы, ипсилатерально направлению вращения головы и 150 ЕД в грудино-ключично-сосцевидную мышцу, контрлатерально вращению. При латероколлисе (боковой кривошее, наклоне головы к плечу) препарат в дозе 350 ЕД вводят ипсилатерально в ременную мышцу и в дозе 150 ЕД - ипсилатерально в грудино-ключично-сосцевидную мышцу. В случаях, сопровождающихся поднятием плеча за счет трапециевидной мышцы или мышцы, поднимающей лопатку, может потребоваться лечение в соответствии с видимой гипертрофией мышц или по данным электромиографии. При введении препарата в 3 мышцы доза 500 ЕД распределяется следующим образом: 300 ЕД вводят в ременную мышцу, 100 ЕД - в грудино-ключично-сосцевидную мышцу, 100 ЕД - в третью мышцу. При антероколлисе (передней кривошее, наклоне головы вперед) вводят по 150 ЕД в обе грудино-ключично-сосцевидные мышцы. При ретроколлисе (задней кривошее, наклоне головы назад) вводят по 250 ЕД в каждую ременную мышцу головы. Затем могут следовать инъекции препарата билатерально в трапециевидные мышцы (по 250 ЕД на мышцу). При необходимости, если не отмечается достаточного эффекта, проводят повторные инъекции спустя 8 недель. Следует учитывать, что двусторонние инъекции в ременные мышцы могут повысить риск развития слабости мышц шеи. При последующем введении препарата в соответствии с клиническим эффектом и отмечаемыми побочными эффектами возможно использование оптимальных доз. Рекомендуются дозы - 250-1000 ЕД. При применении препарата в дозе более 1000 ЕД увеличивается риск развития побочных эффектов, особенно, дисфагии. Поэтому применение препарата в дозе более 1000 ЕД не рекомендуется. Клиническое улучшение при спастической кривошее отмечается в течение 1-2 недель после инъекций. Рекомендуется повторное введение препарата каждые 12-16 недель или при необходимости для предупреждения рецидивов.
Побочное действие
Блефароспазм и гемифациальный спазм. Побочное действие может иметь место при несоблюдении врачом правил выполнения инъекции (разведения, точного расчета вводимой дозы, правильного выбора точек введения, направления иглы и глубины введения) и связанной с этим излишней диффузией препарата в близлежащие к месту инъекции группы мышц. Необходимо также учитывать анатомо-физиологические особенности инъецируемых мышц пациента. Наиболее часто встречается блефароптоз. У нескольких пациентов отмечались диплопия или симптомы, свидетельствующие о распространении миорелаксирующего действия на соседние мышцы лица (эти явления проходят в течение 2–4 нед после произведенной инъекции). Возможно появление сухости глаз и развитие кератита вследствие уменьшения частоты моргания (в этих случаях показано применение искусственной слезы), появление гематомы и отечности век кратковременного характера, а также возникновение обратимой наружной офтальмоплегии при применении препарата в высоких дозах. Инъекции могут сопровождаться чувством жжения в месте введения препарата, которое длится в течение 1–2 мин. Крайне редко отмечаются аллергические реакции в виде кожной сыпи и гриппоподобных симптомов. Спастическая кривошея. Побочное действие развивается в результате проведения глубокой инъекции или инъекции в неправильно выбранные мышцы и точки, что ведет к избыточной слабости близлежащих мышц. Инъекции могут сопровождаться чувством жжения в месте введения препарата, которое длится в течение 1–2 мин. Наиболее часто встречается дисфагия. В двойном слепом плацебо-контролируемом исследовании препарата дисфагия отмечалась у 29% больных, которым назначали Диспорт в дозе 500 ЕД, и у 10% больных, получавших плацебо. Дисфагия носит дозозависимый характер и отмечается наиболее часто при введении препарата в грудино-ключично-сосцевидную мышцу. При развитии дисфагии необходимо воздерживаться от употребления грубой пищи до исчезновения симптомов. У пациентов с выраженной дисфагией при ларингоскопии отмечалось скопление слюны. В редких случаях у таких пациентов может потребоваться аспирация слюны, особенно при нарушениях проходимости дыхательных путей. Возможно развитие слабости мышц шеи, сухости во рту, изменение голоса. В редких случаях отмечались общая слабость, нарушения зрения (включая диплопию и нечеткость зрения), затруднение дыхания (при применении препарата в высоких дозах). Эти побочные эффекты проходят в течение 2–4 нед. Могут развиваться аллергические реакции в виде кожной сыпи и гриппоподобных симптомов. Образование противоботулинических антител отмечено у небольшого числа пациентов, которым проводили терапию Диспортом при лечении кривошеи. Клинически это проявлялось снижением терапевтического эффекта, что требовало постоянного повышения доз препарата. Спастичность руки у взрослых после инсульта. Наиболее часто развивается слабость близлежащих к месту инъекции мышц, гриппоподобные симптомы (6,1%), сухость во рту, боль в месте инъекции, фарингит, общая слабость, запор, диарея, сонливость (каждая побочная реакция отмечалась не более чем у 4,1% пациентов). Бóльшая часть этих побочных эффектов исчезает в течение 2 нед. Динамическая деформация стопы, вызванная спастичностью при ДЦП, у детей старше 2 лет. Может развиваться боль в ноге, фарингит (до 8%), слабость мышц, приводящая к случайным травмам (падениям) (до 7%), бронхит и лихорадка (до 6%). С частотой от 1 до 5% могут проявляться вирусная инфекция, инфекции верхних дыхательных путей, астения, астма, ринит, судороги, кашель, рвота, насморк, диарея, недержание мочи, аномальная походка, гастроэнтерит, ларингит и сонливость. Частота многих из этих реакций (фарингит, бронхит, лихорадка, вирусные инфекции, ринит, инфекции верхних дыхательных путей, кашель, рвота, насморк) аналогична той, которая отмечалась у больных, получавших плацебо. Астения и недержание мочи возникали при введении Диспорта в высоких дозах (20–30 ЕД/кг) и могли быть результатом системного воздействия токсина. Коррекция гиперкинетических складок (мимических морщин) лица. Возможно возникновение обратимого птоза верхнего века (3%), болезненности в месте инъекции, головной боли (1,3%), гематомы в месте инъекции (3–10%), опущение или подъем бровей (<1%). Диплопия встречается крайне редко. Наиболее серьезное осложнение - птоз верхнего века. Вероятной причиной его развития является диффузия препарата в мышцу, поднимающую верхнее веко, при коррекции вертикальных складок над переносицей или горизонтальных морщин на лбу. Птоз носит обратимый характер и исчезает к концу 3–4-й нед после инъекции. Свести к минимуму вероятность возникновения и выраженность данных побочных эффектов можно путем строгого соблюдения методик введения препарата Диспорт при коррекции гиперкинетических складок (мимических морщин) лица и учета анатомо-физиологических особенностей каждого конкретного пациента.
Передозировка
Симптомы: генерализованная мышечная слабость. Лечение: показана поддерживающая терапия, ИВЛ при параличе дыхательных мышц. Специфического антидота нет. Введение анатоксина (противоботулинической сыворотки) не эффективно.
Особые указания
При острых стадиях сопутствующих заболеваний введение препарата возобновляется после выздоровления. Единицы действия препарата Диспорт являются специфическими и не могут сравниваться с таковыми других препаратов, содержащих ботулотоксин. Влияние на способность к вождению автотранспорта и управлению механизмами. Вопрос о возможности занятий потенциально опасными видами деятельности, требующими повышенного внимания и быстроты психомоторных реакций, следует решать только после оценки индивидуальной реакции пациента.
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100 мл содержится: 28,6 мл воды Атлантического океана, 71,4 мл воды очищенной и 0,05 г экстракта Aloe vera. Концентрация соли в КВИКС алоэ соответствует прибл. 9 г NaCl на литр (изотоническая). Не содержит химических добавок и консервантов"}}]},{"id":2,"name":"Описание","slug":"common_description","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Отпуск иммунобиологического лекарственного препарата ОСУЩЕСТВЛЯЕТСЯ ПО РЕЦЕПТУ ВРАЧА и ПРИ НАЛИЧИИ У ПОКУПАТЕЛЯ ТЕРМОКОНТЕЙНЕРА, в который помещается лекарственный препарат, доставка данного лекарственного препарата в медицинскую организацию при условии хранения в специальном термоконтейнере не должна превышать срок 48 часов после его приобретения."}}]},{"id":3,"name":"Фармакологические свойства","slug":"pharmacologic_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Миорелаксирующее."}}]},{"id":4,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"У взрослых: блефароспазм; гемифациальный спазм; спастическая кривошея; спастичность мышц руки после инсульта; гиперкинетические складки (мимические морщины) лица. У детей старше 2 лет: динамическая деформация стопы, вызванная спастичностью при ДЦП."}}]},{"id":5,"name":"Противопоказания","slug":"contraindications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"– беременность; – острая фаза сопутствующих заболеваний."}}]},{"id":6,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Противопоказано при беременности"}}]},{"id":7,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Для взрослых и пожилых пациентов суммарная начальная доза для лечения двустороннего блефароспазма составляет 120 ЕД на каждый глаз. Препарат вводят п/к в объеме 0.1 мл (20 ЕД) медиально, в объеме 0.2 мл (40 ЕД) - латерально в соединение между пресептальной и глазничными частями как нижней, так и верхней орбитальной мышцами каждого глаза. Для проведения инъекций в верхнее веко иглу следует направлять в сторону от центра, чтобы не задеть мышцу, поднимающую верхнее веко. Проявление клинического эффекта можно ожидать в течение 2-4 дней, максимальный лечебный эффект развивается в течение 2 недель. Для профилактики рецидивов введение препарата следует повторять каждые 8 недель или в зависимости от клинической ситуации. При каждом последующем введении дозу следует уменьшать до 80 ЕД на глаз (например, 0.1 мл (20 ЕД) медиально и 0.1 мл (20 ЕД) латерально выше и ниже глаза по способу, представленному выше). В дальнейшем доза препарата может быть снижена до 60 ЕД на глаз, за счет исключения введения медиально в нижнее веко. Последующие дозы определяются в зависимости от полученного эффекта. При одностороннем блефароспазме лечение ограничивается областью пораженного глаза. Аналогичное лечение проводят при гемифациальном спазме. Дозы, рекомендуемые для лечения кривошеи, применяют у взрослых, имеющих нормальную массу тела и удовлетворительное развитие мышц шеи. Снижение дозы препарата возможно при выраженном похудании или у лиц пожилого возраста, со сниженной массой тела. Начальная разовая доза для лечения спастической кривошеи составляет 500 ЕД, препарат вводят частями в 2 или 3 наиболее активные мышцы шеи. При ротационной кривошее 500 ЕД препарата вводят следующим образом: 350 ЕД в ременную мышцу головы, ипсилатерально направлению вращения головы и 150 ЕД в грудино-ключично-сосцевидную мышцу, контрлатерально вращению. При латероколлисе (боковой кривошее, наклоне головы к плечу) препарат в дозе 350 ЕД вводят ипсилатерально в ременную мышцу и в дозе 150 ЕД - ипсилатерально в грудино-ключично-сосцевидную мышцу. В случаях, сопровождающихся поднятием плеча за счет трапециевидной мышцы или мышцы, поднимающей лопатку, может потребоваться лечение в соответствии с видимой гипертрофией мышц или по данным электромиографии. При введении препарата в 3 мышцы доза 500 ЕД распределяется следующим образом: 300 ЕД вводят в ременную мышцу, 100 ЕД - в грудино-ключично-сосцевидную мышцу, 100 ЕД - в третью мышцу. При антероколлисе (передней кривошее, наклоне головы вперед) вводят по 150 ЕД в обе грудино-ключично-сосцевидные мышцы. При ретроколлисе (задней кривошее, наклоне головы назад) вводят по 250 ЕД в каждую ременную мышцу головы. Затем могут следовать инъекции препарата билатерально в трапециевидные мышцы (по 250 ЕД на мышцу). При необходимости, если не отмечается достаточного эффекта, проводят повторные инъекции спустя 8 недель. Следует учитывать, что двусторонние инъекции в ременные мышцы могут повысить риск развития слабости мышц шеи. При последующем введении препарата в соответствии с клиническим эффектом и отмечаемыми побочными эффектами возможно использование оптимальных доз. Рекомендуются дозы - 250-1000 ЕД. При применении препарата в дозе более 1000 ЕД увеличивается риск развития побочных эффектов, особенно, дисфагии. Поэтому применение препарата в дозе более 1000 ЕД не рекомендуется. Клиническое улучшение при спастической кривошее отмечается в течение 1-2 недель после инъекций. Рекомендуется повторное введение препарата каждые 12-16 недель или при необходимости для предупреждения рецидивов."}}]},{"id":8,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Блефароспазм и гемифациальный спазм. Побочное действие может иметь место при несоблюдении врачом правил выполнения инъекции (разведения, точного расчета вводимой дозы, правильного выбора точек введения, направления иглы и глубины введения) и связанной с этим излишней диффузией препарата в близлежащие к месту инъекции группы мышц. Необходимо также учитывать анатомо-физиологические особенности инъецируемых мышц пациента. Наиболее часто встречается блефароптоз. У нескольких пациентов отмечались диплопия или симптомы, свидетельствующие о распространении миорелаксирующего действия на соседние мышцы лица (эти явления проходят в течение 2–4 нед после произведенной инъекции). Возможно появление сухости глаз и развитие кератита вследствие уменьшения частоты моргания (в этих случаях показано применение искусственной слезы), появление гематомы и отечности век кратковременного характера, а также возникновение обратимой наружной офтальмоплегии при применении препарата в высоких дозах. Инъекции могут сопровождаться чувством жжения в месте введения препарата, которое длится в течение 1–2 мин. Крайне редко отмечаются аллергические реакции в виде кожной сыпи и гриппоподобных симптомов. Спастическая кривошея. Побочное действие развивается в результате проведения глубокой инъекции или инъекции в неправильно выбранные мышцы и точки, что ведет к избыточной слабости близлежащих мышц. Инъекции могут сопровождаться чувством жжения в месте введения препарата, которое длится в течение 1–2 мин. Наиболее часто встречается дисфагия. В двойном слепом плацебо-контролируемом исследовании препарата дисфагия отмечалась у 29% больных, которым назначали Диспорт в дозе 500 ЕД, и у 10% больных, получавших плацебо. Дисфагия носит дозозависимый характер и отмечается наиболее часто при введении препарата в грудино-ключично-сосцевидную мышцу. При развитии дисфагии необходимо воздерживаться от употребления грубой пищи до исчезновения симптомов. У пациентов с выраженной дисфагией при ларингоскопии отмечалось скопление слюны. В редких случаях у таких пациентов может потребоваться аспирация слюны, особенно при нарушениях проходимости дыхательных путей. Возможно развитие слабости мышц шеи, сухости во рту, изменение голоса. В редких случаях отмечались общая слабость, нарушения зрения (включая диплопию и нечеткость зрения), затруднение дыхания (при применении препарата в высоких дозах). Эти побочные эффекты проходят в течение 2–4 нед. Могут развиваться аллергические реакции в виде кожной сыпи и гриппоподобных симптомов. Образование противоботулинических антител отмечено у небольшого числа пациентов, которым проводили терапию Диспортом при лечении кривошеи. Клинически это проявлялось снижением терапевтического эффекта, что требовало постоянного повышения доз препарата. Спастичность руки у взрослых после инсульта. Наиболее часто развивается слабость близлежащих к месту инъекции мышц, гриппоподобные симптомы (6,1%), сухость во рту, боль в месте инъекции, фарингит, общая слабость, запор, диарея, сонливость (каждая побочная реакция отмечалась не более чем у 4,1% пациентов). Бóльшая часть этих побочных эффектов исчезает в течение 2 нед. Динамическая деформация стопы, вызванная спастичностью при ДЦП, у детей старше 2 лет. Может развиваться боль в ноге, фарингит (до 8%), слабость мышц, приводящая к случайным травмам (падениям) (до 7%), бронхит и лихорадка (до 6%). С частотой от 1 до 5% могут проявляться вирусная инфекция, инфекции верхних дыхательных путей, астения, астма, ринит, судороги, кашель, рвота, насморк, диарея, недержание мочи, аномальная походка, гастроэнтерит, ларингит и сонливость. Частота многих из этих реакций (фарингит, бронхит, лихорадка, вирусные инфекции, ринит, инфекции верхних дыхательных путей, кашель, рвота, насморк) аналогична той, которая отмечалась у больных, получавших плацебо. Астения и недержание мочи возникали при введении Диспорта в высоких дозах (20–30 ЕД/кг) и могли быть результатом системного воздействия токсина. Коррекция гиперкинетических складок (мимических морщин) лица. Возможно возникновение обратимого птоза верхнего века (3%), болезненности в месте инъекции, головной боли (1,3%), гематомы в месте инъекции (3–10%), опущение или подъем бровей (\u003c1%). Диплопия встречается крайне редко. Наиболее серьезное осложнение - птоз верхнего века. Вероятной причиной его развития является диффузия препарата в мышцу, поднимающую верхнее веко, при коррекции вертикальных складок над переносицей или горизонтальных морщин на лбу. Птоз носит обратимый характер и исчезает к концу 3–4-й нед после инъекции. Свести к минимуму вероятность возникновения и выраженность данных побочных эффектов можно путем строгого соблюдения методик введения препарата Диспорт при коррекции гиперкинетических складок (мимических морщин) лица и учета анатомо-физиологических особенностей каждого конкретного пациента."}}]},{"id":9,"name":"Передозировка","slug":"overdose","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Симптомы: генерализованная мышечная слабость. Лечение: показана поддерживающая терапия, ИВЛ при параличе дыхательных мышц. Специфического антидота нет. Введение анатоксина (противоботулинической сыворотки) не эффективно."}}]},{"id":10,"name":"Особые указания","slug":"cautions","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"При острых стадиях сопутствующих заболеваний введение препарата возобновляется после выздоровления. Единицы действия препарата Диспорт являются специфическими и не могут сравниваться с таковыми других препаратов, содержащих ботулотоксин. Влияние на способность к вождению автотранспорта и управлению механизмами. 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