Препарат для лечения экссудативно-геморрагической формы возр... Инструкция
Показания к применению
Неоваскулярная (влажная) форма возрастной макулярной дегенерации у взрослых
Противопоказания
подтвержденные или предполагаемые инфекции глаза или инфекционные процессы периокулярной локализации; интраокулярное воспаление; детский и подростковый возраст до 18 лет (эффективность и безопасность применения продукта у данной категории заболевших не изучалась); беременность; период лактации; высокая восприимчивость к ранибизумабу или любому другому ...
Препарат для лечения экссудативно-геморрагической формы возрастной макулярной дегенерации (ВМД). Ранибизумаб является человеческим моноклональным фрагментом антител к эндотелиальному фактору роста А (VEGF-A) и экспрессируется рекомбинантным штаммом Escherichia coli. Ранибизумаб избирательно связывается с изоформами эндотелиального фактора роста сосудов, VEGF-А (VEGF110, VEGF121, VEGF165), и предотвращает взаимодействие VEGF-А с его рецепторами на поверхности клеток эндотелия (VEGR1и VEGR2), что приводит к подавлению неоваскуляризации и пролиферации сосудов. Подавляя рост новообразованных сосудов хориоидеи в сетчатку, ранибизумаб останавливает прогрессирование экссудативно-геморрагической формы возрастной макулярной дегенерации (ВМД).
Показания к применению
Неоваскулярная (влажная) форма возрастной макулярной дегенерации у взрослых
Противопоказания
подтвержденные или предполагаемые инфекции глаза или инфекционные процессы периокулярной локализации; интраокулярное воспаление; детский и подростковый возраст до 18 лет (эффективность и безопасность применения продукта у данной категории заболевших не изучалась); беременность; период лактации; высокая восприимчивость к ранибизумабу или любому другому компоненту продукта. С осторожностью надлежит вводить продукт пациентам с известной гипервосприимчивостью в анамнезе (только в последствии тщательной оценки соотношения риск/польза).
Применение при беременности и в период грудного вскармливания
Препарат противопоказан при беременности и лактации.
Способ применения и дозы
Введение препарата должен проводить только квалифицированный врач-офтальмолог, имеющий опыт проведения интравитреальных инъекций. Рекомендуемая доза препарата Луцентис составляет 0,5 мг (0,05 мл) 1 раз в месяц в виде инъекции в стекловидное тело. Первые 3 инъекции препарата Луцентис выполняют с частотой 1 раз в месяц последовательно в течение 3 мес., затем лечение препаратом прекращают (фаза стабилизации) и регулярно (не менее 1 раза в месяц) проверяют остроту зрения.. При снижении остроты зрения более чем на 5 букв по шкале ETDRS (1 строчка по таблице Снеллена) лечение препаратом возобновляют. До введения препарата Луцентис следует проконтролировать качество растворения и Цвет: раствора. Препарат нельзя использовать при изменении цвета раствора и появлении нерастворимых видимых частиц. Инъекцию препарата в стекловидное тело следует проводить в асептических условиях, включающих обработку рук медицинских работников, использование стерильных перчаток, салфеток, векорасширителя (или его аналога) и при необходимости инструментов для парацентеза. Перед введением препарата необходимо провести соответствующую дезинфекцию кожи век и области вокруг глаз, анестезию конъюнктивы и терапию антимикробными препаратами широкого спектра. Антимикробные препараты следует закапывать в конъюнктивальный мешок 3 раза в сутки в течение 3 дней до и после введения препарата. Препарат Луцентис следует вводить в стекловидное тело на 3,5–4 мм кзади от лимба, избегая горизонтального меридиана и направляя иглу к центру глазного яблока. Объем введенного препарата составляет 0,05 мл. Следующая инъекция препарата проводится в другую половину склеры. Поскольку в течение 60 мин после инъекции препарата Луцентис может повышаться внутриглазное давление, следует контролировать его, перфузию диска зрительного нерва и при необходимости применять соответствующее лечение. За один сеанс введение препарата Луцентис проводят только в один глаз.
Побочное действие
Изучение безопасности применения препарата Луцентис проводили в течение 24 мес. в группе с 1315 пациентами в три фазы III стадии, 440 пациентам препарат был назначен в рекомендуемой дозе 0,5 мг. Случаи серьезных побочных реакций, связанных с процедурой введения препарата, включали эндофтальмит, регматогенную отслойку сетчатки глаза, разрыв сетчатки глаза, ятрогенную травматическую катаракту. Другие случаи серьезных побочных реакций, которые наблюдались у пациентов при лечении препаратом Луцентис, - интраокулярное воспаление и повышение внутриглазного давления. Побочные эффекты, которые отмечены ниже, наблюдались чаще (по меньшей мере на 2%) в группе пациентов, получавших Луцентис 0,5 мг, чем в контрольной группе (плацебо или вертепорфин, средство для ФДТ) в объединенных данных трех контролируемых исследованиях III фазы: FVF2598g (MARINA), FVF2587g (ANCHOR) и FVF3192g (PIER). Поэтому их рассматривали как потенциальные побочные реакции препарата. Данные о безопасности применения препарата, которые описаны ниже, также включают все потенциально возможные побочные реакции, связанные со способом введения препарата или самим лекарственным препаратом, в группе из 440 пациентов, которым было назначено по 0,5 мг препарата. Побочные эффекты перечислены по классам систем органов и частоте возникновения согласно следующей систематизации: очень часто (≥1/10), часто (от ≥1/100 до <1/10), нечасто (от ≥1/1 000 до <1/100), редко (от ≥1/10 000 до <1/1 000), очень редко (<1/10 000). Инфекции и инвазии: очень часто - ринофарингит; часто -грипп. Со стороны лимфатической системы и системы кроветворения: часто -анемия. Психические расстройства: часто - тревожность. Со стороны ЦНС: очень часто - головная боль. Со стороны органа зрения: очень часто - интраокулярное воспаление, воспаление стекловидного тела, отслаивание стекловидного тела, кровоизлияние в сетчатку глаза, нарушения зрения, боль в глазу, деструкция стекловидного тела, кровоизлияние в конъюнктиву, раздражение глаза, ощущения постороннего тела в глазу, повышенное слезоотделение, блефарит, сухость глаз, гиперемия глаза, ощущения зуда в глазу; часто -дистрофия сетчатки, нарушения функций сетчатки, отслаивание сетчатки глаза, разрыв сетчатки, отслаивание пигментного эпителия сетчатки, отрыв пигментного эпителия сетчатки, снижения остроты зрения, кровоизлияние в стекловидное тело, нарушение функции стекловидного тела, увеит, ирит, иридоциклит, катаракта, субкапсулярная катаракта, помутнение задней капсулы, точечный кератит, повреждение роговицы, воспаления передней камеры глаза, затуманенное зрение, геморрагии в месте инъекции, кровоизлияние в глаз, конъюнктивит, аллергический конъюнктивит, выделения из глаза, фотопсия, фотофобия, ощущение дискомфорта в глазу, отек век, боль в веке, гиперемия конъюнктивы; нечасто - слепота, эндофтальмит, ползучая язва роговицы, кровотечение в переднюю камеру глаза, кератопатия, спайки радужки, отложения на роговице, отек роговицы, образование линий растяжения (стрии) на роговице, боль в участке инъекции, покраснение в участке инъекции, повышена чувствительность глаза, раздражение века. Со стороны дыхательной системы: часто - кашель. Со стороны ЖКТ: часто - тошнота. Со стороны кожи и подкожных тканей: нечасто - сыпь. Со стороны опорно-двигательного аппарата: очень часто - артралгия. Обследования: очень часто - повышение внутриглазного давления.
Передозировка
О случаях передозировки сообщалось в клинических и постмаркетинговых исследованиях. Побочные реакции, чаще всего связанные с передозировкой - повышение внутриглазного давления и боль в глазу. При передозировке препарата следует проверить внутриглазное давление и при необходимости провести соответствующее лечение.
Особые указания
Интравитреальные инъекции, включая инъекции препарата Луцентис, ассоциированы с эндофтальмитом, интраокулярным воспалением, регматогенной отслойкой сетчатки, разрывом сетчатки глаза, ятрогенной травматической катарактой. Надлежащая асептическая техника проведения инъекций должна быть обязательной при введении препарата Луцентис. Кроме того, следует наблюдать за состоянием пациента в течение 1-й недели после проведения инъекции, чтобы начать своевременное лечение в случае развития инфекционного осложнения. Пациент должен быть хорошо проинструктирован, чтобы он немедленно сообщил о появлении любых признаков, которые могут напоминать эндофтальмит или другие вышеперечисленные осложнения. Повышение внутриглазного давления отмечали на протяжении 60 мин после инъекции, поэтому показатели внутриглазного давления и перфузии диска зрительного нерва следует проверить и соответственно откорректировать. Существует теоретический риск возникновения артериальной тромбоэмболии после интравитреального применения ингибиторов VEGF. Хотя при клинических исследованиях препарата Луцентис наблюдался низкий коэффициент частоты возникновения случаев артериальной тромбоэмболии, диспропорции между группами, в которых проводили лечение, не отмечали. Как и для всех лекарственных средств, содержащих белок, существует потенциальный риск возникновения иммуногенности препарата Луцентис. Безопасность и эффективность препарата при применении для лечения обоих глаз одновременно не изучали. Период беременности и кормления грудью. Исследований применения ранибизумаба в период беременности не проводили, поэтому препарат не применяют в период беременности. Женщинам репродуктивного возраста следует применять эффективную контрацепцию в течение лечения. Не известно, проникает ли препарат Луцентис в грудное молоко, поэтому кормление грудью не рекомендуют в период лечения препаратом. Дети. Безопасность и эффективность влияния ранибизумаба для этой группы пациентов не установлены, поэтому препарат не применяют у детей. Способность влиять на скорость реакции при управлении транспортными средствами и работе с другими механизмами. Лечение препаратом может привести к временному нарушению зрения, что в свою очередь может влиять на способность к управлению транспортными средствами и работе с другими механизмами. Пациентам, отмечающим нарушение зрения, не следует управлять транспортными средствами и работать с другими механизмами до исчезновения вышеуказанных транзиторных симптомов.
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мл раствора для инфузий Акласта содержат: Золедроновой кислоты – 5 мг (эквивалентно 5,33 мг моногидрата золедроновой кислоты); Вспомогательные компоненты."}}]},{"id":2,"name":"Фармакологические свойства","slug":"pharmacologic_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Препарат для лечения экссудативно-геморрагической формы возрастной макулярной дегенерации (ВМД). Ранибизумаб является человеческим моноклональным фрагментом антител к эндотелиальному фактору роста А (VEGF-A) и экспрессируется рекомбинантным штаммом Escherichia coli. Ранибизумаб избирательно связывается с изоформами эндотелиального фактора роста сосудов, VEGF-А (VEGF110, VEGF121, VEGF165), и предотвращает взаимодействие VEGF-А с его рецепторами на поверхности клеток эндотелия (VEGR1и VEGR2), что приводит к подавлению неоваскуляризации и пролиферации сосудов. Подавляя рост новообразованных сосудов хориоидеи в сетчатку, ранибизумаб останавливает прогрессирование экссудативно-геморрагической формы возрастной макулярной дегенерации (ВМД)."}}]},{"id":3,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Неоваскулярная (влажная) форма возрастной макулярной дегенерации у взрослых"}}]},{"id":4,"name":"Противопоказания","slug":"contraindications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"подтвержденные или предполагаемые инфекции глаза или инфекционные процессы периокулярной локализации; интраокулярное воспаление; детский и подростковый возраст до 18 лет (эффективность и безопасность применения продукта у данной категории заболевших не изучалась); беременность; период лактации; высокая восприимчивость к ранибизумабу или любому другому компоненту продукта. С осторожностью надлежит вводить продукт пациентам с известной гипервосприимчивостью в анамнезе (только в последствии тщательной оценки соотношения риск/польза)."}}]},{"id":5,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Препарат противопоказан при беременности и лактации."}}]},{"id":6,"name":"Способ применения и дозы","slug":"dosage","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Введение препарата должен проводить только квалифицированный врач-офтальмолог, имеющий опыт проведения интравитреальных инъекций. Рекомендуемая доза препарата Луцентис составляет 0,5 мг (0,05 мл) 1 раз в месяц в виде инъекции в стекловидное тело. Первые 3 инъекции препарата Луцентис выполняют с частотой 1 раз в месяц последовательно в течение 3 мес., затем лечение препаратом прекращают (фаза стабилизации) и регулярно (не менее 1 раза в месяц) проверяют остроту зрения.. При снижении остроты зрения более чем на 5 букв по шкале ETDRS (1 строчка по таблице Снеллена) лечение препаратом возобновляют. До введения препарата Луцентис следует проконтролировать качество растворения и Цвет: раствора. Препарат нельзя использовать при изменении цвета раствора и появлении нерастворимых видимых частиц. Инъекцию препарата в стекловидное тело следует проводить в асептических условиях, включающих обработку рук медицинских работников, использование стерильных перчаток, салфеток, векорасширителя (или его аналога) и при необходимости инструментов для парацентеза. Перед введением препарата необходимо провести соответствующую дезинфекцию кожи век и области вокруг глаз, анестезию конъюнктивы и терапию антимикробными препаратами широкого спектра. Антимикробные препараты следует закапывать в конъюнктивальный мешок 3 раза в сутки в течение 3 дней до и после введения препарата. Препарат Луцентис следует вводить в стекловидное тело на 3,5–4 мм кзади от лимба, избегая горизонтального меридиана и направляя иглу к центру глазного яблока. Объем введенного препарата составляет 0,05 мл. Следующая инъекция препарата проводится в другую половину склеры. Поскольку в течение 60 мин после инъекции препарата Луцентис может повышаться внутриглазное давление, следует контролировать его, перфузию диска зрительного нерва и при необходимости применять соответствующее лечение. За один сеанс введение препарата Луцентис проводят только в один глаз."}}]},{"id":7,"name":"Побочное действие","slug":"side_effects","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Изучение безопасности применения препарата Луцентис проводили в течение 24 мес. в группе с 1315 пациентами в три фазы III стадии, 440 пациентам препарат был назначен в рекомендуемой дозе 0,5 мг. Случаи серьезных побочных реакций, связанных с процедурой введения препарата, включали эндофтальмит, регматогенную отслойку сетчатки глаза, разрыв сетчатки глаза, ятрогенную травматическую катаракту. Другие случаи серьезных побочных реакций, которые наблюдались у пациентов при лечении препаратом Луцентис, - интраокулярное воспаление и повышение внутриглазного давления. Побочные эффекты, которые отмечены ниже, наблюдались чаще (по меньшей мере на 2%) в группе пациентов, получавших Луцентис 0,5 мг, чем в контрольной группе (плацебо или вертепорфин, средство для ФДТ) в объединенных данных трех контролируемых исследованиях III фазы: FVF2598g (MARINA), FVF2587g (ANCHOR) и FVF3192g (PIER). Поэтому их рассматривали как потенциальные побочные реакции препарата. Данные о безопасности применения препарата, которые описаны ниже, также включают все потенциально возможные побочные реакции, связанные со способом введения препарата или самим лекарственным препаратом, в группе из 440 пациентов, которым было назначено по 0,5 мг препарата. Побочные эффекты перечислены по классам систем органов и частоте возникновения согласно следующей систематизации: очень часто (≥1/10), часто (от ≥1/100 до \u003c1/10), нечасто (от ≥1/1 000 до \u003c1/100), редко (от ≥1/10 000 до \u003c1/1 000), очень редко (\u003c1/10 000). Инфекции и инвазии: очень часто - ринофарингит; часто -грипп. Со стороны лимфатической системы и системы кроветворения: часто -анемия. Психические расстройства: часто - тревожность. Со стороны ЦНС: очень часто - головная боль. Со стороны органа зрения: очень часто - интраокулярное воспаление, воспаление стекловидного тела, отслаивание стекловидного тела, кровоизлияние в сетчатку глаза, нарушения зрения, боль в глазу, деструкция стекловидного тела, кровоизлияние в конъюнктиву, раздражение глаза, ощущения постороннего тела в глазу, повышенное слезоотделение, блефарит, сухость глаз, гиперемия глаза, ощущения зуда в глазу; часто -дистрофия сетчатки, нарушения функций сетчатки, отслаивание сетчатки глаза, разрыв сетчатки, отслаивание пигментного эпителия сетчатки, отрыв пигментного эпителия сетчатки, снижения остроты зрения, кровоизлияние в стекловидное тело, нарушение функции стекловидного тела, увеит, ирит, иридоциклит, катаракта, субкапсулярная катаракта, помутнение задней капсулы, точечный кератит, повреждение роговицы, воспаления передней камеры глаза, затуманенное зрение, геморрагии в месте инъекции, кровоизлияние в глаз, конъюнктивит, аллергический конъюнктивит, выделения из глаза, фотопсия, фотофобия, ощущение дискомфорта в глазу, отек век, боль в веке, гиперемия конъюнктивы; нечасто - слепота, эндофтальмит, ползучая язва роговицы, кровотечение в переднюю камеру глаза, кератопатия, спайки радужки, отложения на роговице, отек роговицы, образование линий растяжения (стрии) на роговице, боль в участке инъекции, покраснение в участке инъекции, повышена чувствительность глаза, раздражение века. Со стороны дыхательной системы: часто - кашель. Со стороны ЖКТ: часто - тошнота. Со стороны кожи и подкожных тканей: нечасто - сыпь. Со стороны опорно-двигательного аппарата: очень часто - артралгия. Обследования: очень часто - повышение внутриглазного давления."}}]},{"id":8,"name":"Передозировка","slug":"overdose","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"О случаях передозировки сообщалось в клинических и постмаркетинговых исследованиях. Побочные реакции, чаще всего связанные с передозировкой - повышение внутриглазного давления и боль в глазу. При передозировке препарата следует проверить внутриглазное давление и при необходимости провести соответствующее лечение."}}]},{"id":9,"name":"Особые указания","slug":"cautions","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Интравитреальные инъекции, включая инъекции препарата Луцентис, ассоциированы с эндофтальмитом, интраокулярным воспалением, регматогенной отслойкой сетчатки, разрывом сетчатки глаза, ятрогенной травматической катарактой. Надлежащая асептическая техника проведения инъекций должна быть обязательной при введении препарата Луцентис. Кроме того, следует наблюдать за состоянием пациента в течение 1-й недели после проведения инъекции, чтобы начать своевременное лечение в случае развития инфекционного осложнения. Пациент должен быть хорошо проинструктирован, чтобы он немедленно сообщил о появлении любых признаков, которые могут напоминать эндофтальмит или другие вышеперечисленные осложнения. Повышение внутриглазного давления отмечали на протяжении 60 мин после инъекции, поэтому показатели внутриглазного давления и перфузии диска зрительного нерва следует проверить и соответственно откорректировать. Существует теоретический риск возникновения артериальной тромбоэмболии после интравитреального применения ингибиторов VEGF. Хотя при клинических исследованиях препарата Луцентис наблюдался низкий коэффициент частоты возникновения случаев артериальной тромбоэмболии, диспропорции между группами, в которых проводили лечение, не отмечали. Как и для всех лекарственных средств, содержащих белок, существует потенциальный риск возникновения иммуногенности препарата Луцентис. Безопасность и эффективность препарата при применении для лечения обоих глаз одновременно не изучали. Период беременности и кормления грудью. Исследований применения ранибизумаба в период беременности не проводили, поэтому препарат не применяют в период беременности. Женщинам репродуктивного возраста следует применять эффективную контрацепцию в течение лечения. Не известно, проникает ли препарат Луцентис в грудное молоко, поэтому кормление грудью не рекомендуют в период лечения препаратом. Дети. Безопасность и эффективность влияния ранибизумаба для этой группы пациентов не установлены, поэтому препарат не применяют у детей. Способность влиять на скорость реакции при управлении транспортными средствами и работе с другими механизмами. Лечение препаратом может привести к временному нарушению зрения, что в свою очередь может влиять на способность к управлению транспортными средствами и работе с другими механизмами. Пациентам, отмечающим нарушение зрения, не следует управлять транспортными средствами и работать с другими механизмами до исчезновения вышеуказанных транзиторных симптомов."}}]}],"source":{"title":"36.6","url":"https://366.ru"}},"description_toggle":false,"short_description":"Препарат для лечения экссудативно-геморрагической формы возрастной макулярной дегенерации (ВМД). Ранибизумаб является человеческим моноклональным фрагментом антител к эндотелиальному фактору роста А (VEGF-A) и экспрессируется рекомбинантным штаммом Escherichia coli. Ранибизумаб избирательно связывается с изоформами эндотелиального фактора роста сосудов, VEGF-А (VEGF110, VEGF121, VEGF165), и предотвращает взаимодействие VEGF-А с его рецепторами на поверхности клеток эндотелия (VEGR1и VEGR2), что приводит к подавлению неоваскуляризации и пролиферации сосудов. 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