Индивидуальная гиперчувствительность к натрия гиалуронату
Инструкция
Состав
Вископротектор Когевиск (далее – раствор, изделие) представляет собой прозрачный вязкий раствор.
Состав на 1 мл: натрия гиалуронат – 16,0 мг (1,6 %), натрия хлорид – 7,9 мг, натрия гидрофосфат безводный – 2,0 мг, натрия дигидрофосфата моногидрат – 0,45 мг, вода для инъекций – до 1 мл. рН – 6,8 – 7,6; динамическая вязкость – от 47 500 до 200 000 мПа·с (при температуре 25 °С и скорости сдвига 1 с-1); осмоляльность – 340 ± 60 мОсм/кг.
Фармакологические свойства
Натрия гиалуронат – это полисахарид с большим молекулярным весом, состоящий из N-ацетилглюкозамина и натрия глюкуроната. Натрия гиалуронат распределяется убиквитарно по тканям организма и присутствует в наибольших концентрациях в стекловидном теле, синовиальной жидкости и пуповине. Натрия гиалуронат выполняет функцию тканевой смазки и призван играть главную роль в модулировании взаимосвязей между примыкающими тканями.
Он также может служить вязкоупругой субстанцией, облегчающей разделение тканей. Натрия гиалуронат, изготовленный из разных материалов, может различаться по молекулярному весу, но иметь одинаковое химическое строение.
Натрия гиалуронат с защитными свойствами можно получить из бактерий определенного вида.
Натрия гиалуронат, входящий в состав изделия Когевиск, представляет собой высокоочищенный продукт ферментации бактерий. Его средний молекулярный вес составляет более 1 000 000 дальтон, он не является антигеном, апирогенен, не вызывает побочных реакций на чужеродные тела и не раздражает слизистую оболочку глаза. Изделие Когевиск не препятствует естественному процессу заживления раны.
Показания к применению
Когевиск предназначен для применения в офтальмологии при хирургических вмешательствах на переднем и заднем отрезках глаза:
• экстракция катаракты
• трансплантация роговицы
• операции при глаукоме
• операции при отслойке сетчатки
Противопоказания
Индивидуальная гиперчувствительность к натрия гиалуронату
Применение при беременности и в период грудного вскармливания
Нет данных о безопасности применения раствора Когевиск во время беременности и в период грудного вскармливания.
Применение во время беременности и в период грудного вскармливания возможно по усмотрению врача-офтальмолога.
Способ применения и дозы
Перед началом применения охлажденный раствор Когевиск следует выдержать при комнатной температуре (в течение 20-60 минут в зависимости от объема).
Операция по экстракции катаракты и имплантация интраокулярной линзы
Необходимое количество раствора Когевиск вводят с помощью канюли в переднюю камеру глаза. Это создает защитный слой для сохранения тканей глаза и обеспечивает легкость маневренности микроинструментов. Раствор Когевиск облегчает контроль над процессами введения, разворачивания и занятия стабильного положения интраокулярной линзы. При необходимости раствор Когевиск можно вводить, чтобы облегчить проведение хирургических процедур.
Трансплантация роговицы
При удалении роговичного диска реципиента передняя камера глаза заполняется раствором Когевиск до уровня поверхности роговицы. Трансплантат из роговицы донора помещается поверх раствора Когевиск и подшивается к оставшейся периферической части роговицы реципиента.
При необходимости раствор Когевиск можно вводить, чтобы облегчить проведение хирургических процедур.
Хирургическое лечение глаукомы
Раствор Когевиск вводится через парацентез для восстановления и поддержания объема передней камеры во время проведения гипотензивных операций. При необходимости раствор Когевиск можно вводить, чтобы облегчить проведение хирургических процедур.
Неиспользованное до конца средство не подлежит хранению.
Порядок работы со шприцем
1. Вскройте контурную ячейковую упаковку/пакет в асептических условиях.
2. Открутите колпачок с кончика шприца (колпачок насажен плотно).
3. Наполните втулку канюли до верха раствором офтальмологическим ирригационным.
4. Выдавите воздух через кончик шприца, держа одной рукой цилиндр, а другой плавно нажимая на поршневой шток. Следите за тем, чтобы не выдавить раствор.
5. Накрутите канюлю на шприц до тех пор, пока она не пройдет путь резьбы и не сядет плотно.
6. Убедитесь, что втулка канюли завинчена до конца.
7. Снимите пластиковый чехол с канюли прямым движением.
Следите за тем, чтобы не открутить канюлю. Выдавите остатки воздуха из системы, держа одной рукой цилиндр шприца, а другой плавно нажимая на поршневой шток, пока на кончике иглы не появится раствор Когевиск.
Побочное действие
Натрия гиалуронат – это компонент, находящийся в тканях организма и легко переносимый слизистой оболочкой человеческого глаза. Обзор клинических исследований изделий аналогичного состава показал, что в редких случаях отмечались послеоперационные воспалительные реакции.
В связи с этим назначалось пероральное и локальное применение стероидов. В связи с тем, что молекулы натрия гиалуроната не вызывают воспалений, любые воспалительные процессы относят к реакциям, вызванным хирургическим вмешательством. Как уже отмечалось выше, использование натрия гиалуроната на переднем отрезке глаза после хирургических вмешательств может привести к увеличению внутриглазного давления. В редких случаях отмечались послеоперационные воспалительные реакции, отек и декомпенсация роговицы. Взаимосвязь этих состояний с использованием данных изделий не установлена.
Взаимодействие с другими лекарственными средствами
Нет данных.
Особые указания
Натрия гиалуронат получен путем ферментации бактерий Streptococcus equi и тщательно очищен.
Только для однократного применения.
Обязательно обращайте внимание на срок годности канюли, указанный на ее упаковке.
Для безопасного использования и утилизации соблюдайте общегосударственные и региональные правила и нормы.
Форма выпуска
По 0,8 или 1,2 мл в предварительно наполненном шприце.
По 1 предварительно наполненному шприцу в пакете или контурной ячейковой упаковке.
По 1 пакету или контурной ячейковой упаковке и 1 или 2 канюли офтальмологические хирургические стерильные или без них или по 2 пакета или контурные ячейковые упаковки и 2 или 4 канюли офтальмологические хирургические стерильные или без них вместе с инструкцией по применению в пачке из картона с контролем первого вскрытия или без контроля первого вскрытия.
Допускается вложение в пачку из картона этикетки слежения в количестве 3 или 5, или 10 шт.
Условия хранения
Всеми видами крытого транспорта в соответствии с правилами перевозки грузов, действующих на этих видах транспорта, при температуре от + 2 °С до + 8 °С.
Не замораживать. Держать вдали от источников тепла.
Срок годности
3 года.
Не применять после окончания срока годности!
Производитель
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лит. А
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Факс: +7 812 385 47 88
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Натрия гиалуронат распределяется убиквитарно по тканям организма и присутствует в наибольших концентрациях в стекловидном теле, синовиальной жидкости и пуповине. Натрия гиалуронат выполняет функцию тканевой смазки и призван играть главную роль в модулировании взаимосвязей между примыкающими тканями."}},{"type":"paragraph","data":{"text":"Он также может служить вязкоупругой субстанцией, облегчающей разделение тканей. Натрия гиалуронат, изготовленный из разных материалов, может различаться по молекулярному весу, но иметь одинаковое химическое строение."}},{"type":"paragraph","data":{"text":"Натрия гиалуронат с защитными свойствами можно получить из бактерий определенного вида."}},{"type":"paragraph","data":{"text":"Натрия гиалуронат, входящий в состав изделия Когевиск, представляет собой высокоочищенный продукт ферментации бактерий. Его средний молекулярный вес составляет более 1 000 000 дальтон, он не является антигеном, апирогенен, не вызывает побочных реакций на чужеродные тела и не раздражает слизистую оболочку глаза. Изделие Когевиск не препятствует естественному процессу заживления раны."}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"Когевиск предназначен для применения в офтальмологии при хирургических вмешательствах на переднем и заднем отрезках глаза:"}},{"type":"paragraph","data":{"text":"• экстракция катаракты"}},{"type":"paragraph","data":{"text":"• трансплантация роговицы"}},{"type":"paragraph","data":{"text":"• операции при глаукоме"}},{"type":"paragraph","data":{"text":"• операции при отслойке сетчатки"}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"paragraph","data":{"text":"Индивидуальная гиперчувствительность к натрия гиалуронату"}}]},{"id":11,"name":"Применение при беременности и в период грудного вскармливания","slug":"pregnancy_warnings","body":[{"type":"paragraph","data":{"text":"Нет данных о безопасности применения раствора Когевиск во время беременности и в период грудного вскармливания."}},{"type":"paragraph","data":{"text":"Применение во время беременности и в период грудного вскармливания возможно по усмотрению врача-офтальмолога."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Перед началом применения охлажденный раствор Когевиск следует выдержать при комнатной температуре (в течение 20-60 минут в зависимости от объема)."}},{"type":"paragraph","data":{"text":"Операция по экстракции катаракты и имплантация интраокулярной линзы"}},{"type":"paragraph","data":{"text":"Необходимое количество раствора Когевиск вводят с помощью канюли в переднюю камеру глаза. Это создает защитный слой для сохранения тканей глаза и обеспечивает легкость маневренности микроинструментов. Раствор Когевиск облегчает контроль над процессами введения, разворачивания и занятия стабильного положения интраокулярной линзы. При необходимости раствор Когевиск можно вводить, чтобы облегчить проведение хирургических процедур."}},{"type":"paragraph","data":{"text":"Трансплантация роговицы"}},{"type":"paragraph","data":{"text":"При удалении роговичного диска реципиента передняя камера глаза заполняется раствором Когевиск до уровня поверхности роговицы. Трансплантат из роговицы донора помещается поверх раствора Когевиск и подшивается к оставшейся периферической части роговицы реципиента."}},{"type":"paragraph","data":{"text":"При необходимости раствор Когевиск можно вводить, чтобы облегчить проведение хирургических процедур."}},{"type":"paragraph","data":{"text":"Хирургическое лечение глаукомы"}},{"type":"paragraph","data":{"text":"Раствор Когевиск вводится через парацентез для восстановления и поддержания объема передней камеры во время проведения гипотензивных операций. При необходимости раствор Когевиск можно вводить, чтобы облегчить проведение хирургических процедур."}},{"type":"paragraph","data":{"text":"Неиспользованное до конца средство не подлежит хранению."}},{"type":"paragraph","data":{"text":"Порядок работы со шприцем"}},{"type":"paragraph","data":{"text":"1. Вскройте контурную ячейковую упаковку/пакет в асептических условиях."}},{"type":"paragraph","data":{"text":"2. Открутите колпачок с кончика шприца (колпачок насажен плотно)."}},{"type":"paragraph","data":{"text":"3. Наполните втулку канюли до верха раствором офтальмологическим ирригационным."}},{"type":"paragraph","data":{"text":"4. Выдавите воздух через кончик шприца, держа одной рукой цилиндр, а другой плавно нажимая на поршневой шток. Следите за тем, чтобы не выдавить раствор."}},{"type":"paragraph","data":{"text":"5. Накрутите канюлю на шприц до тех пор, пока она не пройдет путь резьбы и не сядет плотно."}},{"type":"paragraph","data":{"text":"6. Убедитесь, что втулка канюли завинчена до конца."}},{"type":"paragraph","data":{"text":"7. Снимите пластиковый чехол с канюли прямым движением."}},{"type":"paragraph","data":{"text":"Следите за тем, чтобы не открутить канюлю. Выдавите остатки воздуха из системы, держа одной рукой цилиндр шприца, а другой плавно нажимая на поршневой шток, пока на кончике иглы не появится раствор Когевиск."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"Натрия гиалуронат – это компонент, находящийся в тканях организма и легко переносимый слизистой оболочкой человеческого глаза. Обзор клинических исследований изделий аналогичного состава показал, что в редких случаях отмечались послеоперационные воспалительные реакции."}},{"type":"paragraph","data":{"text":"В связи с этим назначалось пероральное и локальное применение стероидов. В связи с тем, что молекулы натрия гиалуроната не вызывают воспалений, любые воспалительные процессы относят к реакциям, вызванным хирургическим вмешательством. Как уже отмечалось выше, использование натрия гиалуроната на переднем отрезке глаза после хирургических вмешательств может привести к увеличению внутриглазного давления. В редких случаях отмечались послеоперационные воспалительные реакции, отек и декомпенсация роговицы. Взаимосвязь этих состояний с использованием данных изделий не установлена."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Нет данных."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"Натрия гиалуронат получен путем ферментации бактерий Streptococcus equi и тщательно очищен."}},{"type":"paragraph","data":{"text":"Только для однократного применения."}},{"type":"paragraph","data":{"text":"Обязательно обращайте внимание на срок годности канюли, указанный на ее упаковке."}},{"type":"paragraph","data":{"text":"Для безопасного использования и утилизации соблюдайте общегосударственные и региональные правила и нормы."}}]},{"id":18,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"По 0,8 или 1,2 мл в предварительно наполненном шприце."}},{"type":"paragraph","data":{"text":"По 1 предварительно наполненному шприцу в пакете или контурной ячейковой упаковке."}},{"type":"paragraph","data":{"text":"По 1 пакету или контурной ячейковой упаковке и 1 или 2 канюли офтальмологические хирургические стерильные или без них или по 2 пакета или контурные ячейковые упаковки и 2 или 4 канюли офтальмологические хирургические стерильные или без них вместе с инструкцией по применению в пачке из картона с контролем первого вскрытия или без контроля первого вскрытия."}},{"type":"paragraph","data":{"text":"Допускается вложение в пачку из картона этикетки слежения в количестве 3 или 5, или 10 шт."}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"Всеми видами крытого транспорта в соответствии с правилами перевозки грузов, действующих на этих видах транспорта, при температуре от + 2 °С до + 8 °С."}},{"type":"paragraph","data":{"text":"Не замораживать. Держать вдали от источников тепла."}}]},{"id":20,"name":"Срок годности","slug":"expiry_date","body":[{"type":"paragraph","data":{"text":"3 года."}},{"type":"paragraph","data":{"text":"Не применять после окончания срока годности!"}}]},{"id":22,"name":"Производитель","slug":"","body":[{"type":"paragraph","data":{"text":"ООО «Гротекс», Россия"}},{"type":"paragraph","data":{"text":"195279, Санкт-Петербург, Индустриальный пр., д. 71, корп. 2,"}},{"type":"paragraph","data":{"text":" лит. А"}},{"type":"paragraph","data":{"text":"Тел.: +7 812 385 47 87"}},{"type":"paragraph","data":{"text":"Факс: +7 812 385 47 88"}},{"type":"paragraph","data":{"text":"www.solopharm.com"}},{"type":"paragraph","data":{"text":"www.kogevisk.ru"}}]}],"source":null},"description_toggle":false,"short_description":"Натрия гиалуронат – это полисахарид с большим молекулярным весом, состоящий из N-ацетилглюкозамина и натрия глюкуроната. 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