Лайфферон обладает антивирусной, противоопухолевой, иммуномо... Инструкция
Показания к применению
Лайфферон применяют в комплексной терапии у взрослых:
- при остром вирусном гепатите В - среднетяжелых и тяжелых формах в начале желтушного периода до 5-го дня желтухи (в более поздние сроки назначение препарата менее эффективно; препарат не эффективен при развивающейся печеночной коме и холе- статическом течении заболевания);
Порошок или пористая масса белого цвета. Гигроскопичен.
Фармакотерапевтическая группа
Цитокин
Фармакологические свойства
Лайфферон обладает антивирусной, противоопухолевой, иммуномодулируюгцей активностью.
Показания к применению
Лайфферон применяют в комплексной терапии у взрослых:
- при остром вирусном гепатите В - среднетяжелых и тяжелых формах в начале желтушного периода до 5-го дня желтухи (в более поздние сроки назначение препарата менее эффективно; препарат не эффективен при развивающейся печеночной коме и холе- статическом течении заболевания);
- при остром затяжном гепатите В и С хроническом активном гепатите В и С в том числе с дельта-агентом без признаков цирроза и при появлении признаков цирроза печени;
- при вирусных (гриппозных аденовирусных энтеровирусных герпетических паротитных) вирусно-бактериальных и микоплазменных менингоэнцефалитах. Применение препарата наиболее эффективно в первые 4 дня заболевания;
- при раке почки IV стадии волосатоклеточном лейкозе злокачественных лимфо- мах кожи (грибовидный микоз первичный ретикулез ретикулосаркоматоз) саркоме Капоши базально-клеточном и плоскоклеточном раках кожи кератоакантоме хроническом миелолейкозе гистиоцитозе из клеток Лангерганса сублейкемическом миелозе эссенциальной тромбоцитемии;
- при рассеянном склерозе
- при вирусных конъюнктивитах кератоконъюнктивитах кератитах кератоиридоциклитах кератоувеитах.
Лайфферон применяют в комплексной терапии у детей от 1 года:
- при остром лимфобластном лейкозе в периоде ремиссии после окончания индукционной химиотерапии (на 4-5 месяце ремиссии);
- при ювенильном респираторном папилломатозе гортани начиная со следующего дня после удаления папиллом.
Противопоказания
- При гиперчувствительности к компонентам препарата;
- при тяжелых формах аллергических заболеваний;
- при беременности и в период лактации.
Применение при беременности и в период грудного вскармливания
Препарат противопоказан к применению при беременности и в период лактации.
Способ применения и дозы
Лайфферон вводят внутримышечно в очаг или под очаг поражения субконъюнктивально или местно. Непосредственно перед применением содержимое ампулы (флакона) растворяют в воде для инъекций или в 09 % растворе хлорида натрия (в 1 мл - при внутримышечном введении и в очаг в 5 мл - при субконъюнктивальном и местном введении). Раствор препарата должен быть бесцветным со слабой опалесценцией без осадка и посторонних включений. Время растворения должно составлять около 10 минут.
Внутримышечное введение
При остром вирусном гепатите В препарат вводят по 1 млн ME 2 раза в сутки в течение 5-6 дней затем дозу снижают до 1 млн ME в сутки и вводят еще в течение 5 дней. При необходимости (после контрольных биохимических исследований крови) курс лечения может быть продолжен по 1 млн ME 2 раза в неделю в течение 2 недель. Курсовая доза составляет 15-21 млн ME.
При остром затяжном и хроническом вирусном гепатите В при исключении дельта- агента и без признаков цирроза печени препарат вводят по 1 млн ME 2 раза в неделю в течение 1-2 месяцев. При отсутствии эффекта лечение продлить до 3-6 месяцев или после окончания 1-2 месячного лечения провести 2-3 аналогичных курса с интервалом 1-6 месяцев.
При хроническом вирусном гепатите В с дельта-агентом без признаков цирроза печени препарат вводят по 05-1 млн ME в сутки 2 раза в неделю в течение 1 месяца. Повторный курс лечения через 1-6 месяцев.
При хроническом вирусном гепатите В с дельта-агентом и признаками цирроза печени препарат вводят по 025-05 млн ME в сутки 2 раза в неделю в течение 1 месяца. При появлении признаков декомпенсации проводят аналогичные повторные курсы с интервалами не менее 2 месяцев.
При остром затяжном и хронически активном гепатите С без признаков цирроза печени препарат вводят по 3 млн ME 3 раза в неделю в течение 6-8 месяцев. При отсутствии эффекта лечение продлить до 12 месяцев. Повторный курс лечения через 3-6 месяцев.
При вирусных вирусно-бактериальных и микоплазменных менингоэнцефалитах препарат вводят по 1 млн ME 2 раза в день в течение 10 дней в комплексе с противовирусными и антибактериальными химиопрепаратами. Дозу и схему лечения устанавливают индивидуально в зависимости от тяжести состояния больного.
При раке почки препарат применяют по 3 млн ME ежедневно в течение 10 дней. Повторные курсы лечения (3-9 и более) проводят с интервалами в 3 недели. Общее количество препарата составляет от 120 млн ME до 300 млн ME и более.
При волосатоклеточном лейкозе препарат вводят ежедневно по 3-6 млн. ME в течение 2-х месяцев. После нормализации гемограммы суточную дозу препарата снижают до 1-2 млн ME. Затем назначают поддерживающую терапию по 3 млн ME 2 раза в неделю в течение 6-7 недель. Общее количество препарата составляет 420-600 млн ME и более.
При остром лимфобластном лейкозе у детей в периоде ремиссии после окончания индукционной химиотерапии (на 4-5 месяце ремиссии) - по 1 млн ME 1 раз в неделю в течение 6 месяцев затем 1 раз в 2 недели в течение 24 месяцев. Одновременно проводят поддерживающую химиотерапию.
При злокачественных лимфомах и саркоме Капоши препарат вводят по 3 млн ME в сутки ежедневно в течение 10 дней в сочетании с цитостатиками (проспидин циклофос- фан) и глюкокортикостероидами. При опухолевой стадии грибовидного микоза первичном ретикулезе и ретикулосаркоматозе целесообразно чередовать внутримышечное введение препарата по 3 млн ME и внутриочаговое - по 2 млн ME в течение 10 дней.
У больных эритродермической стадией грибовидного микоза при повышении температуры свыше 39°С и в случае обострения процесса введение препарата следует прекратить. При недостаточном терапевтическом эффекте через 10-14 дней назначают повторный курс лечения. После достижения клинического эффекта назначают поддерживающую терапию по 3 млн ME один раз в неделю в течение 6-7 недель.
При хроническом миелолейкозе препарат вводят по 3 млн ME ежедневно или по 6 млн ME через день. Срок лечения от 10 недель до 6 месяцев.
При гистиоцитозе из клеток Лангерганса препарат вводят по 3 млн ME ежедневно в течение 1 месяца. Повторные курсы с 1-2-месячными интервалами в течение 1-3 лет.
При сублейкемическом миелозе и эссенциальной тромбоцитемии для коррекции гипертромбоцитоза - по 1 млн ME ежедневно или через 1 сутки в течение 20 дней.
При ювенильном респираторном папилломатозе гортани препарат вводят по 01-015 млн ME на кг веса тела ежедневно в течение 45-50 дней затем в той же дозировке 3 раза в неделю в течение 1 месяца. Второй и третий курс проводят с интервалом 2-6 месяцев.
При рассеянном склерозе препарат назначают по 1 млн ME при пирамидном синдроме 3 раза в сутки при мозжечковом синдроме - 1-2 раза в сутки в течение 10 дней с последующим введением по 1 млн ME 1 раз в неделю в течение 5-6 месяцев. Общее количество препарата составляет 50-60 млн ME.
У лиц с высокой пирогенной реакцией (39 °С и выше) на введение препарата рекомендуется одновременное применение парацетамола или индометацина.
Перифокальное введение
При базально-клеточном и плоскоклеточном раке кератоакантоме препарат вводят под очаг поражения по 1 млн ME 1 раз в сутки ежедневно в течение 10 дней. В случае выраженных местных воспалительных реакций введение под очаг поражения проводят через 1-2 дня. По окончании курса при необходимости проводят криодеструкцию.
Субконъюнктивальное введение
При стромальных кератитах кератоиридоциклитах кератоувеитах назначают субконъюнктивальные инъекции препарата в дозе по 60 тыс. ME в объеме 05 мл ежедневно или через день в зависимости от тяжести процесса. Инъекции проводят под местной анестезией 05 % раствором дикаина. Курс лечения - от 15 до 25 инъекций.
Местное применение
Для местного применения содержимое ампулы (флакона) препарата с активностью 1 млн ME растворяют в 5 мл раствора хлорида натрия 09 % для инъекций. В случае хранения раствора препарата необходимо соблюдая правила асептики и антисептики перенести содержимое ампулы в стерильный флакон с пробкой и хранить раствор в холодильнике при (4-10) °С не более 12 ч.
При конъюнктивите и поверхностных кератитах на конъюнктиву пораженного глаза наносят по 2 капли раствора 6-8 раз в сутки. По мере исчезновения воспалительных явлений число инсталляций уменьшают до 3-4 раз в сутки. Курс лечения - 2 недели.
Побочное действие
При парентеральном введении препарата возможны озноб повышение температуры утомляемость головная боль недомогание гриппоподобный синдром. Эти побочные эффекты частично купируются парацетамолом или индометацином.
При местном применении препарата на слизистой оболочке глаза возможны конъюнктивальная инфекция гиперемия слизистой оболочки глаза единичные фолликулы отек конъюнктивы нижнего свода.
При применении препарата возможны отклонения от нормы лабораторных показателей проявляющиеся лейкопенией лимфопенией тромбоцитопенией повышением уровня аланин-аминотрансферазы щелочной фосфатазы. Для своевременного выявления указанных отклонений в ходе терапии общие клинические анализы крови необходимо повторять каждые 2 недели а биохимические - каждые 4 недели. Как правило эти изменения обычно бывают незначительными бессимптомными и обратимыми.
Передозировка
Случаев передозировки не наблюдалось. Учитывая что активным веществом является интерферон альфа-2b то при передозировке возможно усиление выраженности побочных эффектов.
Лечение: отмена препарата; при необходимости проводят симптоматическую терапию.
Взаимодействие с другими лекарственными средствами
Интерферон альфа-2b способен снижать активность Р450 цитохрома и следовательно вмешиваться в метаболизм циметидина фенитоина дипиридамола теофиллина диазепама пропраиолола варфарина некоторых цитостатиков. Может усиливать нейротоксическое миелотоксическое или кардиотоксическое действие препаратов назначавшихся ранее или одновременно с ним. Следует избегать совместного назначения с препаратами угнетающими ЦНС иммуносупрессивными препаратами (включая кортикостероиды).
Употребление алкоголя во время лечения не рекомендуется.
Особые указания
В случае тяжелых побочных реакций или сохранении их в течение длительного времени по усмотрению врача допускается временное снижение дозы (при снижении числа тромбоцитов до уровня менее 50000 клеток в 1 мкл абсолютного числа нейтрофилов менее 750 клеток в 1 мкл) или прерывание лечения (при снижении числа тромбоцитов до уровня менее 25000 клеток в 1 мкл абсолютного числа нейтрофилов менее 500 клеток в 1 мкл).
Влияние на способность управлять автомобилем и движущимися механизмами
В период применения препарата пациентам испытывающим усталость сонливость или дезориентацию необходимо воздерживаться от занятий потенциально опасными видами деятельности требующими повышенной концентрации внимания и быстроты психомоторных реакций.
Форма выпуска
Лиофилизат для приготовления раствора для внутримышечного субконъюнктивального введения и закапывания в глаз
Условия хранения
Хранить в защищенном от света месте при температуре не выше 8 °С. Хранить в недоступном для детей месте.
Срок годности
3 года.
Не подлежит применению по истечении срока годности.
Условия отпуска
По рецепту
Производитель
Закрытое акционерное общество "Вектор-Медика" (ЗАО "Вектор-Медика")
Организация, принимающая претензии потребителей
ЗАО "Вектор-Медика"
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При появлении признаков декомпенсации проводят аналогичные повторные курсы с интервалами не менее 2 месяцев."}},{"type":"paragraph","data":{"text":"При остром затяжном и хронически активном гепатите С без признаков цирроза печени препарат вводят по 3 млн ME 3 раза в неделю в течение 6-8 месяцев. При отсутствии эффекта лечение продлить до 12 месяцев. Повторный курс лечения через 3-6 месяцев."}},{"type":"paragraph","data":{"text":"При вирусных вирусно-бактериальных и микоплазменных менингоэнцефалитах препарат вводят по 1 млн ME 2 раза в день в течение 10 дней в комплексе с противовирусными и антибактериальными химиопрепаратами. Дозу и схему лечения устанавливают индивидуально в зависимости от тяжести состояния больного."}},{"type":"paragraph","data":{"text":"При раке почки препарат применяют по 3 млн ME ежедневно в течение 10 дней. Повторные курсы лечения (3-9 и более) проводят с интервалами в 3 недели. Общее количество препарата составляет от 120 млн ME до 300 млн ME и более."}},{"type":"paragraph","data":{"text":"При волосатоклеточном лейкозе препарат вводят ежедневно по 3-6 млн. ME в течение 2-х месяцев. После нормализации гемограммы суточную дозу препарата снижают до 1-2 млн ME. Затем назначают поддерживающую терапию по 3 млн ME 2 раза в неделю в течение 6-7 недель. Общее количество препарата составляет 420-600 млн ME и более."}},{"type":"paragraph","data":{"text":"При остром лимфобластном лейкозе у детей в периоде ремиссии после окончания индукционной химиотерапии (на 4-5 месяце ремиссии) - по 1 млн ME 1 раз в неделю в течение 6 месяцев затем 1 раз в 2 недели в течение 24 месяцев. Одновременно проводят поддерживающую химиотерапию."}},{"type":"paragraph","data":{"text":"При злокачественных лимфомах и саркоме Капоши препарат вводят по 3 млн ME в сутки ежедневно в течение 10 дней в сочетании с цитостатиками (проспидин циклофос- фан) и глюкокортикостероидами. При опухолевой стадии грибовидного микоза первичном ретикулезе и ретикулосаркоматозе целесообразно чередовать внутримышечное введение препарата по 3 млн ME и внутриочаговое - по 2 млн ME в течение 10 дней."}},{"type":"paragraph","data":{"text":"У больных эритродермической стадией грибовидного микоза при повышении температуры свыше 39°С и в случае обострения процесса введение препарата следует прекратить. При недостаточном терапевтическом эффекте через 10-14 дней назначают повторный курс лечения. После достижения клинического эффекта назначают поддерживающую терапию по 3 млн ME один раз в неделю в течение 6-7 недель."}},{"type":"paragraph","data":{"text":"При хроническом миелолейкозе препарат вводят по 3 млн ME ежедневно или по 6 млн ME через день. Срок лечения от 10 недель до 6 месяцев."}},{"type":"paragraph","data":{"text":"При гистиоцитозе из клеток Лангерганса препарат вводят по 3 млн ME ежедневно в течение 1 месяца. Повторные курсы с 1-2-месячными интервалами в течение 1-3 лет."}},{"type":"paragraph","data":{"text":"При сублейкемическом миелозе и эссенциальной тромбоцитемии для коррекции гипертромбоцитоза - по 1 млн ME ежедневно или через 1 сутки в течение 20 дней."}},{"type":"paragraph","data":{"text":"При ювенильном респираторном папилломатозе гортани препарат вводят по 01-015 млн ME на кг веса тела ежедневно в течение 45-50 дней затем в той же дозировке 3 раза в неделю в течение 1 месяца. Второй и третий курс проводят с интервалом 2-6 месяцев."}},{"type":"paragraph","data":{"text":"При рассеянном склерозе препарат назначают по 1 млн ME при пирамидном синдроме 3 раза в сутки при мозжечковом синдроме - 1-2 раза в сутки в течение 10 дней с последующим введением по 1 млн ME 1 раз в неделю в течение 5-6 месяцев. Общее количество препарата составляет 50-60 млн ME."}},{"type":"paragraph","data":{"text":"У лиц с высокой пирогенной реакцией (39 °С и выше) на введение препарата рекомендуется одновременное применение парацетамола или индометацина."}},{"type":"paragraph","data":{"text":"Перифокальное введение"}},{"type":"paragraph","data":{"text":"При базально-клеточном и плоскоклеточном раке кератоакантоме препарат вводят под очаг поражения по 1 млн ME 1 раз в сутки ежедневно в течение 10 дней. В случае выраженных местных воспалительных реакций введение под очаг поражения проводят через 1-2 дня. По окончании курса при необходимости проводят криодеструкцию."}},{"type":"paragraph","data":{"text":"Субконъюнктивальное введение"}},{"type":"paragraph","data":{"text":"При стромальных кератитах кератоиридоциклитах кератоувеитах назначают субконъюнктивальные инъекции препарата в дозе по 60 тыс. ME в объеме 05 мл ежедневно или через день в зависимости от тяжести процесса. Инъекции проводят под местной анестезией 05 % раствором дикаина. Курс лечения - от 15 до 25 инъекций."}},{"type":"paragraph","data":{"text":"Местное применение"}},{"type":"paragraph","data":{"text":"Для местного применения содержимое ампулы (флакона) препарата с активностью 1 млн ME растворяют в 5 мл раствора хлорида натрия 09 % для инъекций. В случае хранения раствора препарата необходимо соблюдая правила асептики и антисептики перенести содержимое ампулы в стерильный флакон с пробкой и хранить раствор в холодильнике при (4-10) °С не более 12 ч."}},{"type":"paragraph","data":{"text":"При конъюнктивите и поверхностных кератитах на конъюнктиву пораженного глаза наносят по 2 капли раствора 6-8 раз в сутки. По мере исчезновения воспалительных явлений число инсталляций уменьшают до 3-4 раз в сутки. Курс лечения - 2 недели."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"При парентеральном введении препарата возможны озноб повышение температуры утомляемость головная боль недомогание гриппоподобный синдром. Эти побочные эффекты частично купируются парацетамолом или индометацином."}},{"type":"paragraph","data":{"text":"При местном применении препарата на слизистой оболочке глаза возможны конъюнктивальная инфекция гиперемия слизистой оболочки глаза единичные фолликулы отек конъюнктивы нижнего свода."}},{"type":"paragraph","data":{"text":"При применении препарата возможны отклонения от нормы лабораторных показателей проявляющиеся лейкопенией лимфопенией тромбоцитопенией повышением уровня аланин-аминотрансферазы щелочной фосфатазы. Для своевременного выявления указанных отклонений в ходе терапии общие клинические анализы крови необходимо повторять каждые 2 недели а биохимические - каждые 4 недели. Как правило эти изменения обычно бывают незначительными бессимптомными и обратимыми."}}]},{"id":14,"name":"Передозировка","slug":"overdose","body":[{"type":"paragraph","data":{"text":"Случаев передозировки не наблюдалось. Учитывая что активным веществом является интерферон альфа-2b то при передозировке возможно усиление выраженности побочных эффектов."}},{"type":"paragraph","data":{"text":"Лечение: отмена препарата; при необходимости проводят симптоматическую терапию."}}]},{"id":15,"name":"Взаимодействие с другими лекарственными средствами","slug":"drugs_interaction","body":[{"type":"paragraph","data":{"text":"Интерферон альфа-2b способен снижать активность Р450 цитохрома и следовательно вмешиваться в метаболизм циметидина фенитоина дипиридамола теофиллина диазепама пропраиолола варфарина некоторых цитостатиков. Может усиливать нейротоксическое миелотоксическое или кардиотоксическое действие препаратов назначавшихся ранее или одновременно с ним. Следует избегать совместного назначения с препаратами угнетающими ЦНС иммуносупрессивными препаратами (включая кортикостероиды)."}},{"type":"paragraph","data":{"text":"Употребление алкоголя во время лечения не рекомендуется."}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"В случае тяжелых побочных реакций или сохранении их в течение длительного времени по усмотрению врача допускается временное снижение дозы (при снижении числа тромбоцитов до уровня менее 50000 клеток в 1 мкл абсолютного числа нейтрофилов менее 750 клеток в 1 мкл) или прерывание лечения (при снижении числа тромбоцитов до уровня менее 25000 клеток в 1 мкл абсолютного числа нейтрофилов менее 500 клеток в 1 мкл)."}}]},{"id":17,"name":"Влияние на способность управлять автомобилем и движущимися механизмами","slug":"","body":[{"type":"paragraph","data":{"text":"В период применения препарата пациентам испытывающим усталость сонливость или дезориентацию необходимо воздерживаться от занятий потенциально опасными видами деятельности требующими повышенной концентрации внимания и быстроты психомоторных реакций."}}]},{"id":18,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"Лиофилизат для приготовления раствора для внутримышечного субконъюнктивального введения и закапывания в глаз"}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"Хранить в защищенном от света месте при температуре не выше 8 °С. Хранить в недоступном для детей месте."}}]},{"id":20,"name":"Срок годности","slug":"expiry_date","body":[{"type":"paragraph","data":{"text":"3 года."}},{"type":"paragraph","data":{"text":"Не подлежит применению по истечении срока годности."}}]},{"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":"Закрытое акционерное общество \"Вектор-Медика\" (ЗАО \"Вектор-Медика\")"}}]},{"id":23,"name":"Организация, принимающая претензии потребителей","body":[{"type":"paragraph","data":{"text":"ЗАО \"Вектор-Медика\""}}]}],"source":null},"description_toggle":false,"short_description":"Лайфферон обладает антивирусной, противоопухолевой, иммуномодулируюгцей активностью.","substance":[{"id":227,"title":"Интерферон альфа-2b человеческий рекомбинантный","title_latin":"Interferon alfa-2b human 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