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
Аллерген туберкулезный рекомбинантный в стандартном разведении. Представляет собой рекомбинантный белок, продуцируемый генетически модифицированной культурой Escherichia coli BL21(DE3)/pCFP-ESAT. Содержит 2 антигена, присутствующие в вирулентных штаммах микобактерий туберкулеза и отсутствующие в вакцинном штамме БЦЖ. Действие препарата Диаскинтест; основано на выявлении клеточного иммунного ответа на специфические для Mycobacterium tuberculosis антигены. При внутрикожном введении Диаскинтест; вызывает у лиц с туберкулезной инфекцией специфическую кожную реакцию, являющуюся проявлением гиперчувствительности замедленного типа.
Показания к применению
Предназначен для постановки внутрикожной пробы во всех возрастных группах с целью:
Диагностики туберкулеза, оценки активности процесса и выявления лиц с высоким риском развития активного туберкулеза
Дифференциальной диагностики туберкулеза
Дифференциальной диагностики поствакцинальной и инфекционной аллергии (гиперчувствительности замедленного типа)
Оценки эффективности противотуберкулезного лечения в комплексе с другими методами. Для индивидуальной и скрининговой диагностики туберкулезной инфекции внутрикожную пробу с препаратом Диаскинтест; применяют по назначению врача фтизиатра или при его методическом обеспечении. Для идентификации (диагностики) туберкулезной инфекции пробу с препаратом Диаскинтест; проводят:
Лицам, направленным в противотуберкулезное учреждение для дополнительного обследования на наличие туберкулезного процесса
Лицам, относящимся к группам высокого риска по заболеванию туберкулезом с учетом эпидемиологических, медицинских и социальных факторов риска
Лицам, направленным к фтизиатру по результатам массовой туберкулинодиагностики. Для дифференциальной диагностики туберкулеза и других заболеваний пробу с препаратом Диаскинтест; проводят в комплексе с клинико-лабораторным и рентгенологическим обследованием в условиях противотуберкулезного учреждения. Для наблюдения за пациентами, состоящими на учете у фтизиатра, с различными проявлениями туберкулезной инфекции в условиях противотуберкулезного учреждения внутрикожную пробу с препаратом Диаскинтест; проводят при контрольном обследовании во всех группах диспансерного учета с интервалом 3-6 месяцев. В связи с тем, что препарат не вызывает реакцию гиперчувствительности замедленного типа, связанную с вакцинацией БЦЖ, проба с препаратом Диаскинтест; не может быть использована вместо туберкулинового теста для отбора лиц на первичную вакцинацию и ревакцинацию БЦЖ
Противопоказания
Острые и хронические (в период обострения) инфекционные заболевания, за исключением случаев подозрительных на туберкулез
Соматические и другие заболевания в период обострения
Распространенные кожные заболевания
Аллергические состояния. В детских коллективах, где имеется карантин по детским инфекциям, проба проводится только после снятия карантина
Применение при беременности и в период грудного вскармливания
Данные о применении препарата Диаскинтест; при беременности и в период лактации (грудного вскармливания) не предоставлены.
Способ применения и дозы
Пробу проводят по назначению врача детям, подросткам и взрослым специально обученной медицинской сестрой, имеющей допуск к проведению внутрикожных тестов. Препарат вводят строго внутрикожно. Для проведения пробы применяют туберкулиновые шприцы и тонкие короткие иглы с косым срезом. Перед употреблением необходимо проверить дату их выпуска и срок годности. Шприцем набирают 0.2 мл (две дозы) препарата Диаскинтест; и выпускают раствор до метки 0.1 мл в стерильный ватный тампон. Пробу проводят обследуемым в положении сидя. После обработки участка кожи на внутренней поверхности средней трети предплечья 70% этиловым спиртом, в верхние слои натянутой кожи параллельно ее поверхности вводят 0.1 мл препарата Диаскинтест;. При постановке пробы, как правило, в коже образуется папула в виде лимонной корочки размером 7-10 мм в диаметре беловатого цвета. Лицам, у которых в анамнезе имелись проявления неспецифической аллергии, пробу рекомендуется проводить на фоне приема десенсибилизирующих препаратов в течение 7 дней (5 дней до постановки пробы и 2 дня после нее). Учет результатовРезультат пробы оценивают врач или обученная медсестра через 72 ч с момента ее проведения путем измерения поперечного (по отношению к оси предплечья) размера гиперемии и инфильтрата (папулы) в миллиметрах прозрачной линейкой. Гиперемию учитывают только в случае отсутствия инфильтрата. Ответная реакция на пробу считается: отрицательной - при полном отсутствии инфильтрата и гиперемии или при наличии уколочной реакции до 2 мм; сомнительной - при наличии гиперемии без инфильтрата; положительной - при наличии инфильтрата (папулы) любого размера. Положительные реакции на Диаскинтест; условно различаются по степени выраженности: слабо выраженная реакция - при наличии инфильтрата размером до 5 мм; умеренно выраженная реакция - при размере инфильтрата 5-9 мм; выраженная реакция - при размере инфильтрата 10-14 мм; гиперергическая реакция - при размере инфильтрата 15 мм и более, при везикуло-некротических изменениях и (или) лимфангоите, лимфадените независимо от размера инфильтрата. Лица с сомнительной и положительной реакцией на Диаскинтест; обследуются на туберкулез. В отличие от реакции гиперчувствительности замедленного типа, кожные проявления неспецифической аллергии (в основном гиперемия) на препарат, как правило, наблюдаются сразу после постановки пробы и через 48-72 ч обычно исчезают. Препарат Диаскинтест; не вызывает реакции гиперчувствительности замедленного типа связанной с вакцинацией БЦЖ. Реакция на Диаскинтест;, как правило, отсутствует:— у лиц, не инфицированных Mycobacterium tuberculosis;— у лиц, ранее инфицированных Mycobacterium tuberculosis с неактивной туберкулезной инфекцией;— у больных туберкулезом в период завершения инволюции туберкулезных изменений при отсутствии клинических, рентгено-томографических, инструментальных и лабораторных признаков активности процесса;— у лиц, излечившихся от туберкулеза. Одновременно проба с препаратом Диаскинтест; может быть отрицательной у больных туберкулезом с выраженными иммунопатологическими нарушениями, обусловленными тяжелым течением туберкулезного процесса, у лиц на ранних стадиях инфицирования Mycobacterium tuberculosis, на ранних стадиях туберкулезного процесса у лиц, имеющих сопутствующие заболевания, сопровождающиеся иммунодефицитным состоянием. В учетных документах отмечают: а) название препарата; б) предприятие-изготовитель, номер серии, срок годности; в) дату проведения пробы; г) введение препарата в левое или правое предплечье; д) результат пробы. Флакон с препаратом после вскрытия допускается хранить не более 2 ч.
Побочное действие
Общие реакции: в отдельных случаях кратковременно - недомогание, головная боль, повышение температуры тела.
Передозировка
Данные по передозировке препарата Диаскинтест; не предоставлены.
Особые указания
Здоровым лицам с отрицательным результатом пробы профилактические прививки (кроме БЦЖ) можно проводить непосредственно после оценки и учета результата пробы.
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При внутрикожном введении Диаскинтест; вызывает у лиц с туберкулезной инфекцией специфическую кожную реакцию, являющуюся проявлением гиперчувствительности замедленного типа."}}]},{"id":4,"name":"Показания к применению","slug":"indications","displayInMenu":true,"body":[{"type":"paragraph","data":{"text":"Предназначен для постановки внутрикожной пробы во всех возрастных группах с целью:"}},{"type":"list","data":{"style":"unordered","items":["Диагностики туберкулеза, оценки активности процесса и выявления лиц с высоким риском развития активного туберкулеза","Дифференциальной диагностики туберкулеза","Дифференциальной диагностики поствакцинальной и инфекционной аллергии (гиперчувствительности замедленного типа)","Оценки эффективности противотуберкулезного лечения в комплексе с другими методами. Для индивидуальной и скрининговой диагностики туберкулезной инфекции внутрикожную пробу с препаратом Диаскинтест; применяют по назначению врача фтизиатра или при его методическом обеспечении. Для идентификации (диагностики) туберкулезной инфекции пробу с препаратом Диаскинтест; проводят:","Лицам, направленным в противотуберкулезное учреждение для дополнительного обследования на наличие туберкулезного процесса","Лицам, относящимся к группам высокого риска по заболеванию туберкулезом с учетом эпидемиологических, медицинских и социальных факторов риска","Лицам, направленным к фтизиатру по результатам массовой туберкулинодиагностики. Для дифференциальной диагностики туберкулеза и других заболеваний пробу с препаратом Диаскинтест; проводят в комплексе с клинико-лабораторным и рентгенологическим обследованием в условиях противотуберкулезного учреждения. Для наблюдения за пациентами, состоящими на учете у фтизиатра, с различными проявлениями туберкулезной инфекции в условиях противотуберкулезного учреждения внутрикожную пробу с препаратом Диаскинтест; проводят при контрольном обследовании во всех группах диспансерного учета с интервалом 3-6 месяцев. В связи с тем, что препарат не вызывает реакцию гиперчувствительности замедленного типа, связанную с вакцинацией БЦЖ, проба с препаратом Диаскинтест; не может быть использована вместо туберкулинового теста для отбора лиц на первичную вакцинацию и ревакцинацию БЦЖ"]}}]},{"id":5,"name":"Противопоказания","slug":"contraindications","displayInMenu":true,"body":[{"type":"list","data":{"style":"unordered","items":["Острые и хронические (в период обострения) инфекционные заболевания, за исключением случаев подозрительных на туберкулез","Соматические и другие заболевания в период обострения","Распространенные кожные заболевания","Аллергические состояния. 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Гиперемию учитывают только в случае отсутствия инфильтрата. Ответная реакция на пробу считается: отрицательной - при полном отсутствии инфильтрата и гиперемии или при наличии уколочной реакции до 2 мм; сомнительной - при наличии гиперемии без инфильтрата; положительной - при наличии инфильтрата (папулы) любого размера. Положительные реакции на Диаскинтест; условно различаются по степени выраженности: слабо выраженная реакция - при наличии инфильтрата размером до 5 мм; умеренно выраженная реакция - при размере инфильтрата 5-9 мм; выраженная реакция - при размере инфильтрата 10-14 мм; гиперергическая реакция - при размере инфильтрата 15 мм и более, при везикуло-некротических изменениях и (или) лимфангоите, лимфадените независимо от размера инфильтрата. Лица с сомнительной и положительной реакцией на Диаскинтест; обследуются на туберкулез. В отличие от реакции гиперчувствительности замедленного типа, кожные проявления неспецифической аллергии (в основном гиперемия) на препарат, как правило, наблюдаются сразу после постановки пробы и через 48-72 ч обычно исчезают. Препарат Диаскинтест; не вызывает реакции гиперчувствительности замедленного типа связанной с вакцинацией БЦЖ. Реакция на Диаскинтест;, как правило, отсутствует:— у лиц, не инфицированных Mycobacterium tuberculosis;— у лиц, ранее инфицированных Mycobacterium tuberculosis с неактивной туберкулезной инфекцией;— у больных туберкулезом в период завершения инволюции туберкулезных изменений при отсутствии клинических, рентгено-томографических, инструментальных и лабораторных признаков активности процесса;— у лиц, излечившихся от туберкулеза. Одновременно проба с препаратом Диаскинтест; может быть отрицательной у больных туберкулезом с выраженными иммунопатологическими нарушениями, обусловленными тяжелым течением туберкулезного процесса, у лиц на ранних стадиях инфицирования Mycobacterium tuberculosis, на ранних стадиях туберкулезного процесса у лиц, имеющих сопутствующие заболевания, сопровождающиеся иммунодефицитным состоянием. В учетных документах отмечают: а) название препарата; б) предприятие-изготовитель, номер серии, срок годности; в) дату проведения пробы; г) введение препарата в левое или правое предплечье; д) результат пробы. 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