Staquis

Country: European Union

Language: Bulgarian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
08-02-2022
Summary of Product characteristics Summary of Product characteristics (SPC)
08-02-2022
Public Assessment Report Public Assessment Report (PAR)
08-02-2022

Active ingredient:

Crisaborole

Available from:

Pfizer Europe MA EEIG 

ATC code:

D11AH06

INN (International Name):

crisaborole

Therapeutic group:

Други дерматологични препарати

Therapeutic area:

Дерматит, Атопич

Therapeutic indications:

Staquis е показан за лечение на лека до умерена атопичен дерматит при възрастни и педиатрични пациенти от 2 години с ≤ 40% от площта на повърхността на тялото (BSA) засегнати.

Product summary:

Revision: 6

Authorization status:

Отменено

Authorization date:

2020-03-27

Patient Information leaflet

                                24
Б. ЛИСТОВКА
Лекарствен продукт с невалидно
разрешение за употреба
25
ЛИСТОВКА: ИНФОРМАЦИЯ ЗА ПАЦИЕНТА
STAQUIS 20 MG/G МАЗ
кризаборол (crisaborole)
Този лекарствен продукт подлежи на
допълнително наблюдение. Това ще
позволи бързото
установяване на нова информация
относно безопасността. Можете да
дадете своя принос като
съобщите всяка нежелана реакция,
която сте получили. За начина на
съобщаване на нежелани
реакции вижте края на точка 4.
ПРОЧЕТЕТЕ ВНИМАТЕЛНО ЦЯЛАТА ЛИСТОВКА,
ПРЕДИ ДА ЗАПОЧНЕТЕ ДА ИЗПОЛЗВАТЕ ТОВА
ЛЕКАРСТВО, ТЪЙ КАТО ТЯ СЪДЪРЖА ВАЖНА
ЗА ВАС ИНФОРМАЦИЯ.
-
Запазете тази листовка. Може да се
наложи да я прочетете отново.
-
Ако имате някакви допълнителни
въпроси, попитайте Вашия лекар,
фармацевт или
медицинска сестра.
-
Това лекарство е предписано лично на
Вас. Не го преотстъпвайте на други
хора. То може
да им навреди, независимо че
признаците на тяхното заболяване са
същите като Вашите.
-
Ако получите някакви нежелани
реакции, уведомете Вашия лекар,
фармацевт или
медицинска сестра. Това включва и
всички възможни нежелани реакции,
неописани в
тази листовка. Вижте точка 4.
КАКВО СЪДЪРЖА ТАЗИ ЛИСТОВКА
1.
Какво пр
                                
                                Read the complete document

Summary of Product characteristics

                                1
ПРИЛОЖЕНИЕ I
КРАТКА ХАРАКТЕРИСТИКА НА ПРОДУКТА
Лекарствен продукт с невалидно
разрешение за употреба
2
Този лекарствен продукт подлежи на
допълнително наблюдение. Това ще
позволи бързото
установяване на нова информация
относно безопасността. От
медицинските специалисти се
изисква да съобщават всяка подозирана
нежелана реакция. За начина на
съобщаване на
нежелани реакции вижте точка 4.8.
1.
ИМЕ НА ЛЕКАРСТВЕНИЯ ПРОДУКТ
Staquis 20 mg/g маз
2.
КАЧЕСТВЕН И КОЛИЧЕСТВЕН СЪСТАВ
Един g маз съдържа 20 mg кризаборол
(crisaborole).
Помощни вещества с известно действие
Пропиленгликол, 90 mg/g маз
За пълния списък на помощните
вещества вижте точка 6.1.
3.
ЛЕКАРСТВЕНА ФОРМА
Маз.
Бяла до почти бяла маз.
4.
КЛИНИЧНИ ДАННИ
4.1
ТЕРАПЕВТИЧНИ ПОКАЗАНИЯ
Staquis е показан за лечение на лека до
умерена форма на атопичен дерматит
при възрастни и
педиатрични пациенти на възраст от 2
години с ≤ 40% засегната телесна
повърхност (body
surface area, BSA).
4.2
ДОЗИРОВКА И НАЧИН НА ПРИЛОЖЕНИЕ
Дозировка
_Възрастни_
Слой от мазта трябва да се прилага два
пъти дневно върху засегнатите
области.
Мазта трябва да се прилага само върху
засегнатите области на кожата до
максимално 40% BSA
                                
                                Read the complete document

Similar products

Active ingredient Crisaborole

Crisaborole

ATC code D11AH06

D11AH06

Marketed by Pfizer Europe MA EEIG 

Pfizer Europe MA EEIG 

INN (International Name) crisaborole

crisaborole

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Patient Information leaflet Patient Information leaflet Spanish 08-02-2022
Summary of Product characteristics Summary of Product characteristics Spanish 08-02-2022
Public Assessment Report Public Assessment Report Spanish 08-02-2022
Patient Information leaflet Patient Information leaflet Czech 08-02-2022
Summary of Product characteristics Summary of Product characteristics Czech 08-02-2022
Public Assessment Report Public Assessment Report Czech 08-02-2022
Patient Information leaflet Patient Information leaflet Danish 08-02-2022
Summary of Product characteristics Summary of Product characteristics Danish 08-02-2022
Public Assessment Report Public Assessment Report Danish 08-02-2022
Patient Information leaflet Patient Information leaflet German 08-02-2022
Summary of Product characteristics Summary of Product characteristics German 08-02-2022
Public Assessment Report Public Assessment Report German 08-02-2022
Patient Information leaflet Patient Information leaflet Estonian 08-02-2022
Summary of Product characteristics Summary of Product characteristics Estonian 08-02-2022
Public Assessment Report Public Assessment Report Estonian 08-02-2022
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Summary of Product characteristics Summary of Product characteristics Greek 08-02-2022
Public Assessment Report Public Assessment Report Greek 08-02-2022
Patient Information leaflet Patient Information leaflet English 08-02-2022
Summary of Product characteristics Summary of Product characteristics English 08-02-2022
Public Assessment Report Public Assessment Report English 08-02-2022
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Summary of Product characteristics Summary of Product characteristics French 08-02-2022
Public Assessment Report Public Assessment Report French 08-02-2022
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Summary of Product characteristics Summary of Product characteristics Polish 08-02-2022
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Summary of Product characteristics Summary of Product characteristics Romanian 08-02-2022
Public Assessment Report Public Assessment Report Romanian 08-02-2022
Patient Information leaflet Patient Information leaflet Slovak 08-02-2022
Summary of Product characteristics Summary of Product characteristics Slovak 08-02-2022
Public Assessment Report Public Assessment Report Slovak 08-02-2022
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Summary of Product characteristics Summary of Product characteristics Slovenian 08-02-2022
Public Assessment Report Public Assessment Report Slovenian 08-02-2022
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