Desloratadine Teva

Country: European Union

Language: Bulgarian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
09-06-2022
Summary of Product characteristics Summary of Product characteristics (SPC)
09-06-2022
Public Assessment Report Public Assessment Report (PAR)
08-12-2011

Active ingredient:

деслоратадин

Available from:

Teva B.V

ATC code:

R06AX27

INN (International Name):

desloratadine

Therapeutic group:

Антихистамини за системно приложение,

Therapeutic area:

Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal

Therapeutic indications:

Дезлоратадин Тева е показан за облекчаване на симптомите, свързани с:алергичен ринит;уртикария.

Product summary:

Revision: 18

Authorization status:

упълномощен

Authorization date:

2011-11-24

Patient Information leaflet

                                18
Б. ЛИСТОВКА
19
ЛИСТОВКА: ИНФОРМАЦИЯ ЗА ПАЦИЕНТА
DESLORATADINE TEVA 5 MG ФИЛМИРАНИ ТАБЛЕТКИ
деслоратадин (desloratadine)
ПРОЧЕТЕТЕ ВНИМАТЕЛНО ЦЯЛАТА ЛИСТОВКА,
ПРЕДИ ДА ЗАПОЧНЕТЕ ДА ПРИЕМАТЕ 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 или
фармацевт.
-
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 или
фармацевт. Това
включва и всички възможни нежелани
реакции, неописани в тази листовка.
Вижте
точка 4.
КАКВО СЪДЪРЖА ТАЗИ ЛИСТОВКА:
1.
Какво представлява Desloratadine Teva и за
какво се използва
2.
Какво трябва да знаете, преди да
приемете Desloratadine Teva
3.
Как да приемате Desloratadine Teva
4.
Възможни нежелани реакции
5.
Как да съхранявате Desloratadine Teva
6.
Съдържание на опаковката и
допълнителна информация
1.
КАКВО ПРЕДСТАВЛЯВА DESLORATADINE TEVA И ЗА
КАКВО СЕ ИЗПОЛЗВА
КАКВО ПРЕДСТАВЛЯВА DESLORATADINE TEVA
Desloratadine Teva съдържа деслоратадин, което
е а
                                
                                Read the complete document

Summary of Product characteristics

                                1
ПРИЛОЖЕНИЕ I
КРАТКА ХАРАКТЕРИСТИКА НА ПРОДУКТА
2
1.
ИМЕ НА ЛЕКАРСТВЕНИЯ ПРОДУКТ
Desloratadine Teva 5 mg филмирани таблетки
2.
КАЧЕСТВЕН И КОЛИЧЕСТВЕН СЪСТАВ
Всяка таблетка съдържа 5 mg
деслоратадин (desloratadine).
Помощно(и) вещество(а) с известно
действие
Всяка филмирана таблетка съдържа 1,2 mg
лактоза монохидрат (вж. точка 4.4).
За пълния списък на помощните
вещества вижте точка 6.1.
3.
ЛЕКАРСТВЕНА ФОРМА
Филмирана таблетка
Синя, кръгла, двойно изпъкнала
филмирана таблетка, гладка от двете
страни.
4.
КЛИНИЧНИ ДАННИ
4.1
ТЕРАПЕВТИЧНИ ПОКАЗАНИЯ
Desloratadine Teva е показан при възрастни и
юноши на възраст 12 и повече години за
облекчаване на симптоми на:
−
алергичен ринит (вж. точка 5.1);
−
уртикария (вж. точка 5.1).
4.2
ДОЗИРОВКА И НАЧИН НА ПРИЛОЖЕНИЕ
Дозировка
_Възрастни и юноши (над 12 години)_
Препоръчителната доза Desloratadine Teva 5 mg
филмирани таблетки е една таблетка
веднъж
дневно.
Интермитентният алергичен ринит
(наличие на симптоми за по-малко от 4
дни в седмицата или
за по-кратко от 4 седмици) трябва да се
лекува в съответствие с оценката на
анамнезата на
съответния пациент, а лечението
трябва да бъде прекратено след
изчезване на симптомите, а
при рециди
                                
                                Read the complete document

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Active ingredient деслоратадин

деслоратадин

ATC code R06AX27

R06AX27

Marketed by Teva B.V

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INN (International Name) desloratadine

desloratadine

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Patient Information leaflet Patient Information leaflet Spanish 09-06-2022
Summary of Product characteristics Summary of Product characteristics Spanish 09-06-2022
Public Assessment Report Public Assessment Report Spanish 08-12-2011
Patient Information leaflet Patient Information leaflet Czech 09-06-2022
Summary of Product characteristics Summary of Product characteristics Czech 09-06-2022
Public Assessment Report Public Assessment Report Czech 08-12-2011
Patient Information leaflet Patient Information leaflet Danish 09-06-2022
Summary of Product characteristics Summary of Product characteristics Danish 09-06-2022
Public Assessment Report Public Assessment Report Danish 08-12-2011
Patient Information leaflet Patient Information leaflet German 09-06-2022
Summary of Product characteristics Summary of Product characteristics German 09-06-2022
Public Assessment Report Public Assessment Report German 08-12-2011
Patient Information leaflet Patient Information leaflet Estonian 09-06-2022
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Public Assessment Report Public Assessment Report Estonian 08-12-2011
Patient Information leaflet Patient Information leaflet Greek 09-06-2022
Summary of Product characteristics Summary of Product characteristics Greek 09-06-2022
Public Assessment Report Public Assessment Report Greek 08-12-2011
Patient Information leaflet Patient Information leaflet English 09-06-2022
Summary of Product characteristics Summary of Product characteristics English 09-06-2022
Public Assessment Report Public Assessment Report English 08-12-2011
Patient Information leaflet Patient Information leaflet French 09-06-2022
Summary of Product characteristics Summary of Product characteristics French 09-06-2022
Public Assessment Report Public Assessment Report French 08-12-2011
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Public Assessment Report Public Assessment Report Italian 08-12-2011
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Public Assessment Report Public Assessment Report Hungarian 08-12-2011
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Public Assessment Report Public Assessment Report Polish 08-12-2011
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Public Assessment Report Public Assessment Report Portuguese 08-12-2011
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Public Assessment Report Public Assessment Report Romanian 08-12-2011
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Public Assessment Report Public Assessment Report Slovak 08-12-2011
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Public Assessment Report Public Assessment Report Slovenian 08-12-2011
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Public Assessment Report Public Assessment Report Finnish 08-12-2011
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