Aerinaze

Country: European Union

Language: Bulgarian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
07-12-2022
Summary of Product characteristics Summary of Product characteristics (SPC)
07-12-2022
Public Assessment Report Public Assessment Report (PAR)
23-11-2011

Active ingredient:

desloratadine, pseudophedrine sulfate

Available from:

N.V. Organon

ATC code:

R01BA52

INN (International Name):

desloratadine, pseudoephedrine

Therapeutic group:

Назални препарати

Therapeutic area:

Ринит, алергични, сезонни

Therapeutic indications:

Симптоматично лечение на сезонен алергичен ринит, придружен от назална конгестия.

Product summary:

Revision: 22

Authorization status:

упълномощен

Authorization date:

2007-07-30

Patient Information leaflet

                                20
Б. ЛИСТОВКА
21
ЛИСТОВКА: ИНФОРМАЦИЯ ЗА ПАЦИЕНТА
AERINAZE 2,5 MG/120 MG ТАБЛЕТКИ С ИЗМЕНЕНО
ОСВОБОЖДАВАНЕ
деслоратадин/псевдоефедринов сулфат
(desloratadine/pseudoephedrine sulphate)
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,
фармацевт или
медицинска сестра.
-
Това лекарство е предписано
единствено и 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
лекарствени 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 представлява Aerinaze и за какво се
използва
2.
Какво трябва да знаете, преди да
приемете Aerinaze
3.
Как да приемате Aerinaze
4.
Възможни нежелани реакции
5.
Как да съхранявате Aerinaze
6.
Съдържание на опаковката и
допълнителна информация
1.
КАКВО ПРЕДСТАВЛЯВА AERINAZE И ЗА 
                                
                                Read the complete document

Summary of Product characteristics

                                1
ПРИЛОЖЕНИЕ I
КРАТКА ХАРАКТЕРИСТИКА НА ПРОДУКТА
2
1.
ИМЕ НА ЛЕКАРСТВЕНИЯ ПРОДУКТ
Aerinaze 2,5 mg/120 mg таблетки с изменено
освобождаване
2.
КАЧЕСТВЕН И КОЛИЧЕСТВЕН СЪСТАВ
_ _
Всяка таблетка съдържа 2,5 mg
деслоратадин (desloratadine) и 120 mg
псевдоефедринов сулфат
(pseudoephedrine
_ _
sulphate).
За пълния списък на помощните
вещества вижте точка 6.1.
3.
ЛЕКАРСТВЕНА ФОРМА
Таблетки с изменено освобождаване
Двуслойни елипсовидни таблетки в
синьо и бяло, маркирани с “D12” върху
синия слой.
4.
КЛИНИЧНИ ДАННИ
4.1
ТЕРАПЕВТИЧНИ ПОКАЗАНИЯ
Aerinaze е показан при възрастни и юноши
на 12 и повече години за симптоматично
лечение на
сезонни алергични ринити, придружени
с назална конгестия.
4.2
ДОЗИРОВКА И НАЧИН НА ПРИЛОЖЕНИЕ
Дозировка
Препоръчваната доза Aerinaze е по една
таблетка два пъти на ден.
Препоръчваната доза и
продължителността на лечението не
трябва да се превишават.
Продължителността на лечението
трябва да бъде възможно най-кратка и
то не бива да
продължава след изчезване на
симптомите. Препоръчително е
лечението да се ограничи до
около 10 дни, тъй като при хронична
употреба активността на
псевдоефедриновия сулфат може
да намалее. След подобряване на
конг
                                
                                Read the complete document

Similar products

Active ingredient desloratadine, pseudophedrine sulfate

desloratadine, pseudophedrine sulfate

ATC code R01BA52

R01BA52

Marketed by N.V. Organon

N.V. Organon

INN (International Name) desloratadine, pseudoephedrine

desloratadine, pseudoephedrine

Documents in other languages

Patient Information leaflet Patient Information leaflet Spanish 07-12-2022
Summary of Product characteristics Summary of Product characteristics Spanish 07-12-2022
Public Assessment Report Public Assessment Report Spanish 23-11-2011
Patient Information leaflet Patient Information leaflet Czech 07-12-2022
Summary of Product characteristics Summary of Product characteristics Czech 07-12-2022
Public Assessment Report Public Assessment Report Czech 23-11-2011
Patient Information leaflet Patient Information leaflet Danish 07-12-2022
Summary of Product characteristics Summary of Product characteristics Danish 07-12-2022
Public Assessment Report Public Assessment Report Danish 23-11-2011
Patient Information leaflet Patient Information leaflet German 07-12-2022
Summary of Product characteristics Summary of Product characteristics German 07-12-2022
Public Assessment Report Public Assessment Report German 23-11-2011
Patient Information leaflet Patient Information leaflet Estonian 07-12-2022
Summary of Product characteristics Summary of Product characteristics Estonian 07-12-2022
Public Assessment Report Public Assessment Report Estonian 23-11-2011
Patient Information leaflet Patient Information leaflet Greek 07-12-2022
Summary of Product characteristics Summary of Product characteristics Greek 07-12-2022
Public Assessment Report Public Assessment Report Greek 23-11-2011
Patient Information leaflet Patient Information leaflet English 07-12-2022
Summary of Product characteristics Summary of Product characteristics English 07-12-2022
Public Assessment Report Public Assessment Report English 23-11-2011
Patient Information leaflet Patient Information leaflet French 07-12-2022
Summary of Product characteristics Summary of Product characteristics French 07-12-2022
Public Assessment Report Public Assessment Report French 23-11-2011
Patient Information leaflet Patient Information leaflet Italian 07-12-2022
Summary of Product characteristics Summary of Product characteristics Italian 07-12-2022
Public Assessment Report Public Assessment Report Italian 23-11-2011
Patient Information leaflet Patient Information leaflet Latvian 07-12-2022
Summary of Product characteristics Summary of Product characteristics Latvian 07-12-2022
Public Assessment Report Public Assessment Report Latvian 23-11-2011
Patient Information leaflet Patient Information leaflet Lithuanian 07-12-2022
Summary of Product characteristics Summary of Product characteristics Lithuanian 07-12-2022
Public Assessment Report Public Assessment Report Lithuanian 23-11-2011
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Summary of Product characteristics Summary of Product characteristics Hungarian 07-12-2022
Public Assessment Report Public Assessment Report Hungarian 23-11-2011
Patient Information leaflet Patient Information leaflet Maltese 07-12-2022
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Public Assessment Report Public Assessment Report Maltese 23-11-2011
Patient Information leaflet Patient Information leaflet Dutch 07-12-2022
Summary of Product characteristics Summary of Product characteristics Dutch 07-12-2022
Public Assessment Report Public Assessment Report Dutch 23-11-2011
Patient Information leaflet Patient Information leaflet Polish 07-12-2022
Summary of Product characteristics Summary of Product characteristics Polish 07-12-2022
Public Assessment Report Public Assessment Report Polish 23-11-2011
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Public Assessment Report Public Assessment Report Portuguese 23-11-2011
Patient Information leaflet Patient Information leaflet Romanian 07-12-2022
Summary of Product characteristics Summary of Product characteristics Romanian 07-12-2022
Public Assessment Report Public Assessment Report Romanian 23-11-2011
Patient Information leaflet Patient Information leaflet Slovak 07-12-2022
Summary of Product characteristics Summary of Product characteristics Slovak 07-12-2022
Public Assessment Report Public Assessment Report Slovak 23-11-2011
Patient Information leaflet Patient Information leaflet Slovenian 07-12-2022
Summary of Product characteristics Summary of Product characteristics Slovenian 07-12-2022
Public Assessment Report Public Assessment Report Slovenian 23-11-2011
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Summary of Product characteristics Summary of Product characteristics Finnish 07-12-2022
Public Assessment Report Public Assessment Report Finnish 23-11-2011
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Public Assessment Report Public Assessment Report Swedish 23-11-2011
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Summary of Product characteristics Summary of Product characteristics Norwegian 07-12-2022
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Patient Information leaflet Patient Information leaflet Croatian 07-12-2022
Summary of Product characteristics Summary of Product characteristics Croatian 07-12-2022

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Aerinaze