Ultibro Breezhaler

Country: European Union

Language: Bulgarian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
01-09-2021
Summary of Product characteristics Summary of Product characteristics (SPC)
01-09-2021
Public Assessment Report Public Assessment Report (PAR)
03-10-2013

Active ingredient:

indacaterol, бромид Glycopyrronium

Available from:

Novartis Europharm Limited

ATC code:

R03AL04

INN (International Name):

indacaterol, glycopyrronium bromide

Therapeutic group:

Adrenergics в комбинация с антихолинергическими ВКЛ. тройни комбинации с кортикостероидни лекарства за обструктивна заболявания на дихателните пътища,

Therapeutic area:

Белодробна болест, хронична обструктивна болест

Therapeutic indications:

Ultibro Breezhaler е показан като поддържащо бронходилататорно лечение за облекчаване на симптомите при възрастни пациенти с хронично обструктивно белодробно заболяване (COPD).

Product summary:

Revision: 13

Authorization status:

упълномощен

Authorization date:

2013-09-19

Patient Information leaflet

                                41
Б. ЛИСТОВКА
42
ЛИСТОВКА: ИНФОРМАЦИЯ ЗА ПОТРЕБИТЕЛЯ
ULTIBRO BREEZHALER 85 МИКРОГРАМА/43 МИКРОГРАМА
ПРАХ ЗА ИНХАЛАЦИИ, ТВЪРДИ КАПСУЛИ
индакатерол/гликопирониум
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 представлява Ultibro Breezhaler и за
какво се използва
2.
Какво трябва да знаете, преди да
използвате Ultibro Breezhaler
3.
Как да използвате Ultibro Breezhaler
4.
Възможни нежелани реакции
5.
Как да съхранявате Ultibro Breezhaler
6.
Съдържание на опаковката и
допълнителна информация
Инструкции за употреба на инхалатор
                                
                                Read the complete document

Summary of Product characteristics

                                1
ПРИЛОЖЕНИЕ I
КРАТКА ХАРАКТЕРИСТИКА НА ПРОДУКТА
2
1.
ИМЕ НА ЛЕКАРСТВЕНИЯ ПРОДУКТ
Ultibro Breezhaler 85 микрограма/43 микрограма
прах за инхалация, твърди капсули
2.
КАЧЕСТВЕН И КОЛИЧЕСТВЕН СЪСТАВ
Всяка капсула съдържа 143 микрограма
индакатерол малеат (indacaterol maleate), което
съответства на 110 микрограма
индакатерол и 63 микрограма
гликопирониев бромид
(glycopyrronium bromide), което съответства на 50
микрограма гликопирониум.
Всяка доставена доза (дозата, която се
отделя от накрайника на инхалатора)
съдържа
110 микрограма индакатерол малеат,
което съответства на 85 микрограма
индакатерол и
54 микрограма гликопирониев бромид,
което съответства на 43 микрограма
гликопирониум.
Помощно(и) вещество(а) с известно
действие
Всяка капсула съдържа 23,5 mg лактоза
(като монохидрат).
За пълния списък на помощните
вещества вижте точка 6.1.
3.
ЛЕКАРСТВЕНА ФОРМА
Прах за инхалация, твърда капсула
(прах за инхалация)
Капсули с прозрачно жълто капаче и
безцветно прозрачно тяло, съдържащи
бял до почти бял
прах, с код на продукта “IGP110.50”,
отпечатан в синьо под две сини черти
върху тялото и
логото на компанията (
), отпечатано в черно върху капачето.
4.
КЛИНИЧНИ ДАНН
                                
                                Read the complete document

Similar products

Active ingredient indacaterol, бромид Glycopyrronium

indacaterol, бромид Glycopyrronium

ATC code R03AL04

R03AL04

Marketed by Novartis Europharm Limited

Novartis Europharm Limited

INN (International Name) indacaterol, glycopyrronium bromide

indacaterol, glycopyrronium bromide

Documents in other languages

Patient Information leaflet Patient Information leaflet Spanish 01-09-2021
Summary of Product characteristics Summary of Product characteristics Spanish 01-09-2021
Public Assessment Report Public Assessment Report Spanish 03-10-2013
Patient Information leaflet Patient Information leaflet Czech 01-09-2021
Summary of Product characteristics Summary of Product characteristics Czech 01-09-2021
Public Assessment Report Public Assessment Report Czech 03-10-2013
Patient Information leaflet Patient Information leaflet Danish 01-09-2021
Summary of Product characteristics Summary of Product characteristics Danish 01-09-2021
Public Assessment Report Public Assessment Report Danish 03-10-2013
Patient Information leaflet Patient Information leaflet German 01-09-2021
Summary of Product characteristics Summary of Product characteristics German 01-09-2021
Public Assessment Report Public Assessment Report German 03-10-2013
Patient Information leaflet Patient Information leaflet Estonian 01-09-2021
Summary of Product characteristics Summary of Product characteristics Estonian 01-09-2021
Public Assessment Report Public Assessment Report Estonian 03-10-2013
Patient Information leaflet Patient Information leaflet Greek 01-09-2021
Summary of Product characteristics Summary of Product characteristics Greek 01-09-2021
Public Assessment Report Public Assessment Report Greek 03-10-2013
Patient Information leaflet Patient Information leaflet English 01-09-2021
Summary of Product characteristics Summary of Product characteristics English 01-09-2021
Public Assessment Report Public Assessment Report English 03-10-2013
Patient Information leaflet Patient Information leaflet French 01-09-2021
Summary of Product characteristics Summary of Product characteristics French 01-09-2021
Public Assessment Report Public Assessment Report French 03-10-2013
Patient Information leaflet Patient Information leaflet Italian 01-09-2021
Summary of Product characteristics Summary of Product characteristics Italian 01-09-2021
Public Assessment Report Public Assessment Report Italian 03-10-2013
Patient Information leaflet Patient Information leaflet Latvian 01-09-2021
Summary of Product characteristics Summary of Product characteristics Latvian 01-09-2021
Public Assessment Report Public Assessment Report Latvian 03-10-2013
Patient Information leaflet Patient Information leaflet Lithuanian 01-09-2021
Summary of Product characteristics Summary of Product characteristics Lithuanian 01-09-2021
Public Assessment Report Public Assessment Report Lithuanian 03-10-2013
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Summary of Product characteristics Summary of Product characteristics Hungarian 01-09-2021
Public Assessment Report Public Assessment Report Hungarian 03-10-2013
Patient Information leaflet Patient Information leaflet Maltese 01-09-2021
Summary of Product characteristics Summary of Product characteristics Maltese 01-09-2021
Public Assessment Report Public Assessment Report Maltese 03-10-2013
Patient Information leaflet Patient Information leaflet Dutch 01-09-2021
Summary of Product characteristics Summary of Product characteristics Dutch 01-09-2021
Public Assessment Report Public Assessment Report Dutch 03-10-2013
Patient Information leaflet Patient Information leaflet Polish 01-09-2021
Summary of Product characteristics Summary of Product characteristics Polish 01-09-2021
Public Assessment Report Public Assessment Report Polish 03-10-2013
Patient Information leaflet Patient Information leaflet Portuguese 01-09-2021
Summary of Product characteristics Summary of Product characteristics Portuguese 01-09-2021
Public Assessment Report Public Assessment Report Portuguese 03-10-2013
Patient Information leaflet Patient Information leaflet Romanian 01-09-2021
Summary of Product characteristics Summary of Product characteristics Romanian 01-09-2021
Public Assessment Report Public Assessment Report Romanian 03-10-2013
Patient Information leaflet Patient Information leaflet Slovak 01-09-2021
Summary of Product characteristics Summary of Product characteristics Slovak 01-09-2021
Public Assessment Report Public Assessment Report Slovak 03-10-2013
Patient Information leaflet Patient Information leaflet Slovenian 01-09-2021
Summary of Product characteristics Summary of Product characteristics Slovenian 01-09-2021
Public Assessment Report Public Assessment Report Slovenian 03-10-2013
Patient Information leaflet Patient Information leaflet Finnish 01-09-2021
Summary of Product characteristics Summary of Product characteristics Finnish 01-09-2021
Public Assessment Report Public Assessment Report Finnish 03-10-2013
Patient Information leaflet Patient Information leaflet Swedish 01-09-2021
Summary of Product characteristics Summary of Product characteristics Swedish 01-09-2021
Public Assessment Report Public Assessment Report Swedish 03-10-2013
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Summary of Product characteristics Summary of Product characteristics Norwegian 01-09-2021
Patient Information leaflet Patient Information leaflet Icelandic 01-09-2021
Summary of Product characteristics Summary of Product characteristics Icelandic 01-09-2021
Patient Information leaflet Patient Information leaflet Croatian 01-09-2021
Summary of Product characteristics Summary of Product characteristics Croatian 01-09-2021
Public Assessment Report Public Assessment Report Croatian 03-10-2013

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