Budesonide/Formoterol Teva

Country: European Union

Language: Bulgarian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
31-01-2017
Summary of Product characteristics Summary of Product characteristics (SPC)
31-01-2017
Public Assessment Report Public Assessment Report (PAR)
31-01-2017

Active ingredient:

Budesonide, formoterol fumarate dihydrate

Available from:

Teva Pharma B.V.

ATC code:

R03AK07

INN (International Name):

budesonide, formoterol

Therapeutic group:

Лекарства за обструктивна заболявания на дихателните пътища,

Therapeutic area:

Pulmonary Disease, Chronic Obstructive; Asthma

Therapeutic indications:

Budesonide / Formoterol Teva е показан само при възрастни на 18-годишна възраст. AsthmaBudesonide/формотерола Тева е посочено в редовното лечение на астма, където използването на комбинации (ингаляционных кортикостероид и дълго действащ β2 адренорецепторите) доста уместно:при пациенти не се контролира адекватно ингаляционными с кортикостероиди и "необходимо" ингаляционных страните извън еврозоната β2 адреномиметиков. Орин пациенти вече са адекватно контролирани в двата ингаляционных кортикостероид и дълго действащ β2 адреномиметиков. COPDSymptomatic лечение на пациенти с тежка хронична обструктивна белодробна болест (ОФВ1 < 50%, прогнозира нормално) и многократни решетка, които имат значителни симптоми, въпреки редовна терапия с длинн-действа наречени бронходилататори.

Product summary:

Revision: 2

Authorization status:

Отменено

Authorization date:

2014-11-19

Patient Information leaflet

                                46
Б. ЛИСТОВКА
Лекарствен продукт с невалидно
разрешение за употреба
47
ЛИСТОВКА: ИНФОРМАЦИЯ ЗА ПАЦИЕНТА
БУДЕЗОНИДИД/ФОРМОТЕРОЛ TEVA 160
МИКРОГРАМА/4,5 МИКРОГРАМА ПРАХ ЗА
ИНХАЛАЦИЯ
будезонид/формотеролов фумарат
дихидрат (budesonide/formoterol fumarate dihydrate)
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
лекарствени реакции, уведомете Вашия
лекар,
фармацевт или медицинска сестра. Това
включва всички възможни нежелани
реакции,
неописани в тази листовка. Вижте точка
4.
КАКВО СЪДЪРЖА ТАЗИ ЛИСТОВКА
1.
Какво представлява
Будезонидид/Формотерол Teva и за какво
се използва (стр. 3)
2.
Какво трябва да знаете, преди да
използвате Будезонидид/Формотерол Teva
(стр. 5)
3.
Как да използвате
Будезонидид
                                
                                Read the complete document

Summary of Product characteristics

                                1
ПРИЛОЖЕНИЕ I
КРАТКА ХАРАКТЕРИСТИКА НА ПРОДУКТА
Лекарствен продукт с невалидно
разрешение за употреба
2
1.
ИМЕ НА ЛЕКАРСТВЕНИЯ ПРОДУКТ
Будезонидид/Формотерол Teva 160
микрограма/4,5 микрограма прах за
инхалация
2.
КАЧЕСТВЕН И КОЛИЧЕСТВЕН СЪСТАВ
Всяка доставена доза (дозата, която
излиза от мундщука на Spiromax) съдържа 160
микрограма
будезонид (budesonide) и 4,5 микрограма
формотеролов фумарат дихидрат (formoterol
fumarate
dihydrate).
Това съответства на измерена доза от
200 микрограма будезонид и 6 микрограма
формотеролов
фумарат дихидрат.
Помощно(и) вещество(а) с известно
действие:
Всяка доза съдържа приблизително 5
милиграма лактоза (като монохидрат).
За пълния списък на помощните
вещества вижте точка 6.1.
3.
ЛЕКАРСТВЕНА ФОРМА
Прах за инхалация
Бял прах
Бял инхалатор с полупрозрачен
виненочервен капак на мундщука.
4.
КЛИНИЧНИ ДАННИ
4.1
ТЕРАПЕВТИЧНИ ПОКАЗАНИЯ
Будезонидид/Формотерол Teva е показан
само при възрастни на 18 и повече
години.
Астма
_ _
Будезонидид/Формотерол Teva е показан
за редовно лечение на астма, когато е
подходящо
използването на комбинация
(инхалаторен кортикостероид и
дългодействащ β
2
-адреноцепторен
агонист):
-
при пациент
                                
                                Read the complete document

Similar products

Active ingredient Budesonide, formoterol fumarate dihydrate

Budesonide, formoterol fumarate dihydrate

ATC code R03AK07

R03AK07

Marketed by Teva Pharma B.V.

Teva Pharma B.V.

INN (International Name) budesonide, formoterol

budesonide, formoterol

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Budesonide/Formoterol Teva