Tracleer

Country: European Union

Language: Bulgarian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
13-02-2023
Summary of Product characteristics Summary of Product characteristics (SPC)
13-02-2023
Public Assessment Report Public Assessment Report (PAR)
03-12-2019

Active ingredient:

bosentan (as monohydrate)

Available from:

Janssen-Cilag International N.V.  

ATC code:

C02KX01

INN (International Name):

bosentan

Therapeutic group:

Гипотензивные,

Therapeutic area:

Scleroderma, Systemic; Hypertension, Pulmonary

Therapeutic indications:

Лечение на белодробна артериална хипертония (ПАХ) за подобряване на капацитета на упражняване и симптоми при пациенти с функционален клас III на СЗО. Efficacy has been shown in: , Primary (idiopathic and familial) PAH;, PAH secondary to scleroderma without significant interstitial pulmonary disease;, PAH associated with congenital systemic-to-pulmonary shunts and Eisenmenger's physiology. Някои подобрения са също така е показано при пациенти с ЛАГ, които функционален клас II. Tracleer също отбеляза спад в броя на новите дигиталната язви при пациенти със системна склеродермией и текущи заболявания цифрови язва .

Product summary:

Revision: 42

Authorization status:

упълномощен

Authorization date:

2002-05-14

Patient Information leaflet

                                69
Б. ЛИСТОВКА
70
ЛИСТОВКА: ИНФОРМАЦИЯ НА ПОТРЕБИТЕЛЯ
TRACLEER 62,5 MG ФИЛМИРАНИ ТАБЛЕТКИ
TRACLEER 125 MG ФИЛМИРАНИ ТАБЛЕТКИ
бозентан (bosentan)
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 Tracleer и за какво се
използва
2.
Какво трябва да знаете, преди да
приемете Tracleer
3.
Как да приемате Tracleer
4.
Възможни нежелани реакции
5.
Как да съхранявате Tracleer
6.
Съдържание на опаковката и
допълнителна информация
1.
КАКВО ПРЕДСТАВЛЯВА TRACLEER И ЗА КАКВО СЕ
ИЗПОЛЗВА
Таблетките Tracleer съдържат бозентан,
който блокира естествения хормон,
наречен е
                                
                                Read the complete document

Summary of Product characteristics

                                1
ПРИЛОЖЕНИЕ I
КРАТКА ХАРАКТЕРИСТИКА НА ПРОДУКТА
2
1.
ИМЕ НА ЛЕКАРСТВЕНИЯ ПРОДУКТ
Tracleer 62,5 mg филмирани таблетки
Tracleer 125 mg филмирани таблетки
2.
КАЧЕСТВЕН И КОЛИЧЕСТВЕН СЪСТАВ
Tracleer 62,5 mg филмирани таблетки
Всяка филмирана таблетка съдържа 62,5 mg
бозентан (bosentan) (като монохидрат).
Tracleer 125 mg филмирани таблетки
Всяка филмирана таблетка съдържа 125 mg
бозентан (bosentan) (като монохидрат).
Помощно вещество с известно действие
Това лекарство съдържа по-малко от 1 mmol
натрий (23 mg) на таблетка, т.е. може да се
каже,
че практически не съдържа натрий.
За пълния списък на помощните
вещества вижте точка 6.1.
3.
ЛЕКАРСТВЕНА ФОРМА
Филмиранa таблеткa (таблетки):
Tracleer 62,5 mg филмирани таблетки
Оранжево-бели, кръгли,
двойноизпъкнали, филмирани таблетки,
с вдлъбнато релефно
означение “62,5” от едната страна.
Tracleer 125 mg филмирани таблетки
Оранжево-бели, овални,
двойноизпъкнали, филмирани таблетки,
с вдлъбнато релефно
означение “125” от едната страна.
4.
КЛИНИЧНИ ДАННИ
4.1
ТЕРАПЕВТИЧНИ ПОКАЗАНИЯ
Лечение на белодробна артериална
хипертония (БАХ) за подобряване на
физическия капацитет
и симптоматиката при пациенти с
функционален клас III по СЗО. С доказана
е
                                
                                Read the complete document

Similar products

Active ingredient bosentan (as monohydrate)

bosentan (as monohydrate)

ATC code C02KX01

C02KX01

Marketed by Janssen-Cilag International N.V.  

Janssen-Cilag International N.V.  

INN (International Name) bosentan

bosentan

Documents in other languages

Patient Information leaflet Patient Information leaflet Spanish 13-02-2023
Summary of Product characteristics Summary of Product characteristics Spanish 13-02-2023
Public Assessment Report Public Assessment Report Spanish 03-12-2019
Patient Information leaflet Patient Information leaflet Czech 13-02-2023
Summary of Product characteristics Summary of Product characteristics Czech 13-02-2023
Public Assessment Report Public Assessment Report Czech 03-12-2019
Patient Information leaflet Patient Information leaflet Danish 13-02-2023
Summary of Product characteristics Summary of Product characteristics Danish 13-02-2023
Public Assessment Report Public Assessment Report Danish 03-12-2019
Patient Information leaflet Patient Information leaflet German 13-02-2023
Summary of Product characteristics Summary of Product characteristics German 13-02-2023
Public Assessment Report Public Assessment Report German 03-12-2019
Patient Information leaflet Patient Information leaflet Estonian 13-02-2023
Summary of Product characteristics Summary of Product characteristics Estonian 13-02-2023
Public Assessment Report Public Assessment Report Estonian 03-12-2019
Patient Information leaflet Patient Information leaflet Greek 13-02-2023
Summary of Product characteristics Summary of Product characteristics Greek 13-02-2023
Public Assessment Report Public Assessment Report Greek 03-12-2019
Patient Information leaflet Patient Information leaflet English 13-02-2023
Summary of Product characteristics Summary of Product characteristics English 13-02-2023
Public Assessment Report Public Assessment Report English 03-12-2019
Patient Information leaflet Patient Information leaflet French 13-02-2023
Summary of Product characteristics Summary of Product characteristics French 13-02-2023
Public Assessment Report Public Assessment Report French 03-12-2019
Patient Information leaflet Patient Information leaflet Italian 13-02-2023
Summary of Product characteristics Summary of Product characteristics Italian 13-02-2023
Public Assessment Report Public Assessment Report Italian 03-12-2019
Patient Information leaflet Patient Information leaflet Latvian 13-02-2023
Summary of Product characteristics Summary of Product characteristics Latvian 13-02-2023
Public Assessment Report Public Assessment Report Latvian 03-12-2019
Patient Information leaflet Patient Information leaflet Lithuanian 13-02-2023
Summary of Product characteristics Summary of Product characteristics Lithuanian 13-02-2023
Public Assessment Report Public Assessment Report Lithuanian 03-12-2019
Patient Information leaflet Patient Information leaflet Hungarian 13-02-2023
Summary of Product characteristics Summary of Product characteristics Hungarian 13-02-2023
Public Assessment Report Public Assessment Report Hungarian 03-12-2019
Patient Information leaflet Patient Information leaflet Maltese 13-02-2023
Summary of Product characteristics Summary of Product characteristics Maltese 13-02-2023
Public Assessment Report Public Assessment Report Maltese 03-12-2019
Patient Information leaflet Patient Information leaflet Dutch 13-02-2023
Summary of Product characteristics Summary of Product characteristics Dutch 13-02-2023
Public Assessment Report Public Assessment Report Dutch 03-12-2019
Patient Information leaflet Patient Information leaflet Polish 13-02-2023
Summary of Product characteristics Summary of Product characteristics Polish 13-02-2023
Public Assessment Report Public Assessment Report Polish 03-12-2019
Patient Information leaflet Patient Information leaflet Portuguese 13-02-2023
Summary of Product characteristics Summary of Product characteristics Portuguese 13-02-2023
Public Assessment Report Public Assessment Report Portuguese 03-12-2019
Patient Information leaflet Patient Information leaflet Romanian 13-02-2023
Summary of Product characteristics Summary of Product characteristics Romanian 13-02-2023
Public Assessment Report Public Assessment Report Romanian 03-12-2019
Patient Information leaflet Patient Information leaflet Slovak 13-02-2023
Summary of Product characteristics Summary of Product characteristics Slovak 13-02-2023
Public Assessment Report Public Assessment Report Slovak 03-12-2019
Patient Information leaflet Patient Information leaflet Slovenian 13-02-2023
Summary of Product characteristics Summary of Product characteristics Slovenian 13-02-2023
Public Assessment Report Public Assessment Report Slovenian 03-12-2019
Patient Information leaflet Patient Information leaflet Finnish 13-02-2023
Summary of Product characteristics Summary of Product characteristics Finnish 13-02-2023
Public Assessment Report Public Assessment Report Finnish 03-12-2019
Patient Information leaflet Patient Information leaflet Swedish 13-02-2023
Summary of Product characteristics Summary of Product characteristics Swedish 13-02-2023
Public Assessment Report Public Assessment Report Swedish 03-12-2019
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Summary of Product characteristics Summary of Product characteristics Norwegian 13-02-2023
Patient Information leaflet Patient Information leaflet Icelandic 13-02-2023
Summary of Product characteristics Summary of Product characteristics Icelandic 13-02-2023
Patient Information leaflet Patient Information leaflet Croatian 13-02-2023
Summary of Product characteristics Summary of Product characteristics Croatian 13-02-2023
Public Assessment Report Public Assessment Report Croatian 03-12-2019

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Tracleer