Tekturna

Country: European Union

Language: Bulgarian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
09-09-2009
Summary of Product characteristics Summary of Product characteristics (SPC)
09-09-2009
Public Assessment Report Public Assessment Report (PAR)
09-09-2009

Active ingredient:

алискирен

Available from:

Novartis Europharm Ltd.

ATC code:

C09XA02

INN (International Name):

aliskiren

Therapeutic group:

Агенти, действащи върху системата ренин-ангиотензин

Therapeutic area:

Хипертония

Therapeutic indications:

Лечение на есенциална хипертония.

Product summary:

Revision: 4

Authorization status:

Отменено

Authorization date:

2007-08-22

Patient Information leaflet

                                ПРИЛОЖЕНИЕ I
КРАТКА ХАРАКТЕРИСТИКА НА ПРОДУКТА
1
Лекарствен продукт, който вече не е
разрешен за употреба
1.
ИМЕ НА ЛЕКАРСТВЕНИЯ ПРОДУКТ
Tekturna 150 mg филмирани таблетки
2.
КАЧЕСТВЕН И КОЛИЧЕСТВЕН СЪСТАВ
Всяка таблетка съдържа 150 m
g алискирен (
_aliskiren_
) (
като хемифумарат).
За пълния списък на помощните
вещества, вижте точка 6.1.
3.
ЛЕКАРСТВЕНА ФОРМА
Филмирана таблетка
Бледорозова, двойноизпъкнала, кръгла
таблетка с отпечатано ‘IL’ от едната
страна и ‘NVR’ от
другата.
4.
КЛИНИЧНИ ДАННИ
4.1
ТЕРАПЕВТИЧНИ ПО
КАЗАНИЯ
Лечение на есенциална хипертония.
4.2
ДОЗИРОВКА И НА
ЧИН НА ПРИЛО
ЖЕНИЕ
Препоръчваната доза на Tekturna е
150 m
g веднъж дневно. При пациенти, при
които
артериалното налягане не се
контролира адекватно, дозата може да
се увеличи до 300 mg
веднъж дневно.
Траен антихипертензивен ефект се
наблюдава до две седмици (85-90%) след
започване на
лечението с доза от 150 mg веднъж дневно.
Tekturna може да се използва
самостоятелно или в комбинация с
дру
ги антихипертензивни
средства (вж. точки 4.4 и 5.1).
Tekturna трябва да се приема
веднъж дневно с
лека храна, за предпочитане по едно и
също
време всеки ден. Tekturna не трябва да се
приема едновременно със со
                                
                                Read the complete document

Summary of Product characteristics

                                ПРИЛОЖЕНИЕ I
КРАТКА ХАРАКТЕРИСТИКА НА ПРОДУКТА
1
Лекарствен продукт, който вече не е
разрешен за употреба
1.
ИМЕ НА ЛЕКАРСТВЕНИЯ ПРОДУКТ
Tekturna 150 mg филмирани таблетки
2.
КАЧЕСТВЕН И КОЛИЧЕСТВЕН СЪСТАВ
Всяка таблетка съдържа 150 m
g алискирен (
_aliskiren_
) (
като хемифумарат).
За пълния списък на помощните
вещества, вижте точка 6.1.
3.
ЛЕКАРСТВЕНА ФОРМА
Филмирана таблетка
Бледорозова, двойноизпъкнала, кръгла
таблетка с отпечатано ‘IL’ от едната
страна и ‘NVR’ от
другата.
4.
КЛИНИЧНИ ДАННИ
4.1
ТЕРАПЕВТИЧНИ ПО
КАЗАНИЯ
Лечение на есенциална хипертония.
4.2
ДОЗИРОВКА И НА
ЧИН НА ПРИЛО
ЖЕНИЕ
Препоръчваната доза на Tekturna е
150 m
g веднъж дневно. При пациенти, при
които
артериалното налягане не се
контролира адекватно, дозата може да
се увеличи до 300 mg
веднъж дневно.
Траен антихипертензивен ефект се
наблюдава до две седмици (85-90%) след
започване на
лечението с доза от 150 mg веднъж дневно.
Tekturna може да се използва
самостоятелно или в комбинация с
дру
ги антихипертензивни
средства (вж. точки 4.4 и 5.1).
Tekturna трябва да се приема
веднъж дневно с
лека храна, за предпочитане по едно и
също
време всеки ден. Tekturna не трябва да се
приема едновременно със со
                                
                                Read the complete document

Similar products

Active ingredient алискирен

алискирен

ATC code C09XA02

C09XA02

Marketed by Novartis Europharm Ltd.

Novartis Europharm Ltd.

INN (International Name) aliskiren

aliskiren

Documents in other languages

Patient Information leaflet Patient Information leaflet Spanish 09-09-2009
Summary of Product characteristics Summary of Product characteristics Spanish 09-09-2009
Public Assessment Report Public Assessment Report Spanish 09-09-2009
Patient Information leaflet Patient Information leaflet Czech 09-09-2009
Summary of Product characteristics Summary of Product characteristics Czech 09-09-2009
Public Assessment Report Public Assessment Report Czech 09-09-2009
Patient Information leaflet Patient Information leaflet Danish 09-09-2009
Summary of Product characteristics Summary of Product characteristics Danish 09-09-2009
Public Assessment Report Public Assessment Report Danish 09-09-2009
Patient Information leaflet Patient Information leaflet German 09-09-2009
Summary of Product characteristics Summary of Product characteristics German 09-09-2009
Public Assessment Report Public Assessment Report German 09-09-2009
Patient Information leaflet Patient Information leaflet Estonian 09-09-2009
Summary of Product characteristics Summary of Product characteristics Estonian 09-09-2009
Public Assessment Report Public Assessment Report Estonian 09-09-2009
Patient Information leaflet Patient Information leaflet Greek 09-09-2009
Summary of Product characteristics Summary of Product characteristics Greek 09-09-2009
Public Assessment Report Public Assessment Report Greek 09-09-2009
Patient Information leaflet Patient Information leaflet English 09-09-2009
Summary of Product characteristics Summary of Product characteristics English 09-09-2009
Public Assessment Report Public Assessment Report English 09-09-2009
Patient Information leaflet Patient Information leaflet French 09-09-2009
Summary of Product characteristics Summary of Product characteristics French 09-09-2009
Public Assessment Report Public Assessment Report French 09-09-2009
Patient Information leaflet Patient Information leaflet Italian 09-09-2009
Summary of Product characteristics Summary of Product characteristics Italian 09-09-2009
Public Assessment Report Public Assessment Report Italian 09-09-2009
Patient Information leaflet Patient Information leaflet Latvian 09-09-2009
Summary of Product characteristics Summary of Product characteristics Latvian 09-09-2009
Public Assessment Report Public Assessment Report Latvian 09-09-2009
Patient Information leaflet Patient Information leaflet Lithuanian 09-09-2009
Summary of Product characteristics Summary of Product characteristics Lithuanian 09-09-2009
Public Assessment Report Public Assessment Report Lithuanian 09-09-2009
Patient Information leaflet Patient Information leaflet Hungarian 09-09-2009
Summary of Product characteristics Summary of Product characteristics Hungarian 09-09-2009
Public Assessment Report Public Assessment Report Hungarian 09-09-2009
Patient Information leaflet Patient Information leaflet Maltese 09-09-2009
Summary of Product characteristics Summary of Product characteristics Maltese 09-09-2009
Public Assessment Report Public Assessment Report Maltese 09-09-2009
Patient Information leaflet Patient Information leaflet Dutch 09-09-2009
Summary of Product characteristics Summary of Product characteristics Dutch 09-09-2009
Public Assessment Report Public Assessment Report Dutch 09-09-2009
Patient Information leaflet Patient Information leaflet Polish 09-09-2009
Summary of Product characteristics Summary of Product characteristics Polish 09-09-2009
Public Assessment Report Public Assessment Report Polish 09-09-2009
Patient Information leaflet Patient Information leaflet Portuguese 09-09-2009
Summary of Product characteristics Summary of Product characteristics Portuguese 09-09-2009
Public Assessment Report Public Assessment Report Portuguese 09-09-2009
Patient Information leaflet Patient Information leaflet Romanian 09-09-2009
Summary of Product characteristics Summary of Product characteristics Romanian 09-09-2009
Public Assessment Report Public Assessment Report Romanian 09-09-2009
Patient Information leaflet Patient Information leaflet Slovak 09-09-2009
Summary of Product characteristics Summary of Product characteristics Slovak 09-09-2009
Public Assessment Report Public Assessment Report Slovak 09-09-2009
Patient Information leaflet Patient Information leaflet Slovenian 09-09-2009
Summary of Product characteristics Summary of Product characteristics Slovenian 09-09-2009
Public Assessment Report Public Assessment Report Slovenian 09-09-2009
Patient Information leaflet Patient Information leaflet Finnish 09-09-2009
Summary of Product characteristics Summary of Product characteristics Finnish 09-09-2009
Public Assessment Report Public Assessment Report Finnish 09-09-2009
Patient Information leaflet Patient Information leaflet Swedish 09-09-2009
Summary of Product characteristics Summary of Product characteristics Swedish 09-09-2009
Public Assessment Report Public Assessment Report Swedish 09-09-2009

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Tekturna