Sabervel

Country: European Union

Language: Bulgarian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
29-09-2014
Summary of Product characteristics Summary of Product characteristics (SPC)
29-09-2014
Public Assessment Report Public Assessment Report (PAR)
23-04-2012

Active ingredient:

ирбесартан

Available from:

Pharmathen S.A.

ATC code:

C09CA04

INN (International Name):

irbesartan

Therapeutic group:

Агенти, действащи върху системата ренин-ангиотензин

Therapeutic area:

Хипертония

Therapeutic indications:

Sabervel е показан при възрастни за лечение на есенциална хипертония. Също така е показан за лечение на бъбречна недостатъчност при възрастни пациенти със захарен диабет, хипертония и тип 2 в състава на антигипертензивных лечебни храни .

Product summary:

Revision: 2

Authorization status:

Отменено

Authorization date:

2012-04-13

Patient Information leaflet

                                Б. ЛИСТОВКА
54
Лекарствен продукт с невалидно
разрешение за употреба
ЛИСТОВКА: ИНФОРМАЦИЯ ЗА ПОТРЕБИТЕЛЯ
SABERVEL 75 MG ФИЛМИРАНИ ТАБЛЕТКИ
ирбесартан (irbesartan)
ПРОЧЕТЕТЕ ВНИМАТЕЛНО ЦЯЛАТА ЛИСТОВКА
ПРЕДИ ДА ЗАПОЧНЕТЕ ДА ПРИЕМАТЕ ТОВА
ЛЕКАРСТВО.
•
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 от това, че
техните симптоми са същите като
Вашите.
•
Ако някоя от нежеланите лекарствени
реакции стане сериозна, или
забележите други,
неописани в тази листовка нежелани
реакции, моля уведомете Вашия лекар
или
фармацевт.
В ТАЗИ ЛИСТОВКА:
1.
Какво представлява Sabervel и за какво се
използва
2.
Преди да приемете Sabervel
3.
Как да приемате Sabervel
4.
Възможни нежелани реакции
5.
Как да съхранявате Sabervel
6.
Допълнителна информация
1. КАКВО ПРЕДСТАВЛЯВА SABERVEL И ЗА КАКВО
СЕ ИЗПОЛЗВА
Sabervel принадлежи към групата
лекарствени продукти, известни като
антагонисти на
ангиотензин-II рецепторите.
Ангиотензин-II е вещество, което се
образува в организ
                                
                                Read the complete document

Summary of Product characteristics

                                ПРИЛОЖЕНИЕ I
КРАТКА ХАРАКТЕРИСТИКА НА ПРОДУКТА
1
Лекарствен продукт с невалидно
разрешение за употреба
1.
ИМЕ НА ЛЕКАРСТВЕНИЯ ПРОДУКТ
Sabervel 75 mg филмирани
таблетки
2.
КАЧЕСТВЕН И КОЛИЧЕСТВЕН СЪСТАВ
Всяка филмирана таблетка съдържа 75 mg
ирбесартан
_(irbesartan). _
_ _
Помощни вещества с известен ефект:
20 mg лактоза монохидрат на филмирана
таблетка.
За пълния списък на помощните
вещества, вижте точка 6.1.
3.
ЛЕКАРСТВЕНА ФОРМА
Филмирана таблетка
Бялa, вдлъбната, кръгла, филмирана
таблетка с диаметър 7 mm.
4.
КЛИНИЧНИ ДАННИ
4.1
ТЕРАПЕВТИЧНИ ПОКАЗАНИЯ
Sabervel показан за лечение на есенциална
хипертония при възрастни. Той също
така е показан
и за лечение на бъбречно заболяване
при възрастни пациенти с хипертония
и захарен диабет
тип 2, като част от схема за
антихипертензивно лечение (вж. точки
4.3, 4.4, 4.5 и 5.1).
4.2
ДОЗИРОВКА И НАЧИН НА ПРИЛОЖЕНИЕ
Дозировка
Обичайната препоръчвана начална и
поддържаща доза е 150 mg веднъж дневно, с
или без
храна. Sabervel в доза от 150 mg веднъж
дневно, обикновено
води до по-добър 24 часов контрол
на кравното налягане, в сравнение със
75 mg. Въпреки това, може да се обмисли
започване на
лечението със 75 mg, особено при
пациент
                                
                                Read the complete document

Similar products

Active ingredient ирбесартан

ирбесартан

ATC code C09CA04

C09CA04

Marketed by Pharmathen S.A.

Pharmathen S.A.

INN (International Name) irbesartan

irbesartan

Documents in other languages

Patient Information leaflet Patient Information leaflet Spanish 29-09-2014
Summary of Product characteristics Summary of Product characteristics Spanish 29-09-2014
Public Assessment Report Public Assessment Report Spanish 23-04-2012
Patient Information leaflet Patient Information leaflet Czech 29-09-2014
Summary of Product characteristics Summary of Product characteristics Czech 29-09-2014
Public Assessment Report Public Assessment Report Czech 23-04-2012
Patient Information leaflet Patient Information leaflet Danish 29-09-2014
Summary of Product characteristics Summary of Product characteristics Danish 29-09-2014
Public Assessment Report Public Assessment Report Danish 23-04-2012
Patient Information leaflet Patient Information leaflet German 29-09-2014
Summary of Product characteristics Summary of Product characteristics German 29-09-2014
Public Assessment Report Public Assessment Report German 23-04-2012
Patient Information leaflet Patient Information leaflet Estonian 29-09-2014
Summary of Product characteristics Summary of Product characteristics Estonian 29-09-2014
Public Assessment Report Public Assessment Report Estonian 23-04-2012
Patient Information leaflet Patient Information leaflet Greek 29-09-2014
Summary of Product characteristics Summary of Product characteristics Greek 29-09-2014
Public Assessment Report Public Assessment Report Greek 23-04-2012
Patient Information leaflet Patient Information leaflet English 29-09-2014
Summary of Product characteristics Summary of Product characteristics English 29-09-2014
Public Assessment Report Public Assessment Report English 23-04-2012
Patient Information leaflet Patient Information leaflet French 29-09-2014
Summary of Product characteristics Summary of Product characteristics French 29-09-2014
Public Assessment Report Public Assessment Report French 23-04-2012
Patient Information leaflet Patient Information leaflet Italian 29-09-2014
Summary of Product characteristics Summary of Product characteristics Italian 29-09-2014
Public Assessment Report Public Assessment Report Italian 23-04-2012
Patient Information leaflet Patient Information leaflet Latvian 29-09-2014
Summary of Product characteristics Summary of Product characteristics Latvian 29-09-2014
Public Assessment Report Public Assessment Report Latvian 23-04-2012
Patient Information leaflet Patient Information leaflet Lithuanian 29-09-2014
Summary of Product characteristics Summary of Product characteristics Lithuanian 29-09-2014
Public Assessment Report Public Assessment Report Lithuanian 23-04-2012
Patient Information leaflet Patient Information leaflet Hungarian 29-09-2014
Summary of Product characteristics Summary of Product characteristics Hungarian 29-09-2014
Public Assessment Report Public Assessment Report Hungarian 23-04-2012
Patient Information leaflet Patient Information leaflet Maltese 29-09-2014
Summary of Product characteristics Summary of Product characteristics Maltese 29-09-2014
Public Assessment Report Public Assessment Report Maltese 23-04-2012
Patient Information leaflet Patient Information leaflet Dutch 29-09-2014
Summary of Product characteristics Summary of Product characteristics Dutch 29-09-2014
Public Assessment Report Public Assessment Report Dutch 23-04-2012
Patient Information leaflet Patient Information leaflet Polish 29-09-2014
Summary of Product characteristics Summary of Product characteristics Polish 29-09-2014
Public Assessment Report Public Assessment Report Polish 23-04-2012
Patient Information leaflet Patient Information leaflet Portuguese 29-09-2014
Summary of Product characteristics Summary of Product characteristics Portuguese 29-09-2014
Public Assessment Report Public Assessment Report Portuguese 23-04-2012
Patient Information leaflet Patient Information leaflet Romanian 29-09-2014
Summary of Product characteristics Summary of Product characteristics Romanian 29-09-2014
Public Assessment Report Public Assessment Report Romanian 23-04-2012
Patient Information leaflet Patient Information leaflet Slovak 29-09-2014
Summary of Product characteristics Summary of Product characteristics Slovak 29-09-2014
Public Assessment Report Public Assessment Report Slovak 23-04-2012
Patient Information leaflet Patient Information leaflet Slovenian 29-09-2014
Summary of Product characteristics Summary of Product characteristics Slovenian 29-09-2014
Public Assessment Report Public Assessment Report Slovenian 23-04-2012
Patient Information leaflet Patient Information leaflet Finnish 29-09-2014
Summary of Product characteristics Summary of Product characteristics Finnish 29-09-2014
Public Assessment Report Public Assessment Report Finnish 23-04-2012
Patient Information leaflet Patient Information leaflet Swedish 29-09-2014
Summary of Product characteristics Summary of Product characteristics Swedish 29-09-2014
Public Assessment Report Public Assessment Report Swedish 23-04-2012
Patient Information leaflet Patient Information leaflet Norwegian 29-09-2014
Summary of Product characteristics Summary of Product characteristics Norwegian 29-09-2014
Patient Information leaflet Patient Information leaflet Icelandic 29-09-2014
Summary of Product characteristics Summary of Product characteristics Icelandic 29-09-2014
Patient Information leaflet Patient Information leaflet Croatian 29-09-2014
Summary of Product characteristics Summary of Product characteristics Croatian 29-09-2014

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Sabervel