Tacforius

Country: European Union

Language: Bulgarian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
10-01-2023
Summary of Product characteristics Summary of Product characteristics (SPC)
10-01-2023
Public Assessment Report Public Assessment Report (PAR)
26-01-2018

Active ingredient:

такролимус монохидрат

Available from:

Teva B.V.

ATC code:

L04AD02

INN (International Name):

tacrolimus

Therapeutic group:

Имуносупресори

Therapeutic area:

Liver Transplantation; Kidney Transplantation

Therapeutic indications:

Профилактика на отхвърляне на трансплантат при възрастни пациенти с бъбречни или чернодробни алографти. Лечение на отхвърляне на алографта, резистентно на лечение с други имуносупресивни лекарствени продукти при възрастни пациенти.

Product summary:

Revision: 7

Authorization status:

упълномощен

Authorization date:

2017-12-08

Patient Information leaflet

                                56
Б. ЛИСТОВКА
57
ЛИСТОВКА: ИНФОРМАЦИЯ ЗА ПАЦИЕНТА
TACFORIUS 0,5 MG ТВЪРДИ КАПСУЛИ С УДЪЛЖЕНО
ОСВОБОЖДАВАНЕ
TACFORIUS 1 MG ТВЪРДИ КАПСУЛИ С УДЪЛЖЕНО
ОСВОБОЖДАВАНЕ
TACFORIUS 3 MG ТВЪРДИ КАПСУЛИ С УДЪЛЖЕНО
ОСВОБОЖДАВАНЕ
TACFORIUS 5 MG ТВЪРДИ КАПСУЛИ С УДЪЛЖЕНО
ОСВОБОЖДАВАНЕ
такролимус (tacrolimus)
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 Tacforius и за какво се
използва
2.
Какво трябва да знаете, преди да
приемете Tacforius
3.
Как да приемате Tacforius
4.
Възможни нежелани реакции
5.
Как да съхранявате Tacforius
6.
Съдържание на опаковката и
допълните
                                
                                Read the complete document

Summary of Product characteristics

                                1
ПРИЛОЖЕНИЕ I
КРАТКА ХАРАКТЕРИСТИКА НА ПРОДУКТА
2
1.
ИМЕ НА ЛЕКАРСТВЕНИЯ ПРОДУКТ
Tacforius 0,5 mg твърди капсули с удължено
освобождаване
Tacforius 1 mg твърди капсули с удължено
освобождаване
Tacforius 3 mg твърди капсули с удължено
освобождаване
Tacforius 5 mg твърди капсули с удължено
освобождаване
2.
КАЧЕСТВЕН И КОЛИЧЕСТВЕН СЪСТАВ
Tacforius 0,5 mg твърди капсули с удължено
освобождаване
Всяка твърда капсула с удължено
освобождаване съдържа 0,5 mg такролимус
(tacrolimus) (като
монохидрат).
_Помощно вещество с известно действие
_
Всяка капсула съдържа 53,725 mg лактоза.
Tacforius 1 mg твърди капсули с удължено
освобождаване
Всяка твърда капсула с удължено
освобождаване съдържа 1 mg такролимус
(tacrolimus) (като
монохидрат).
_Помощно вещество с известно действие
_
Всяка капсула съдържа 107,45 mg лактоза.
Tacforius 3 mg твърди капсули с удължено
освобождаване
Всяка твърда капсула с удължено
освобождаване съдържа 3 mg такролимус
(tacrolimus) (като
монохидрат).
_Помощно вещество с известно действие
_
Всяка капсула съдържа 322,35 mg лактоза.
Tacforius 5 mg твърди капсули с удължено
освобождаване
Всяка твърда капсула с удължено
освобождаване съдържа 5 mg такролимус
(tacrolimus) (като
монохидрат).
_По
                                
                                Read the complete document

Similar products

Active ingredient такролимус монохидрат

такролимус монохидрат

ATC code L04AD02

L04AD02

Marketed by Teva B.V.

Teva B.V.

INN (International Name) tacrolimus

tacrolimus

Documents in other languages

Patient Information leaflet Patient Information leaflet Spanish 10-01-2023
Summary of Product characteristics Summary of Product characteristics Spanish 10-01-2023
Public Assessment Report Public Assessment Report Spanish 26-01-2018
Patient Information leaflet Patient Information leaflet Czech 10-01-2023
Summary of Product characteristics Summary of Product characteristics Czech 10-01-2023
Public Assessment Report Public Assessment Report Czech 26-01-2018
Patient Information leaflet Patient Information leaflet Danish 10-01-2023
Summary of Product characteristics Summary of Product characteristics Danish 10-01-2023
Public Assessment Report Public Assessment Report Danish 26-01-2018
Patient Information leaflet Patient Information leaflet German 10-01-2023
Summary of Product characteristics Summary of Product characteristics German 10-01-2023
Public Assessment Report Public Assessment Report German 26-01-2018
Patient Information leaflet Patient Information leaflet Estonian 10-01-2023
Summary of Product characteristics Summary of Product characteristics Estonian 10-01-2023
Public Assessment Report Public Assessment Report Estonian 26-01-2018
Patient Information leaflet Patient Information leaflet Greek 10-01-2023
Summary of Product characteristics Summary of Product characteristics Greek 10-01-2023
Public Assessment Report Public Assessment Report Greek 26-01-2018
Patient Information leaflet Patient Information leaflet English 10-01-2023
Summary of Product characteristics Summary of Product characteristics English 10-01-2023
Public Assessment Report Public Assessment Report English 26-01-2018
Patient Information leaflet Patient Information leaflet French 10-01-2023
Summary of Product characteristics Summary of Product characteristics French 10-01-2023
Public Assessment Report Public Assessment Report French 26-01-2018
Patient Information leaflet Patient Information leaflet Italian 10-01-2023
Summary of Product characteristics Summary of Product characteristics Italian 10-01-2023
Public Assessment Report Public Assessment Report Italian 26-01-2018
Patient Information leaflet Patient Information leaflet Latvian 10-01-2023
Summary of Product characteristics Summary of Product characteristics Latvian 10-01-2023
Public Assessment Report Public Assessment Report Latvian 26-01-2018
Patient Information leaflet Patient Information leaflet Lithuanian 10-01-2023
Summary of Product characteristics Summary of Product characteristics Lithuanian 10-01-2023
Public Assessment Report Public Assessment Report Lithuanian 26-01-2018
Patient Information leaflet Patient Information leaflet Hungarian 10-01-2023
Summary of Product characteristics Summary of Product characteristics Hungarian 10-01-2023
Public Assessment Report Public Assessment Report Hungarian 26-01-2018
Patient Information leaflet Patient Information leaflet Maltese 10-01-2023
Summary of Product characteristics Summary of Product characteristics Maltese 10-01-2023
Public Assessment Report Public Assessment Report Maltese 26-01-2018
Patient Information leaflet Patient Information leaflet Dutch 10-01-2023
Summary of Product characteristics Summary of Product characteristics Dutch 10-01-2023
Public Assessment Report Public Assessment Report Dutch 26-01-2018
Patient Information leaflet Patient Information leaflet Polish 10-01-2023
Summary of Product characteristics Summary of Product characteristics Polish 10-01-2023
Public Assessment Report Public Assessment Report Polish 26-01-2018
Patient Information leaflet Patient Information leaflet Portuguese 10-01-2023
Summary of Product characteristics Summary of Product characteristics Portuguese 10-01-2023
Public Assessment Report Public Assessment Report Portuguese 26-01-2018
Patient Information leaflet Patient Information leaflet Romanian 10-01-2023
Summary of Product characteristics Summary of Product characteristics Romanian 10-01-2023
Public Assessment Report Public Assessment Report Romanian 26-01-2018
Patient Information leaflet Patient Information leaflet Slovak 10-01-2023
Summary of Product characteristics Summary of Product characteristics Slovak 10-01-2023
Public Assessment Report Public Assessment Report Slovak 26-01-2018
Patient Information leaflet Patient Information leaflet Slovenian 10-01-2023
Summary of Product characteristics Summary of Product characteristics Slovenian 10-01-2023
Public Assessment Report Public Assessment Report Slovenian 26-01-2018
Patient Information leaflet Patient Information leaflet Finnish 10-01-2023
Summary of Product characteristics Summary of Product characteristics Finnish 10-01-2023
Public Assessment Report Public Assessment Report Finnish 26-01-2018
Patient Information leaflet Patient Information leaflet Swedish 10-01-2023
Summary of Product characteristics Summary of Product characteristics Swedish 10-01-2023
Public Assessment Report Public Assessment Report Swedish 26-01-2018
Patient Information leaflet Patient Information leaflet Norwegian 10-01-2023
Summary of Product characteristics Summary of Product characteristics Norwegian 10-01-2023
Patient Information leaflet Patient Information leaflet Icelandic 10-01-2023
Summary of Product characteristics Summary of Product characteristics Icelandic 10-01-2023
Patient Information leaflet Patient Information leaflet Croatian 10-01-2023
Summary of Product characteristics Summary of Product characteristics Croatian 10-01-2023
Public Assessment Report Public Assessment Report Croatian 26-01-2018

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