Dimethyl fumarate Accord

Country: European Union

Language: Bulgarian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
01-01-1970
Summary of Product characteristics Summary of Product characteristics (SPC)
01-01-1970
Public Assessment Report Public Assessment Report (PAR)
22-02-2023

Active ingredient:

диметил фумарат

Available from:

Accord Healthcare S.L.U.

ATC code:

L04AX07

INN (International Name):

dimethyl fumarate

Therapeutic group:

Имуносупресори

Therapeutic area:

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis

Therapeutic indications:

Dimethyl fumarate Accord is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS).

Authorization status:

упълномощен

Authorization date:

2023-02-15

Patient Information leaflet

                                35
Б. ЛИСТОВКА
36
ЛИСТОВКА: ИНФОРМАЦИЯ ЗА ПАЦИЕНТА
ДИМЕТИЛФУМАРАТ ACCORD 120 MG
СТОМАШНО-УСТОЙЧИВИ ТВЪРДИ КАПСУЛИ
ДИМЕТИЛФУМАРАТ ACCORD 240 MG
СТОМАШНО-УСТОЙЧИВИ ТВЪРДИ КАПСУЛИ
диметилфумарат (dimethyl fumarate)
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 Диметилфумарат
Accord и за какво се използва
2.
Какво трябва да знаете, преди да
приемете Диметилфумарат Accord
3.
Как да приемате Диметилфумарат Accord
4.
Възможни нежелани реакции
5.
Как да съхранявате Диметилфумарат Accord
6.
Съдържание на опаковката и
допълнителна информация
1.
                                
                                Read the complete document

Summary of Product characteristics

                                1
ПРИЛОЖЕНИЕ I
КРАТКА ХАРАКТЕРИСТИКА НА ПРОДУКТА
2
1.
ИМЕ НА ЛЕКАРСТВЕНИЯ ПРОДУКТ
Диметилфумарат Accord 120 mg
стомашно-устойчиви твърди капсули
Диметилфумарат Accord 240 mg
стомашно-устойчиви твърди капсули
2.
КАЧЕСТВЕН И КОЛИЧЕСТВЕН СЪСТАВ
Диметилфумарат Accord 120 mg
стомашно-устойчиви твърди капсули
Всяка стомашно-устойчива твърда
капсула съдържа 120 mg диметилфумарат
(dimethyl
fumarate)
Диметилфумарат Accord 240 mg
стомашно-устойчиви твърди капсули
Всяка стомашно-устойчива твърда
капсула съдържа 240 mg диметилфумарат
(dimethyl
fumarate)
За пълния списък на помощните
вещества вижте точка 6.1.
3.
ЛЕКАРСТВЕНА ФОРМА
Стомашно-устойчива твърда капсула
(стомашно-устойчива капсула)
Диметилфумарат Accord 120 mg
стомашно-устойчиви твърди капсули
Твърди желатинови капсули с размер
“0” (приблизително 21,3 x 7,5 mm) със зелено
капаче и
бяло тяло, с отпечатан надпис “HR1” с
черно мастило върху тялото на
капсулата, съдържащо
бели до почти бели, кръгли,
двойноизпъкнали минитаблетки с
ентеросолвентно покритие,
гладки от двете страни.
Диметилфумарат Accord 240 mg
стомашно-устойчиви твърди капсули
Твърди желатинови капсули с размер
„0“ (приблизително 21,3 x 7,5 mm) със зелено
ка
                                
                                Read the complete document

Similar products

Active ingredient диметил фумарат

диметил фумарат

ATC code L04AX07

L04AX07

Marketed by Accord Healthcare S.L.U.

Accord Healthcare S.L.U.

INN (International Name) dimethyl fumarate

dimethyl fumarate

Documents in other languages

Patient Information leaflet Patient Information leaflet Spanish 22-12-2023
Summary of Product characteristics Summary of Product characteristics Spanish 22-12-2023
Public Assessment Report Public Assessment Report Spanish 22-02-2023
Patient Information leaflet Patient Information leaflet Czech 01-01-1970
Summary of Product characteristics Summary of Product characteristics Czech 01-01-1970
Public Assessment Report Public Assessment Report Czech 22-02-2023
Patient Information leaflet Patient Information leaflet Danish 01-01-1970
Summary of Product characteristics Summary of Product characteristics Danish 01-01-1970
Public Assessment Report Public Assessment Report Danish 22-02-2023
Patient Information leaflet Patient Information leaflet German 01-01-1970
Summary of Product characteristics Summary of Product characteristics German 01-01-1970
Public Assessment Report Public Assessment Report German 22-02-2023
Patient Information leaflet Patient Information leaflet Estonian 22-12-2023
Summary of Product characteristics Summary of Product characteristics Estonian 22-12-2023
Public Assessment Report Public Assessment Report Estonian 22-02-2023
Patient Information leaflet Patient Information leaflet Greek 01-01-1970
Summary of Product characteristics Summary of Product characteristics Greek 01-01-1970
Public Assessment Report Public Assessment Report Greek 22-02-2023
Patient Information leaflet Patient Information leaflet English 22-12-2023
Summary of Product characteristics Summary of Product characteristics English 22-12-2023
Public Assessment Report Public Assessment Report English 22-02-2023
Patient Information leaflet Patient Information leaflet French 01-01-1970
Summary of Product characteristics Summary of Product characteristics French 01-01-1970
Public Assessment Report Public Assessment Report French 22-02-2023
Patient Information leaflet Patient Information leaflet Italian 01-01-1970
Summary of Product characteristics Summary of Product characteristics Italian 01-01-1970
Public Assessment Report Public Assessment Report Italian 22-02-2023
Patient Information leaflet Patient Information leaflet Latvian 01-01-1970
Summary of Product characteristics Summary of Product characteristics Latvian 01-01-1970
Public Assessment Report Public Assessment Report Latvian 22-02-2023
Patient Information leaflet Patient Information leaflet Lithuanian 01-01-1970
Summary of Product characteristics Summary of Product characteristics Lithuanian 01-01-1970
Public Assessment Report Public Assessment Report Lithuanian 22-02-2023
Patient Information leaflet Patient Information leaflet Hungarian 01-01-1970
Summary of Product characteristics Summary of Product characteristics Hungarian 01-01-1970
Public Assessment Report Public Assessment Report Hungarian 22-02-2023
Patient Information leaflet Patient Information leaflet Maltese 01-01-1970
Summary of Product characteristics Summary of Product characteristics Maltese 01-01-1970
Public Assessment Report Public Assessment Report Maltese 22-02-2023
Patient Information leaflet Patient Information leaflet Dutch 01-01-1970
Summary of Product characteristics Summary of Product characteristics Dutch 01-01-1970
Public Assessment Report Public Assessment Report Dutch 22-02-2023
Patient Information leaflet Patient Information leaflet Polish 01-01-1970
Summary of Product characteristics Summary of Product characteristics Polish 01-01-1970
Public Assessment Report Public Assessment Report Polish 22-02-2023
Patient Information leaflet Patient Information leaflet Portuguese 01-01-1970
Summary of Product characteristics Summary of Product characteristics Portuguese 01-01-1970
Public Assessment Report Public Assessment Report Portuguese 22-02-2023
Patient Information leaflet Patient Information leaflet Romanian 22-12-2023
Summary of Product characteristics Summary of Product characteristics Romanian 22-12-2023
Public Assessment Report Public Assessment Report Romanian 22-02-2023
Patient Information leaflet Patient Information leaflet Slovak 22-12-2023
Summary of Product characteristics Summary of Product characteristics Slovak 22-12-2023
Public Assessment Report Public Assessment Report Slovak 22-02-2023
Patient Information leaflet Patient Information leaflet Slovenian 22-12-2023
Summary of Product characteristics Summary of Product characteristics Slovenian 22-12-2023
Public Assessment Report Public Assessment Report Slovenian 22-02-2023
Patient Information leaflet Patient Information leaflet Finnish 01-01-1970
Summary of Product characteristics Summary of Product characteristics Finnish 01-01-1970
Public Assessment Report Public Assessment Report Finnish 22-02-2023
Patient Information leaflet Patient Information leaflet Swedish 22-12-2023
Summary of Product characteristics Summary of Product characteristics Swedish 22-12-2023
Public Assessment Report Public Assessment Report Swedish 22-02-2023
Patient Information leaflet Patient Information leaflet Norwegian 01-01-1970
Summary of Product characteristics Summary of Product characteristics Norwegian 01-01-1970
Patient Information leaflet Patient Information leaflet Icelandic 01-01-1970
Summary of Product characteristics Summary of Product characteristics Icelandic 01-01-1970
Patient Information leaflet Patient Information leaflet Croatian 01-01-1970
Summary of Product characteristics Summary of Product characteristics Croatian 01-01-1970
Public Assessment Report Public Assessment Report Croatian 22-02-2023

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