Levetiracetam Sun

Country: European Union

Language: Bulgarian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
22-09-2023
Summary of Product characteristics Summary of Product characteristics (SPC)
22-09-2023
Public Assessment Report Public Assessment Report (PAR)
03-09-2021

Active ingredient:

леветирацетам

Available from:

Sun Pharmaceutical Industries Europe B.V.

ATC code:

N03AX14

INN (International Name):

levetiracetam

Therapeutic group:

Други противоэпилептические средства

Therapeutic area:

епилепсия

Therapeutic indications:

Levetiracetam Sun е показан като монотерапия при лечението на парциални пристъпи със или без вторична генерализация при пациенти на възраст от 16 години с новодиагностицирана епилепсия. Леветирацетам Слънцето се посочва като съпътстваща терапия:при лечение на парциальных пристъпи С или без вторична генерализации при възрастни и деца от четири години с епилепсия;при лечение на миоклонические гърчове при възрастни и юноши на 12 години с непълнолетни миоклоническая епилепсия;лечение на първични генерализованных тонико-клонических спазми при възрастни и юноши на 12 години с идиопатична генерализирана епилепсия. Слънцето Леветирацетам концентрат е алтернатива за пациенти, когато пероральное прилагането на временно не е възможно.

Product summary:

Revision: 19

Authorization status:

упълномощен

Authorization date:

2011-12-14

Patient Information leaflet

                                27
Б. ЛИСТОВКА
28
ЛИСТОВКА: ИНФОРМАЦИЯ ЗА ПОТРЕБИТЕЛЯ
LEVETIRACETAM SUN 100 MG/ML КОНЦЕНТРАТ ЗА
ИНФУЗИОНЕН РАЗТВОР
Леветирацетам (Levetiracetam)
ПРОЧЕТЕТЕ ВНИМАТЕЛНО ЦЯЛАТА ЛИСТОВКА,
ПРЕДИ ВИЕ ИЛИ ВАШЕТО ДЕТЕ 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.
-
Ако получите някакви нежелани
лекарствени 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 Levetiracetam SUN и за
какво се използва
2.
Какво трябва да знаете, преди да
приемете Levetiracetam SUN
3.
Как да приемате Levetiracetam SUN
4.
Възможни нежел
А
ни реакции
5.
Как да съхранявате Levetiracetam SUN
6.
Съдържание на опаковката и
допълнителна информация
1.
КАКВО ПРЕДСТАВЛЯВА LEVETIRACETAM SUN И ЗА
КАКВО СЕ ИЗПОЛЗВА
Levetiracetam е антиепилептично лекарство
(лекарство за лечение на пристъпите
при
епилепсия).
Levetiracetam SUN се използва:
-
самостоятелно при възрастни и юноши
на възраст 16 и повече години с
новодиагнос
                                
                                Read the complete document

Summary of Product characteristics

                                1
ПРИЛОЖЕНИЕ I
КРАТКА ХАРАКТЕРИСТИКА НА ПРОДУКТА
                                
                                Read the complete document

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Active ingredient леветирацетам

леветирацетам

ATC code N03AX14

N03AX14

Marketed by Sun Pharmaceutical Industries Europe B.V.

Sun Pharmaceutical Industries Europe B.V.

INN (International Name) levetiracetam

levetiracetam

Documents in other languages

Patient Information leaflet Patient Information leaflet Spanish 22-09-2023
Summary of Product characteristics Summary of Product characteristics Spanish 22-09-2023
Public Assessment Report Public Assessment Report Spanish 03-09-2021
Patient Information leaflet Patient Information leaflet Czech 22-09-2023
Summary of Product characteristics Summary of Product characteristics Czech 22-09-2023
Public Assessment Report Public Assessment Report Czech 03-09-2021
Patient Information leaflet Patient Information leaflet Danish 22-09-2023
Summary of Product characteristics Summary of Product characteristics Danish 22-09-2023
Public Assessment Report Public Assessment Report Danish 03-09-2021
Patient Information leaflet Patient Information leaflet German 22-09-2023
Summary of Product characteristics Summary of Product characteristics German 22-09-2023
Public Assessment Report Public Assessment Report German 03-09-2021
Patient Information leaflet Patient Information leaflet Estonian 22-09-2023
Summary of Product characteristics Summary of Product characteristics Estonian 22-09-2023
Public Assessment Report Public Assessment Report Estonian 03-09-2021
Patient Information leaflet Patient Information leaflet Greek 22-09-2023
Summary of Product characteristics Summary of Product characteristics Greek 22-09-2023
Public Assessment Report Public Assessment Report Greek 03-09-2021
Patient Information leaflet Patient Information leaflet English 22-09-2023
Summary of Product characteristics Summary of Product characteristics English 22-09-2023
Public Assessment Report Public Assessment Report English 03-09-2021
Patient Information leaflet Patient Information leaflet French 22-09-2023
Summary of Product characteristics Summary of Product characteristics French 22-09-2023
Public Assessment Report Public Assessment Report French 03-09-2021
Patient Information leaflet Patient Information leaflet Italian 22-09-2023
Summary of Product characteristics Summary of Product characteristics Italian 22-09-2023
Public Assessment Report Public Assessment Report Italian 03-09-2021
Patient Information leaflet Patient Information leaflet Latvian 22-09-2023
Summary of Product characteristics Summary of Product characteristics Latvian 22-09-2023
Public Assessment Report Public Assessment Report Latvian 03-09-2021
Patient Information leaflet Patient Information leaflet Lithuanian 22-09-2023
Summary of Product characteristics Summary of Product characteristics Lithuanian 22-09-2023
Public Assessment Report Public Assessment Report Lithuanian 03-09-2021
Patient Information leaflet Patient Information leaflet Hungarian 22-09-2023
Summary of Product characteristics Summary of Product characteristics Hungarian 22-09-2023
Public Assessment Report Public Assessment Report Hungarian 03-09-2021
Patient Information leaflet Patient Information leaflet Maltese 22-09-2023
Summary of Product characteristics Summary of Product characteristics Maltese 22-09-2023
Public Assessment Report Public Assessment Report Maltese 03-09-2021
Patient Information leaflet Patient Information leaflet Dutch 22-09-2023
Summary of Product characteristics Summary of Product characteristics Dutch 22-09-2023
Public Assessment Report Public Assessment Report Dutch 03-09-2021
Patient Information leaflet Patient Information leaflet Polish 22-09-2023
Summary of Product characteristics Summary of Product characteristics Polish 22-09-2023
Public Assessment Report Public Assessment Report Polish 03-09-2021
Patient Information leaflet Patient Information leaflet Portuguese 22-09-2023
Summary of Product characteristics Summary of Product characteristics Portuguese 22-09-2023
Public Assessment Report Public Assessment Report Portuguese 03-09-2021
Patient Information leaflet Patient Information leaflet Romanian 22-09-2023
Summary of Product characteristics Summary of Product characteristics Romanian 22-09-2023
Public Assessment Report Public Assessment Report Romanian 03-09-2021
Patient Information leaflet Patient Information leaflet Slovak 22-09-2023
Summary of Product characteristics Summary of Product characteristics Slovak 22-09-2023
Public Assessment Report Public Assessment Report Slovak 03-09-2021
Patient Information leaflet Patient Information leaflet Slovenian 22-09-2023
Summary of Product characteristics Summary of Product characteristics Slovenian 22-09-2023
Public Assessment Report Public Assessment Report Slovenian 03-09-2021
Patient Information leaflet Patient Information leaflet Finnish 22-09-2023
Summary of Product characteristics Summary of Product characteristics Finnish 22-09-2023
Public Assessment Report Public Assessment Report Finnish 03-09-2021
Patient Information leaflet Patient Information leaflet Swedish 22-09-2023
Summary of Product characteristics Summary of Product characteristics Swedish 22-09-2023
Public Assessment Report Public Assessment Report Swedish 03-09-2021
Patient Information leaflet Patient Information leaflet Norwegian 22-09-2023
Summary of Product characteristics Summary of Product characteristics Norwegian 22-09-2023
Patient Information leaflet Patient Information leaflet Icelandic 22-09-2023
Summary of Product characteristics Summary of Product characteristics Icelandic 22-09-2023
Patient Information leaflet Patient Information leaflet Croatian 22-09-2023
Summary of Product characteristics Summary of Product characteristics Croatian 22-09-2023
Public Assessment Report Public Assessment Report Croatian 03-09-2021

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