Rilonacept Regeneron (previously Arcalyst)

Country: European Union

Language: Bulgarian

Source: EMA (European Medicines Agency)

Buy It Now

Patient Information leaflet Patient Information leaflet (PIL)
24-09-2012
Summary of Product characteristics Summary of Product characteristics (SPC)
24-09-2012
Public Assessment Report Public Assessment Report (PAR)
24-09-2010

Active ingredient:

Rilonacept

Available from:

Regeneron UK Limited

ATC code:

L04AC08

INN (International Name):

rilonacept

Therapeutic group:

Имуносупресори

Therapeutic area:

Криопиринассоциированные Периодични Синдроми

Therapeutic indications:

Rilonacept Regeneron е показан за лечение на периодични синдроми, свързани cryopyrin (CAPS) с тежки симптоми, включително Фамилна студена авто възпалителни синдром (FCAS) и синдром на Muckle-Wells (MWS) при възрастни и деца на възраст 12 години and по-стари.

Product summary:

Revision: 5

Authorization status:

Отменено

Authorization date:

2009-10-23

Patient Information leaflet

                                Лекарствен продукт, който вече не е
разрешен за употреба
26
Б. ЛИСТОВКА
Лекарствен продукт, който вече не е
разрешен за употреба
27
ЛИСТОВКА: ИНФОРМАЦИЯ ЗА ПОТРЕБИТЕЛЯ
RILONACEPT REGENERON 80 MG/ML ПРАХ И РАЗТВОРИТЕЛ ЗА
ИНЖЕКЦИОНЕН РАЗТВОР
Рилонасепт (rilonacept)
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 единствено и
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 нежеланите
лекарствени реакции, уведомете Вашия
лекар или
фармацевт. Това включва и всички въ
зможни
нежелани реакции, неописани в тази
листовка.
КАКВО СЪДЪРЖА ТАЗИ ЛИСТОВКА:
1.
Какво представлява Rilonacept Regeneron и за
какво се използва
2.
Какво трябва да знаете, преди да
използвате Rilonacept Regeneron
3.
Как да използвате Rilonacept Regeneron
4.
Възможни нежелани реакции
5.
Как да съхранявате Rilonacept Regeneron
6.
Съдържание на о
                                
                                Read the complete document

Summary of Product characteristics

                                Лекарствен продукт, който вече не е
разрешен за употреба
1
ПРИЛОЖЕНИЕ I
КРАТКА ХАРАКТЕРИСТИКА НА ПРОДУКТА
_ _
Лекарствен продукт, който вече не е
разрешен за употреба
2
1.
ИМЕ НА ЛЕКАРСТВЕНИЯ ПРОДУКТ
Rilonacept Regeneron 80 mg/ml прах и разтворител за
инжекционен разтвор.
2.
КАЧЕСТВЕН И КОЛИЧЕСТВЕН СЪСТАВ
Всеки флакон с прах съдържа 220 mg
рилонасепт (rilonacept). След разтваряне
всеки ml от
разтвора съдържа 80 mg рилонасепт.
За пълния списък на помощните
вещества вижте точка 6.1.
3.
ЛЕКАРСТВЕНА ФОРМА
Прах и разтворител за инжекционен
разтвор.
Прахът е бял до по
чти
бял.
Разтворителят е бистър, безцветен
разтвор.
4.
КЛИНИЧНИ ДАННИ
4.1
ТЕРАПЕВТИЧНИ ПОКАЗАНИЯ
Rilonacept Regeneron е показан за лечението на
свързани с криопирин периодични
синдроми
(CAPS) с тежки симптоми, включително
фамилен студов автоинфламаторен
синдром (FCAS) и
синдром на Muckle-Wells (MWS) при възрастни и
деца на възраст над 12 години.
4.2
ДОЗИРОВКА И НАЧИН НА П
РИЛОЖЕНИЕ
Лечениет
о трябва да се започва и контролира от
лекар специалист с опит в
диагностиката и
лечението на CAPS.
След подходящо обучение за правилната
инжекционна техника пациентите могат
да си
самоинжектират Rilonacept Regeneron, ако
техният 
                                
                                Read the complete document

Similar products

Active ingredient Rilonacept

Rilonacept

ATC code L04AC08

L04AC08

Marketed by Regeneron UK Limited

Regeneron UK Limited

INN (International Name) rilonacept

rilonacept

Documents in other languages

Patient Information leaflet Patient Information leaflet Spanish 24-09-2012
Summary of Product characteristics Summary of Product characteristics Spanish 24-09-2012
Public Assessment Report Public Assessment Report Spanish 24-09-2010
Patient Information leaflet Patient Information leaflet Czech 24-09-2012
Summary of Product characteristics Summary of Product characteristics Czech 24-09-2012
Public Assessment Report Public Assessment Report Czech 24-09-2010
Patient Information leaflet Patient Information leaflet Danish 24-09-2012
Summary of Product characteristics Summary of Product characteristics Danish 24-09-2012
Public Assessment Report Public Assessment Report Danish 24-09-2010
Patient Information leaflet Patient Information leaflet German 24-09-2012
Summary of Product characteristics Summary of Product characteristics German 24-09-2012
Public Assessment Report Public Assessment Report German 24-09-2010
Patient Information leaflet Patient Information leaflet Estonian 24-09-2012
Summary of Product characteristics Summary of Product characteristics Estonian 24-09-2012
Public Assessment Report Public Assessment Report Estonian 24-09-2010
Patient Information leaflet Patient Information leaflet Greek 24-09-2012
Summary of Product characteristics Summary of Product characteristics Greek 24-09-2012
Public Assessment Report Public Assessment Report Greek 24-09-2010
Patient Information leaflet Patient Information leaflet English 24-09-2012
Summary of Product characteristics Summary of Product characteristics English 24-09-2012
Public Assessment Report Public Assessment Report English 24-09-2010
Patient Information leaflet Patient Information leaflet French 24-09-2012
Summary of Product characteristics Summary of Product characteristics French 24-09-2012
Public Assessment Report Public Assessment Report French 24-09-2010
Patient Information leaflet Patient Information leaflet Italian 24-09-2012
Summary of Product characteristics Summary of Product characteristics Italian 24-09-2012
Public Assessment Report Public Assessment Report Italian 24-09-2010
Patient Information leaflet Patient Information leaflet Latvian 24-09-2012
Summary of Product characteristics Summary of Product characteristics Latvian 24-09-2012
Public Assessment Report Public Assessment Report Latvian 24-09-2010
Patient Information leaflet Patient Information leaflet Lithuanian 24-09-2012
Summary of Product characteristics Summary of Product characteristics Lithuanian 24-09-2012
Public Assessment Report Public Assessment Report Lithuanian 24-09-2010
Patient Information leaflet Patient Information leaflet Hungarian 24-09-2012
Summary of Product characteristics Summary of Product characteristics Hungarian 24-09-2012
Public Assessment Report Public Assessment Report Hungarian 24-09-2010
Patient Information leaflet Patient Information leaflet Maltese 24-09-2012
Summary of Product characteristics Summary of Product characteristics Maltese 24-09-2012
Public Assessment Report Public Assessment Report Maltese 24-09-2010
Patient Information leaflet Patient Information leaflet Dutch 24-09-2012
Summary of Product characteristics Summary of Product characteristics Dutch 24-09-2012
Public Assessment Report Public Assessment Report Dutch 24-09-2010
Patient Information leaflet Patient Information leaflet Polish 24-09-2012
Summary of Product characteristics Summary of Product characteristics Polish 24-09-2012
Public Assessment Report Public Assessment Report Polish 24-09-2010
Patient Information leaflet Patient Information leaflet Portuguese 24-09-2012
Summary of Product characteristics Summary of Product characteristics Portuguese 24-09-2012
Public Assessment Report Public Assessment Report Portuguese 24-09-2010
Patient Information leaflet Patient Information leaflet Romanian 24-09-2012
Summary of Product characteristics Summary of Product characteristics Romanian 24-09-2012
Public Assessment Report Public Assessment Report Romanian 24-09-2010
Patient Information leaflet Patient Information leaflet Slovak 24-09-2012
Summary of Product characteristics Summary of Product characteristics Slovak 24-09-2012
Public Assessment Report Public Assessment Report Slovak 24-09-2010
Patient Information leaflet Patient Information leaflet Slovenian 24-09-2012
Summary of Product characteristics Summary of Product characteristics Slovenian 24-09-2012
Public Assessment Report Public Assessment Report Slovenian 24-09-2010
Patient Information leaflet Patient Information leaflet Finnish 24-09-2012
Summary of Product characteristics Summary of Product characteristics Finnish 24-09-2012
Public Assessment Report Public Assessment Report Finnish 24-09-2010
Patient Information leaflet Patient Information leaflet Swedish 24-09-2012
Summary of Product characteristics Summary of Product characteristics Swedish 24-09-2012
Public Assessment Report Public Assessment Report Swedish 24-09-2010
Patient Information leaflet Patient Information leaflet Norwegian 24-09-2012
Summary of Product characteristics Summary of Product characteristics Norwegian 24-09-2012
Patient Information leaflet Patient Information leaflet Icelandic 24-09-2012
Summary of Product characteristics Summary of Product characteristics Icelandic 24-09-2012

Search alerts related to this product

Alerts Rilonacept Regeneron

Rilonacept Regeneron

View documents history

Documents history Documents history

Rilonacept Regeneron (previously Arcalyst)