Vimizim

Country: European Union

Language: Bulgarian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
08-02-2019
Summary of Product characteristics Summary of Product characteristics (SPC)
08-02-2019
Public Assessment Report Public Assessment Report (PAR)
26-06-2014

Active ingredient:

recombinant human n-acetylgalactosamine-6-sulfatase

Available from:

BioMarin International Limited

ATC code:

A16AB12

INN (International Name):

elosulfase alfa

Therapeutic group:

Други стомашно-чревния тракт и обмяната на веществата средства,

Therapeutic area:

Мукополизахаридоза IV

Therapeutic indications:

Vimizim е показан за лечението на мукополизахаридоза, тип IVA (Morquio А синдром, MPS IVA) при пациенти от всички възрасти.

Product summary:

Revision: 13

Authorization status:

упълномощен

Authorization date:

2014-04-27

Patient Information leaflet

                                21
Б. ЛИСТОВКА
22
ЛИСТОВКА: ИНФОРМАЦИЯ ЗА ПОТРЕБИТЕЛЯ
VIMIZIM 1 MG/ML КОНЦЕНТРАТ ЗА ИНФУЗИОНЕН
РАЗТВОР
елосулфаза алфа (elosulfase alfa)
Този лекарствен продукт подлежи на
допълнително наблюдение. Това ще
позволи бързото
установяване на нова информация
относно безопасността. Можете да
дадете своя принос като
съобщите всяка нежелана реакция,
която сте получили. За начина на
съобщаване на нежелани
реакции вижте края на точка 4.
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.
-
Ако получите някакви нежелани
реакции, уведомете Вашия лекар. Това
включва и
всички възможни нежелани реакции,
неописани в тази листовка. Вижте точка
4.
КАКВО СЪДЪРЖА ТАЗИ ЛИСТОВКА
1.
Какво представлява Vimizim и за какво се
използва
2.
Какво трябва да знаете, преди да
приемете Vimizim
3.
Как се прилага Vimizim
4.
Възможни нежелани реакции
5.
Как да съхранявате Vimizim
6.
Съдържание на опаковката и
допълнителна информация
1.
КАКВО ПРЕДСТАВЛЯВА VIMIZIM И ЗА КАКВО СЕ
И
                                
                                Read the complete document

Summary of Product characteristics

                                1
ПРИЛОЖЕНИЕ I
КРАТКА ХАРАКТЕРИСТИКА НА ПРОДУКТА
2
▼
Този лекарствен продукт подлежи на
допълнително наблюдение. Това ще
позволи бързото
установяване на нова информация
относно безопасността. От
медицинските специалисти се
изисква да съобщават всяка подозирана
нежелана реакция. За начина на
съобщаване на
нежелани реакции вижте точка 4.8.
1.
ИМЕ НА ЛЕКАРСТВЕНИЯ ПРОДУКТ
Vimizim 1 mg/ml концентрат за инфузионен
разтвор
2.
КАЧЕСТВЕН И КОЛИЧЕСТВЕН СЪСТАВ
Всеки ml от разтвора съдържа 1 mg
елосулфаза алфа* (elosulfase alfa). Всеки
флакон от 5 ml
съдържа 5 mg елосулфаза алфа
*Елосулфаза алфа е рекомбинантна
форма на човешки
N-ацетилгалактозaмин-6-сулфатаза
(rhGALNS) и се произвежда в овариални
клетки на китайски хамстер чрез
рекомбинантна ДНК
технология.
Помощни вещества с известно действие:
Всеки флакон от 5 ml съдържа 8 mg натрий и
100 mg сорбитол (Е420).
За пълния списък на помощните
вещества вижте точка 6.1.
3.
ЛЕКАРСТВЕНА ФОРМА
Концентрат за инфузионен разтвор
(стерилен концентрат).
Бистър до леко опалесцентен и
безцветен до бледожълт разтвор.
4.
КЛИНИЧНИ ДАННИ
4.1
ТЕРАПЕВТИЧНИ ПОКАЗАНИЯ
Vimizim е показан за лечение на
мукополизахаридоза тип IVA (Синд
                                
                                Read the complete document

Similar products

Active ingredient recombinant human n-acetylgalactosamine-6-sulfatase

recombinant human n-acetylgalactosamine-6-sulfatase

ATC code A16AB12

A16AB12

Marketed by BioMarin International Limited

BioMarin International Limited

INN (International Name) elosulfase alfa

elosulfase alfa

Documents in other languages

Patient Information leaflet Patient Information leaflet Spanish 08-02-2019
Summary of Product characteristics Summary of Product characteristics Spanish 08-02-2019
Public Assessment Report Public Assessment Report Spanish 26-06-2014
Patient Information leaflet Patient Information leaflet Czech 08-02-2019
Summary of Product characteristics Summary of Product characteristics Czech 08-02-2019
Public Assessment Report Public Assessment Report Czech 26-06-2014
Patient Information leaflet Patient Information leaflet Danish 08-02-2019
Summary of Product characteristics Summary of Product characteristics Danish 08-02-2019
Public Assessment Report Public Assessment Report Danish 26-06-2014
Patient Information leaflet Patient Information leaflet German 08-02-2019
Summary of Product characteristics Summary of Product characteristics German 08-02-2019
Public Assessment Report Public Assessment Report German 26-06-2014
Patient Information leaflet Patient Information leaflet Estonian 08-02-2019
Summary of Product characteristics Summary of Product characteristics Estonian 08-02-2019
Public Assessment Report Public Assessment Report Estonian 26-06-2014
Patient Information leaflet Patient Information leaflet Greek 08-02-2019
Summary of Product characteristics Summary of Product characteristics Greek 08-02-2019
Public Assessment Report Public Assessment Report Greek 26-06-2014
Patient Information leaflet Patient Information leaflet English 08-02-2019
Summary of Product characteristics Summary of Product characteristics English 08-02-2019
Public Assessment Report Public Assessment Report English 26-06-2014
Patient Information leaflet Patient Information leaflet French 08-02-2019
Summary of Product characteristics Summary of Product characteristics French 08-02-2019
Public Assessment Report Public Assessment Report French 26-06-2014
Patient Information leaflet Patient Information leaflet Italian 08-02-2019
Summary of Product characteristics Summary of Product characteristics Italian 08-02-2019
Public Assessment Report Public Assessment Report Italian 26-06-2014
Patient Information leaflet Patient Information leaflet Latvian 08-02-2019
Summary of Product characteristics Summary of Product characteristics Latvian 08-02-2019
Public Assessment Report Public Assessment Report Latvian 26-06-2014
Patient Information leaflet Patient Information leaflet Lithuanian 08-02-2019
Summary of Product characteristics Summary of Product characteristics Lithuanian 08-02-2019
Public Assessment Report Public Assessment Report Lithuanian 26-06-2014
Patient Information leaflet Patient Information leaflet Hungarian 08-02-2019
Summary of Product characteristics Summary of Product characteristics Hungarian 08-02-2019
Public Assessment Report Public Assessment Report Hungarian 26-06-2014
Patient Information leaflet Patient Information leaflet Maltese 08-02-2019
Summary of Product characteristics Summary of Product characteristics Maltese 08-02-2019
Public Assessment Report Public Assessment Report Maltese 26-06-2014
Patient Information leaflet Patient Information leaflet Dutch 08-02-2019
Summary of Product characteristics Summary of Product characteristics Dutch 08-02-2019
Public Assessment Report Public Assessment Report Dutch 26-06-2014
Patient Information leaflet Patient Information leaflet Polish 08-02-2019
Summary of Product characteristics Summary of Product characteristics Polish 08-02-2019
Public Assessment Report Public Assessment Report Polish 26-06-2014
Patient Information leaflet Patient Information leaflet Portuguese 08-02-2019
Summary of Product characteristics Summary of Product characteristics Portuguese 08-02-2019
Public Assessment Report Public Assessment Report Portuguese 26-06-2014
Patient Information leaflet Patient Information leaflet Romanian 08-02-2019
Summary of Product characteristics Summary of Product characteristics Romanian 08-02-2019
Public Assessment Report Public Assessment Report Romanian 26-06-2014
Patient Information leaflet Patient Information leaflet Slovak 08-02-2019
Summary of Product characteristics Summary of Product characteristics Slovak 08-02-2019
Public Assessment Report Public Assessment Report Slovak 26-06-2014
Patient Information leaflet Patient Information leaflet Slovenian 08-02-2019
Summary of Product characteristics Summary of Product characteristics Slovenian 08-02-2019
Public Assessment Report Public Assessment Report Slovenian 26-06-2014
Patient Information leaflet Patient Information leaflet Finnish 08-02-2019
Summary of Product characteristics Summary of Product characteristics Finnish 08-02-2019
Public Assessment Report Public Assessment Report Finnish 26-06-2014
Patient Information leaflet Patient Information leaflet Swedish 08-02-2019
Summary of Product characteristics Summary of Product characteristics Swedish 08-02-2019
Public Assessment Report Public Assessment Report Swedish 26-06-2014
Patient Information leaflet Patient Information leaflet Norwegian 08-02-2019
Summary of Product characteristics Summary of Product characteristics Norwegian 08-02-2019
Patient Information leaflet Patient Information leaflet Icelandic 08-02-2019
Summary of Product characteristics Summary of Product characteristics Icelandic 08-02-2019
Patient Information leaflet Patient Information leaflet Croatian 08-02-2019
Summary of Product characteristics Summary of Product characteristics Croatian 08-02-2019
Public Assessment Report Public Assessment Report Croatian 26-06-2014

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