Neupopeg

Country: European Union

Language: Bulgarian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
26-01-2009
Summary of Product characteristics Summary of Product characteristics (SPC)
26-01-2009
Public Assessment Report Public Assessment Report (PAR)
26-01-2009

Active ingredient:

пегфилграстин

Available from:

Dompé Biotec S.p.A.

ATC code:

L03AA13

INN (International Name):

pegfilgrastim

Therapeutic group:

Иммуностимуляторы,

Therapeutic area:

Neutropenia; Cancer

Therapeutic indications:

Намаляване на продължителността на неутропения и честотата на фебрилна неутропения при пациенти, лекувани с цитотоксична химиотерапия за злокачествено заболяване (с изключение на хронична миелоидна левкемия и миелодиспластични синдроми).

Product summary:

Revision: 9

Authorization status:

Отменено

Authorization date:

2002-08-22

Patient Information leaflet

                                Лекарствен продукт, който вече не е
разрешен за употреба
Б. ЛИСТОВКА
32
Лекарствен продукт, който вече не е
разрешен за употреба
ЛИСТОВКА: ИНФОРМАЦИЯ ЗА ПОТРЕБИТЕЛЯ
NEUPOPEG 6 MG ИНЖ
ЕКЦИОНЕН РАЗТВОР В ПРЕДВАРИТЕЛНО
НАПЪЛНЕНА СПРИНЦОВКА
пегфилграстим (pegfilgrasti
m)
ПРОЧЕТЕТЕ ВНИМАТЕЛНО ЦЯЛАТА ЛИСТОВКА
ПРЕДИ ДА ЗАПОЧНЕТЕ ДА ПРИЛАГАТЕ ТОВА
ЛЕКАРСТВО.
-
Запазете тази листовка. Може да се
наложи да я прочетете отново.
-
Ако имате някакви допълнителни
въпроси, попитайте Вашия лекар или
фармацевт.
-
Това лек
арство е предписано на Вас. Не го
преотстъпвайте на други хора. То може
да им
навреди, независимо от това, че
техните симптоми са същите като
Вашите.
-
Ако някоя от нежеланите лекарствени
реакции стане сериозна, или
забележите други,
неописани в тази листовка нежелани
реакции, моля уведомете Вашия лекар
или
фармацевт
В ТАЗИ ЛИСТОВКА
:
1.
Какво пред
ставлява Neupopeg и за какво се използва
2.
Преди да изп
олзвате Neupopeg
3.
Как да из
ползвате Neupopeg
4.
Възможни не
желани реакции
5.
Как да съхранявате Neup
opeg
6.
Допълнителна информация
1.
КАКВО ПР
ЕДСТАВЛЯВА NEUPOPEG И ЗА КАКВО СЕ ИЗПОЛЗВА
Neupopeg се у
потребява за намаляване
продължителността на не
                                
                                Read the complete document

Summary of Product characteristics

                                Лекарствен продукт, който вече не е
разрешен за употреба
ПРИЛОЖЕНИЕ I
КРАТКА ХАРАКТЕР
ИСТИКА НА ПРОДУКТА
1
Лекарствен продукт, който вече не е
разрешен за употреба
1.
ИМЕ НА ЛЕКАРСТВЕНИЯ ПРОДУКТ
Neupopeg 6 mg ин
жекционен разтвор
2.
КАЧЕ
СТВЕН И КОЛИЧЕСТВЕН СЪСТАВ
Всяка предварително напълнена
спринцовка съд
ържа 6 mg пегфилграстим (
_pegfilgrastim_
) * в
0,6 ml инжекционен разтвор.
Концентрацията е 10 mg/ml на базата само
на протеин**.
*Произведен от клетки на
_Escherichia coli_
чрез рекомбинантна ДНК технология
, последвано от
конюгация с полиетиленгликол (ПЕГ).
**Концентрацията е
20 mg/ml, ако е включена частта от
молекулата на ПЕГ.
Активността на този проду
кт не трябва да се сравнява с
активността на други пегилирани или
непегилирани протеини от същия
терапевтичен клас. За повече
информация, вижте точка 5.1.
Помощни вещества:
Помощни ве
щества, които имат доказано действие
или ефект: сорбитол Е420, натриев ацетат
(вж. точка 4.4).
За пълния списък на помощните
вещества, вижте точка 6.1.
3.
ЛЕКАР
СТВЕНА ФОРМА
Инжекционен разтвор.
Бистър,
безцветен инжекционен разтвор.
4.
КЛ
ИНИЧНИ ДАННИ
4.1
ТЕРА
ПЕВТИЧНИ ПОКАЗАНИЯ
Намаляване продълж
ителността на неутро
                                
                                Read the complete document

Similar products

Active ingredient пегфилграстин

пегфилграстин

ATC code L03AA13

L03AA13

Marketed by Dompé Biotec S.p.A.

Dompé Biotec S.p.A.

INN (International Name) pegfilgrastim

pegfilgrastim

Documents in other languages

Patient Information leaflet Patient Information leaflet Spanish 26-01-2009
Summary of Product characteristics Summary of Product characteristics Spanish 26-01-2009
Public Assessment Report Public Assessment Report Spanish 26-01-2009
Patient Information leaflet Patient Information leaflet Czech 26-01-2009
Summary of Product characteristics Summary of Product characteristics Czech 26-01-2009
Public Assessment Report Public Assessment Report Czech 26-01-2009
Patient Information leaflet Patient Information leaflet Danish 26-01-2009
Summary of Product characteristics Summary of Product characteristics Danish 26-01-2009
Public Assessment Report Public Assessment Report Danish 26-01-2009
Patient Information leaflet Patient Information leaflet German 26-01-2009
Summary of Product characteristics Summary of Product characteristics German 26-01-2009
Public Assessment Report Public Assessment Report German 26-01-2009
Patient Information leaflet Patient Information leaflet Estonian 26-01-2009
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Public Assessment Report Public Assessment Report Estonian 26-01-2009
Patient Information leaflet Patient Information leaflet Greek 26-01-2009
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Public Assessment Report Public Assessment Report Greek 26-01-2009
Patient Information leaflet Patient Information leaflet English 26-01-2009
Summary of Product characteristics Summary of Product characteristics English 26-01-2009
Public Assessment Report Public Assessment Report English 26-01-2009
Patient Information leaflet Patient Information leaflet French 26-01-2009
Summary of Product characteristics Summary of Product characteristics French 26-01-2009
Public Assessment Report Public Assessment Report French 26-01-2009
Patient Information leaflet Patient Information leaflet Italian 26-01-2009
Summary of Product characteristics Summary of Product characteristics Italian 26-01-2009
Public Assessment Report Public Assessment Report Italian 26-01-2009
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Public Assessment Report Public Assessment Report Hungarian 26-01-2009
Patient Information leaflet Patient Information leaflet Maltese 26-01-2009
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Public Assessment Report Public Assessment Report Maltese 26-01-2009
Patient Information leaflet Patient Information leaflet Dutch 26-01-2009
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Public Assessment Report Public Assessment Report Dutch 26-01-2009
Patient Information leaflet Patient Information leaflet Polish 26-01-2009
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Public Assessment Report Public Assessment Report Polish 26-01-2009
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Patient Information leaflet Patient Information leaflet Slovak 26-01-2009
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Public Assessment Report Public Assessment Report Slovak 26-01-2009
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Public Assessment Report Public Assessment Report Slovenian 26-01-2009
Patient Information leaflet Patient Information leaflet Finnish 26-01-2009
Summary of Product characteristics Summary of Product characteristics Finnish 26-01-2009
Public Assessment Report Public Assessment Report Finnish 26-01-2009
Patient Information leaflet Patient Information leaflet Swedish 26-01-2009
Summary of Product characteristics Summary of Product characteristics Swedish 26-01-2009
Public Assessment Report Public Assessment Report Swedish 26-01-2009

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Neupopeg