Nespo

Country: European Union

Language: Bulgarian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
29-01-2009
Summary of Product characteristics Summary of Product characteristics (SPC)
29-01-2009
Public Assessment Report Public Assessment Report (PAR)
29-01-2009

Active ingredient:

дарбепоетин алфа

Available from:

Dompé Biotec S.p.A.

ATC code:

B03XA02

INN (International Name):

darbepoetin alfa

Therapeutic group:

Антианемични препарати

Therapeutic area:

Kidney Failure, Chronic; Anemia; Cancer

Therapeutic indications:

Лечение на симптоматична анемия, свързана с хронична бъбречна недостатъчност (CRF) при възрастни и педиатрични пациенти. Лечение на симптоматична анемия при възрастни онкологични пациенти, с миелоидными злокачествени заболявания, подложени на химиотерапия.

Product summary:

Revision: 19

Authorization status:

Отменено

Authorization date:

2001-06-08

Patient Information leaflet

                                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
Nespo 10 микрограма инжекционен разтвор в
предварително напълнена спринцовка.
2.
КАЧЕСТВЕН И КОЛИЧЕСТВЕН СЪСТАВ
Всяка предварително напълнена
спринцовка съдържа 10 микрограма
дарбепоетин алфа
(
_darbepoetin alfa_
) в 0,4 ml (25 µg/ml).
Дарбепоетин алфа се произвежда по
генна технология в клетки от яйчник на
китайски хамстер
(CHO-K1).
За помощните вещества, вижте точка 6.1.
3.
ЛЕКАРСТВЕНА ФОРМА
Инжекционен разтвор (инжекци
я).
4.
КЛИНИЧНИ ДАННИ
4.1
ТЕРАПЕВТИЧНИ ПОКАЗАНИЯ
Лечение на симптоматична анемия,
свързана с хронична бъбречна
недостатъчност (ХБН) при
възрастни и педиатрични пациенти.
Лечение на симптоматична анемия при
възрастни пациенти с немиелоидни
злокачествени
заболявания, които са подложени на
химиотерапия.
_ _
4.2
ДОЗИРОВКА И НАЧИН НА ПРИЛОЖЕНИЕ
Лечението с Nespo трябва да бъде зап
очнато от лекар специалист по
посочените по-горе
заболявания.
Nespo се доставя в предварително
напълнени спринцовки. Указанията за
приложение са
представе
                                
                                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
Nespo 10 микрограма инжекционен разтвор в
предварително напълнена спринцовка.
2.
КАЧЕСТВЕН И КОЛИЧЕСТВЕН СЪСТАВ
Всяка предварително напълнена
спринцовка съдържа 10 микрограма
дарбепоетин алфа
(
_darbepoetin alfa_
) в 0,4 ml (25 µg/ml).
Дарбепоетин алфа се произвежда по
генна технология в клетки от яйчник на
китайски хамстер
(CHO-K1).
За помощните вещества, вижте точка 6.1.
3.
ЛЕКАРСТВЕНА ФОРМА
Инжекционен разтвор (инжекци
я).
4.
КЛИНИЧНИ ДАННИ
4.1
ТЕРАПЕВТИЧНИ ПОКАЗАНИЯ
Лечение на симптоматична анемия,
свързана с хронична бъбречна
недостатъчност (ХБН) при
възрастни и педиатрични пациенти.
Лечение на симптоматична анемия при
възрастни пациенти с немиелоидни
злокачествени
заболявания, които са подложени на
химиотерапия.
_ _
4.2
ДОЗИРОВКА И НАЧИН НА ПРИЛОЖЕНИЕ
Лечението с Nespo трябва да бъде зап
очнато от лекар специалист по
посочените по-горе
заболявания.
Nespo се доставя в предварително
напълнени спринцовки. Указанията за
приложение са
представе
                                
                                Read the complete document

Similar products

Active ingredient дарбепоетин алфа

дарбепоетин алфа

ATC code B03XA02

B03XA02

Marketed by Dompé Biotec S.p.A.

Dompé Biotec S.p.A.

INN (International Name) darbepoetin alfa

darbepoetin alfa

Documents in other languages

Patient Information leaflet Patient Information leaflet Spanish 29-01-2009
Summary of Product characteristics Summary of Product characteristics Spanish 29-01-2009
Public Assessment Report Public Assessment Report Spanish 29-01-2009
Patient Information leaflet Patient Information leaflet Czech 29-01-2009
Summary of Product characteristics Summary of Product characteristics Czech 29-01-2009
Public Assessment Report Public Assessment Report Czech 29-01-2009
Patient Information leaflet Patient Information leaflet Danish 29-01-2009
Summary of Product characteristics Summary of Product characteristics Danish 29-01-2009
Public Assessment Report Public Assessment Report Danish 29-01-2009
Patient Information leaflet Patient Information leaflet German 29-01-2009
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Public Assessment Report Public Assessment Report German 29-01-2009
Patient Information leaflet Patient Information leaflet Estonian 29-01-2009
Summary of Product characteristics Summary of Product characteristics Estonian 29-01-2009
Public Assessment Report Public Assessment Report Estonian 29-01-2009
Patient Information leaflet Patient Information leaflet Greek 29-01-2009
Summary of Product characteristics Summary of Product characteristics Greek 29-01-2009
Public Assessment Report Public Assessment Report Greek 29-01-2009
Patient Information leaflet Patient Information leaflet English 29-01-2009
Summary of Product characteristics Summary of Product characteristics English 29-01-2009
Public Assessment Report Public Assessment Report English 29-01-2009
Patient Information leaflet Patient Information leaflet French 29-01-2009
Summary of Product characteristics Summary of Product characteristics French 29-01-2009
Public Assessment Report Public Assessment Report French 29-01-2009
Patient Information leaflet Patient Information leaflet Italian 29-01-2009
Summary of Product characteristics Summary of Product characteristics Italian 29-01-2009
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Summary of Product characteristics Summary of Product characteristics Latvian 29-01-2009
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Patient Information leaflet Patient Information leaflet Hungarian 29-01-2009
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Public Assessment Report Public Assessment Report Hungarian 29-01-2009
Patient Information leaflet Patient Information leaflet Maltese 29-01-2009
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Patient Information leaflet Patient Information leaflet Dutch 29-01-2009
Summary of Product characteristics Summary of Product characteristics Dutch 29-01-2009
Public Assessment Report Public Assessment Report Dutch 29-01-2009
Patient Information leaflet Patient Information leaflet Polish 29-01-2009
Summary of Product characteristics Summary of Product characteristics Polish 29-01-2009
Public Assessment Report Public Assessment Report Polish 29-01-2009
Patient Information leaflet Patient Information leaflet Portuguese 29-01-2009
Summary of Product characteristics Summary of Product characteristics Portuguese 29-01-2009
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Patient Information leaflet Patient Information leaflet Romanian 29-01-2009
Summary of Product characteristics Summary of Product characteristics Romanian 29-01-2009
Public Assessment Report Public Assessment Report Romanian 29-01-2009
Patient Information leaflet Patient Information leaflet Slovak 29-01-2009
Summary of Product characteristics Summary of Product characteristics Slovak 29-01-2009
Public Assessment Report Public Assessment Report Slovak 29-01-2009
Patient Information leaflet Patient Information leaflet Slovenian 29-01-2009
Summary of Product characteristics Summary of Product characteristics Slovenian 29-01-2009
Public Assessment Report Public Assessment Report Slovenian 29-01-2009
Patient Information leaflet Patient Information leaflet Finnish 29-01-2009
Summary of Product characteristics Summary of Product characteristics Finnish 29-01-2009
Public Assessment Report Public Assessment Report Finnish 29-01-2009
Patient Information leaflet Patient Information leaflet Swedish 29-01-2009
Summary of Product characteristics Summary of Product characteristics Swedish 29-01-2009
Public Assessment Report Public Assessment Report Swedish 29-01-2009

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Nespo