Fiasp

Country: European Union

Language: Bulgarian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
23-09-2021
Summary of Product characteristics Summary of Product characteristics (SPC)
23-09-2021
Public Assessment Report Public Assessment Report (PAR)
26-08-2019

Active ingredient:

инсулин аспарт

Available from:

Novo Nordisk A/S

ATC code:

A10AB05

INN (International Name):

insulin aspart

Therapeutic group:

Drugs used in diabetes, Insulins and analogues for injection, fast-acting

Therapeutic area:

Захарен диабет

Therapeutic indications:

Лечение на захарен диабет при възрастни, юноши и деца на възраст над 1 година.

Product summary:

Revision: 8

Authorization status:

упълномощен

Authorization date:

2017-01-09

Patient Information leaflet

                                54
Б. ЛИСТОВКА
55
ЛИСТОВКА: ИНФОРМАЦИЯ ЗА ПАЦИЕНТА
FIASP 100 ЕДИНИЦИ/ML FLEXTOUCH ИНЖЕКЦИОНЕН
РАЗТВОР В ПРЕДВАРИТЕЛНО НАПЪЛНЕНА
ПИСАЛКА
инсулин аспарт (insulin aspart)
ПРОЧЕТЕТЕ ВНИМАТЕЛНО ЦЯЛАТА ЛИСТОВКА,
ПРЕДИ ДА ЗАПОЧНЕТЕ ДА ИЗПОЛЗВАТЕ 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,
фармацевт или
медицинска сестра.
–
Това лекарство е предписано 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 нежелани
реакции, уведомете Вашия лекар,
фармацевт или
медицинска сестра. Това включва и
всички възможни нежелани реакции,
неописани в
тази листовка. Вижте точка 4.
КАКВО СЪДЪРЖА ТАЗИ ЛИСТОВКА
1.
Какво представлява Fiasp и за какво се
използва
2.
Какво трябва да знаете, преди да
използвате Fiasp
3.
Как да използвате Fiasp
4.
Възможни нежелани реакции
5.
Как да съхранявате Fiasp
6.
Съдържание на опаковката и
допълнителна информация
1
КАКВО ПРЕДСТАВЛЯВА FIASP И ЗА КАКВО СЕ
ИЗПОЛЗВА
Fiasp е инсулин, 
                                
                                Read the complete document

Summary of Product characteristics

                                1
ПРИЛОЖЕНИЕ I
КРАТКА ХАРАКТЕРИСТИКА НА ПРОДУКТА
2
1.
ИМЕ НА ЛЕКАРСТВЕНИЯ ПРОДУКТ
Fiasp 100 единици/ml FlexTouch инжекционен
разтвор в предварително напълнена
писалка
Fiasp 100 единици/ml Penfill инжекционен
разтвор в патрон
Fiasp 100 единици/ml инжекционен разтвор
във флакон
Fiasp 100 единици/ml PumpCart инжекционен
разтвор в патрон
2.
КАЧЕСТВЕН И КОЛИЧЕСТВЕН СЪСТАВ
1 ml разтвор съдържа 100 единици инсулин
аспарт* (insulin aspart) (еквивалентни на 3,5 mg).
Fiasp 100 единици/ml FlexTouch инжекционен
разтвор в предварително напълнена
писалка
Всяка предварително напълнена
писалка съдържа 300 единици инсулин
аспарт в 3 ml разтвор.
Fiasp 100 единици/ml Penfill инжекционен
разтвор в патрон
Всеки патрон съдържа 300 единици
инсулин аспарт в 3 ml разтвор.
Fiasp 100 единици/ml инжекционен разтвор
във флакон
Всеки флакон съдържа 1 000 единици
инсулин аспарт в 10 ml разтвор.
Fiasp 100 единици/ml PumpCart инжекционен
разтвор в патрон
Всеки патрон съдържа 160 единици
инсулин аспарт в 1,6 ml разтвор.
*Инсулин аспарт е произведен в
_Saccharomyces cerevisiae _
по рекомбинантна ДНК технология.
За пълния списък на помощните
вещества вижте точка 6.1.
3.
ЛЕКАРСТВЕНА ФОРМА
Fiasp 100 единици/ml FlexTouch инжекционен
разтвор в предварително нап
                                
                                Read the complete document

Similar products

Active ingredient инсулин аспарт

инсулин аспарт

ATC code A10AB05

A10AB05

Marketed by Novo Nordisk A/S

Novo Nordisk A/S

INN (International Name) insulin aspart

insulin aspart

Documents in other languages

Patient Information leaflet Patient Information leaflet Spanish 23-09-2021
Summary of Product characteristics Summary of Product characteristics Spanish 23-09-2021
Public Assessment Report Public Assessment Report Spanish 26-08-2019
Patient Information leaflet Patient Information leaflet Czech 23-09-2021
Summary of Product characteristics Summary of Product characteristics Czech 23-09-2021
Public Assessment Report Public Assessment Report Czech 26-08-2019
Patient Information leaflet Patient Information leaflet Danish 23-09-2021
Summary of Product characteristics Summary of Product characteristics Danish 23-09-2021
Public Assessment Report Public Assessment Report Danish 26-08-2019
Patient Information leaflet Patient Information leaflet German 23-09-2021
Summary of Product characteristics Summary of Product characteristics German 23-09-2021
Public Assessment Report Public Assessment Report German 26-08-2019
Patient Information leaflet Patient Information leaflet Estonian 23-09-2021
Summary of Product characteristics Summary of Product characteristics Estonian 23-09-2021
Public Assessment Report Public Assessment Report Estonian 26-08-2019
Patient Information leaflet Patient Information leaflet Greek 23-09-2021
Summary of Product characteristics Summary of Product characteristics Greek 23-09-2021
Public Assessment Report Public Assessment Report Greek 26-08-2019
Patient Information leaflet Patient Information leaflet English 23-09-2021
Summary of Product characteristics Summary of Product characteristics English 23-09-2021
Public Assessment Report Public Assessment Report English 26-08-2019
Patient Information leaflet Patient Information leaflet French 23-09-2021
Summary of Product characteristics Summary of Product characteristics French 23-09-2021
Public Assessment Report Public Assessment Report French 26-08-2019
Patient Information leaflet Patient Information leaflet Italian 23-09-2021
Summary of Product characteristics Summary of Product characteristics Italian 23-09-2021
Public Assessment Report Public Assessment Report Italian 26-08-2019
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Public Assessment Report Public Assessment Report Latvian 26-08-2019
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Public Assessment Report Public Assessment Report Lithuanian 26-08-2019
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Summary of Product characteristics Summary of Product characteristics Hungarian 23-09-2021
Public Assessment Report Public Assessment Report Hungarian 26-08-2019
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Public Assessment Report Public Assessment Report Maltese 26-08-2019
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Public Assessment Report Public Assessment Report Dutch 26-08-2019
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Summary of Product characteristics Summary of Product characteristics Polish 23-09-2021
Public Assessment Report Public Assessment Report Polish 26-08-2019
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Summary of Product characteristics Summary of Product characteristics Portuguese 23-09-2021
Public Assessment Report Public Assessment Report Portuguese 26-08-2019
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Summary of Product characteristics Summary of Product characteristics Romanian 23-09-2021
Public Assessment Report Public Assessment Report Romanian 26-08-2019
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Summary of Product characteristics Summary of Product characteristics Slovak 23-09-2021
Public Assessment Report Public Assessment Report Slovak 26-08-2019
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Summary of Product characteristics Summary of Product characteristics Slovenian 23-09-2021
Public Assessment Report Public Assessment Report Slovenian 26-08-2019
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Summary of Product characteristics Summary of Product characteristics Finnish 23-09-2021
Public Assessment Report Public Assessment Report Finnish 26-08-2019
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Patient Information leaflet Patient Information leaflet Croatian 23-09-2021
Summary of Product characteristics Summary of Product characteristics Croatian 23-09-2021
Public Assessment Report Public Assessment Report Croatian 26-08-2019

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