Tresiba

Country: European Union

Language: Bulgarian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
21-02-2022
Summary of Product characteristics Summary of Product characteristics (SPC)
21-02-2022
Public Assessment Report Public Assessment Report (PAR)
20-03-2015

Active ingredient:

инсулин degludec

Available from:

Novo Nordisk A/S

ATC code:

A10AE06

INN (International Name):

insulin degludec

Therapeutic group:

Лекарства, използвани при диабет

Therapeutic area:

Захарен диабет

Therapeutic indications:

Лечение на захарен диабет при възрастни.

Product summary:

Revision: 16

Authorization status:

упълномощен

Authorization date:

2013-01-20

Patient Information leaflet

                                47
Б. ЛИСТОВКА
48
ЛИСТОВКА: ИНФОРМАЦИЯ ЗА ПАЦИЕНТА
TRESIBA 100 ЕДИНИЦИ/ML ИНЖЕКЦИОНЕН РАЗТВОР В
ПРЕДВАРИТЕЛНО НАПЪЛНЕНА ПИСАЛКА
инсулин деглудек (insulin degludec)
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
лекарствени 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 Tresiba и за какво се
използва
2.
Какво трябва да знаете, преди да
използвате Tresiba
3.
Как да използвате Tresiba
4.
Възможни нежелани реакции
5.
Как да съхранявате Tresiba
6.
Съдържание на опаковката и
допълнителна информация
1.
КАКВО ПРЕДСТАВЛЯВА TRESIBA И ЗА КАКВО СЕ
ИЗПОЛ
                                
                                Read the complete document

Summary of Product characteristics

                                1
ПРИЛОЖЕНИЕ I
КРАТКА ХАРАКТЕРИСТИКА НА ПРОДУКТ
2
1.
ИМЕ НА ЛЕКАРСТВЕНИЯ ПРОДУКТ
Tresiba 100 единици/ml инжекционен разтвор в
предварително напълнена писалка
Tresiba 200 единици/ml инжекционен разтвор в
предварително напълнена писалка
Tresiba 100 единици/ml инжекционен разтвор в
патрон
2.
КАЧЕСТВЕН И КОЛИЧЕСТВЕН СЪСТАВ
Tresiba 100 единици/ml инжекционен разтвор в
предварително напълнена писалка
Една предварително напълнена писалка
съдържа 300 единици инсулин деглудек
(insulin
degludec) в 3 ml разтвор.
1 ml разтвор съдържа 100 единици инсулин
деглудек* (еквивалентни на 3,66 mg
инсулин
деглудек).
Tresiba 200 единици/ml инжекционен разтвор в
предварително напълнена писалка
Една предварително напълнена писалка
съдържа 600 единици инсулин деглудек
(insulin
degludec) в 3 ml разтвор.
1 ml разтвор съдържа 200 единици инсулин
деглудек* (еквивалентни на 7,32 mg
инсулин
деглудек).
Tresiba 100 единици/ml инжекционен разтвор в
патрон
Един патрон съдържа 300 единици инсулин
деглудек (insulin degludec) в 3 ml разтвор.
1 ml разтвор съдържа 100 единици инсулин
деглудек* (еквивалентни на 3,66 mg
инсулин
деглудек).
*Произведен в
_Saccharomyces cerevisiae_
по рекомбинантна ДНК технология.
За пълния списък на помощните
вещес
                                
                                Read the complete document

Similar products

Active ingredient инсулин degludec

инсулин degludec

ATC code A10AE06

A10AE06

Marketed by Novo Nordisk A/S

Novo Nordisk A/S

INN (International Name) insulin degludec

insulin degludec

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Patient Information leaflet Patient Information leaflet Spanish 21-02-2022
Summary of Product characteristics Summary of Product characteristics Spanish 21-02-2022
Public Assessment Report Public Assessment Report Spanish 20-03-2015
Patient Information leaflet Patient Information leaflet Czech 21-02-2022
Summary of Product characteristics Summary of Product characteristics Czech 21-02-2022
Public Assessment Report Public Assessment Report Czech 20-03-2015
Patient Information leaflet Patient Information leaflet Danish 21-02-2022
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Public Assessment Report Public Assessment Report Danish 20-03-2015
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Public Assessment Report Public Assessment Report German 20-03-2015
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Public Assessment Report Public Assessment Report Estonian 20-03-2015
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Public Assessment Report Public Assessment Report Greek 20-03-2015
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Public Assessment Report Public Assessment Report English 20-03-2015
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Public Assessment Report Public Assessment Report French 20-03-2015
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Summary of Product characteristics Summary of Product characteristics Slovak 21-02-2022
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