Lantus

Country: European Union

Language: Bulgarian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
10-07-2023
Summary of Product characteristics Summary of Product characteristics (SPC)
10-07-2023
Public Assessment Report Public Assessment Report (PAR)
14-08-2012

Active ingredient:

инсулин гларжин

Available from:

sanofi-aventis Deutschland GmbH

ATC code:

A10AE04

INN (International Name):

insulin glargine

Therapeutic group:

Лекарства, използвани при диабет

Therapeutic area:

Захарен диабет

Therapeutic indications:

Лечение на захарен диабет при възрастни, юноши и деца на възраст над 2 години.

Product summary:

Revision: 40

Authorization status:

упълномощен

Authorization date:

2000-06-09

Patient Information leaflet

                                40
Б. ЛИСТОВКА
41
Листовка: информация за потребителя
Lantus 100 единици/ml инжекционен разтвор
във флакон
Инсулин гларжин (Insulin glargine)
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 или
фармацевт. Това включва и всички
възможни нежелани реакции, неописани
в тази
листовка. Вижте точка 4.
Какво съдържа тази листовка
1.
Какво представлява Lantus и за какво се
използва
2.
Какво трябва да знаете, преди да
използвате Lantus
3.
Как да използвате Lantus
4.
Възможни нежелани реакции
5.
Как да съхранявате Lantus
6.
Съдържание на опаковката и
допълнителна информация
1.
Какво представлява Lantus и за какво се
използва
Lantus съдържа инсулин гларжин. Това е
модифицир
                                
                                Read the complete document

Summary of Product characteristics

                                1
ПРИЛОЖЕНИЕ I
КРАТКА ХАРАКТЕРИСТИКА НА ПРОДУКТА
2
1.
ИМЕ НА ЛЕКАРСТВЕНИЯ ПРОДУКТ
Lantus 100 единици/ml инжекционен разтвор
във флакон
Lantus 100 единици/ml инжекционен разтвор в
патрон
Lantus 100 единици/ml инжекционен разтвор в
предварително напълнена писалка
2.
КАЧЕСТВЕН И КОЛИЧЕСТВЕН СЪСТАВ
Всеки ml съдържа 100 единици инсулин
гларжин (insulin glargine)* (еквивалентни на 3,64
mg).
Lantus 100 единици/ml инжекционен разтвор
във флакон
Всеки флакон съдържа 5 ml инжекционен
разтвор, еквивалентни на 500 единици
или 10 ml
инжекционен разтвор, еквивалентни на 1
000 единици.
Lantus 100 единици/ml инжекционен разтвор в
патрон, Lantus SoloStar 100 единици/ml
инжекционен разтвор в предварително
напълнена писалка
Всеки патрон или писалка съдържат 3 ml
инжекционен разтвор, еквивалентни на
300 единици.
*Инсулин гларжин се произвежда по
рекомбинантна ДНК технология в Escherichia
coli.
За пълния списък на помощните
вещества вижте точка 6.1.
3.
ЛЕКАРСТВЕНА ФОРМА
Инжекционен разтвор
Бистър безцветен разтвор.
4.
КЛИНИЧНИ ДАННИ
4.1
Терапевтични показания
Лечение на захарен диабет при
възрастни, юноши и деца на възраст 2
години и повече.
4.2
Дозировка и начин на приложение
Дозировка
Lantus съдържа ин
                                
                                Read the complete document

Similar products

Active ingredient инсулин гларжин

инсулин гларжин

ATC code A10AE04

A10AE04

Marketed by sanofi-aventis Deutschland GmbH

sanofi-aventis Deutschland GmbH

INN (International Name) insulin glargine

insulin glargine

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Patient Information leaflet Patient Information leaflet Spanish 10-07-2023
Summary of Product characteristics Summary of Product characteristics Spanish 10-07-2023
Public Assessment Report Public Assessment Report Spanish 14-08-2012
Patient Information leaflet Patient Information leaflet Czech 10-07-2023
Summary of Product characteristics Summary of Product characteristics Czech 10-07-2023
Public Assessment Report Public Assessment Report Czech 14-08-2012
Patient Information leaflet Patient Information leaflet Danish 10-07-2023
Summary of Product characteristics Summary of Product characteristics Danish 10-07-2023
Public Assessment Report Public Assessment Report Danish 14-08-2012
Patient Information leaflet Patient Information leaflet German 10-07-2023
Summary of Product characteristics Summary of Product characteristics German 10-07-2023
Public Assessment Report Public Assessment Report German 14-08-2012
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Public Assessment Report Public Assessment Report Estonian 14-08-2012
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Summary of Product characteristics Summary of Product characteristics Greek 10-07-2023
Public Assessment Report Public Assessment Report Greek 14-08-2012
Patient Information leaflet Patient Information leaflet English 10-07-2023
Summary of Product characteristics Summary of Product characteristics English 10-07-2023
Public Assessment Report Public Assessment Report English 14-08-2012
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Public Assessment Report Public Assessment Report French 14-08-2012
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Lantus