Doribax

Country: European Union

Language: Bulgarian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
17-10-2014
Summary of Product characteristics Summary of Product characteristics (SPC)
17-10-2014
Public Assessment Report Public Assessment Report (PAR)
17-10-2014

Active ingredient:

дорипенем

Available from:

Janssen-Cilag International NV

ATC code:

J01DH04

INN (International Name):

doripenem

Therapeutic group:

Антибактериални средства за подаване на заявления,

Therapeutic area:

Pneumonia, Ventilator-Associated; Pneumonia, Bacterial; Urinary Tract Infections; Bacterial Infections; Cross Infection

Therapeutic indications:

Doribax е показан за лечение на следните инфекции при възрастни:нозокомиальная пневмония (включително фен-ассоциированная пневмония);трансфери интраабдоминальные инфекции;трансфери инфекция на пикочните пътища. Трябва да се вземат предвид официалните препоръки за правилното използване на антибактериални агенти.

Product summary:

Revision: 10

Authorization status:

Отменено

Authorization date:

2008-07-25

Patient Information leaflet

                                42
Б. ЛИСТОВКА
Лекарствен продукт, който вече не е
разрешен за употреба
43
ЛИСТОВКА: ИНФОРМАЦИЯ ЗА ПОТРЕБИТЕЛЯ
DORIBAX 250 MG ПРАХ ЗА ИНФУЗИОНЕН РАЗТВОР
дорипенем (doripenem)
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.
-
Ако получите някакви нежелани
лекарствени реакции, уведомете Вашия
лекар,
фармацевт или медицинска сестра. Това
включва и всички възможни нежелани
реакции,
неописани в тази листовка.
КАКВО СЪДЪРЖА ТАЗИ ЛИСТОВКА:
1.
Какво представлява Doribax и за какво се
използва
2.
Какво трябва да знаете, преди да
използвате Doribax
3.
Как да използвате Doribax
4.
Възможни нежелани реакции
5.
Как да съхранявате Doribax
6.
Съдържание на опаковката и
допълнителна информация
1.
КАКВО ПРЕДСТАВЛЯВА DORIBAX И ЗА КАКВО СЕ
ИЗПОЛЗВА
Doribax съдържа активното вещество
дорипенем. Това лекарство е
антибиотик, който действа
като убива различните видове бактерии
(микроби), които причиняват инфекции в
различни
                                
                                Read the complete document

Summary of Product characteristics

                                1
ПРИЛОЖЕНИЕ І
КРАТКА ХАРАКТЕРИСТИКА НА ПРОДУКТА
Лекарствен продукт, който вече не е
разрешен за употреба
2
1.
ИМЕ НА ЛЕКАРСТВЕНИЯ ПРОДУКТ
Doribax 250 mg прах за инфузионен разтвор
2.
КАЧЕСТВЕН И КОЛИЧЕСТВЕН СЪСТАВ
Всеки флакон съдържа дорипенем
монохидрат, еквивалентен на 250 mg
дорипенем
(doripenem).
3.
ЛЕКАРСТВЕНА ФОРМА
Прах за инфузионен разтвор (прах за
инфузия)
Бял до леко жълтеникав, почти бял
кристален прах
4.
КЛИНИЧНИ ДАННИ
4.1
ТЕРАПЕВТИЧНИ ПОКАЗАНИЯ
Doribax е показан за лечение на следните
инфекции при възрастни (вж. точка 4.4 и
5.1):
•
Нозокомиална пневмония (включително
вентилационна пневмония)
•
Усложнени интраабдоминални инфекции
•
Усложнени инфекции на пикочните
пътища
Трябва да се има предвид официалното
ръководство за подходящо използване
на
антибактериалните средства.
4.2
ДОЗИРОВКА И НАЧИН НА ПРИЛОЖЕНИЕ
Дозировка
Препоръчваната доза и начин на
приложение според инфекцията са
показани на следната
таблица:
Инфекция
Доза
Честота
Време за инфузия
Нозокомиална пневмония,
включително вентилационна
пневмония
500 mg или
1 g
*
на всеки 8 часа
1 или 4 часа**
Усложнена интраабдоминална
инфекция
500 mg
на всеки 8 часа
1 час
Услож
                                
                                Read the complete document

Similar products

Active ingredient дорипенем

дорипенем

ATC code J01DH04

J01DH04

Marketed by Janssen-Cilag International NV

Janssen-Cilag International NV

INN (International Name) doripenem

doripenem

Documents in other languages

Patient Information leaflet Patient Information leaflet Spanish 17-10-2014
Summary of Product characteristics Summary of Product characteristics Spanish 17-10-2014
Public Assessment Report Public Assessment Report Spanish 17-10-2014
Patient Information leaflet Patient Information leaflet Czech 17-10-2014
Summary of Product characteristics Summary of Product characteristics Czech 17-10-2014
Public Assessment Report Public Assessment Report Czech 17-10-2014
Patient Information leaflet Patient Information leaflet Danish 17-10-2014
Summary of Product characteristics Summary of Product characteristics Danish 17-10-2014
Public Assessment Report Public Assessment Report Danish 17-10-2014
Patient Information leaflet Patient Information leaflet German 17-10-2014
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Public Assessment Report Public Assessment Report German 17-10-2014
Patient Information leaflet Patient Information leaflet Estonian 17-10-2014
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Public Assessment Report Public Assessment Report Estonian 17-10-2014
Patient Information leaflet Patient Information leaflet Greek 17-10-2014
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Public Assessment Report Public Assessment Report Greek 17-10-2014
Patient Information leaflet Patient Information leaflet English 17-10-2014
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Public Assessment Report Public Assessment Report English 17-10-2014
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Public Assessment Report Public Assessment Report Slovak 17-10-2014
Patient Information leaflet Patient Information leaflet Slovenian 17-10-2014
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Public Assessment Report Public Assessment Report Slovenian 17-10-2014
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