Eviplera

Country: European Union

Language: Bulgarian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
13-12-2022
Summary of Product characteristics Summary of Product characteristics (SPC)
13-12-2022
Public Assessment Report Public Assessment Report (PAR)
26-07-2016

Active ingredient:

emtricitabine, rilpivirine hydrochloride, tenofovir disoproxil fumarate

Available from:

Gilead Sciences International Ltd 

ATC code:

J05AR08

INN (International Name):

emtricitabine, rilpivirine, tenofovir disoproxil

Therapeutic group:

Антивирусни средства за системно приложение

Therapeutic area:

ХИВ инфекции

Therapeutic indications:

Eviplera е показан за лечение на възрастни, заразени с човешкия имунодефицитен вирус тип 1 (HIV-1) без известни мутации, свързани с резистентност към не нуклеозидните обратна транскриптаза инхибитор (NNRTI) клас, tenofovir или emtricitabine, и с вирусно натоварване ≤ 100 000 HIV-1 РНК копия/mL. Както при другите антиретровирусни лекарствени продукти, тестовете за генотипна резистентност и / или данните за историческата резистентност трябва да ръководят употребата на Eviplera.

Product summary:

Revision: 25

Authorization status:

упълномощен

Authorization date:

2011-11-27

Patient Information leaflet

                                51
Б. ЛИСТОВКА
52
ЛИСТОВКА: ИНФОРМАЦИЯ ЗА ПОТРЕБИТЕЛЯ
EVIPLERA 200 MG/25 MG/245 MG ФИЛМИРАНИ ТАБЛЕТКИ
eмтрицитабин/рилпивирин/тенофовир
дизопроксил (еmtricitabine/rilpivirine/tenofovir
disoproxil)
ПРОЧЕТЕТЕ ВНИМАТЕЛНО ЦЯЛАТА ЛИСТОВКА,
ПРЕДИ ДА ЗАПОЧНЕТЕ ДА ПРИЕМАТЕ 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 или
фармацевт.
–
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 Eviplera и за какво се
използва
2.
Какво трябва да знаете, преди да
приемете Eviplera
3.
Как да приемате Eviplera
4.
Възможни нежелани реакции
5.
Как да съхранявате Eviplera
6.
Съдържание на опаковката и
допълнителна информация
1.
КАКВО ПРЕДСТАВЛЯВА EVIPLERA И ЗА КАКВО СЕ
ИЗПОЛЗВА
EVIPLERA СЪДЪРЖА ТРИ АКТИВНИ
                                
                                Read the complete document

Summary of Product characteristics

                                1
ПРИЛОЖЕНИЕ I
КРАТКА ХАРАКТЕРИСТИКА НА ПРОДУКТА
2
1.
ИМЕ НА ЛЕКАРСТВЕНИЯ ПРОДУКТ
Eviplera 200 mg/25 mg/245 mg филмирани таблетки
2.
КАЧЕСТВЕН И КОЛИЧЕСТВЕН СЪСТАВ
Всяка филмирана таблетка съдържа 200 mg
емтрицитабин (emtricitabine), 25 mg рилпивирин
(rilpivirine) (като хидрохлорид) и 245 mg
тенофовир дизопроксил (tenofovir disoproxil)
(като
фумарат).
Помощни вещества с известно действие
Всяка филмирана таблетка съдържа 277 mg
лактоза монохидрат и 4 микрограма
сънсет жълто
алуминиев лак (E110).
За пълния списък на помощните
вещества вижте точка 6.1.
3.
ЛЕКАРСТВЕНА ФОРМА
Филмирана таблетка
Розово-лилава филмирана таблетка с
форма на капсула с размери 19 mm x 8,5 mm, с
вдлъбнато
релефно означение „GSI“ от едната
страна и гладка от другата.
4.
КЛИНИЧНИ ДАННИ
4.1
ТЕРАПЕВТИЧНИ ПОКАЗАНИЯ
Eviplera е показан за лечение на
възрастни, инфектирани с човешкия
вирус на имунната
недостатъчност тип 1 (HIV-1) без известни
мутации, свързани с резистентност към
класа на
ненуклеозидните инхибитори на
обратната транскриптаза (ННИОТ),
тенофовир, емтрицитабин
и с вирусно натоварване ≤ 100 000 HIV-1 РНК
копия/ml (вж. точки 4.2, 4.4 и 5.1).
Употребата на Eviplera трябва да се базира
на генотипно изследване за
рези
                                
                                Read the complete document

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Active ingredient emtricitabine, rilpivirine hydrochloride, tenofovir disoproxil fumarate

emtricitabine, rilpivirine hydrochloride, tenofovir disoproxil fumarate

ATC code J05AR08

J05AR08

Marketed by Gilead Sciences International Ltd 

Gilead Sciences International Ltd 

INN (International Name) emtricitabine, rilpivirine, tenofovir disoproxil

emtricitabine, rilpivirine, tenofovir disoproxil

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Patient Information leaflet Patient Information leaflet Spanish 13-12-2022
Summary of Product characteristics Summary of Product characteristics Spanish 13-12-2022
Public Assessment Report Public Assessment Report Spanish 26-07-2016
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Summary of Product characteristics Summary of Product characteristics Czech 13-12-2022
Public Assessment Report Public Assessment Report Czech 26-07-2016
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Summary of Product characteristics Summary of Product characteristics Danish 13-12-2022
Public Assessment Report Public Assessment Report Danish 26-07-2016
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Public Assessment Report Public Assessment Report German 26-07-2016
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Public Assessment Report Public Assessment Report Estonian 26-07-2016
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Public Assessment Report Public Assessment Report Greek 26-07-2016
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Summary of Product characteristics Summary of Product characteristics English 13-12-2022
Public Assessment Report Public Assessment Report English 26-07-2016
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Public Assessment Report Public Assessment Report French 26-07-2016
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Eviplera