Vemlidy

Country: European Union

Language: Bulgarian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
31-05-2023
Summary of Product characteristics Summary of Product characteristics (SPC)
31-05-2023
Public Assessment Report Public Assessment Report (PAR)
10-03-2017

Active ingredient:

тенофовир алафенамид фумарат

Available from:

Gilead Sciences Ireland UC

ATC code:

J05AF13

INN (International Name):

tenofovir alafenamide

Therapeutic group:

Антивирусни средства за системно приложение

Therapeutic area:

Хепатит Б

Therapeutic indications:

Vemlidy is indicated for the treatment of chronic hepatitis B (CHB) in adults and paediatric patients 6 years of age and older weighing at least 25 kg (see section 5.

Product summary:

Revision: 16

Authorization status:

упълномощен

Authorization date:

2017-01-09

Patient Information leaflet

                                39
Б. ЛИСТОВКА
40
ЛИСТОВКА: ИНФОРМАЦИЯ ЗА ПАЦИЕНТА
VEMLIDY 25 MG ФИЛМИРАНИ ТАБЛЕТКИ
тенофовир алафенамид (tenofovir alafenamide)
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
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 Vemlidy и за какво се
използва
2.
Какво трябва да знаете, преди да
приемете Vemlidy
3.
Как да приемате Vemlidy
4.
Възможни нежелани реакции
5.
Как да съхранявате Vemlidy
6.
Съдържание на опаковката и
допълнителна информация
АКО VEMLIDY Е ПРЕДПИСАН ЗА ВАШЕТО ДЕТЕ,
ОБЪРНЕТЕ ВНИМАНИЕ, ЧЕ ЦЯЛАТА
ИНФОРМАЦИЯ В
ТАЗИ ЛИСТОВКА Е АДРЕСИРАНА ДО ВАШЕТО
ДЕТЕ (В ТОЗИ СЛУЧАЙ ЧЕТЕТЕ „В
                                
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Summary of Product characteristics

                                1
ПРИЛОЖЕНИЕ I
КРАТКА ХАРАКТЕРИСТИКА НА ПРОДУКТА
2
1.
ИМЕ НА ЛЕКАРСТВЕНИЯ ПРОДУКТ
Vemlidy 25 mg филмирани таблетки
2.
КАЧЕСТВЕН И КОЛИЧЕСТВЕН СЪСТАВ
Всяка филмирана таблетка съдържа
тенофовир алафенамид фумарат (tenofovir
alafenamide
fumarate), еквивалентен на 25 mg тенофовир
алафенамид.
Помощно вещество с известно действие
Всяка таблетка съдържа 95 mg лактоза
(под формата на монохидрат).
За пълния списък на помощните
вещества вижте точка 6.1.
3.
ЛЕКАРСТВЕНА ФОРМА
Филмирана таблетка
Кръгли, жълти, филмирани таблетки с
диаметър 8 mm, с вдлъбнато релефно
означение „GSI“ от
едната страна на таблетката и „25“ от
другата страна.
4.
КЛИНИЧНИ ДАННИ
4.1
ТЕРАПЕВТИЧНИ ПОКАЗАНИЯ
Vemlidy е показан за лечение на хроничен
хепатит B при възрастни и педиатрични
пациенти на
6 години и по-големи с телесно тегло
най-малко 25 kg (вж. точка 5.1).
4.2
ДОЗИРОВКА И НАЧИН НА ПРИЛОЖЕНИЕ
Терапията трябва да се започне от
лекар с опит в лечението на хроничен
хепатит B.
Дозировка
Възрастни и педиатрични пациенти
най-малко на 6 години и по-големи, с
телесно тегло най-
малко 25 kg: eдна таблетка веднъж дневно.
_Преустановяване на лечението _
Прекратяване на лечението може да се
обмисли,
                                
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Active ingredient тенофовир алафенамид фумарат

тенофовир алафенамид фумарат

ATC code J05AF13

J05AF13

Marketed by Gilead Sciences Ireland UC

Gilead Sciences Ireland UC

INN (International Name) tenofovir alafenamide

tenofovir alafenamide

Documents in other languages

Patient Information leaflet Patient Information leaflet Spanish 31-05-2023
Summary of Product characteristics Summary of Product characteristics Spanish 31-05-2023
Public Assessment Report Public Assessment Report Spanish 10-03-2017
Patient Information leaflet Patient Information leaflet Czech 31-05-2023
Summary of Product characteristics Summary of Product characteristics Czech 31-05-2023
Public Assessment Report Public Assessment Report Czech 10-03-2017
Patient Information leaflet Patient Information leaflet Danish 31-05-2023
Summary of Product characteristics Summary of Product characteristics Danish 31-05-2023
Public Assessment Report Public Assessment Report Danish 10-03-2017
Patient Information leaflet Patient Information leaflet German 31-05-2023
Summary of Product characteristics Summary of Product characteristics German 31-05-2023
Public Assessment Report Public Assessment Report German 10-03-2017
Patient Information leaflet Patient Information leaflet Estonian 31-05-2023
Summary of Product characteristics Summary of Product characteristics Estonian 31-05-2023
Public Assessment Report Public Assessment Report Estonian 10-03-2017
Patient Information leaflet Patient Information leaflet Greek 31-05-2023
Summary of Product characteristics Summary of Product characteristics Greek 31-05-2023
Public Assessment Report Public Assessment Report Greek 10-03-2017
Patient Information leaflet Patient Information leaflet English 05-09-2022
Summary of Product characteristics Summary of Product characteristics English 05-09-2022
Public Assessment Report Public Assessment Report English 10-03-2017
Patient Information leaflet Patient Information leaflet French 31-05-2023
Summary of Product characteristics Summary of Product characteristics French 31-05-2023
Public Assessment Report Public Assessment Report French 10-03-2017
Patient Information leaflet Patient Information leaflet Italian 31-05-2023
Summary of Product characteristics Summary of Product characteristics Italian 31-05-2023
Public Assessment Report Public Assessment Report Italian 10-03-2017
Patient Information leaflet Patient Information leaflet Latvian 31-05-2023
Summary of Product characteristics Summary of Product characteristics Latvian 31-05-2023
Public Assessment Report Public Assessment Report Latvian 10-03-2017
Patient Information leaflet Patient Information leaflet Lithuanian 31-05-2023
Summary of Product characteristics Summary of Product characteristics Lithuanian 31-05-2023
Public Assessment Report Public Assessment Report Lithuanian 10-03-2017
Patient Information leaflet Patient Information leaflet Hungarian 31-05-2023
Summary of Product characteristics Summary of Product characteristics Hungarian 31-05-2023
Public Assessment Report Public Assessment Report Hungarian 10-03-2017
Patient Information leaflet Patient Information leaflet Maltese 31-05-2023
Summary of Product characteristics Summary of Product characteristics Maltese 31-05-2023
Public Assessment Report Public Assessment Report Maltese 10-03-2017
Patient Information leaflet Patient Information leaflet Dutch 31-05-2023
Summary of Product characteristics Summary of Product characteristics Dutch 31-05-2023
Public Assessment Report Public Assessment Report Dutch 10-03-2017
Patient Information leaflet Patient Information leaflet Polish 31-05-2023
Summary of Product characteristics Summary of Product characteristics Polish 31-05-2023
Public Assessment Report Public Assessment Report Polish 10-03-2017
Patient Information leaflet Patient Information leaflet Portuguese 31-05-2023
Summary of Product characteristics Summary of Product characteristics Portuguese 31-05-2023
Public Assessment Report Public Assessment Report Portuguese 10-03-2017
Patient Information leaflet Patient Information leaflet Romanian 31-05-2023
Summary of Product characteristics Summary of Product characteristics Romanian 31-05-2023
Public Assessment Report Public Assessment Report Romanian 10-03-2017
Patient Information leaflet Patient Information leaflet Slovak 31-05-2023
Summary of Product characteristics Summary of Product characteristics Slovak 31-05-2023
Public Assessment Report Public Assessment Report Slovak 10-03-2017
Patient Information leaflet Patient Information leaflet Slovenian 31-05-2023
Summary of Product characteristics Summary of Product characteristics Slovenian 31-05-2023
Public Assessment Report Public Assessment Report Slovenian 10-03-2017
Patient Information leaflet Patient Information leaflet Finnish 31-05-2023
Summary of Product characteristics Summary of Product characteristics Finnish 31-05-2023
Public Assessment Report Public Assessment Report Finnish 10-03-2017
Patient Information leaflet Patient Information leaflet Swedish 31-05-2023
Summary of Product characteristics Summary of Product characteristics Swedish 31-05-2023
Public Assessment Report Public Assessment Report Swedish 10-03-2017
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Summary of Product characteristics Summary of Product characteristics Norwegian 31-05-2023
Patient Information leaflet Patient Information leaflet Icelandic 31-05-2023
Summary of Product characteristics Summary of Product characteristics Icelandic 31-05-2023
Patient Information leaflet Patient Information leaflet Croatian 31-05-2023
Summary of Product characteristics Summary of Product characteristics Croatian 31-05-2023
Public Assessment Report Public Assessment Report Croatian 10-03-2017

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