Simbrinza

Country: European Union

Language: Bulgarian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
19-12-2022
Summary of Product characteristics Summary of Product characteristics (SPC)
19-12-2022
Public Assessment Report Public Assessment Report (PAR)
31-07-2014

Active ingredient:

brinzolamide, бримонидин тартрат

Available from:

Novartis Europharm Limited

ATC code:

S01EC54

INN (International Name):

brinzolamide, brimonidine tartrate

Therapeutic group:

Офталмологични

Therapeutic area:

Ocular Hypertension; Glaucoma, Open-Angle

Therapeutic indications:

Намаляване на повишено вътреочно налягане (ВО) при възрастни пациенти с глаукома с отворен ъгъл или очна хипертония, при които монотерапията не осигурява достатъчно намаляване на ВОН.

Product summary:

Revision: 10

Authorization status:

упълномощен

Authorization date:

2014-07-18

Patient Information leaflet

                                25
Б. ЛИСТОВКА
26
ЛИСТОВКА: ИНФОРМАЦИЯ ЗА ПОТРЕБИТЕЛЯ
SIMBRINZA 10 MG/ML + 2 MG/ML КАПКИ ЗА ОЧИ,
СУСПЕНЗИЯ
бринзоламид/бримонидинов тартарат
(brinzolamide/brimonidine tartrate)
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,
оптометрист (оптик)
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,
оптометрист (оптик)
или фармацевт. Това включва и всички
възможни нежелани реакции, неописани
в тази
листовка. Вижте точка 4.
КАКВО СЪДЪРЖА ТАЗИ ЛИСТОВКА
1.
Какво представлява SIMBRINZA и за какво се
използва
2.
Какво трябва да знаете, преди да
използвате SIMBRINZA
3.
Как да използвате SIMBRINZA
4.
Възможни нежелани реакции
5
Как да съхранявате SIMBRINZA
6.
Съдържание на опаковката и
допълнителна информация
1.
КАКВО ПРЕДСТАВЛЯВА SIMBRINZA И ЗА КАКВО СЕ
ИЗПОЛЗВА
SIMBRINZA съ
                                
                                Read the complete document

Summary of Product characteristics

                                1
ПРИЛОЖЕНИЕ I
КРАТКА ХАРАКТЕРИСТИКА НА ПРОДУКТА
2
1.
ИМЕ НА ЛЕКАРСТВЕНИЯ ПРОДУКТ
SIMBRINZA 10 mg/ml + 2 mg/ml капки за очи,
суспензия
2.
КАЧЕСТВЕН И КОЛИЧЕСТВЕН СЪСТАВ
1 ml от суспензията съдържа 10 mg
бринзоламид (brinzolamide) и 2 mg бримонидинов
тартарат
(brimonidine tartrate), еквивалентни на 1,3 mg
бримонидин.
Помощно вещество с известно действие
Всеки ml от суспензията съдържа 0,03 mg
бензалкониев хлорид.
За пълния списък на помощните
вещества вижте точка 6.1.
3.
ЛЕКАРСТВЕНА ФОРМА
Капки за очи, суспензия (капки за очи)
Бяла до почти бяла еднородна
суспензия, pH 6,5 (приблизително)
4.
КЛИНИЧНИ ДАННИ
4.1
ТЕРАПЕВТИЧНИ ПОКАЗАНИЯ
Намаляване на повишеното вътреочно
налягане (ВОН) при възрастни пациенти
с
откритоъгълна глаукома или очна
хипертензия, при които монотерапията
не осигурява
достатъчно намаляване на ВОН (вж.
точка 5.1).
4.2
ДОЗИРОВКА И НАЧИН НА ПРИЛОЖЕНИЕ
Дозировка
_Употреба при възрастни, включително
старческа възраст _
Препоръчителната доза е една капка
SIMBRINZA в засегнатото око (очи) два пъти
дневно.
_Пропусната доза _
Ако е пропусната доза, лечението
трябва да се продължи със следващата
планирана доза.
_Чернодробно и/или бъбречно увреждане
_
SIMBRINZA не 
                                
                                Read the complete document

Similar products

Active ingredient brinzolamide, бримонидин тартрат

brinzolamide, бримонидин тартрат

ATC code S01EC54

S01EC54

Marketed by Novartis Europharm Limited

Novartis Europharm Limited

INN (International Name) brinzolamide, brimonidine tartrate

brinzolamide, brimonidine tartrate

Documents in other languages

Patient Information leaflet Patient Information leaflet Spanish 19-12-2022
Summary of Product characteristics Summary of Product characteristics Spanish 19-12-2022
Public Assessment Report Public Assessment Report Spanish 31-07-2014
Patient Information leaflet Patient Information leaflet Czech 19-12-2022
Summary of Product characteristics Summary of Product characteristics Czech 19-12-2022
Public Assessment Report Public Assessment Report Czech 31-07-2014
Patient Information leaflet Patient Information leaflet Danish 19-12-2022
Summary of Product characteristics Summary of Product characteristics Danish 19-12-2022
Public Assessment Report Public Assessment Report Danish 31-07-2014
Patient Information leaflet Patient Information leaflet German 19-12-2022
Summary of Product characteristics Summary of Product characteristics German 19-12-2022
Public Assessment Report Public Assessment Report German 31-07-2014
Patient Information leaflet Patient Information leaflet Estonian 19-12-2022
Summary of Product characteristics Summary of Product characteristics Estonian 19-12-2022
Public Assessment Report Public Assessment Report Estonian 31-07-2014
Patient Information leaflet Patient Information leaflet Greek 19-12-2022
Summary of Product characteristics Summary of Product characteristics Greek 19-12-2022
Public Assessment Report Public Assessment Report Greek 31-07-2014
Patient Information leaflet Patient Information leaflet English 19-12-2022
Summary of Product characteristics Summary of Product characteristics English 19-12-2022
Public Assessment Report Public Assessment Report English 31-07-2014
Patient Information leaflet Patient Information leaflet French 19-12-2022
Summary of Product characteristics Summary of Product characteristics French 19-12-2022
Public Assessment Report Public Assessment Report French 31-07-2014
Patient Information leaflet Patient Information leaflet Italian 19-12-2022
Summary of Product characteristics Summary of Product characteristics Italian 19-12-2022
Public Assessment Report Public Assessment Report Italian 31-07-2014
Patient Information leaflet Patient Information leaflet Latvian 19-12-2022
Summary of Product characteristics Summary of Product characteristics Latvian 19-12-2022
Public Assessment Report Public Assessment Report Latvian 31-07-2014
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Summary of Product characteristics Summary of Product characteristics Lithuanian 19-12-2022
Public Assessment Report Public Assessment Report Lithuanian 31-07-2014
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Summary of Product characteristics Summary of Product characteristics Hungarian 19-12-2022
Public Assessment Report Public Assessment Report Hungarian 31-07-2014
Patient Information leaflet Patient Information leaflet Maltese 19-12-2022
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Public Assessment Report Public Assessment Report Maltese 31-07-2014
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Summary of Product characteristics Summary of Product characteristics Dutch 19-12-2022
Public Assessment Report Public Assessment Report Dutch 31-07-2014
Patient Information leaflet Patient Information leaflet Polish 19-12-2022
Summary of Product characteristics Summary of Product characteristics Polish 19-12-2022
Public Assessment Report Public Assessment Report Polish 31-07-2014
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Summary of Product characteristics Summary of Product characteristics Portuguese 19-12-2022
Public Assessment Report Public Assessment Report Portuguese 31-07-2014
Patient Information leaflet Patient Information leaflet Romanian 19-12-2022
Summary of Product characteristics Summary of Product characteristics Romanian 19-12-2022
Public Assessment Report Public Assessment Report Romanian 31-07-2014
Patient Information leaflet Patient Information leaflet Slovak 19-12-2022
Summary of Product characteristics Summary of Product characteristics Slovak 19-12-2022
Public Assessment Report Public Assessment Report Slovak 31-07-2014
Patient Information leaflet Patient Information leaflet Slovenian 19-12-2022
Summary of Product characteristics Summary of Product characteristics Slovenian 19-12-2022
Public Assessment Report Public Assessment Report Slovenian 31-07-2014
Patient Information leaflet Patient Information leaflet Finnish 19-12-2022
Summary of Product characteristics Summary of Product characteristics Finnish 19-12-2022
Public Assessment Report Public Assessment Report Finnish 31-07-2014
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Summary of Product characteristics Summary of Product characteristics Swedish 19-12-2022
Public Assessment Report Public Assessment Report Swedish 31-07-2014
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Summary of Product characteristics Summary of Product characteristics Norwegian 19-12-2022
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Patient Information leaflet Patient Information leaflet Croatian 19-12-2022
Summary of Product characteristics Summary of Product characteristics Croatian 19-12-2022
Public Assessment Report Public Assessment Report Croatian 31-07-2014

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