Scintimun

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)
30-09-2014

Active ingredient:

besilesomab

Available from:

CIS bio international 

ATC code:

V09HA03

INN (International Name):

besilesomab

Therapeutic group:

Диагностични радиофармацевтици

Therapeutic area:

Osteomyelitis; Radionuclide Imaging

Therapeutic indications:

Този лекарствен продукт е само за диагностика и одобреното показание е scintigraphic изображения, във връзка с други подходящи изображения условия, за определяне на местоположението на възпаление/инфекция в периферни кости при възрастни с предполагаеми остеомиелит. Scintimun не трябва да се използва за диагностициране на инфекция с диабет.

Product summary:

Revision: 6

Authorization status:

упълномощен

Authorization date:

2010-01-11

Patient Information leaflet

                                24
Б. ЛИСТОВКА
25
ЛИСТОВКА: ИНФОРМАЦИЯ ЗА ПАЦИЕНТА
SCINTIMUN
1 MG КИТ ЗА РАДИОФАРМАЦЕВТИЧЕН ПРЕПАPAТ
бесилесомаб
ПРОЧЕТЕТЕ ВНИМАТЕЛНО ЦЯЛАТА ЛИСТОВКА,
ПРЕДИ ДА ВИ БЪДЕ ПРИЛОЖЕНО 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
специалист по
нуклеарна медицина, който ще
наблюдава процедурата.
-
Ако получите някакви нежелани
лекарствени реакции, уведомете Вашия
лекар по
нуклеарна медицина или фармацевт.
Това включва и всички възможни
нежелани
реакции, неописани в тази листовка.
Вижте точка 4.
КАКВО СЪДЪРЖА ТАЗИ ЛИСТОВКА
1.
Какво представлява Scintimun и за какво се
използва
2.
Какво трябва да знаете, преди да Ви
бъде приложен Scintimun
3.
Как се прилага Scintimun
4.
Възможни нежелани реакции
5.
Как да съхранявате Scintimun
6.
Съдържание на опаковката и
допълнителна информация
1.
КАКВО ПРЕДСТАВЛЯВА SCINTIMUN И ЗА КАКВО СЕ
ИЗПОЛЗВА
Scintimun
е лекарство, съдържащо антитяло
(бесилесомаб), което се използва, за да
се свърже
към определени клетки, наречени
гранулоцити (вид бели кръвни клетки,
участващи във
възпа
                                
                                Read the complete document

Summary of Product characteristics

                                1
ПРИЛОЖЕНИЕ I
КРАТКА ХАРАКТЕРИСТИКА НА ПРОДУКТА
2
1.
ИМЕ НА ЛЕКАРСТВЕНИЯ ПРОДУКТ
Scintimun 1 mg кит за радиофармацевтичен
препаpaт
2.
КАЧЕСТВЕН И КОЛИЧЕСТВЕН СЪСТАВ
Всеки флакон Scintimun съдържа 1 mg
бесилесомаб.
Бесилесомаб е антигранулоцитно
моноклонално антитяло (BW 250/183),
получено в миши
клетки.
Радионуклидът не е част от кита.
Помощни вещества с известно действие
Всеки флакон Scintimun съдържа 2 mg
сорбитол.
За пълния списък на помощните
вещества вижте точка 6.1.
3.
ЛЕКАРСТВЕНА ФОРМА
Кит за радиофармацевтичен
препаpaт
Scintimun: бял прях
Разтворител за Scintimun: бял прях
4.
КЛИНИЧНИ ДАННИ
4.1
ТЕРАПЕВТИЧНИ ПОКАЗАНИЯ
Този лекарствен продукт е
предназначен само за диагностични
цели.
След изотопно маркиране с разтвор на
натриев пертехнетат (
99m
Tc), полученият разтвор на
технециев (
99m
Tc) бесилесомаб е показан при възрастни
за сцинтиграфско изследване в
съчетание с други подходящи образни
техники, за определяне на
локализацията на
възпаление/инфекция в периферните
кости при възрастни със съмнение за
остеомиелит.
Scintimun не трябва да се използва за
диагностика на инфекция при диабетно
стъпало.
4.2
ДОЗИРОВКА И НАЧИН НА ПРИЛОЖЕНИЕ
Този лекарств
                                
                                Read the complete document

Similar products

Active ingredient besilesomab

besilesomab

ATC code V09HA03

V09HA03

Marketed by CIS bio international 

CIS bio international 

INN (International Name) besilesomab

besilesomab

Documents in other languages

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 30-09-2014
Patient Information leaflet Patient Information leaflet Czech 13-12-2022
Summary of Product characteristics Summary of Product characteristics Czech 13-12-2022
Public Assessment Report Public Assessment Report Czech 30-09-2014
Patient Information leaflet Patient Information leaflet Danish 13-12-2022
Summary of Product characteristics Summary of Product characteristics Danish 13-12-2022
Public Assessment Report Public Assessment Report Danish 30-09-2014
Patient Information leaflet Patient Information leaflet German 13-12-2022
Summary of Product characteristics Summary of Product characteristics German 13-12-2022
Public Assessment Report Public Assessment Report German 30-09-2014
Patient Information leaflet Patient Information leaflet Estonian 13-12-2022
Summary of Product characteristics Summary of Product characteristics Estonian 13-12-2022
Public Assessment Report Public Assessment Report Estonian 30-09-2014
Patient Information leaflet Patient Information leaflet Greek 13-12-2022
Summary of Product characteristics Summary of Product characteristics Greek 13-12-2022
Public Assessment Report Public Assessment Report Greek 30-09-2014
Patient Information leaflet Patient Information leaflet English 13-12-2022
Summary of Product characteristics Summary of Product characteristics English 13-12-2022
Public Assessment Report Public Assessment Report English 30-09-2014
Patient Information leaflet Patient Information leaflet French 13-12-2022
Summary of Product characteristics Summary of Product characteristics French 13-12-2022
Public Assessment Report Public Assessment Report French 30-09-2014
Patient Information leaflet Patient Information leaflet Italian 13-12-2022
Summary of Product characteristics Summary of Product characteristics Italian 13-12-2022
Public Assessment Report Public Assessment Report Italian 30-09-2014
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Public Assessment Report Public Assessment Report Latvian 30-09-2014
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Public Assessment Report Public Assessment Report Lithuanian 30-09-2014
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Public Assessment Report Public Assessment Report Hungarian 30-09-2014
Patient Information leaflet Patient Information leaflet Maltese 13-12-2022
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Public Assessment Report Public Assessment Report Maltese 30-09-2014
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Public Assessment Report Public Assessment Report Dutch 30-09-2014
Patient Information leaflet Patient Information leaflet Polish 13-12-2022
Summary of Product characteristics Summary of Product characteristics Polish 13-12-2022
Public Assessment Report Public Assessment Report Polish 30-09-2014
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Public Assessment Report Public Assessment Report Portuguese 30-09-2014
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Summary of Product characteristics Summary of Product characteristics Romanian 13-12-2022
Public Assessment Report Public Assessment Report Romanian 30-09-2014
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Summary of Product characteristics Summary of Product characteristics Slovak 13-12-2022
Public Assessment Report Public Assessment Report Slovak 30-09-2014
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Summary of Product characteristics Summary of Product characteristics Slovenian 13-12-2022
Public Assessment Report Public Assessment Report Slovenian 30-09-2014
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Summary of Product characteristics Summary of Product characteristics Finnish 13-12-2022
Public Assessment Report Public Assessment Report Finnish 30-09-2014
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Public Assessment Report Public Assessment Report Swedish 30-09-2014
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Patient Information leaflet Patient Information leaflet Croatian 13-12-2022
Summary of Product characteristics Summary of Product characteristics Croatian 13-12-2022
Public Assessment Report Public Assessment Report Croatian 30-09-2014

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