Cyanokit

Country: European Union

Language: Bulgarian

Source: EMA (European Medicines Agency)

Buy It Now

Patient Information leaflet Patient Information leaflet (PIL)
18-01-2019
Summary of Product characteristics Summary of Product characteristics (SPC)
18-01-2019
Public Assessment Report Public Assessment Report (PAR)
23-07-2015

Active ingredient:

хидроксокобаламин

Available from:

SERB SA

ATC code:

V03AB33

INN (International Name):

hydroxocobalamin

Therapeutic group:

Всички други терапевтични продукти

Therapeutic area:

отравяне

Therapeutic indications:

Лечение на известно или предполагаемо цианидно отравяне. Cyanokit трябва да се прилага съвместно със съответните обеззаразяване и мерки за подкрепа.

Product summary:

Revision: 10

Authorization status:

упълномощен

Authorization date:

2007-11-23

Patient Information leaflet

                                45
Б. ЛИСТОВКА
46
ЛИСТОВКА: ИНФОРМАЦИЯ ЗА ПОТРЕБИТЕЛЯ
CYANOKIT 2,5 G ПРАХ ЗА ИНФУЗИОНЕН РАЗТВОР
хидроксокобаламин (hydroxocobalamin)
ПРОЧЕТЕТЕ ВНИМАТЕЛНО ЦЯЛАТА ЛИСТОВКА,
ПРЕДИ 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.

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 Cyanokit и за какво се
използва
2.
Какво трябва да знаете, преди да се
използва Cyanokit
3.
Как се използва Cyanokit
4.
Възможни нежелани реакции
5.
Как се съхранява Cyanokit
6.
Съдържание на опаковката и
допълнителна информация
1.
КАКВО ПРЕДСТАВЛЯВА CYANOKIT И ЗА КАКВО СЕ
ИЗПОЛЗВА
Cyanokit съдържа активното вещество
хидроксокобаламин.
Cyanokit е антидот за лечение на
установено цианидно отравяне или при
съмнение за такова,
при всички възрастови групи.
Cyanokit трябва да се прилага
едновременно с подходящи очистващи и
поддържащи мерки.
Циан
                                
                                Read the complete document

Summary of Product characteristics

                                1
ПРИЛОЖЕНИЕ I
КРАТКА ХАРАКТЕРИСТИКА НА ПРОДУКТА
2
1.
ИМЕ НА ЛЕКАРСТВЕНИЯ ПРОДУКТ
Cyanokit 2,5 g прах за инфузионен разтвор
2.
КАЧЕСТВЕН И КОЛИЧЕСТВЕН СЪСТАВ
Всеки флакон съдържа 2,5 g
хидроксокобаламин _(hydroxocobalamin)_.
След разтваряне със 100 mL разтворител
всеки mL от приготвения разтвор
съдържа 25 mg
хидроксокобаламин.
За пълния списък на помощните
вещества вижте точка 6.1.
3.
ЛЕКАРСТВЕНА ФОРМА
Прах за инфузионен разтвор
Тъмночервен кристален прах
4.
КЛИНИЧНИ ДАННИ
4.1
ТЕРАПЕВТИЧНИ ПОКАЗАНИЯ
Лечение на установено цианидно
отравяне или при съмнение за такова
при всички възрастови
групи.
Cyanokit трябва да се прилага
едновременно със съответна
деконтаминация и поддържащи
мерки (вж. точка 4.4).
4.2
ДОЗИРОВКА И НАЧИН НА ПРИЛОЖЕНИЕ
Дозировка
_Начална доза _
_Възрастни_: Началната доза Cyanokit е 5 g (2 x
100 mL).
_Педиатрична популация:_ При
кърмачета, деца и юноши (0 до 18 години),
началната доза
Cyanokit е 70 mg/kg телесно тегло, но не повече
от 5 g.
Телесно тегло
в kg
5
10
20
30
40
50
60
Начална доза
в g
в mL
0,35
14
0,70
28
1,40
56
2,10
84
2,80
112
3,50
140
4,20
168
_Последваща доза _
В зависимост от тежестта на
отравянето и клиничния отговор (вж.
точка 4.4), може да се
приложи втора доза.
_Възрастни_: Пос
                                
                                Read the complete document

Similar products

Active ingredient хидроксокобаламин

хидроксокобаламин

ATC code V03AB33

V03AB33

Marketed by SERB SA

SERB SA

INN (International Name) hydroxocobalamin

hydroxocobalamin

Documents in other languages

Patient Information leaflet Patient Information leaflet Spanish 18-01-2019
Summary of Product characteristics Summary of Product characteristics Spanish 18-01-2019
Public Assessment Report Public Assessment Report Spanish 23-07-2015
Patient Information leaflet Patient Information leaflet Czech 18-01-2019
Summary of Product characteristics Summary of Product characteristics Czech 18-01-2019
Public Assessment Report Public Assessment Report Czech 23-07-2015
Patient Information leaflet Patient Information leaflet Danish 18-01-2019
Summary of Product characteristics Summary of Product characteristics Danish 18-01-2019
Public Assessment Report Public Assessment Report Danish 23-07-2015
Patient Information leaflet Patient Information leaflet German 18-01-2019
Summary of Product characteristics Summary of Product characteristics German 18-01-2019
Public Assessment Report Public Assessment Report German 23-07-2015
Patient Information leaflet Patient Information leaflet Estonian 18-01-2019
Summary of Product characteristics Summary of Product characteristics Estonian 18-01-2019
Public Assessment Report Public Assessment Report Estonian 23-07-2015
Patient Information leaflet Patient Information leaflet Greek 18-01-2019
Summary of Product characteristics Summary of Product characteristics Greek 18-01-2019
Public Assessment Report Public Assessment Report Greek 23-07-2015
Patient Information leaflet Patient Information leaflet English 18-01-2019
Summary of Product characteristics Summary of Product characteristics English 18-01-2019
Public Assessment Report Public Assessment Report English 23-07-2015
Patient Information leaflet Patient Information leaflet French 18-01-2019
Summary of Product characteristics Summary of Product characteristics French 18-01-2019
Public Assessment Report Public Assessment Report French 23-07-2015
Patient Information leaflet Patient Information leaflet Italian 18-01-2019
Summary of Product characteristics Summary of Product characteristics Italian 18-01-2019
Public Assessment Report Public Assessment Report Italian 23-07-2015
Patient Information leaflet Patient Information leaflet Latvian 18-01-2019
Summary of Product characteristics Summary of Product characteristics Latvian 18-01-2019
Public Assessment Report Public Assessment Report Latvian 23-07-2015
Patient Information leaflet Patient Information leaflet Lithuanian 18-01-2019
Summary of Product characteristics Summary of Product characteristics Lithuanian 18-01-2019
Public Assessment Report Public Assessment Report Lithuanian 23-07-2015
Patient Information leaflet Patient Information leaflet Hungarian 18-01-2019
Summary of Product characteristics Summary of Product characteristics Hungarian 18-01-2019
Public Assessment Report Public Assessment Report Hungarian 23-07-2015
Patient Information leaflet Patient Information leaflet Maltese 18-01-2019
Summary of Product characteristics Summary of Product characteristics Maltese 18-01-2019
Public Assessment Report Public Assessment Report Maltese 23-07-2015
Patient Information leaflet Patient Information leaflet Dutch 18-01-2019
Summary of Product characteristics Summary of Product characteristics Dutch 18-01-2019
Public Assessment Report Public Assessment Report Dutch 23-07-2015
Patient Information leaflet Patient Information leaflet Polish 18-01-2019
Summary of Product characteristics Summary of Product characteristics Polish 18-01-2019
Public Assessment Report Public Assessment Report Polish 23-07-2015
Patient Information leaflet Patient Information leaflet Portuguese 18-01-2019
Summary of Product characteristics Summary of Product characteristics Portuguese 18-01-2019
Public Assessment Report Public Assessment Report Portuguese 23-07-2015
Patient Information leaflet Patient Information leaflet Romanian 18-01-2019
Summary of Product characteristics Summary of Product characteristics Romanian 18-01-2019
Public Assessment Report Public Assessment Report Romanian 23-07-2015
Patient Information leaflet Patient Information leaflet Slovak 18-01-2019
Summary of Product characteristics Summary of Product characteristics Slovak 18-01-2019
Public Assessment Report Public Assessment Report Slovak 23-07-2015
Patient Information leaflet Patient Information leaflet Slovenian 18-01-2019
Summary of Product characteristics Summary of Product characteristics Slovenian 18-01-2019
Public Assessment Report Public Assessment Report Slovenian 23-07-2015
Patient Information leaflet Patient Information leaflet Finnish 18-01-2019
Summary of Product characteristics Summary of Product characteristics Finnish 18-01-2019
Public Assessment Report Public Assessment Report Finnish 23-07-2015
Patient Information leaflet Patient Information leaflet Swedish 18-01-2019
Summary of Product characteristics Summary of Product characteristics Swedish 18-01-2019
Public Assessment Report Public Assessment Report Swedish 23-07-2015
Patient Information leaflet Patient Information leaflet Norwegian 18-01-2019
Summary of Product characteristics Summary of Product characteristics Norwegian 18-01-2019
Patient Information leaflet Patient Information leaflet Icelandic 18-01-2019
Summary of Product characteristics Summary of Product characteristics Icelandic 18-01-2019
Patient Information leaflet Patient Information leaflet Croatian 18-01-2019
Summary of Product characteristics Summary of Product characteristics Croatian 18-01-2019
Public Assessment Report Public Assessment Report Croatian 23-07-2015

Search alerts related to this product

Alerts Cyanokit хидроксокобаламин hydroxocobalamin

Cyanokit хидроксокобаламин hydroxocobalamin

View documents history

Documents history Documents history

Cyanokit