Kovaltry

Country: European Union

Language: Bulgarian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
26-07-2022
Summary of Product characteristics Summary of Product characteristics (SPC)
26-07-2022
Public Assessment Report Public Assessment Report (PAR)
07-03-2016

Active ingredient:

Octocog Алфа

Available from:

Bayer AG

ATC code:

B02BD02

INN (International Name):

octocog alfa

Therapeutic group:

Антихеморагични

Therapeutic area:

Хемофилия А

Therapeutic indications:

Лечение и профилактика на кървене при пациенти с хемофилия А (дефицит на вроден дефицит на фактор VІІІ). Kovaltry може да се използва за всички възрастови групи.

Product summary:

Revision: 12

Authorization status:

упълномощен

Authorization date:

2016-02-18

Patient Information leaflet

                                72
Б. ЛИСТОВКА
73
ЛИСТОВКА: ИНФОРМАЦИЯ ЗА ПОТРЕБИТЕЛЯ
KOVALTRY 250
IU ПРАХ И РАЗТВОРИТЕЛ ЗА ИНЖЕКЦИОНЕН
РАЗТВОР
KOVALTRY 500 IU ПРАХ И РАЗТВОРИТЕЛ ЗА
ИНЖЕКЦИОНЕН РАЗТВОР
KOVALTRY 1000 IU ПРАХ И РАЗТВОРИТЕЛ ЗА
ИНЖЕКЦИОНЕН РАЗТВОР
KOVALTRY 2000 IU ПРАХ И РАЗТВОРИТЕЛ ЗА
ИНЖЕКЦИОНЕН РАЗТВОР
KOVALTRY 3000 IU ПРАХ И РАЗТВОРИТЕЛ ЗА
ИНЖЕКЦИОНЕН РАЗТВОР
октоког алфа (рекомбинантен човешки
коагулационен фактор VІІІ)
_ _
(octocog alfa (recombinant human coagulation factor VIII))
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 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 Kovaltry и за какво се
използва
2.
Какво трябва да зна
                                
                                Read the complete document

Summary of Product characteristics

                                1
ПРИЛОЖЕНИЕ I
КРАТКА ХАРАКТЕРИСТИКА НА ПРОДУКТА
2
1.
ИМЕ НА ЛЕКАРСТВЕНИЯ ПРОДУКТ
Kovaltry 250 IU прах и разтворител за
инжекционен разтвор
Kovaltry 500 IU прах и разтворител за
инжекционен разтвор
Kovaltry 1000 IU прах и разтворител за
инжекционен разтвор
Kovaltry 2000 IU прах и разтворител за
инжекционен разтвор
Kovaltry 3000 IU прах и разтворител за
инжекционен разтвор
2.
КАЧЕСТВЕН И КОЛИЧЕСТВЕН СЪСТАВ
Kovaltry 250 IU
прах и разтворител за инж
екционен разтвор
Kovaltry съдържа приблизително 250 IU (100 IU/1
ml) рекомбинантен човешки
коагулационен
фактор VIII (INN: октоког алфа (octocog alfa))
след реконституиране.
Kovaltry 500 I
U прах и разтворител за инжекционен
разтвор
Kovaltry съдържа приблизително 500 IU (200 IU/1
ml) рекомбинантен човешки
коагулационен
фактор VIII (INN: октоког алфа (octocog alfa))
след реконституиране.
Kovaltry 1000 I
U прах и разтворител за инжекционен
разтвор
Kovaltry съдържа приблизително 1000 IU (400 IU/1
ml) рекомбинантен човешки
коагулационен
фактор VІІІ (INN: октоког алфа (octocog alfa))
след реконституиране.
Kovaltry 2000 I
U прах и разтворител за инжекционен
разтвор
Kovaltry съдържа приблизително 2000 IU (400 IU/1
ml) рекомбинантен човешки
коагулационен
фактор VIII (INN: октоког алфа (octocog alfa))
след реконституиран
                                
                                Read the complete document

Similar products

Active ingredient Octocog Алфа

Octocog Алфа

ATC code B02BD02

B02BD02

Marketed by Bayer AG

Bayer AG

INN (International Name) octocog alfa

octocog alfa

Documents in other languages

Patient Information leaflet Patient Information leaflet Spanish 26-07-2022
Summary of Product characteristics Summary of Product characteristics Spanish 26-07-2022
Public Assessment Report Public Assessment Report Spanish 07-03-2016
Patient Information leaflet Patient Information leaflet Czech 26-07-2022
Summary of Product characteristics Summary of Product characteristics Czech 26-07-2022
Public Assessment Report Public Assessment Report Czech 07-03-2016
Patient Information leaflet Patient Information leaflet Danish 26-07-2022
Summary of Product characteristics Summary of Product characteristics Danish 26-07-2022
Public Assessment Report Public Assessment Report Danish 07-03-2016
Patient Information leaflet Patient Information leaflet German 26-07-2022
Summary of Product characteristics Summary of Product characteristics German 26-07-2022
Public Assessment Report Public Assessment Report German 07-03-2016
Patient Information leaflet Patient Information leaflet Estonian 26-07-2022
Summary of Product characteristics Summary of Product characteristics Estonian 26-07-2022
Public Assessment Report Public Assessment Report Estonian 07-03-2016
Patient Information leaflet Patient Information leaflet Greek 26-07-2022
Summary of Product characteristics Summary of Product characteristics Greek 26-07-2022
Public Assessment Report Public Assessment Report Greek 07-03-2016
Patient Information leaflet Patient Information leaflet English 26-07-2022
Summary of Product characteristics Summary of Product characteristics English 26-07-2022
Public Assessment Report Public Assessment Report English 07-03-2016
Patient Information leaflet Patient Information leaflet French 26-07-2022
Summary of Product characteristics Summary of Product characteristics French 26-07-2022
Public Assessment Report Public Assessment Report French 07-03-2016
Patient Information leaflet Patient Information leaflet Italian 26-07-2022
Summary of Product characteristics Summary of Product characteristics Italian 26-07-2022
Public Assessment Report Public Assessment Report Italian 07-03-2016
Patient Information leaflet Patient Information leaflet Latvian 26-07-2022
Summary of Product characteristics Summary of Product characteristics Latvian 26-07-2022
Public Assessment Report Public Assessment Report Latvian 07-03-2016
Patient Information leaflet Patient Information leaflet Lithuanian 26-07-2022
Summary of Product characteristics Summary of Product characteristics Lithuanian 26-07-2022
Public Assessment Report Public Assessment Report Lithuanian 07-03-2016
Patient Information leaflet Patient Information leaflet Hungarian 26-07-2022
Summary of Product characteristics Summary of Product characteristics Hungarian 26-07-2022
Public Assessment Report Public Assessment Report Hungarian 07-03-2016
Patient Information leaflet Patient Information leaflet Maltese 26-07-2022
Summary of Product characteristics Summary of Product characteristics Maltese 26-07-2022
Public Assessment Report Public Assessment Report Maltese 07-03-2016
Patient Information leaflet Patient Information leaflet Dutch 26-07-2022
Summary of Product characteristics Summary of Product characteristics Dutch 26-07-2022
Public Assessment Report Public Assessment Report Dutch 07-03-2016
Patient Information leaflet Patient Information leaflet Polish 26-07-2022
Summary of Product characteristics Summary of Product characteristics Polish 26-07-2022
Public Assessment Report Public Assessment Report Polish 07-03-2016
Patient Information leaflet Patient Information leaflet Portuguese 26-07-2022
Summary of Product characteristics Summary of Product characteristics Portuguese 26-07-2022
Public Assessment Report Public Assessment Report Portuguese 07-03-2016
Patient Information leaflet Patient Information leaflet Romanian 26-07-2022
Summary of Product characteristics Summary of Product characteristics Romanian 26-07-2022
Public Assessment Report Public Assessment Report Romanian 07-03-2016
Patient Information leaflet Patient Information leaflet Slovak 26-07-2022
Summary of Product characteristics Summary of Product characteristics Slovak 26-07-2022
Public Assessment Report Public Assessment Report Slovak 07-03-2016
Patient Information leaflet Patient Information leaflet Slovenian 26-07-2022
Summary of Product characteristics Summary of Product characteristics Slovenian 26-07-2022
Public Assessment Report Public Assessment Report Slovenian 07-03-2016
Patient Information leaflet Patient Information leaflet Finnish 26-07-2022
Summary of Product characteristics Summary of Product characteristics Finnish 26-07-2022
Public Assessment Report Public Assessment Report Finnish 07-03-2016
Patient Information leaflet Patient Information leaflet Swedish 26-07-2022
Summary of Product characteristics Summary of Product characteristics Swedish 26-07-2022
Public Assessment Report Public Assessment Report Swedish 07-03-2016
Patient Information leaflet Patient Information leaflet Norwegian 26-07-2022
Summary of Product characteristics Summary of Product characteristics Norwegian 26-07-2022
Patient Information leaflet Patient Information leaflet Icelandic 26-07-2022
Summary of Product characteristics Summary of Product characteristics Icelandic 26-07-2022
Patient Information leaflet Patient Information leaflet Croatian 26-07-2022
Summary of Product characteristics Summary of Product characteristics Croatian 26-07-2022
Public Assessment Report Public Assessment Report Croatian 07-03-2016

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Kovaltry