Arepanrix

Country: European Union

Language: Bulgarian

Source: EMA (European Medicines Agency)

Buy It Now

Patient Information leaflet Patient Information leaflet (PIL)
25-10-2011
Summary of Product characteristics Summary of Product characteristics (SPC)
25-10-2011
Public Assessment Report Public Assessment Report (PAR)
25-10-2011

Active ingredient:

вирус на грип сплит, инактивированная, съдържащ антигени*: A/Калифорния/7/2009 (Н1N1), V като деформация на (х-179а)*размножени в кокоши яйца.

Available from:

GlaxoSmithKline Biologicals S.A.

ATC code:

J07BB02

INN (International Name):

pandemic influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)

Therapeutic group:

Грипни ваксини

Therapeutic area:

Influenza, Human; Immunization; Disease Outbreaks

Therapeutic indications:

Профилактика на грип в официално обявена пандемична ситуация. Пандемичната ваксина срещу грип трябва да се използва в съответствие с официалните указания.

Product summary:

Revision: 1

Authorization status:

Отменено

Authorization date:

2010-03-23

Patient Information leaflet

                                35
Б. ЛИСТОВКА
Лекарствен продукт, който вече не е
разрешен за употреба
36
ЛИСТОВКА: ИНФОРМАЦИЯ ЗА ПОТРЕБИТЕЛЯ
AREPANRIX СУСПЕНЗИЯ И ЕМУЛСИЯ ЗА
ИНЖЕКЦИОННА ЕМУЛСИЯ
Ваксина срещу пандемичен грип (H1N1)
(фрагментиран вирион, инактивиран, с
адювант)
(Pandemic influenza vaccine (H1N1) (split virion, inactivated,
adjuvanted))
ЗА НАЙ-АКТУАЛНА ИНФОРМАЦИЯ, МОЛЯ,
КОНСУЛТИРАЙТЕ СЕ С УЕБСАЙТА НА
ЕВРОПЕЙСКАТА
АГЕНЦИЯ ПО ЛЕКАРСТВАТА (EMEA):
HTTP://WWW.EMEA.EUROPA.EU/.
ПРОЧЕТЕТЕ ВНИМАТЕЛНО ЦЯЛАТА ЛИСТОВКА,
ПРЕДИ ДА ВИ БЪДЕ ПРИЛОЖЕНА ТАЗИ
ВАКСИНА.
-
Запазете тази листовка. Може да имате
нужда да я прочетете отново.
-
Ако имате някакви допълнителни
въпроси, попитайте Вашия лекар или
медицинска
сестра.
-
Ако някоя от нежеланите лекарствени
реакции стане сериозна или забележите
други,
неописани в тази
листовка нежелани реакции,
моля уведомете Вашия лекар.
В ТАЗИ ЛИСТОВКА
:
1.
Какво представлява Arepanrix и за какво се
използва
2.
Преди да Ви бъде приложен Arepanrix
3.
Как се прилага Arepanrix
4.
Възможни нежелани реакции
5.
Как да съхранявате Arepanrix
6.
Допълнителна информация
1.
КАКВО ПРЕДСТАВЛЯВА AREPANRIX И ЗА КАКВО СЕ
ИЗПОЛЗВА
Arepanrix е ваксина за предпазване
срещу пандемичен грип.
Пандемичният грип е
вид г
                                
                                Read the complete document

Summary of Product characteristics

                                1
ПРИЛОЖЕНИЕ I
КРАТКА ХАРАКТЕРИСТИКА НА ПРОДУКТА
Лекарствен продукт, който вече не е
разрешен за употреба
2
1.
ИМЕ НА ЛЕКАРСТВЕНИЯ ПРОДУКТ
Arepanrix суспензия и емулсия за
инжекционна емулсия.
Ваксина срещу пандемичен грип (H1N1)v
(фрагментиран вирион, инактивиран, с
адювант)
_(Pandemic influenza vaccine (H1N1)v (split virion, inactivated,
adjuvanted)) _
2.
КАЧЕСТВЕН И КОЛИЧЕСТВЕН СЪСТАВ
След смесване 1 доза (0,5 ml) съдържа:
Фрагментиран грипен вирус,
инактивиран, съдържащ антиген
*
, еквивалентен на:
A/California/7/2009/(H1N1)v-подобен щам (X-179A)
3,75 микрограма
**
*
размножен в яйца
**
хемаглутинин
Тази ваксина отговаря на препоръката
на СЗО и на решението на ЕС за
пандемия.
AS03 адювант, съставен от сквален (10,69
милиграма), DL-
α
-токоферол (11,86 милиграма) и
полисорбат 80 (4,86 милиграма)
След смесване на суспензията и
емулсията се получава многодозова
ваксина във флакон. За
броя на дозите в един флакон, вижте
точка 6.5.
Помощни вещества
: ваксината съдър
жа 5 микрограма тиомерсал.
За пълния списък на помощните
вещества вижте точка 6.1.
3.
ЛЕКАРСТВЕНА ФОРМА
Суспензия и емулсия за инжекционна
емулсия.
Суспензията е полупрозрачна до почти
бяла опалесцираща суспензия, която
може да образув
                                
                                Read the complete document

Similar products

Active ingredient вирус на грип сплит, инактивированная, съдържащ антигени*: A/Калифорния/7/2009 (Н1N1), V като деформация на (х-179а)*размножени в кокоши яйца.

вирус на грип сплит, инактивированная, съдържащ антигени*: A/Калифорния/7/2009 (Н1N1), V като деформация на (х-179а)*размножени в кокоши яйца.

ATC code J07BB02

J07BB02

Marketed by GlaxoSmithKline Biologicals S.A.

GlaxoSmithKline Biologicals S.A.

INN (International Name) pandemic influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)

pandemic influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)

Documents in other languages

Patient Information leaflet Patient Information leaflet Spanish 25-10-2011
Summary of Product characteristics Summary of Product characteristics Spanish 25-10-2011
Public Assessment Report Public Assessment Report Spanish 25-10-2011
Patient Information leaflet Patient Information leaflet Czech 25-10-2011
Summary of Product characteristics Summary of Product characteristics Czech 25-10-2011
Public Assessment Report Public Assessment Report Czech 25-10-2011
Patient Information leaflet Patient Information leaflet Danish 25-10-2011
Summary of Product characteristics Summary of Product characteristics Danish 25-10-2011
Public Assessment Report Public Assessment Report Danish 25-10-2011
Patient Information leaflet Patient Information leaflet German 25-10-2011
Summary of Product characteristics Summary of Product characteristics German 25-10-2011
Public Assessment Report Public Assessment Report German 25-10-2011
Patient Information leaflet Patient Information leaflet Estonian 25-10-2011
Summary of Product characteristics Summary of Product characteristics Estonian 25-10-2011
Public Assessment Report Public Assessment Report Estonian 25-10-2011
Patient Information leaflet Patient Information leaflet Greek 25-10-2011
Summary of Product characteristics Summary of Product characteristics Greek 25-10-2011
Public Assessment Report Public Assessment Report Greek 25-10-2011
Patient Information leaflet Patient Information leaflet English 25-10-2011
Summary of Product characteristics Summary of Product characteristics English 25-10-2011
Public Assessment Report Public Assessment Report English 25-10-2011
Patient Information leaflet Patient Information leaflet French 25-10-2011
Summary of Product characteristics Summary of Product characteristics French 25-10-2011
Public Assessment Report Public Assessment Report French 25-10-2011
Patient Information leaflet Patient Information leaflet Italian 25-10-2011
Summary of Product characteristics Summary of Product characteristics Italian 25-10-2011
Public Assessment Report Public Assessment Report Italian 25-10-2011
Patient Information leaflet Patient Information leaflet Latvian 25-10-2011
Summary of Product characteristics Summary of Product characteristics Latvian 25-10-2011
Public Assessment Report Public Assessment Report Latvian 25-10-2011
Patient Information leaflet Patient Information leaflet Lithuanian 25-10-2011
Summary of Product characteristics Summary of Product characteristics Lithuanian 25-10-2011
Public Assessment Report Public Assessment Report Lithuanian 25-10-2011
Patient Information leaflet Patient Information leaflet Hungarian 25-10-2011
Summary of Product characteristics Summary of Product characteristics Hungarian 25-10-2011
Public Assessment Report Public Assessment Report Hungarian 25-10-2011
Patient Information leaflet Patient Information leaflet Maltese 25-10-2011
Summary of Product characteristics Summary of Product characteristics Maltese 25-10-2011
Public Assessment Report Public Assessment Report Maltese 25-10-2011
Patient Information leaflet Patient Information leaflet Dutch 25-10-2011
Summary of Product characteristics Summary of Product characteristics Dutch 25-10-2011
Public Assessment Report Public Assessment Report Dutch 25-10-2011
Patient Information leaflet Patient Information leaflet Polish 25-10-2011
Summary of Product characteristics Summary of Product characteristics Polish 25-10-2011
Public Assessment Report Public Assessment Report Polish 25-10-2011
Patient Information leaflet Patient Information leaflet Portuguese 25-10-2011
Summary of Product characteristics Summary of Product characteristics Portuguese 25-10-2011
Public Assessment Report Public Assessment Report Portuguese 25-10-2011
Patient Information leaflet Patient Information leaflet Romanian 25-10-2011
Summary of Product characteristics Summary of Product characteristics Romanian 25-10-2011
Public Assessment Report Public Assessment Report Romanian 25-10-2011
Patient Information leaflet Patient Information leaflet Slovak 25-10-2011
Summary of Product characteristics Summary of Product characteristics Slovak 25-10-2011
Public Assessment Report Public Assessment Report Slovak 25-10-2011
Patient Information leaflet Patient Information leaflet Slovenian 25-10-2011
Summary of Product characteristics Summary of Product characteristics Slovenian 25-10-2011
Public Assessment Report Public Assessment Report Slovenian 25-10-2011
Patient Information leaflet Patient Information leaflet Finnish 25-10-2011
Summary of Product characteristics Summary of Product characteristics Finnish 25-10-2011
Public Assessment Report Public Assessment Report Finnish 25-10-2011
Patient Information leaflet Patient Information leaflet Swedish 25-10-2011
Summary of Product characteristics Summary of Product characteristics Swedish 25-10-2011
Public Assessment Report Public Assessment Report Swedish 25-10-2011
Patient Information leaflet Patient Information leaflet Norwegian 25-10-2011
Summary of Product characteristics Summary of Product characteristics Norwegian 25-10-2011
Patient Information leaflet Patient Information leaflet Icelandic 25-10-2011
Summary of Product characteristics Summary of Product characteristics Icelandic 25-10-2011

Search alerts related to this product

Alerts Arepanrix вирус на грип сплит, pandemic influenza vaccine

Arepanrix вирус на грип сплит, pandemic influenza vaccine

View documents history

Documents history Documents history

Arepanrix