Euroopan unioni - espanja - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - virus de la gripe dividido, inactivado, que contiene el antígeno: a / vietnam / 1194/2004 (h5n1) como la cepa utilizada (nibrg-14) - influenza, human; immunization; disease outbreaks - vacunas - inmunización activa contra el subtipo h5n1 del virus influenza a. esta indicación se basa en la inmunogenicidad de datos de sujetos sanos a partir de la edad de 18 años en adelante tras la administración de dos dosis de la vacuna preparada a partir de a/vietnam/1194/2004 nibrg-14 (h5n1) (véase la sección 5. prepandémico influenza vaccine (h5n1) (split virión, inactivado, con adyuvante) de glaxosmithkline biologicals 3. 75 µg debe ser utilizado de acuerdo con las directrices oficiales.

Euroopan unioni - malta - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - virus tal-influwenza maqsuma, inattivat, li fih antiġen: razza użata bħala a / vietnam / 1194/2004 (h5n1) użata (nibrg-14) - influenza, human; immunization; disease outbreaks - vaċċini - immunizzazzjoni attiva kontra s-sottotip h5n1 tal-virus influwenza a.. din l-indikazzjoni hija bbażata fuq dejta ta 'immunoġeniċità minn individwi b'saħħithom mill-età ta' 18-il sena'l quddiem wara l-amministrazzjoni ta 'żewġ dożi ta' vaċċin ippreparati minn a/vietnam/1194/2004 nibrg-14 (h5n1) (ara sezzjoni 5. vaċċin għal influwenza prepandemika (h5n1) (virjon maqsum, mhux attivat, supplimentat) glaxosmithkline biologicals 3. 75 µg għandu jintuża skond gwida uffiċjali.

Euroopan unioni - bulgaria - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - отделянето на вируса на грип, инактивированные, които съдържат антиген: а/Виетнам/1194/2004 (h5n1) като щам се използва (nibrg-14) - influenza, human; immunization; disease outbreaks - Ваксини - Активна имунизация срещу подтип h5n1 на вируса на грипа А. Тази справка се основава на имуногенност на данни от здрави доброволци на възраст между 18 и следваща година след въвеждането на две дози ваксини, приготвени от а/Виетнам/1194/2004 nibrg-14 (h5n1 в) (виж раздел 5. Ваксината prepandemic грип (h5n1) (split Вирион, инактивированный, адъювантом) glaxosmithkline Байолоджикалз 3. 75 микрограма трябва да се прилага в съответствие с официално ръководство.

Euroopan unioni - hollanti - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - gesplitst influenzavirus, geïnactiveerd, met antigeen: a / vietnam / 1194/2004 (h5n1) zoals gebruikte stam (nibrg-14) - influenza, human; immunization; disease outbreaks - vaccins - actieve immunisatie tegen het h5n1-subtype van influenza a-virus. deze indicatie is gebaseerd op immunogeniciteit gegevens van gezonde proefpersonen vanaf de leeftijd van 18 jaar na toediening van twee doses van het vaccin, bereid van a/vietnam/1194/2004 nibrg-14 (h5n1) (zie sectie 5. prepandemic influenza vaccine (h5n1) (split virion, geïnactiveerd, adjuvanted) glaxosmithkline biologicals 3. 75 µg moet worden gebruikt in overeenstemming met officiële richtlijnen.

Euroopan unioni - tšekki - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - rozdělený virus chřipky, inaktivovaný, obsahující antigen: použitý kmen a / vietnam / 1194/2004 (h5n1) (nibrg-14) - influenza, human; immunization; disease outbreaks - vakcíny - aktivní imunizace proti podtypu h5n1 viru chřipky a. tato indikace je založena na údajích o imunogenicitě získaných zdravých subjektů ve věku 18 let a dále po podání dvou dávek vakcíny připravené z a/vietnam/1194/2004 nibrg-14 (h5n1) (viz bod 5. prepandemická vakcína proti chřipce (h5n1) (štěpený virion, inaktivovaná, obsahující adjuvans) glaxosmithkline biologicals 3. 75 mikrogramů by měl být používán v souladu s oficiálními pokyny.

Euroopan unioni - sloveeni - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - deaktiviran virus gripe, ki vsebuje antigen: a / vietnam / 1194/2004 (h5n1), podoben sevu (nibrg-14) - influenza, human; immunization; disease outbreaks - cepiva - aktivna imunizacija proti podtipu h5n1 virusa influenca a. ta navedba temelji na immunogenicity podatkov iz zdravih predmetov iz 18. leta starosti dalje po uporabi zdravila dva odmerka cepiva, pripravljeni iz a/vietnam/1194/2004 nibrg-14 (h5n1) (glej točko 5. prepandemic cepiva proti gripi (h5n1) (split virion, inaktivirano, adjuvanted) glaxosmithkline biologicals 3. 75 µg je treba uporabljati v skladu z uradnimi smernice.

Euroopan unioni - englanti - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - split influenza virus, inactivated, containing antigen: a/vietnam/1194/2004 (h5n1) like strain used (nibrg-14) - influenza, human; immunization; disease outbreaks - vaccines - active immunisation against h5n1 subtype of influenza a virus.this indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of vaccine prepared from a/vietnam/1194/2004 nibrg-14 (h5n1) (see section 5.1).prepandemic influenza vaccine (h5n1) (split virion, inactivated, adjuvanted) glaxosmithkline biologicals 3.75 µg should be used in accordance with official guidance.

Moldova - romania - AMDM (Agenţia Medicamentului şi Dispozitivelor Medicale)

glaxosmithkline consumer healthcare, glaxosmithkline export ltd. - paracetamolum + acid ascorbicum + phenylephrini hydrochloridum - pulbere pentru suspensie orala - 750 mg + 60 mg + 10 mg

Euroopan unioni - portugali - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - vírus da gripe dividida, inativado, contendo antígeno: a / vietnam / 1194/2004 (h5n1) como a estirpe utilizada (nibrg-14) - influenza, human; immunization; disease outbreaks - vacinas - imunização ativa contra o subtipo h5n1 do vírus da influenza a. esta indicação é baseada na imunogenicidade de dados de indivíduos saudáveis, a partir da idade de 18 anos em diante, após a administração de duas doses da vacina preparada a partir de a/vietnam/1194/2004 nibrg-14 (h5n1) (consulte a secção 5. prepandemic influenza vaccine (h5n1) (split virion, inactivated, com adjuvante) glaxosmithkline biologicals 3. 75 µg deve ser usado de acordo com orientação oficial.

Euroopan unioni - italia - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - virus dell'influenza spaccata, antigene inattivato: a / vietnam / 1194/2004 (h5n1) come ceppo utilizzato (nibrg-14) - influenza, human; immunization; disease outbreaks - vaccini - immunizzazione attiva contro il sottotipo h5n1 del virus dell'influenza a. questa indicazione si basa sui dati di immunogenicità di soggetti sani a partire dall'età di 18 anni in poi, a seguito di somministrazione di due dosi di vaccino, preparato da a/vietnam/1194/2004 nibrg-14 (h5n1) (vedere la sezione 5. prepandemic influenza vaccine (h5n1) (virione split, inattivato, adiuvato) glaxosmithkline biologicals 3. 75 µg dovrebbe essere usato in conformità con le linee guida ufficiali.