Pandemic Influenza Vaccine H5N1 Baxter AG

Country: European Union

Language: Croatian

Source: EMA (European Medicines Agency)

Buy It Now

Patient Information leaflet Patient Information leaflet (PIL)
13-09-2023
Summary of Product characteristics Summary of Product characteristics (SPC)
13-09-2023
Public Assessment Report Public Assessment Report (PAR)
13-09-2023

Active ingredient:

cjepivo protiv influence (cijeli virion, inaktivirano) koji sadrži antigen: A / Vietnam / 1203/2004 (H5N1)

Available from:

Resilience Biomanufacturing Ireland Limited

ATC code:

J07BB01

INN (International Name):

pandemic influenza vaccine (H5N1) (whole virion, inactivated, prepared in cell culture)

Therapeutic group:

cjepiva

Therapeutic area:

Influenza, Human; Immunization; Disease Outbreaks

Therapeutic indications:

Profilakcija gripe u službeno prijavljenoj pandemijskoj situaciji. Cjepivo protiv influence pandemije treba koristiti u skladu s službenim smjernicama.

Product summary:

Revision: 8

Authorization status:

povučen

Authorization date:

2009-10-16

Patient Information leaflet

                                39
B. UPUTA O LIJEKU
Lijek koji više nije odobren
40
UPUTA O LIJEKU: INFORMACIJA ZA KORISNIKA
CJEPIVO PROTIV PANDEMIJSKE INFLUENCE H5N1 BAXTER
SUSPENZIJA ZA INJEKCIJU
CJEPIVO PROTIV PANDEMIJSKE INFLUENCE (H5N1) (CIJELI VIRION,
INAKTIVIRANO, PRIPREMLJENO U
STANIČNOJ KULTURI)
PAŽLJIVO PROČITAJTE CIJELU UPUTU PRIJE NEGO ŠTO PRIMITE CJEPIVO JER
SADRŽI VAMA VAŽNE PODATKE.
-
Sačuvajte ovu uputu. Možda ćete je trebati ponovno pročitati.
-
Ako imate dodatnih pitanja, obratite se svome liječniku ili
ljekarniku.
-
Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti
liječnika ili ljekarnika.
To uključuje i svaku moguću nuspojavu koja nije navedena u ovoj
uputi. Pogledajte dio 4.
ŠTO SE NALAZI U OVOJ UPUTI
1.
Što je CJEPIVO PROTIV PANDEMIJSKE INFLUENCE H5N1 BAXTER
i za što se koristi
2.
Što morate znati prije nego što primite CJEPIVO PROTIV PANDEMIJSKE
INFLUENCE
H5N1 BAXTER
3.
Kako se CJEPIVO PROTIV PANDEMIJSKE INFLUENCE H5N1 BAXTER
primjenjuje
4.
Moguće nuspojave
5.
Kako čuvati CJEPIVO PROTIV PANDEMIJSKE INFLUENCE H5N1 BAXTER
6.
Sadržaj pakiranja i druge informacije
1.
ŠTO JE CJEPIVO PROTIV PANDEMIJSKE INFLUENCE H5N1 BAXTER
I ZA ŠTO SE
KORISTI
CJEPIVO PROTIV PANDEMIJSKE INFLUENCE H5N1 BAXTER
cjepivo je koje se koristi u osoba
starih 6 mjeseci i više. Koristi se za sprječavanje influence
(gripe) u slučaju službeno proglašene
pandemije.
Pandemijska gripa je vrsta influence koja se javlja svakih nekoliko
desetljeća i koja svojim brzim
širenjem zahvaća većinu država i regija diljem svijeta. Simptomi
(znakovi) pandemijske gripe slični
su onima 'obične' gripe, no uglavnom su teži.
Cjepivo djeluje na način da pomaže tijelu da proizvede vlastitu
zaštitu (protutijela) protiv bolesti.
2.
ŠTO MORATE ZNATI PRIJE NEGO ŠTO PRIMITE CJEPIVO PROTIV PANDEMIJSKE
INFLUENCE H5N1 BAXTER
NEMOJTE PRIMITI CJEPIVO PROTIV PANDEMIJSKE INFLUENCE H5N1 BAXTER
•
ako ste prethodno imali ozbiljnu alergijsku reakciju (npr. po život
opasnu) na CJEPIVO
PROTIV PANDEMIJSKE INFLUENCE H5N1 BAXTER
•
ako ste 
                                
                                Read the complete document

Summary of Product characteristics

                                1
DODATAK I
SAŽETAK OPISA SVOJSTAVA LIJEKA
Lijek koji više nije odobren
2
1.
NAZIV LIJEKA
CJEPIVO PROTIV PANDEMIJSKE INFLUENCE H5N1 BAXTER
Suspenzija za injekciju
Cjepivo protiv pandemijske influence (H5N1) (cijeli virion,
inaktivirano, pripremljeno u staničnoj kulturi)
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
Cjepivo protiv influence (cijeli virion, inaktivirano) koje sadrži
antigen*:
A/Vietnam/1203/2004 (H5N1)
7,5 mikrograma**
po dozi od 0,5 ml
*
proizveden na Vero stanicama
**
hemaglutinina
Ovo cjepivo odgovara preporuci SZO i odluci EU za pandemiju.
Cjepivo je dostupno u višedoznom spremniku (za broj doza po bočici,
vidjeti dio 6.5.).
Za cjeloviti popis pomoćnih tvari vidjeti dio 6.1.
3.
FARMACEUTSKI OBLIK
Suspenzija za injekciju.
Cjepivo je gotovo bijela, opalescentna, prozirna suspenzija.
4.
KLINIČKI PODACI
4.1
TERAPIJSKE INDIKACIJE
Prevencija influence u službeno proglašenoj pandemijskoj situaciji.
Cjepivo protiv pandemijske
influence treba koristiti u skladu sa službenim preporukama.
4.2
DOZIRANJE I NAČIN PRIMJENE
Doziranje
_Odrasli i djeca starija od 6 mjeseci: _
Jedna doza od 0,5 ml na odabrani datum.
Drugu je dozu cjepiva potrebno dati nakon razdoblja od najmanje 3
tjedna.
Način primjene
Imunizacija se provodi intramuskularnom injekcijom u deltoidni mišić
ili anterolateralno područje
bedra, ovisno o mišićnoj masi.
Za dodatne informacije, vidjeti dio 5.1.
4.3
KONTRAINDIKACIJE
Podatak o anafilaktičkoj (tj. po život opasnoj) reakciji na djelatnu
tvar, na bilo koju od pomoćnih tvari
navedenih u dijelu 6.1. ili na ostatne tvari u tragovima (npr.
formaldehid, benzonazu, saharozu) ovog
cjepiva. Međutim, u pandemijskoj će situaciji možda biti potrebno
dati cjepivo pod uvjetom da je
resuscitacija, u slučaju potrebe, odmah dostupna.
Lijek koji više nije odobren
3
Vidjeti dio 4.4.
4.4
POSEBNA UPOZORENJA I MJERE OPREZA PRI UPORABI
•
Nakon primjene sličnog cjelovirionskog cjepiva protiv influence H1N1
uzgojenog
na Vero stanicama, koje je primijenjeno tijekom pandemije,
zabilježene su rea
                                
                                Read the complete document

Similar products

Active ingredient cjepivo protiv influence (cijeli virion, inaktivirano) koji sadrži antigen: A / Vietnam / 1203/2004 (H5N1)

cjepivo protiv influence (cijeli virion, inaktivirano) koji sadrži antigen: A / Vietnam / 1203/2004 (H5N1)

ATC code J07BB01

J07BB01

Marketed by Resilience Biomanufacturing Ireland Limited

Resilience Biomanufacturing Ireland Limited

INN (International Name) pandemic influenza vaccine (H5N1) (whole virion, inactivated, prepared in cell culture)

pandemic influenza vaccine (H5N1) (whole virion, inactivated, prepared in cell culture)

Documents in other languages

Patient Information leaflet Patient Information leaflet Bulgarian 13-09-2023
Summary of Product characteristics Summary of Product characteristics Bulgarian 13-09-2023
Public Assessment Report Public Assessment Report Bulgarian 13-09-2023
Patient Information leaflet Patient Information leaflet Spanish 13-09-2023
Summary of Product characteristics Summary of Product characteristics Spanish 13-09-2023
Public Assessment Report Public Assessment Report Spanish 13-09-2023
Patient Information leaflet Patient Information leaflet Czech 13-09-2023
Summary of Product characteristics Summary of Product characteristics Czech 13-09-2023
Public Assessment Report Public Assessment Report Czech 13-09-2023
Patient Information leaflet Patient Information leaflet Danish 13-09-2023
Summary of Product characteristics Summary of Product characteristics Danish 13-09-2023
Public Assessment Report Public Assessment Report Danish 13-09-2023
Patient Information leaflet Patient Information leaflet German 13-09-2023
Summary of Product characteristics Summary of Product characteristics German 13-09-2023
Public Assessment Report Public Assessment Report German 13-09-2023
Patient Information leaflet Patient Information leaflet Estonian 13-09-2023
Summary of Product characteristics Summary of Product characteristics Estonian 13-09-2023
Public Assessment Report Public Assessment Report Estonian 13-09-2023
Patient Information leaflet Patient Information leaflet Greek 13-09-2023
Summary of Product characteristics Summary of Product characteristics Greek 13-09-2023
Public Assessment Report Public Assessment Report Greek 13-09-2023
Patient Information leaflet Patient Information leaflet English 13-09-2023
Summary of Product characteristics Summary of Product characteristics English 13-09-2023
Public Assessment Report Public Assessment Report English 13-09-2023
Patient Information leaflet Patient Information leaflet French 13-09-2023
Summary of Product characteristics Summary of Product characteristics French 13-09-2023
Public Assessment Report Public Assessment Report French 13-09-2023
Patient Information leaflet Patient Information leaflet Italian 13-09-2023
Summary of Product characteristics Summary of Product characteristics Italian 13-09-2023
Public Assessment Report Public Assessment Report Italian 13-09-2023
Patient Information leaflet Patient Information leaflet Latvian 13-09-2023
Summary of Product characteristics Summary of Product characteristics Latvian 13-09-2023
Public Assessment Report Public Assessment Report Latvian 13-09-2023
Patient Information leaflet Patient Information leaflet Lithuanian 13-09-2023
Summary of Product characteristics Summary of Product characteristics Lithuanian 13-09-2023
Public Assessment Report Public Assessment Report Lithuanian 13-09-2023
Patient Information leaflet Patient Information leaflet Hungarian 13-09-2023
Summary of Product characteristics Summary of Product characteristics Hungarian 13-09-2023
Public Assessment Report Public Assessment Report Hungarian 13-09-2023
Patient Information leaflet Patient Information leaflet Maltese 13-09-2023
Summary of Product characteristics Summary of Product characteristics Maltese 13-09-2023
Public Assessment Report Public Assessment Report Maltese 13-09-2023
Patient Information leaflet Patient Information leaflet Dutch 13-09-2023
Summary of Product characteristics Summary of Product characteristics Dutch 13-09-2023
Public Assessment Report Public Assessment Report Dutch 13-09-2023
Patient Information leaflet Patient Information leaflet Polish 13-09-2023
Summary of Product characteristics Summary of Product characteristics Polish 13-09-2023
Public Assessment Report Public Assessment Report Polish 13-09-2023
Patient Information leaflet Patient Information leaflet Portuguese 13-09-2023
Summary of Product characteristics Summary of Product characteristics Portuguese 13-09-2023
Public Assessment Report Public Assessment Report Portuguese 13-09-2023
Patient Information leaflet Patient Information leaflet Romanian 13-09-2023
Summary of Product characteristics Summary of Product characteristics Romanian 13-09-2023
Public Assessment Report Public Assessment Report Romanian 13-09-2023
Patient Information leaflet Patient Information leaflet Slovak 13-09-2023
Summary of Product characteristics Summary of Product characteristics Slovak 13-09-2023
Public Assessment Report Public Assessment Report Slovak 13-09-2023
Patient Information leaflet Patient Information leaflet Slovenian 13-09-2023
Summary of Product characteristics Summary of Product characteristics Slovenian 13-09-2023
Public Assessment Report Public Assessment Report Slovenian 13-09-2023
Patient Information leaflet Patient Information leaflet Finnish 13-09-2023
Summary of Product characteristics Summary of Product characteristics Finnish 13-09-2023
Public Assessment Report Public Assessment Report Finnish 13-09-2023
Patient Information leaflet Patient Information leaflet Swedish 13-09-2023
Summary of Product characteristics Summary of Product characteristics Swedish 13-09-2023
Public Assessment Report Public Assessment Report Swedish 13-09-2023
Patient Information leaflet Patient Information leaflet Norwegian 13-09-2023
Summary of Product characteristics Summary of Product characteristics Norwegian 13-09-2023
Patient Information leaflet Patient Information leaflet Icelandic 13-09-2023
Summary of Product characteristics Summary of Product characteristics Icelandic 13-09-2023

Search alerts related to this product

Alerts Pandemic Influenza Vaccine H5N1 cjepivo protiv influence koji

Pandemic Influenza Vaccine H5N1 cjepivo protiv influence koji

View documents history

Documents history Documents history

Pandemic Influenza Vaccine H5N1 Baxter AG