Zoonotic Influenza Vaccine Seqirus

Country: European Union

Language: Croatian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
10-11-2023
Summary of Product characteristics Summary of Product characteristics (SPC)
10-11-2023
Public Assessment Report Public Assessment Report (PAR)
10-11-2023

Active ingredient:

zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted), influenza virus surface antigens (haemagglutinin and neuraminidase) of strain: A/turkey/Turkey/1/05 (H5N1)-like strain (NIBRG-23)

Available from:

Seqirus S.r.l. 

INN (International Name):

zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)

Therapeutic group:

cjepiva

Therapeutic area:

Influenza A Virus, H5N1 Subtype

Therapeutic indications:

Active immunisation against H5 subtype of Influenza A virus.

Authorization status:

odobren

Patient Information leaflet

                                29
B. UPUTA O LIJEKU
30
UPUTA O LIJEKU: INFORMACIJE ZA KORISNIKA
ZOONOTIC INFLUENZA VACCINE SEQIRUS SUSPENZIJA ZA INJEKCIJU U
NAPUNJENOJ ŠTRCALJKI
Cjepivo protiv zoonozne influence (H5N1) (površinski antigen,
inaktivirano, adjuvantirano)
PAŽLJIVO PROČITAJTE CIJELU UPUTU PRIJE NEGO PRIMITE OVO CJEPIVO JER
SADRŽI VAMA VAŽNE PODATKE.
-
Sačuvajte ovu uputu. Možda ćete je trebati ponovno pročitati.
-
Ako imate dodatnih pitanja, obratite se liječniku ili medicinskoj
sestri.
-
Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti
liječnika ili medicinsku sestru. To
uključuje i svaku moguću nuspojavu koja nije navedena u ovoj uputi.
Pogledajte dio 4.
ŠTO SE NALAZI U OVOJ UPUTI:
1.
Što je Zoonotic Influenza Vaccine Seqirus i za što se koristi
2.
Što morate znati prije nego primite cjepivo Zoonotic Influenza
Vaccine Seqirus
3.
Kako se Zoonotic Influenza Vaccine Seqirus daje
4.
Moguće nuspojave
5.
Kako čuvati cjepivo Zoonotic Influenza Vaccine Seqirus
6.
Sadržaj pakiranja i druge informacije
1.
ŠTO JE ZOONOTIC INFLUENZA VACCINE SEQIRUS I ZA ŠTO SE KORISTI
Zoonotic Influenza Vaccine Seqirus cjepivo je za primjenu u odraslih
osoba u dobi od 18 godina
nadalje, namijenjeno za primjenu u kontekstu izbijanja gripe izazvane
zoonoznim virusom (virusom
koji dolazi od ptica) s pandemijskim potencijalom, a radi
sprječavanja gripe uzrokovane virusima
sličnima soju u cjepivu kako je navedeno u dijelu 6.
Virusi zoonozne gripe ponekad inficiraju ljude i mogu izazvati bolest
koja se kreće u rasponu od blage
infekcije gornjih dišnih putova (vrućica i kašalj) do brzo
napredujuće i teške upale pluća, sindroma
akutnog respiratornog distresa, šoka pa čak i smrti. Infekcija se u
ljudi prvenstveno prenosi kontaktom
sa zaraženim životinjama, ali se ne širi lako kontaktom između
ljudi.
Cjepivo Zoonotic Influenza Vaccine Seqirus također je namijenjeno za
primjenu kada se predviđa
mogućnost pandemije izazvane istim ili sličnim sojem virusa.
Kada osoba primi cjepivo, imunološki sustav (prirodni obramb
                                
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Summary of Product characteristics

                                1
PRILOG I.
SAŽETAK OPISA SVOJSTAVA LIJEKA
_ _
_ _
2
1.
NAZIV LIJEKA
Zoonotic Influenza Vaccine Seqirus suspenzija za injekciju u
napunjenoj štrcaljki
Cjepivo protiv zoonozne influence (H5N1) (površinski antigen,
inaktivirano, adjuvantirano).
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
Površinski antigeni virusa influence (hemaglutinin i neuraminidaza)*
soja:
A/turkey/Turkey/1/2005 (H5N1)-sličan soj (NIBRG-23) (klada 2.2.1) 7,5
mikrograma**
po dozi od 0,5 ml
*
umnožen u oplođenim kokošjim jajima iz jata zdravih kokoši
**
izraženo u mikrogramima hemaglutinina (HA).
Adjuvans MF59C.1 koji sadrži:
skvalen
9,75 miligrama na 0,5 ml
polisorbat 80
1,175 miligrama na 0,5 ml
sorbitan trioleat
1,175 miligrama na 0,5 ml
natrijev citrat
0,66 miligrama na 0,5 ml
citratnu kiselinu
0,04 miligrama na 0,5 ml
Pomoćne tvari s pomoćnim učinkom
Cjepivo sadrži 1,899 miligrama natrija i 0,081 miligrama kalija po
dozi od 0,5 ml.
Zoonotic Influenza Vaccine Seqirus može sadržavati ostatne tragove
jaja i pilećih proteina,
ovalbumina, kanamicina, neomicinsulfata, formaldehida, hidrokortizona
i cetiltrimetilamonijeva
bromida koji se upotrebljavaju tijekom postupka proizvodnje (vidjeti
dio 4.3).
Za cjeloviti popis pomoćnih tvari vidjeti dio 6.1.
3.
FARMACEUTSKI OBLIK
Suspenzija za injekciju (injekcija)
4.
KLINIČKI PODACI
4.1
TERAPIJSKE INDIKACIJE
Aktivna imunizacija protiv podtipa H5N1 virusa influence A.
Ova indikacija temelji se na podacima o imunogenosti u zdravih
ispitanika u dobi od 18 godina naviše
nakon primjene dviju doza cjepiva koje sadrži soj podtipa H5N1
(vidjeti dio 4.4 i 5.1).
Cjepivo Zoonotic Influenza Vaccine Seqirus mora se koristiti u skladu
sa službenim preporukama.
_ _
4.2
DOZIRANJE I NAČIN PRIMJENE
Doziranje
_Odrasli i starije osobe (18 godina naviše) _
Jedna doza od 0,5 ml.
3
Drugu je dozu od 0,5 ml potrebno dati nakon intervala od najmanje 3
tjedna.
Cjepivo Zoonotic Influenza Vaccine Seqirus procijenjeno je u zdravih
odraslih osoba (u dobi
od 18 do 60 godina) i zdravih starijih osoba (u dobi od 60 god
                                
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Similar products

Active ingredient zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted), influenza virus surface antigens (haemagglutinin and neuraminidase) of strain: A/turkey/Turkey/1/05 (H5N1)-like strain (NIBRG-23)

zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted), influenza virus surface antigens (haemagglutinin and neuraminidase) of strain: A/turkey/Turkey/1/05 (H5N1)-like strain (NIBRG-23)

Marketed by Seqirus S.r.l. 

Seqirus S.r.l. 

INN (International Name) zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)

zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)

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