Focetria

Country: European Union

Language: Croatian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
13-02-2015
Summary of Product characteristics Summary of Product characteristics (SPC)
13-02-2015

Active ingredient:

Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain: A/California/7/2009 (H1N1)-derived strain used NYMC X-181

Available from:

Novartis Vaccines and Diagnostics S.r.l.

ATC code:

J07BB02

INN (International Name):

influenza vaccine H1N1v (surface antigen, inactivated, adjuvanted)

Therapeutic group:

Cjepiva protiv gripe

Therapeutic area:

Influenza, Human; Immunization; Disease Outbreaks

Therapeutic indications:

Profilakcija influence uzrokovana virusom A (H1N1v) 2009. Focetria mora se koristiti u skladu sa službenim vodstvom.

Product summary:

Revision: 9

Authorization status:

povučen

Authorization date:

2007-05-02

Patient Information leaflet

                                34
B. UPUTA O LIJEKU
Lijek koji više nije odobren
35
UPUTA O LIJEKU: INFORMACIJA ZA KORISNIKA
FOCETRIA SUSPENZIJA ZA INJEKCIJU
cjepivo protiv influence H1N1v (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 svom liječniku ili
medicinskoj sestri.
-
Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti
liječnika. To uključuje i svaku
moguću nuspojavu koja nije navedena u ovoj uputi.
ŠTO SE NALAZI U OVOJ UPUTI
:
1.
Što je Focetria i za što se koristi
2.
Što morate znati prije nego što primite Focetriu
3.
Kako se Focetria primjenjuje
4.
Moguće nuspojave
5.
Kako čuvati Focetriu
6.
Sadržaj pakovanja i dodatne informacije
1.
ŠTO JE FOCETRIA I ZA ŠTO SE KORISTI
Focetria je cjepivo za sprječavanje influence (gripe) uzrokovane
virusom A(H1N1v) 2009.
Kada osoba primi cjepivo, imunološki sustav (prirodni obrambeni
sustav tijela) stvorit će vlastitu
zaštitu (protutijela) protiv bolesti. Nijedan sastojak cjepiva ne
može uzrokovati gripu.
2.
ŠTO MORATE ZNATI PRIJE NEGO ŠTO PRIMITE FOCETRIU
NEMOJTE PRIMITI FOCETRIU:

ako ste već imali naglu, po život opasnu alergijsku reakciju na bilo
koji sastojak Focetrie (oni su
navedeni na kraju upute) ili na bilo koje tvari koje mogu biti
prisutne u tragovima kako slijedi:
jaja i pileći protein, ovalbumin, formaldehid, kanamicin i neomicin
sulfat (antibiotici)
i cetiltrimetilamonijev bromid (CTAB). Znakovi alergijske reakcije
mogu uključivati kožni osip
koji svrbi, nedostatak zraka i oticanje lica ili jezika.
UPOZORENJA I MJERE OPREZA
PRIJE PRIMANJA FOCETRIE RAZGOVARAJTE S LIJEČNIKOM ILI MEDICINSKOM
SESTROM.
BUDITE POSEBNO OPREZNI S FOCETRIOM:

ako ste imali bilo koju alergijsku reakciju osim nagle, po život
opasne alergijske reakcije na bilo
koji sastojak cjepiva, na tiomersal (samo za oblik višedozne
bočice), na jaja, pileći protein,
ov
                                
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Summary of Product characteristics

                                1
DODATAK I
SAŽETAK OPISA SVOJSTAVA LIJEKA
Lijek koji više nije odobren
2
1.
NAZIV GOTOVOG LIJEKA
Focetria suspenzija za injekciju u napunjenoj štrcaljki
cjepivo protiv influence H1N1v (površinski antigen, inaktivirano,
adjuvantirano)
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
Površinski antigeni virusa influence (hemaglutinin i neuraminidaza)*
soja:
A/California/07/2009 (H1N1) -iz kojeg je izveden korišten
soj NYMC X-181
7,5 mikrograma** po dozi od 0,5 ml
*
umnožen na jajima
**
izraženo u mikrogramima hemaglutinina.
Adjuvans MF59C.1 sadrži:
skvalen
9,75 miligrama
polisorbat 80
1,175 miligrama
sorbitantrioleat
1,175 miligrama
Za cjeloviti popis pomoćnih tvari, vidjeti dio 6.1.
3.
FARMACEUTSKI OBLIK
Suspenzija za injekciju u napunjenoj štrcaljki.
Mliječnobijela tekućina.
4.
KLINIČKI PODACI
4.1
TERAPIJSKE INDIKACIJE
Profilaksa influence uzrokovane virusom A (H1N1v) 2009 (vidjeti dio
4.4).
Focetriu treba primjenjivati prema službenim preporukama.
4.2
DOZIRANJE I NAČIN PRIMJENE
Preporuke za doziranje uzimaju u obzir podatke o sigurnosti i
imunogenosti iz kliničkih ispitivanja
u zdravih ispitanika.
Doziranje
Odrasli (18 do 60 godina):
Jedna doza od 0,5 ml odabranog datuma.
Podaci o imunogenosti dobiveni tri tjedna nakon jedne doze Focetrie
H1N1v ukazuju na mogućnost da
je jednokratna doza dovoljna.
Ako se primjenjuje druga doza, treba napraviti razmak od barem tri
tjedna između prve i druge doze.
Starije osobe (>60 godina):
Jedna doza od 0,5 ml odabranog datuma.
Drugu dozu cjepiva treba primijeniti nakon razmaka od najmanje tri
tjedna.
Lijek koji više nije odobren
3
_Pedijatrijska populacija _
Djeca i adolescenti u dobi od 3 do 17 godina:
Jedna doza od 0,5 ml odabranog datuma.
Podaci o imunogenosti dobiveni tri tjedna nakon jedne doze Focetrie
H1N1v ukazuju na mogućnost da
je jednokratna doza dovoljna. Ako se primjenjuje druga doza, treba
napraviti razmak od najmanje tri
tjedna između prve i druge doze.
Djeca u dobi od 6 mjeseci do 35 mjeseci:
Jedna doza od 0,5 ml odabranog datuma.
Postoji dodatni im
                                
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Similar products

Active ingredient Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain: A/California/7/2009 (H1N1)-derived strain used NYMC X-181

Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain: A/California/7/2009 (H1N1)-derived strain used NYMC X-181

ATC code J07BB02

J07BB02

Marketed by Novartis Vaccines and Diagnostics S.r.l.

Novartis Vaccines and Diagnostics S.r.l.

INN (International Name) influenza vaccine H1N1v (surface antigen, inactivated, adjuvanted)

influenza vaccine H1N1v (surface antigen, inactivated, adjuvanted)

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