Pandemrix

Country: European Union

Language: Croatian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
10-06-2016
Summary of Product characteristics Summary of Product characteristics (SPC)
10-06-2016
Public Assessment Report Public Assessment Report (PAR)
10-06-2016

Active ingredient:

split influenza virus inaktiviran, koji sadrži ekvivalent antigena s A / California / 07/2009 (H1N1) - dobivenog soka korištenog NYMC X-179A

Available from:

GlaxoSmithKline Biologicals S.A.

ATC code:

J07BB02

INN (International Name):

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

Therapeutic group:

Cjepiva protiv gripe

Therapeutic area:

Influenza, Human; Immunization; Disease Outbreaks

Therapeutic indications:

Profilaksa influence uzrokovana virusom A (H1N1) v 2009. Pandemrix treba se koristiti samo ako preporučena godišnja sezonske gripe nego kad se trovalentno / rekombinantno cjepivo nisu dostupne i ako cijepljenje protiv (H1N1) v smatra potrebnim (vidjeti dio 4. 4 i 4. Cjepivo Pandemrix mora se koristiti u skladu sa službenim vodstvom.

Product summary:

Revision: 23

Authorization status:

povučen

Authorization date:

2008-05-20

Patient Information leaflet

                                36
B. UPUTA O LIJEKU
37
UPUTA O LIJEKU: INFORMACIJE ZA KORISNIKA
PANDEMRIX SUSPENZIJA I EMULZIJA ZA EMULZIJU ZA INJEKCIJU
Cjepivo protiv influence (H1N1)v (fragmentirani virion, inaktivirano,
adjuvantirano)
Ovaj je lijek pod dodatnim praćenjem. Time se omogućuje brzo
otkrivanje novih sigurnosnih
informacija. Prijavom svih sumnji na nuspojavu i Vi možete pomoći.
Za postupak prijavljivanja
nuspojava, pogledajte dio 4.
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.
-
Ovo cjepivo propisano je samo Vama. Nemojte ga davati drugima.
-
Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti
liječnika. To uključuje i svaku
moguću nuspojavu koja nije navedena u ovoj uputi. Pogledajte dio 4.
ŠTO SE NALAZI U OVOJ UPUTI:
1.
Što je Pandemrix i za što se koristi
2.
Što morate znati prije nego primite Pandemrix
3.
Kako primjenjivati Pandemrix
4.
Moguće nuspojave
5.
Kako čuvati Pandemrix
6.
Sadržaj pakiranja i druge informacije
1.
ŠTO JE PANDEMRIX I ZA ŠTO SE KORISTI
ŠTO JE PANDEMRIX I ZA ŠTO SE KORISTI
Pandemrix je cjepivo kojim se sprječava influenca (gripa) uzrokovana
virusom A(H1N1)v 2009.
Vaš će liječnik umjesto cjepiva Pandemrix obično preporučiti
drugo cjepivo (godišnje
trovalentno/četverovalentno cjepivo protiv influence), ali ako
trovalentna/četverovalentna cjepiva nisu
dostupna, a potrebna Vam je zaštita od gripe uzrokovane A(H1N1)v
virusom, Pandemrix može biti
jedna od opcija (pogledajte dio
_Upozorenja i mjere opreza_
).
KAKO PANDEMRIX DJELUJE
Kada osoba primi cjepivo, imunološki sustav (prirodni obrambeni
sustav tijela) stvorit će svoju
vlastitu zaštitu (protutijela) protiv bolesti. Ni jedan sastojak
cjepiva ne može izazvati gripu.
2.
ŠTO MORATE ZNATI PRIJE NEGO PRIMITE PANDEMRIX
NEMOJTE PRIMITI PANDEMRIX:
•
ako ste prije imali iznenadnu životno ugrožavajuću alergijsku
reakc
                                
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Summary of Product characteristics

                                1
DODATAK I
SAŽETAK OPISA SVOJSTAVA LIJEKA
2
Ovaj je lijek pod dodatnim praćenjem. Time se omogućuje brzo
otkrivanje novih
sigurnosnih informacija. Od zdravstvenih radnika se traži da prijave
svaku sumnju na nuspojavu
za ovaj lijek. Za postupak prijavljivanja nuspojava vidjeti dio 4.8.
1.
NAZIV LIJEKA
Pandemrix suspenzija i emulzija za emulziju za injekciju.
Cjepivo protiv influence (H1N1)v (fragmentirani virion, inaktivirano,
adjuvantirano)
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
Nakon miješanja, 1 doza (0,5 ml) sadrži:
fragmentirani virus influence, inaktiviran, sadrži antigen
*
koji odgovara:
_ _
A/California/07/2009 (H1N1) iz kojeg je izveden korišteni soj NYMC
X-179A
3,75 mikrograma
**
*
umnožen na jajima
**
hemaglutinin
AS03 adjuvans sadrži skvalen (10,69 miligrama), DL-
α
-tokoferol (11,86 miligrama) i polisorbat 80
(4,86 miligrama)
Miješanjem suspenzije i emulzije dobiva se višedozno cjepivo u
bočici. Za broj doza u bočici vidjeti
dio 6.5.
Pomoćna tvar s poznatim učinkom:
cjepivo sadrži 5 mikrograma tiomersala
Za cjeloviti popis pomoćnih tvari vidjeti dio 6.1.
3.
FARMACEUTSKI OBLIK
Suspenzija i emulzija za emulziju za injekciju.
Suspenzija je bezbojna, blago opalescentna tekućina.
Emulzija je bjelkasta do žućkasta mliječna homogena tekućina.
4.
KLINIČKI PODACI
4.1
TERAPIJSKE INDIKACIJE
Profilaksa influence koju uzrokuje virus A (H1N1)v 2009. Pandemrix se
smije primijeniti samo u
slučajevima kada preporučena godišnja sezonska
trovalentna/četverovalentna cjepiva protiv influence
nisu dostupna te ako se imunizacija protiv (H1N1)v smatra nužnom
(vidjeti dijelove 4.4 i 4.8).
Pandemrix se mora primjenjivati u skladu sa službenim smjernicama.
4.2
DOZIRANJE I NAČIN PRIMJENE
Doziranje
3
Preporuke o dozama vode računa o podacima o sigurnosti i imunogenosti
dobivenim u kliničkim
ispitivanjima na zdravim ispitanicima.
Za više informacija vidjeti dijelove 4.4, 4.8 i 5.1.
Nema podataka o primjeni u djece u dobi mlađoj od 6 mjeseci.
_Odrasli u dobi od 18 godina i stariji: _
Jedna doza 
                                
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Similar products

Active ingredient split influenza virus inaktiviran, koji sadrži ekvivalent antigena s A / California / 07/2009 (H1N1) - dobivenog soka korištenog NYMC X-179A

split influenza virus inaktiviran, koji sadrži ekvivalent antigena s A / California / 07/2009 (H1N1) - dobivenog soka korištenog NYMC X-179A

ATC code J07BB02

J07BB02

Marketed by GlaxoSmithKline Biologicals S.A.

GlaxoSmithKline Biologicals S.A.

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

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

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Pandemrix