Rotarix

Country: European Union

Language: Croatian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
31-07-2023
Summary of Product characteristics Summary of Product characteristics (SPC)
31-07-2023
Public Assessment Report Public Assessment Report (PAR)
31-03-2016

Active ingredient:

ljudski rotavirus, živi atenuiran

Available from:

GlaxoSmithKline Biologicals S.A.

ATC code:

J07BH01

INN (International Name):

rotavirus vaccine, live

Therapeutic group:

cjepiva

Therapeutic area:

Immunization; Rotavirus Infections

Therapeutic indications:

Rotarix je indiciran za aktivnu imunizaciju dojenčadi u dobi od 6 do 24 tjedna za prevenciju gastroenteritisa izazvanog infekcijom rotavirusom. Korištenje izvedbe nema statističke značajnosti treba se osloniti na službene preporuke.

Product summary:

Revision: 41

Authorization status:

odobren

Authorization date:

2006-02-21

Patient Information leaflet

                                61
B. UPUTA O LIJEKU
62
UPUTA O LIJEKU: INFORMACIJE ZA KORISNIKA
ROTARIX PRAŠAK I OTAPALO ZA ORALNU SUSPENZIJU
Cjepivo protiv rotavirusa, živo
PAŽLJIVO PROČITAJTE CIJELU UPUTU PRIJE NEGO VAŠE DIJETE PRIMI OVO
CJEPIVO JER SADRŽI VAMA VAŽNE
PODATKE.
-
Sačuvajte ovu uputu. Možda ćete je trebati ponovno pročitati.
-
Ako imate dodatnih pitanja, obratite se liječniku ili ljekarniku.
-
Ovo cjepivo propisano je samo Vašem djetetu. Nemojte ga davati
drugima.
-
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 Rotarix i za što se koristi
2.
Što morate znati prije nego Vaše dijete primi Rotarix
3.
Kako primjenjivati Rotarix
4.
Moguće nuspojave
5.
Kako čuvati Rotarix
6.
Sadržaj pakiranja i druge informacije
1.
ŠTO JE ROTARIX I ZA ŠTO SE KORISTI
Rotarix je virusno cjepivo, koje sadrži živi oslabljeni ljudski
rotavirus i koje pomaže zaštititi Vaše
dijete starije od 6 tjedana od gastroenteritisa (proljeva i
povraćanja) uzrokovanih infekcijom
rotavirusom.
KAKO ROTARIX DJELUJE:
Infekcija rotavirusom je najčešći uzrok teškog proljeva u
dojenčadi i male djece. Rotavirus se lako širi
s ruku na usta zbog kontakta sa stolicom zaražene osobe. Većina
djece koja obole od rotavirusnog
proljeva oporave se sama. Međutim, neka djeca se teško razbole uz
jako povraćanje, proljev i po život
opasan gubitak tekućine koji zahtijeva bolničko liječenje.
Kad osoba primi cjepivo, imunološki sustav (prirodna obrana
organizma) će stvoriti protutijela protiv
najčešćih tipova rotavirusa. Ta protutijela štite od bolesti
uzrokovanih tim tipovima rotavirusa.
Kao i sva ostala cjepiva, Rotarix možda neće u potpunosti zaštititi
sve cijepljene osobe od infekcije
rotavirusom za čije je spriječavanje namijenjen.
2.
ŠTO MORATE ZNATI PRIJE NEGO VAŠE DIJETE PRIMI ROTARIX
ROTARIX SE NE SMIJE DATI:
•
ako je Vaše dijete prethodno imalo alergijsku
                                
                                Read the complete document

Summary of Product characteristics

                                1
PRILOG I.
SAŽETAK OPISA SVOJSTAVA LIJEKA
2
1.
NAZIV LIJEKA
Rotarix prašak i otapalo za
ORALNU
suspenziju
Cjepivo protiv rotavirusa, živo
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
Nakon rekonstitucije, 1 doza (1 ml) sadrži:
Humani rotavirus soj RIX4414 (živi, atenuirani)*
ne manje od 10
6,0
CCID
50
*proizveden na Vero stanicama
Pomoćne tvari s poznatim učinkom:
Cjepivo sadrži 13,5 mg sorbitola, 9 mg saharoze, 10 mikrograma
glukoze i 0,15 mikrograma
fenilalanina po dozi (vidjeti dio 4.4).
Za cjeloviti popis pomoćnih tvari vidjeti dio 6.1.
3.
FARMACEUTSKI OBLIK
Prašak i otapalo za
ORALNU
suspenziju.
Prašak je bijele boje.
Otapalo je mutna tekućina s bijelim talogom koji se polako taloži i
bezbojnim supernatantom.
4.
KLINIČKI PODACI
4.1
TERAPIJSKE INDIKACIJE
Rotarix je indiciran za aktivnu imunizaciju dojenčadi u dobi od 6. do
24. tjedna za prevenciju
gastroenteritisa izazvanog infekcijom rotavirusa (vidjeti dijelove
4.2, 4.4 i 5.1).
Primjena cjepiva Rotarix mora se temeljiti na službenim preporukama.
4.2
DOZIRANJE I NAČIN PRIMJENE
Doziranje
Ciklus cijepljenja sastoji se od dvije doze. Prvu dozu moguće je
primijeniti od navršenih 6 tjedana
života. Razmak između doza mora biti najmanje 4 tjedna. Ciklus
cijepljenja preporučljivo je dovršiti
prije navršenih 16 tjedana života, ali se mora dovršiti do dobi od
24 tjedna.
Isti režim doziranja cjepiva Rotarix se može primijeniti i kod
prijevremeno rođene dojenčadi rođene
nakon najmanje 27. tjedna gestacijske dobi (vidjeti dijelove 4.8 i
5.1).
U kliničkim ispitivanjima rijetko je zabilježeno pljuvanje ili
regurgitacija cjepiva i u takvim
slučajevima nije se davala zamjenska doza. Međutim, u malo
vjerojatnom slučaju da dojenče ispljune
ili regurgitira većinu doze cjepiva, može se dati jedna zamjenska
doza tijekom istog posjeta liječniku.
Preporučuje se da dojenče koje primi prvu dozu cjepiva Rotarix
dovrši 2-dozni režim cijepljenja
cjepivom Rotarix. Nema podataka o sigurnosti, imunogenosti ili
djelotvornosti kad se u prvoj dozi
primje
                                
                                Read the complete document

Similar products

Active ingredient ljudski rotavirus, živi atenuiran

ljudski rotavirus, živi atenuiran

ATC code J07BH01

J07BH01

Marketed by GlaxoSmithKline Biologicals S.A.

GlaxoSmithKline Biologicals S.A.

INN (International Name) rotavirus vaccine, live

rotavirus vaccine, live

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