Fluenz

Country: European Union

Language: Croatian

Source: EMA (European Medicines Agency)

Buy It Now

Patient Information leaflet Patient Information leaflet (PIL)
03-12-2014
Summary of Product characteristics Summary of Product characteristics (SPC)
03-12-2014
Public Assessment Report Public Assessment Report (PAR)
03-12-2014

Active ingredient:

Реассортанта virusa gripe (live аттенуированная) sljedećih sojeva:a/California/7/2009 pdm09 (Н1N1)kao soj A/Victoria/361/2011 (Н3N2), kao što su napon, B/Ma/2/2012 kao soj

Available from:

MedImmune LLC

ATC code:

J07BB03

INN (International Name):

influenza vaccine (live attenuated, nasal)

Therapeutic group:

cjepiva

Therapeutic area:

Influenza, Human; Immunization

Therapeutic indications:

Profilaksa gripe kod osoba od 24 mjeseca do 18 godina starosti. Korištenje Fluenz mora se temeljiti na službenim preporukama.

Product summary:

Revision: 4

Authorization status:

povučen

Authorization date:

2011-01-27

Patient Information leaflet

                                21
B. UPUTA O LIJEKU
Lijeku je ukinuto odobrenje za stavljanje lijeka u promet
22
UPUTA O LIJEKU: INFORMACIJA ZA KORISNIKA
FLUENZ SPREJ ZA NOS, SUSPENZIJA
Cjepivo protiv influence (živo oslabljeno, za nos)
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 PRIMJENE CJEPIVA JER SADRŽI
VAŽNE PODATKE ZA VAS ILI
VAŠE DIJETE.
-
Sačuvajte ovu uputu. Možda ćete ju trebati ponovo pročitati.
-
Ako imate dodatnih pitanja, obratite se svom liječniku, medicinskoj
sestri ili ljekarniku.
-
Ovo je cjepivo propisano samo Vama ili Vašem djetetu. Nemojte ga
davati drugima.
-
Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti
liječnika, medicinsku sestru
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 Fluenz i za što se koristi
2.
Što morate znati prije nego počnete primati Fluenz
3.
Kako se Fluenz daje
4.
Moguće nuspojave
5.
Kako čuvati Fluenz
6.
Sadržaj pakovanja i dodatne informacije
1.
ŠTO JE FLUENZ I ZA ŠTO SE KORISTI
Fluenz je cjepivo protiv influence (gripe). Upotrebljava se u djece i
adolescenata u dobi od 24 mjeseca
do mlađih od 18 godina.
Kad osoba primi cjepivo, imunološki sustav (prirodni obrambeni sustav
tijela) proizvest će
vlastitu zaštitu protiv virusa gripe. Niti jedan sastojak cjepiva ne
može prouzročiti gripu.
Virusi cjepiva Fluenz uzgojeni su u kokošjim jajima. Cjepivo je
usmjereno protiv tri soja virusa
gripe svake godine, u skladu s godišnjim preporukama Svjetske
zdravstvene organizacije.
2.
ŠTO MORATE ZNATI PRIJE NEGO POČNETE PRIMATI FLUENZ
NEĆETE PRIMITI FLUENZ

AKO STE ALERGIČNI
na jaja, proteine jajeta, gentamicin ili želatinu ili bilo koji drugi
sastojak
cjepiva Fluenz (naveden u dijelu 6 „Sadržaj pakovanja i dodatne
informacije“). Za znakove
alergijske r
                                
                                Read the complete document

Summary of Product characteristics

                                1
DODATAK I
SAŽETAK OPISA SVOJSTAVA LIJEKA
Lijeku je ukinuto odobrenje za stavljanje lijeka u promet
2
Ovaj je lijek pod dodatnim praćenjem. Time se omogućuje brzo
otkrivanje novih sigurnosnih
informacija. Od zdravstvenih djelatnika se traži da prijave svaku
sumnju na nuspojavu za ovaj lijek.
Za postupak prijavljivanja nuspojava vidjeti dio 4.8.
_ _
1.
NAZIV GOTOVOG LIJEKA
FLUENZ sprej za nos, suspenzija
cjepivo protiv influence, živo, atenuirano, za nos
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
Presloženi virus influence* (živi, atenuirani) sljedećih sojeva**:
A/California/7/2009 (H1N1) pdm09 kao soj
(A/California/7/2009, MEDI 228029)
10
7,0±0,5
FFU***
A/Victoria/361/2011 (H3N2) kao soj
(A/Texas/50/2012, MEDI 237514)
10
7,0±0,5
FFU***
B/Massachusetts/2/2012 kao soj
(B/Massachusetts/2/2012, MEDI 237751)
10
7,0±0,5
FFU***
.......................................................................................................po
dozi od 0,2 ml
*
umnoženih u oplođenim kokošjim jajima iz jata zdravih kokoši.
**
proizvedeni u VERO stanicama tehnologijom reverzne genetike. Ovaj
proizvod sadrži genetski
modificirane organizme (GMO).
***
jedinice fluorescentnog žarišta
Ovo cjepivo odgovara preporuci SZO (za sjevernu hemisferu) i odluci EU
za sezonu 2013/2014.
Cjepivo može sadržavati ostatke sljedećih tvari: proteina jajeta
(npr. ovalbumina) i gentamicina.
Za cjeloviti popis pomoćnih tvari, vidjeti dio 6.1.
3.
FARMACEUTSKI OBLIK
Sprej za nos, suspenzija
Suspenzija je bezbojna do blijedo žuta, bistra do opalescentna. Može
sadržavati sitne, bijele čestice.
4.
KLINIČKI PODACI
4.1
TERAPIJSKE INDIKACIJE
Profilaksa influence u osoba u dobi od 24 mjeseca do 18 godina.
FLUENZ se smije upotrebljavati samo u skladu sa službenim
preporukama.
Lijeku je ukinuto odobrenje za stavljanje lijeka u promet
3
4.2
DOZIRANJE I NAČIN PRIMJENE
Doziranje
_Djeca i adolescenti stariji od 24 mjeseca: _
0,2 ml (primjenjuje se kao 0,1 ml po nosnici).
Djeca koja prethodno nisu bila cijepljena protiv sezonske influence
moraju pri
                                
                                Read the complete document

Similar products

Active ingredient Реассортанта virusa gripe (live аттенуированная) sljedećih sojeva:a/California/7/2009 pdm09 (Н1N1)kao soj A/Victoria/361/2011 (Н3N2), kao što su napon, B/Ma/2/2012 kao soj

Реассортанта virusa gripe (live аттенуированная) sljedećih sojeva:a/California/7/2009 pdm09 (Н1N1)kao soj A/Victoria/361/2011 (Н3N2), kao što su napon, B/Ma/2/2012 kao soj

ATC code J07BB03

J07BB03

Marketed by MedImmune LLC

MedImmune LLC

INN (International Name) influenza vaccine (live attenuated, nasal)

influenza vaccine (live attenuated, nasal)

Documents in other languages

Patient Information leaflet Patient Information leaflet Bulgarian 03-12-2014
Summary of Product characteristics Summary of Product characteristics Bulgarian 03-12-2014
Public Assessment Report Public Assessment Report Bulgarian 03-12-2014
Patient Information leaflet Patient Information leaflet Spanish 03-12-2014
Summary of Product characteristics Summary of Product characteristics Spanish 03-12-2014
Public Assessment Report Public Assessment Report Spanish 03-12-2014
Patient Information leaflet Patient Information leaflet Czech 03-12-2014
Summary of Product characteristics Summary of Product characteristics Czech 03-12-2014
Public Assessment Report Public Assessment Report Czech 03-12-2014
Patient Information leaflet Patient Information leaflet Danish 03-12-2014
Summary of Product characteristics Summary of Product characteristics Danish 03-12-2014
Public Assessment Report Public Assessment Report Danish 03-12-2014
Patient Information leaflet Patient Information leaflet German 03-12-2014
Summary of Product characteristics Summary of Product characteristics German 03-12-2014
Public Assessment Report Public Assessment Report German 03-12-2014
Patient Information leaflet Patient Information leaflet Estonian 03-12-2014
Summary of Product characteristics Summary of Product characteristics Estonian 03-12-2014
Public Assessment Report Public Assessment Report Estonian 03-12-2014
Patient Information leaflet Patient Information leaflet Greek 03-12-2014
Summary of Product characteristics Summary of Product characteristics Greek 03-12-2014
Public Assessment Report Public Assessment Report Greek 03-12-2014
Patient Information leaflet Patient Information leaflet English 03-12-2014
Summary of Product characteristics Summary of Product characteristics English 03-12-2014
Public Assessment Report Public Assessment Report English 03-12-2014
Patient Information leaflet Patient Information leaflet French 03-12-2014
Summary of Product characteristics Summary of Product characteristics French 03-12-2014
Public Assessment Report Public Assessment Report French 03-12-2014
Patient Information leaflet Patient Information leaflet Italian 03-12-2014
Summary of Product characteristics Summary of Product characteristics Italian 03-12-2014
Public Assessment Report Public Assessment Report Italian 03-12-2014
Patient Information leaflet Patient Information leaflet Latvian 03-12-2014
Summary of Product characteristics Summary of Product characteristics Latvian 03-12-2014
Public Assessment Report Public Assessment Report Latvian 03-12-2014
Patient Information leaflet Patient Information leaflet Lithuanian 03-12-2014
Summary of Product characteristics Summary of Product characteristics Lithuanian 03-12-2014
Public Assessment Report Public Assessment Report Lithuanian 03-12-2014
Patient Information leaflet Patient Information leaflet Hungarian 03-12-2014
Summary of Product characteristics Summary of Product characteristics Hungarian 03-12-2014
Public Assessment Report Public Assessment Report Hungarian 03-12-2014
Patient Information leaflet Patient Information leaflet Maltese 03-12-2014
Summary of Product characteristics Summary of Product characteristics Maltese 03-12-2014
Public Assessment Report Public Assessment Report Maltese 03-12-2014
Patient Information leaflet Patient Information leaflet Dutch 03-12-2014
Summary of Product characteristics Summary of Product characteristics Dutch 03-12-2014
Public Assessment Report Public Assessment Report Dutch 03-12-2014
Patient Information leaflet Patient Information leaflet Polish 03-12-2014
Summary of Product characteristics Summary of Product characteristics Polish 03-12-2014
Public Assessment Report Public Assessment Report Polish 03-12-2014
Patient Information leaflet Patient Information leaflet Portuguese 03-12-2014
Summary of Product characteristics Summary of Product characteristics Portuguese 03-12-2014
Public Assessment Report Public Assessment Report Portuguese 03-12-2014
Patient Information leaflet Patient Information leaflet Romanian 03-12-2014
Summary of Product characteristics Summary of Product characteristics Romanian 03-12-2014
Public Assessment Report Public Assessment Report Romanian 03-12-2014
Patient Information leaflet Patient Information leaflet Slovak 03-12-2014
Summary of Product characteristics Summary of Product characteristics Slovak 03-12-2014
Public Assessment Report Public Assessment Report Slovak 03-12-2014
Patient Information leaflet Patient Information leaflet Slovenian 03-12-2014
Summary of Product characteristics Summary of Product characteristics Slovenian 03-12-2014
Public Assessment Report Public Assessment Report Slovenian 03-12-2014
Patient Information leaflet Patient Information leaflet Finnish 03-12-2014
Summary of Product characteristics Summary of Product characteristics Finnish 03-12-2014
Public Assessment Report Public Assessment Report Finnish 03-12-2014
Patient Information leaflet Patient Information leaflet Swedish 03-12-2014
Summary of Product characteristics Summary of Product characteristics Swedish 03-12-2014
Public Assessment Report Public Assessment Report Swedish 03-12-2014
Patient Information leaflet Patient Information leaflet Norwegian 03-12-2014
Summary of Product characteristics Summary of Product characteristics Norwegian 03-12-2014
Patient Information leaflet Patient Information leaflet Icelandic 03-12-2014
Summary of Product characteristics Summary of Product characteristics Icelandic 03-12-2014

Search alerts related to this product

Alerts Fluenz Реассортанта virusa gripe sljedećih influenza vaccine

Fluenz Реассортанта virusa gripe sljedećih influenza vaccine

View documents history

Documents history Documents history

Fluenz