Suvaxyn Aujeszky 783 + O/W

Country: European Union

Language: Croatian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
22-02-2021
Summary of Product characteristics Summary of Product characteristics (SPC)
22-02-2021

Active ingredient:

živjeti atenuirani virus Aujeszkoga bolest

Available from:

Zoetis Belgium SA

ATC code:

QI09AA01

INN (International Name):

live attenuated Aujeszky's disease virus

Therapeutic group:

svinje

Therapeutic area:

Immunologicals

Therapeutic indications:

Aktivna imunizacija svinja u dobi od 10 tjedana prije sprečavanje smrtnosti i kliničkih znakova bolesti aujeszkoga i smanjiti izlučivanje virusa bolesti aujeszkoga. Pasivna imunizacija potomstva cijepljena svinja i krmača za smanjenje smrtnosti i kliničkih znakova bolesti aujeszkoga i smanjiti izlučivanje virusa bolesti aujeszkoga području .

Product summary:

Revision: 15

Authorization status:

odobren

Authorization date:

1998-08-07

Patient Information leaflet

                                18
B. UPUTA O VMP
19
UPUTA O VMP:
SUVAXYN AUJESZKY 783 + O/W, LIOFILIZAT I OTAPALO ZA EMULZIJU ZA
INJEKCIJU ZA SVINJE
1.
NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE U PROMET I
NOSITELJA ODOBRENJA ZA PROIZVODNJU ODGOVORNOG ZA PUŠTANJE
SERIJE U PROMET, AKO JE RAZLIČITO
Nositelj odobrenja za stavljanje u promet:
Zoetis Belgium SA
Rue Laid Burniat 1
1348 Louvain-la-Neuve
BELGIJA
Proizvođač odgovoran za puštanje serije u promet:
Zoetis Manufacturing & Research Spain, S.L.
Ctra. de Camprodón s/n
°
Finca La Riba
Vall de Bianya
Gerona, 17813
ŠPANJOLSKA
2.
NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA
Suvaxyn Aujeszky 783 + O/W, liofilizat i otapalo za emulziju za
injekciju za svinje
3.
KVALITATIVNI I KVANTITATIVNI SASTAV DJELATNE(IH) TVARI I DRUGIH
SASTOJAKA
Svaka doza (2 ml) sadrži:
Liofilizat:
DJELATNA TVAR:
Živi, atenuirani virus bolesti Aujeszkoga, soj NIA
3
-783
≥
10
5,2
CCID
50
*
*CCID
50
= količina virusa koja inficira 50% inokuliranih staničnih kultura.
Otapalo:
Aluminijev hidroksid, mineralno ulje (Marcol 52), manid monooleat
(Arlacel A), polisorbat 80
(Tween 80), tiomersal.
Izgled veterinarsko-medicinskog proizvoda prije rekonstitucije:
Otapalo: bijela, neprozirna tekućina
Liofilizat: bijelo žućkasti liofilizat
4.
INDIKACIJA(E)
Aktivna imunizacija svinja od 10 tjedana starosti nadalje radi
sprječavanja smrtnosti i kliničkih
znakova bolesti Aujeszkoga i reduciranja lučenja terenskog virusa
bolesti Aujeszkoga.
20
Pasivna imunizacija potomstva cijepljenih nazimica i krmača radi
reduciranja smrtnosti i kliničkih
znakova bolesti Aujeszkoga i reduciranja lučenja terenskog virusa
bolesti Aujeszkoga.
Početak imunosti: 3 tjedna nakon osnovnog cijepljenja.
Trajanje imunosti: 3 mjeseca nakon osnovnog cijepljenja.
5.
KONTRAINDIKACIJE
Nema.
6.
NUSPOJAVE
Blage, prolazne i lokalne reakcije do 2 cm u promjeru nakon prvog
cijepljenja i do 5 cm nakon drugog
cijepljenja vrlo su često zabilježenje u do 50% svinja u
laboratorijskim i terenskim ispitivanjima.
Općenito, te se reakcije povlače unutar 3 tjed
                                
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Summary of Product characteristics

                                1
DODATAK I
SAŽETAK OPISA SVOJSTAVA
2
1.
NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA
Suvaxyn Aujeszky 783 + O/W, liofilizat i otapalo za emulziju za
injekciju za svinje
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
Svaka doza (2 ml) sadrži:
Liofilizat:
DJELATNA TVAR
Živi, atenuirani virus bolesti Aujeszkoga, soj NIA
3
-783
≥
10
5,2
CCID
50
*
*CCID
50
= količina virusa koja inficira 50% inokuliranih staničnih kultura.
Otapalo:
ADJUVANSI:
Aluminijev hidroksid
2,1 mg
Mineralno ulje (Marcol 52)
425
µ
l
Manid monooleat (Arlacel A)
46
µ
l
Polisorbat 80 (Tween 80)
17
µ
l
POMOĆNA TVAR:
Tiomersal
0,15 mg
Potpuni popis pomoćnih tvari vidi u odjeljku 6.1.
3.
FARMACEUTSKI OBLIK
Liofilizat i otapalo za emulziju za injekciju.
Izgled veterinarsko-medicinskog proizvoda prije rekonstitucije:
Otapalo: bijela, neprozirna tekućina
Liofilizat: bijelo žućkasti liofilizat
4.
KLINIČKE POJEDINOSTI
4.1
CILJNE VRSTE ŽIVOTINJA
Svinje.
4.2
INDIKACIJE ZA PRIMJENU, NAVESTI CILJNE VRSTE ŽIVOTINJA
Aktivna imunizacija svinja od 10 tjedana starosti nadalje radi
sprječavanja smrtnosti i kliničkih
znakova bolesti Aujeszkoga i reduciranja lučenja terenskog virusa
bolesti Aujeszkoga. Pasivna
imunizacija potomstva cijepljenih nazimica i krmača radi reduciranja
smrtnosti i kliničkih znakova
bolesti Aujeszkoga i reduciranja lučenja terenskog virusa bolesti
Aujeszkoga.
3
Početak imunosti:3 tjedna nakon osnovnog cijepljenja.
Trajanje imunosti: 3 mjeseca nakon osnovnog cijepljenja.
4.3
KONTRAINDIKACIJE
Nema.
4.4
POSEBNA UPOZORENJA ZA SVAKU OD CILJNIH VRSTA ŽIVOTINJA
Cijepiti samo zdrave životinje.
Prisutnost majčinskih protutijela za virus bolesti Aujeszkoga može
negativno utjecati na rezultat
cijepljenja.
4.5
POSEBNE MJERE OPREZA PRILIKOM PRIMJENE
Posebne mjere opreza prilikom primjene na životinjama
Svaki praščić cijepljenih nazimica ili krmača trebao bi unijeti
dovoljnu količinu kolostruma i mlijeka.
Posebne mjere opreza koje mora poduzeti osoba koja primjenjuje
veterinarsko medicinski proizvod na
životinjama
Oprati i dezinficir
                                
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Active ingredient živjeti atenuirani virus Aujeszkoga bolest

živjeti atenuirani virus Aujeszkoga bolest

ATC code QI09AA01

QI09AA01

Marketed by Zoetis Belgium SA

Zoetis Belgium SA

INN (International Name) live attenuated Aujeszky's disease virus

live attenuated Aujeszky's disease virus

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