Eryseng

Country: European Union

Language: Croatian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
10-05-2019
Summary of Product characteristics Summary of Product characteristics (SPC)
10-05-2019
Public Assessment Report Public Assessment Report (PAR)
02-10-2014

Active ingredient:

Erysipelothrix rhusiopathiae, soj R32E11 (inaktiviran)

Available from:

Laboratorios Hipra, S.A.

ATC code:

QI09AB03

INN (International Name):

Erysipelothrix rhusiopathiae

Therapeutic group:

svinje

Therapeutic area:

Immunologicals for suidae, Inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia) escherichia + clostridium

Therapeutic indications:

Za aktivne imunizacije mužjaci i ženke svinja za smanjenje kliničkih manifestacija (oštećenje kože i groznica) svinjske vrbanca, uzrokovane Эризипелотриксов rhusiopathiae, серотип серотип 1 i 2.

Product summary:

Revision: 4

Authorization status:

odobren

Authorization date:

2014-07-04

Patient Information leaflet

                                13
B. UPUTA O VMP
14
UPUTA O VMP:
ERYSENG SUSPENZIJA ZA INJEKCIJE 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 i proizvođač odgovoran za
puštanje serije
u promet:
LABORATORIOS HIPRA, S.A.
Avda. la Selva, 135
17170 Amer (Girona)
Španjolska
2.
NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA
ERYSENG suspenzija za injekcije za svinje
3.
KVALITATIVNI I KVANTITATIVNI SASTAV DJELATNE(IH) TVARI I DRUGIH
SASTOJAKA
Svaka doza od 2 ml sadrži:
Inaktivirani
_Erysipelothrix rhusiopathiae_
, soj R32E11 ................... ELISA > 3,34 log
2
IE
50 %
*
* IE
50 %
inhibicije ELISA 50%.
Aluminijev hidroksid
............................................................................................
5,29 mg (aluminij)
DEAE-dekstran
Ginseng.
Bjelkasta suspenzija za injekciju.
4.
INDIKACIJE
Za aktivnu imunizaciju mužjaka i ženki svinja, za smanjivanje
kliničkih znakova (kožnih lezija i
vrućice) vrbanca svinja kojeg uzrokuje
_Erysipelothrix rhusiopathiae_
, serotip 1 i serotip 2.
Pojava imuniteta: tri tjedna nakon završetka sheme osnovnog
cijepljenja.
Trajanje imuniteta: šest mjeseci.
5.
KONTRAINDIKACIJE
Ne primjenjivati u slučaju preosjetljivosti na djelatne tvari, na
adjuvanse ili na bilo koju od pomoćnih
tvari.
6.
NUSPOJAVE
Vrlo česte nuspojave:
- Tijekom ispitivanja neškodljivosti na mjestu uboda bila je
primijećena blaga do srednje teška upala
koja se uobičajeno povuče u roku od četiri dana ali u nekim
slučajevima može trajati do 12 dana nakon
cijepljenja.
Česte nuspojave:
- Tijekom ispitivanja neškodljivosti u prvih 6 sati nakon cijepljenja
bilo je primijećeno prolazno
15
povećanje temperature, koje se povuče spontano u roku od 24 sata.
Vrlo rijetke nuspojave:
- Reakcije anafilaktičkog tipa zabilježene su u spontanim
izvješćima i preporučuje se odgovarajuća
simptomatska terapija.
Učestalost nuspojava je određena sukladno sljedećim pravilima
                                
                                Read the complete document

Summary of Product characteristics

                                1
DODATAK I
SAŽETAK OPISA SVOJSTAVA
2
1.
NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA
ERYSENG suspenzija za injekcije za svinje
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
Svaka doza od 2 ml sadrži:
DJELATNE TVARI:
Inaktivirani
_Erysipelothrix rhusiopathiae_
, soj R32E11 .................. ELISA > 3,34 log
2
IE
50 %
*
* IE
50 %
inhibicije ELISA 50%.
ADJUVANSI:
Aluminijev hidroksid …………………….
................................................ 5,29 mg (aluminija)
DEAE-dekstran
Ginseng
Potpuni popis pomoćnih tvari vidi u odjeljku 6.1.
3.
FARMACEUTSKI OBLIK
Suspenzija za injekciju.
Bjelkasta suspenzija.
4.
KLINIČKE POJEDINOSTI
4.1
CILJNE VRSTE ŽIVOTINJA
Svinje
4.2
INDIKACIJE ZA PRIMJENU, NAVESTI CILJNE VRSTE ŽIVOTINJA
Za aktivnu imunizaciju mužjaka i ženki svinja, za smanjivanje
kliničkih znakova (kožnih lezija i
vrućice) vrbanca svinja kojeg uzrokuje
_Erysipelothrix rhusiopathiae_
, serotip 1 i serotip 2.
Pojava imuniteta: tri tjedna nakon završetka sheme osnovnog
cijepljenja.
Trajanje imuniteta: šest mjeseci.
4.3
KONTRAINDIKACIJE
Ne primjenjivati u slučaju preosjetljivosti na djelatne tvari, na
adjuvanse ili na bilo koju od pomoćnih
tvari.
4.4
POSEBNA UPOZORENJA ZA SVAKU OD CILJNIH VRSTA ŽIVOTINJA
Cijepite samo zdrave životinje.
4.5
POSEBNE MJERE OPREZA PRILIKOM PRIMJENE
Posebne mjere opreza prilikom primjene na životinjama
Nema.
3
Posebne mjere opreza koje mora poduzeti osoba koja primjenjuje
veterinarsko-medicinski proizvod na
životinjama
U slučaju da se nehotice samoinjiciranja, odmah potražite pomoć
liječnika i pokažite mu uputu o VMP
ili etiketu.
4.6
NUSPOJAVE (UČESTALOST I OZBILJNOST)
Vrlo česte nuspojave:
- Tijekom ispitivanja neškodljivosti na mjestu uboda bila je
primijećena blaga do srednje teška upala
koja se uobičajeno povuče u roku od četiri dana ali u nekim
slučajevima može trajati do 12 dana nakon
cijepljenja.
Česte nuspojave:
- Tijekom ispitivanja neškodljivosti u prvih 6 sati nakon cijepljenja
bilo je primijećeno prolazno
povećanje temperature, koje se povu
                                
                                Read the complete document

Similar products

Active ingredient Erysipelothrix rhusiopathiae, soj R32E11 (inaktiviran)

Erysipelothrix rhusiopathiae, soj R32E11 (inaktiviran)

ATC code QI09AB03

QI09AB03

Marketed by Laboratorios Hipra, S.A.

Laboratorios Hipra, S.A.

INN (International Name) Erysipelothrix rhusiopathiae

Erysipelothrix rhusiopathiae

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Eryseng