Suvaxyn CSF Marker

Country: European Union

Language: Slovenian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
03-12-2021
Summary of Product characteristics Summary of Product characteristics (SPC)
03-12-2021
Public Assessment Report Public Assessment Report (PAR)
03-12-2021

Active ingredient:

Live Recombinant E2 gene-deleted bovine viral diarrhoea virus containing classical swine fever virus E2 gene (CP7_E2alf)

Available from:

Zoetis Belgium SA

ATC code:

QI09AD04

INN (International Name):

classical swine fever vaccine (live recombinant)

Therapeutic group:

Prašiči

Therapeutic area:

Live viral vaccines, Immunologicals for suidae

Therapeutic indications:

Za aktivno imunizacijo prašičev od 7 tednov dalje za preprečevanje smrtnosti in zmanjšanje okužb in bolezni, ki jih povzroča virus klasične prašičje kuge (CSFV). Onset of immunity: 14 days after vaccinationDuration of immunity: at least 6 months after vaccinationFor active immunisation of breeding females to reduce transplacental infection caused by CSFV. Onset of immunity: 21 days after vaccinationDuration of immunity has not been demonstrated.

Product summary:

Revision: 4

Authorization status:

Pooblaščeni

Authorization date:

2015-02-10

Patient Information leaflet

                                15
B. NAVODILO ZA UPORABO
16
NAVODILO ZA UPORABO
SUVAXYN CSF MARKER LIOFILIZAT IN VEHIKEL ZA SUSPENZIJO ZA INJICIRANJE
ZA PRAŠIČE
1.
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER
PROIZVAJALEC ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJ, ČE STA
RAZLIČNA
Imetnik dovoljenja za promet z zdravilom in proizvajalec odgvoren za
sproščanje serij:
Zoetis Belgium SA
Rue Laid Burniat 1
1348 Louvain-la-Neuve
BELGIJA
2.
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI
Suvaxyn CSF Marker liofilizat in vehikel za suspenzijo za injiciranje
za prašiče
3.
NAVEDBA UČINKOVIN IN DRUGIH SESTAVIN
UČINKOVINA:
LIOFILIZAT:
živi rekombinatni virus goveje diareje z izbrisanim genom E2,
ki vsebuje gen E2 (CP7_E2alf) virusa klasične prašičje kuge 10
4,8
* do 10
6,5
TCID**
50
* najmanj 100 PD
50
** infektivni odmerek za tkivno kulturo
VEHIKEL:
natrijev klorid 9 mg/ml
voda za injekcije q.s.p. 1 ml
Liofilizat: pelet belkaste barve
Vehikel: bistra, brezbarvna tekočina
Po rekonstituciji mora biti suspenzija bistra tekočina, rahlo
rožnate barve.
4.
INDIKACIJA
Aktivna imunizacija prašičev, starejših od 7 tednov za
preprečevanje smrtnosti, za zmanjšanje tveganja
okužbe in kliničnih znakov bolezni, ki jih povzroča virus klasične
prašičje kuge (KPK).
Nastop imunosti: 14 dni po cepljenju.
Trajanje imunosti: vsaj 6 mesecev po cepljenju.
Za aktivno imunizacijo plemenskih svinj, da se zmanjša okužbe preko
placente, ki jih povzroča virus
KPK.
Nastop imunosti: 21 dni po cepljenju.
Trajanje imunosti ni bilo dokazano.
17
5.
KONTRAINDIKACIJE
Jih ni.
6.
NEŽELENI UČINKI
V laboratorijskih študijah varnosti pri brejih živalih so opazili
naslednje neželene učinke:
Zelo pogosto se je pojavila lokalna in prehodna reakcija tkiva v
obliki otekline do 5 mm v premeru na
mestu injiciranja, ki je trajala do 1 dneva. Pogosto so poročali o
prehodnem zvišanju telesne
temperature za 2,9 °C, ki se je pojavilo 4 ure po cepljenju. Spontano
je izzvenela v 1 dnevu po
cepljenju.
Pogostost neželenih učinkov je določena po naslednjem
                                
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Summary of Product characteristics

                                1
PRILOGA I
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
2
1.
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI
Suvaxyn CSF Marker liofilizat in vehikel za suspenzijo za injiciranje
za prašiče
2.
KAKOVOSTNA IN KOLIČINSKA SESTAVA
Vsak odmerek po 1 ml vsebuje:
UČINKOVINA:
LIOFILIZAT:_ _
živi rekombinatni virus goveje diareje z izbrisanim genom E2,
ki vsebuje gen E2 (CP7_E2alf) virusa klasične prašičje kuge 10
4,8
* do 10
6,5
TCID**
50
* najmanj 100 PD
50
** infektivni odmerek za tkivno kulturo
VEHIKEL:
natrijev klorid 9 mg/ml
voda za injekcije q.s.p. 1 ml
Za celoten seznam pomožnih snovi, glejte poglavje 6.1.
3.
FARMACEVTSKA OBLIKA
Liofilizat in vehikel za suspenzijo za injiciranje.
Liofilizat: pelet belkaste barve
Vehikel: bistra, brezbarvna tekočina
Po rekonstituciji mora biti suspenzija bistra tekočina, rahlo
rožnate barve.
4.
KLINIČNI PODATKI
4.1
CILJNE ŽIVALSKE VRSTE
Prašiči
4.2
INDIKACIJE ZA UPORABO PRI CILJNIH ŽIVALSKIH VRSTAH
Aktivna imunizacija prašičev, starejših od 7 tednov za
preprečevanje smrtnosti, za zmanjšanje tveganja
okužbe in kliničnih znakov bolezni, ki jih povzroča virus klasične
prašičje kuge (KPK).
Nastop imunosti: 14 dni po cepljenju.
Trajanje imunosti: vsaj 6 mesecev po cepljenju.
Aktivna imunizacija plemenskih svinj, da se zmanjša okužbe preko
placente, ki jih povzroča virus
KPK.
Nastop imunosti: 21 dni po cepljenju.
Trajanje imunosti ni bilo dokazano.
4.3
KONTRAINDIKACIJE
Jih ni.
3
4.4
POSEBNA OPOZORILA ZA VSAKO CILJNO ŽIVALSKO VRSTO
Cepite samo zdrave živali.
Predložena dokumentacija podpira uporabo tega cepiva le v primeru
izbruha bolezni v čredah znotraj
omejenih nadzorovanih območij.
Zaščita pred transplacentarnim prenosom virusa KPK je bila dokazana
21 dni po cepljenju pri 6 brejih
svinjah izpostavljenih zmerno virulentnemu sevu virusa KPK. Delna
zaščita pred transplacentarnim
prenosom virusa KPK je bila ugotovljena pri 6 brejih svinjah
izpostavljenih visoko virulentnemu sevu
virusa KPK. Rojstvo trajno okuženih pujskov z imunsko toleranco
predstavlja 
                                
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Similar products

Active ingredient Live Recombinant E2 gene-deleted bovine viral diarrhoea virus containing classical swine fever virus E2 gene (CP7_E2alf)

Live Recombinant E2 gene-deleted bovine viral diarrhoea virus containing classical swine fever virus E2 gene (CP7_E2alf)

ATC code QI09AD04

QI09AD04

Marketed by Zoetis Belgium SA

Zoetis Belgium SA

INN (International Name) classical swine fever vaccine (live recombinant)

classical swine fever vaccine (live recombinant)

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Alerts Suvaxyn CSF Marker Live Recombinant gene-deleted bovine classical swine fever vaccine

Suvaxyn CSF Marker Live Recombinant gene-deleted bovine classical swine fever vaccine

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