Circovac

Country: European Union

Language: Slovenian

Source: EMA (European Medicines Agency)

Buy It Now

Patient Information leaflet Patient Information leaflet (PIL)
08-12-2021
Summary of Product characteristics Summary of Product characteristics (SPC)
08-12-2021
Public Assessment Report Public Assessment Report (PAR)
19-09-2017

Active ingredient:

inaktivirani prašičji cirkovirus tipa 2 (PCV2)

Available from:

CEVA-Phylaxia Oltóanyagtermelõ Zrt.

ATC code:

QI09AA07

INN (International Name):

adjuvanted inactivated vaccine against porcine circovirus type 2

Therapeutic group:

Prašiči (mladice in svinje)

Therapeutic area:

Imunologija za suidae

Therapeutic indications:

Svinje in giltsPassive imunizacijo za pujske preko kolostrum, ko aktivno imunizacijo za svinje in brejih, da zmanjšajo poškodbe v lymphoid tkiva povezana z PCV2 okužbe in kot pomoč pri zmanjšanju PCV2-povezana umrljivost. PigletsActive imunizacijo za pujske za zmanjšanje fekalne izločanje PCV2 in virus obremenitev v krvi, in kot pomoč pri zmanjšanju PCV2-povezane klinične znake, vključno hujšanje, hujšanje in umrljivost, kot tudi za zmanjšanje virus obremenitev in poškodb v lymphoid tkiva povezana z PCV2 okužbe.

Product summary:

Revision: 12

Authorization status:

Pooblaščeni

Authorization date:

2007-06-21

Patient Information leaflet

                                17
B. NAVODILO ZA UPORABO
18
NAVODILO ZA UPORABO
CIRCOVAC
EMULZIJA IN SUSPENZIJA ZA EMULZIJO ZA INJICIRANJE ZA PRAŠIČE
1.
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER
PROIZVAJALEC ZDRAVILA, ODGOVORNEGA ZA SPROŠČANJE SERIJ, ČE STA
RAZLIČNA
Imetnik dovoljenja za promet z zdravilom:
CEVA-PHYLAXIA Co. Ltd., Szállás u. 5., 1107 Budapest, Madžarska
Proizvajalec, odgovoren za sproščanje serij:
MERIAL, Laboratoire Porte des Alpes, Rue de l’Aviation, F-69800
Saint Priest, Francija
in
CEVA-PHYLAXIA Co. Ltd., Szállás u. 5., 1107 Budapest, Madžarska
2.
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI
Circovac emulzija in suspenzija za emulzijo za injiciranje.
3.
NAVEDBA UČINKOVIN(E) IN DRUGE(IH) SESTAVIN
Svetla opalescentna tekočina pred rekonstitucijo.
Vsak ml rekonstituiranega cepiva vsebuje:
UČINKOVINA:
inaktiviran prašičji cirko virus tip 2 (PCV2)
.......................................................

1,8 log10 ELISA enot
POMOŽNA SNOV:
tiomersal
.......................................................................................................................................
0,10 mg
DODATEK:
parafin, tekoči
..................................................................................................................
247 do 250,5 mg
4.
INDIKACIJA(E)
PUJSKI:
Aktivna imunizacija pujskov za zmanjšanje izločanja PCV2 s fecesom
in količine virusa v krvi in
kot pomoč pri zmanjšanju kliničnih znakov, povezanih s PCV2,
vključno s hiranjem, izgubo telesne teže
in smrtnosti ter tudi zmanjšanje prisotnosti virusa in poškodb na
limfoidnem tkivu, povezanih z okužbo s
PCV2.
Nastop imunosti: 2 tedna.
Trajanje imunosti: najmanj 14 tednov po cepljenju.
SVINJE IN MLADICE:
Pasivna imunizacija prašičev s kolostrumom po cepljenju svinj in
mladic z namenom
zmanjšati lezije limfnega tkiva, ki jih je povzročila okužba s PCV2
kot pomoč za znižanje mortalnosti
zaradi PCV2.
Trajanje imunosti: do 5 tednov po prenosu pasivnih protiteles s
kolostrumom.
19
5.
KONTRAINDIKACIJE
Niso znan
                                
                                Read the complete document

Summary of Product characteristics

                                1
DODATEK I
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
                                
                                Read the complete document

Similar products

Active ingredient inaktivirani prašičji cirkovirus tipa 2 (PCV2)

inaktivirani prašičji cirkovirus tipa 2 (PCV2)

ATC code QI09AA07

QI09AA07

Marketed by CEVA-Phylaxia Oltóanyagtermelõ Zrt.

CEVA-Phylaxia Oltóanyagtermelõ Zrt.

INN (International Name) adjuvanted inactivated vaccine against porcine circovirus type 2

adjuvanted inactivated vaccine against porcine circovirus type 2

Documents in other languages

Patient Information leaflet Patient Information leaflet Bulgarian 08-12-2021
Summary of Product characteristics Summary of Product characteristics Bulgarian 08-12-2021
Public Assessment Report Public Assessment Report Bulgarian 19-09-2017
Patient Information leaflet Patient Information leaflet Spanish 08-12-2021
Summary of Product characteristics Summary of Product characteristics Spanish 08-12-2021
Public Assessment Report Public Assessment Report Spanish 19-09-2017
Patient Information leaflet Patient Information leaflet Czech 08-12-2021
Summary of Product characteristics Summary of Product characteristics Czech 08-12-2021
Public Assessment Report Public Assessment Report Czech 19-09-2017
Patient Information leaflet Patient Information leaflet Danish 08-12-2021
Summary of Product characteristics Summary of Product characteristics Danish 08-12-2021
Public Assessment Report Public Assessment Report Danish 19-09-2017
Patient Information leaflet Patient Information leaflet German 08-12-2021
Summary of Product characteristics Summary of Product characteristics German 08-12-2021
Public Assessment Report Public Assessment Report German 19-09-2017
Patient Information leaflet Patient Information leaflet Estonian 08-12-2021
Summary of Product characteristics Summary of Product characteristics Estonian 08-12-2021
Public Assessment Report Public Assessment Report Estonian 19-09-2017
Patient Information leaflet Patient Information leaflet Greek 08-12-2021
Summary of Product characteristics Summary of Product characteristics Greek 08-12-2021
Public Assessment Report Public Assessment Report Greek 19-09-2017
Patient Information leaflet Patient Information leaflet English 08-12-2021
Summary of Product characteristics Summary of Product characteristics English 08-12-2021
Public Assessment Report Public Assessment Report English 19-09-2017
Patient Information leaflet Patient Information leaflet French 08-12-2021
Summary of Product characteristics Summary of Product characteristics French 08-12-2021
Public Assessment Report Public Assessment Report French 19-09-2017
Patient Information leaflet Patient Information leaflet Italian 08-12-2021
Summary of Product characteristics Summary of Product characteristics Italian 08-12-2021
Public Assessment Report Public Assessment Report Italian 19-09-2017
Patient Information leaflet Patient Information leaflet Latvian 08-12-2021
Summary of Product characteristics Summary of Product characteristics Latvian 08-12-2021
Public Assessment Report Public Assessment Report Latvian 19-09-2017
Patient Information leaflet Patient Information leaflet Lithuanian 08-12-2021
Summary of Product characteristics Summary of Product characteristics Lithuanian 08-12-2021
Public Assessment Report Public Assessment Report Lithuanian 19-09-2017
Patient Information leaflet Patient Information leaflet Hungarian 08-12-2021
Summary of Product characteristics Summary of Product characteristics Hungarian 08-12-2021
Public Assessment Report Public Assessment Report Hungarian 19-09-2017
Patient Information leaflet Patient Information leaflet Maltese 08-12-2021
Summary of Product characteristics Summary of Product characteristics Maltese 08-12-2021
Public Assessment Report Public Assessment Report Maltese 19-09-2017
Patient Information leaflet Patient Information leaflet Dutch 08-12-2021
Summary of Product characteristics Summary of Product characteristics Dutch 08-12-2021
Public Assessment Report Public Assessment Report Dutch 19-09-2017
Patient Information leaflet Patient Information leaflet Polish 08-12-2021
Summary of Product characteristics Summary of Product characteristics Polish 08-12-2021
Public Assessment Report Public Assessment Report Polish 19-09-2017
Patient Information leaflet Patient Information leaflet Portuguese 08-12-2021
Summary of Product characteristics Summary of Product characteristics Portuguese 08-12-2021
Public Assessment Report Public Assessment Report Portuguese 19-09-2017
Patient Information leaflet Patient Information leaflet Romanian 08-12-2021
Summary of Product characteristics Summary of Product characteristics Romanian 08-12-2021
Public Assessment Report Public Assessment Report Romanian 19-09-2017
Patient Information leaflet Patient Information leaflet Slovak 08-12-2021
Summary of Product characteristics Summary of Product characteristics Slovak 08-12-2021
Public Assessment Report Public Assessment Report Slovak 19-09-2017
Patient Information leaflet Patient Information leaflet Finnish 08-12-2021
Summary of Product characteristics Summary of Product characteristics Finnish 08-12-2021
Public Assessment Report Public Assessment Report Finnish 19-09-2017
Patient Information leaflet Patient Information leaflet Swedish 08-12-2021
Summary of Product characteristics Summary of Product characteristics Swedish 08-12-2021
Public Assessment Report Public Assessment Report Swedish 19-09-2017
Patient Information leaflet Patient Information leaflet Norwegian 08-12-2021
Summary of Product characteristics Summary of Product characteristics Norwegian 08-12-2021
Patient Information leaflet Patient Information leaflet Icelandic 08-12-2021
Summary of Product characteristics Summary of Product characteristics Icelandic 08-12-2021
Patient Information leaflet Patient Information leaflet Croatian 08-12-2021
Summary of Product characteristics Summary of Product characteristics Croatian 08-12-2021
Public Assessment Report Public Assessment Report Croatian 19-09-2017

Search alerts related to this product

Alerts Circovac inaktivirani prašičji cirkovirus tipa adjuvanted inactivated vaccine against

Circovac inaktivirani prašičji cirkovirus tipa adjuvanted inactivated vaccine against

View documents history

Documents history Documents history

Circovac