CircoMax Myco

Country: European Union

Language: Croatian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
01-01-1970
Summary of Product characteristics Summary of Product characteristics (SPC)
01-01-1970
Public Assessment Report Public Assessment Report (PAR)
01-01-1970

Active ingredient:

Inactivated Mycoplasma hyopneumoniae, strain P-5722-3, Inactivated recombinant chimeric porcine circovirus type 1 containing the porcine circovirus type 2a open reading frame 2 (ORF2) protein, Inactivated recombinant chimeric porcine circovirus type 1 containing the porcine circovirus type 2b ORF2 protein

Available from:

Zoetis Belgium

ATC code:

QI09AL08

Therapeutic group:

Svinja (za tov)

Therapeutic area:

Imunološke za suidae

Therapeutic indications:

Active immunisation of pigs against porcine circovirus type 2 to reduce viral load in blood and lymphoid tissues, fecal shedding and the lesions in lymphoid tissues associated with PCV2 infection. Protection was demonstrated against porcine circovirus types 2a, 2b and 2d. Active immunisation of pigs against Mycoplasma hyopneumoniae to reduce the lung lesions associated with Mycoplasma hyopneumoniae infection.  Onset of immunity (both vaccination schedules): 3 weeks after (the last) vaccination.  Duration of immunity (both vaccination schedules): 23 weeks after (the last) vaccination.  In addition, vaccination has been shown to reduce body weight gain losses under field conditions.

Authorization status:

odobren

Authorization date:

2020-12-09

Patient Information leaflet

                                17
B. UPUTA O VMP
18
UPUTA O VMP:
CIRCOMAX MYCO EMULZIJA 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 i proizvođač odgovoran za
puštanje serije
u promet:
Zoetis Belgium SA
Rue Laid Burniat 1
1348 Louvain-la-Neuve
BELGIJA
2.
NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA
CircoMax Myco emulzija za injekciju za svinje
3.
SASTAV DJELATNE(IH) TVARI I DRUGIH SASTOJAKA
2 ml sadrži:
DJELATNE TVARI:
Inaktivirani rekombinirani himerni cirkovirus svinja tip 1 koji
sadrži
protein ORF2 (engl.
_open reading frame_
; otvoreni okvir čitanja)
cirkovirusa svinja tip 2a
Inaktivirani rekombinirani himerni cirkovirus svinja tip 1 koji
sadrži
protein ORF2 cirkovirusa svinja tip 2b
Inaktivirana
_Mycoplasma hyopneumoniae, _
soj P-5722-3
_ _
1,5 – 4,9 RP*
1,5 – 5,9 RP*
1,5 – 4,7 RP*
ADJUVANS:
Skvalan
Poloksamer 401
Polisorbat 80
0,4% (v/v)
0,2% (v/v)
0,032% (v/v)
POMOĆNE TVARI:
Tiomersal
0,2 mg
*Jedinica relativne potencije određena pomoću ELISA kvantifikacije
antigena (
_in vitro _
ispitivanje
potencije) u usporedbi s referentnim cjepivom.
Bijela homogena emulzija.
4.
INDIKACIJE
Aktivna imunizacija svinja protiv cirkovirusa svinja tipa 2 (PCV2)
kako bi se smanjila količina virusa
u krvi i limfoidnim tkivima, izlučivanje virusa izmetom i lezije u
limfoidnim tkivima povezane s
infekcijom s PCV2. Dokazana je zaštita protiv cirkovirusa svinja tipa
2a, 2b i 2d.
Aktivna imunizacija svinja na
_Mycoplasma hyopneumoniae_
kako bi se smanjile lezije na plućima
povezane s infekcijom s
_ Mycoplasma hyopneumoniae_
.
19
Početak imunosti (oba rasporeda cijepljenja): 3 tjedna nakon
(posljednjeg) cijepljenja.
Trajanje imunosti (oba rasporeda cijepljenja): 23 tjedna nakon
(posljednjeg) cijepljenja.
Dodatno, dokazano je da cijepljenje smanjuje gubitak prirasta tjelesne
težine u terenskim uvjetima.
5.
KONTRAINDIKACIJE
Nema.
6.
NUSPOJAVE
Prolazni porast tjelesne temper
                                
                                Read the complete document

Summary of Product characteristics

                                1
DODATAK I
SAŽETAK OPISA SVOJSTAVA
2
1.
NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA
CircoMax Myco emulzija za injekciju za svinje
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
2 ml sadrži:
DJELATNE TVARI:
Inaktivirani rekombinirani himerni cirkovirus svinja tip 1 koji
sadrži protein
ORF2 (engl.
_open reading frame_
; otvoreni okvir čitanja) cirkovirusa svinja tip
2a
Inaktivirani rekombinirani himerni cirkovirus svinja tip 1 koji
sadrži protein
ORF2 cirkovirusa svinja tip 2b
Inaktivirana
_Mycoplasma hyopneumoniae, _
soj P-5722-3
_ _
1,5 – 4,9 RP*
1,5 – 5,9 RP*
1,5 – 4,7 RP*
ADJUVANS:
Skvalan
Poloksamer 401
Polisorbat 80
0,4% (v/v)
0,2% (v/v)
0,032% (v/v)
POMOĆNE TVARI:
Tiomersal
0,2 mg
*Jedinica relativne potencije određena pomoću ELISA kvantifikacije
antigena (
_in vitro_
ispitivanje
potencije) u usporedbi s referentnim cjepivom.
Potpuni popis pomoćnih tvari vidi u odjeljku 6.1.
3.
FARMACEUTSKI OBLIK
Emulzija za injekciju.
Bijela homogena emulzija.
4.
KLINIČKE POJEDINOSTI
4.1
CILJNE VRSTE ŽIVOTINJA
Svinje (za tov).
4.2
INDIKACIJE ZA PRIMJENU, NAVESTI CILJNE VRSTE ŽIVOTINJA
Aktivna imunizacija svinja protiv cirkovirusa svinja tipa 2 (PCV2)
kako bi se smanjila količina virusa
u krvi i limfoidnim tkivima, izlučivanje virusa izmetom i lezije u
limfoidnim tkivima povezane s
infekcijom s PCV2. Dokazana je zaštita protiv cirkovirusa svinja tipa
2a, 2b i 2d.
Aktivna imunizacija svinja na
_Mycoplasma hyopneumoniae_
kako bi se smanjile lezije na plućima
povezane s infekcijom s
_ Mycoplasma hyopneumoniae_
.
Početak imunosti (oba rasporeda cijepljenja): 3 tjedna nakon
(posljednjeg) cijepljenja.
Trajanje imunosti (oba rasporeda cijepljenja): 23 tjedna nakon
(posljednjeg) cijepljenja.
3
Dodatno, dokazano je da cijepljenje smanjuje gubitak prirasta tjelesne
težine u terenskim uvjetima.
4.3
KONTRAINDIKACIJE
Nema.
4.4
POSEBNA UPOZORENJA ZA SVAKU OD CILJNIH VRSTA ŽIVOTINJA
Cijepiti samo zdrave životinje.
4.5
POSEBNE MJERE OPREZA PRILIKOM PRIMJENE
Posebne mjere opreza prilikom primjene na životinjama
Nema dostupni
                                
                                Read the complete document

Similar products

Active ingredient Inactivated Mycoplasma hyopneumoniae, strain P-5722-3, Inactivated recombinant chimeric porcine circovirus type 1 containing the porcine circovirus type 2a open reading frame 2 (ORF2) protein, Inactivated recombinant chimeric porcine circovirus type 1 containing the porcine circovirus type 2b ORF2 protein

Inactivated Mycoplasma hyopneumoniae, strain P-5722-3, Inactivated recombinant chimeric porcine circovirus type 1 containing the porcine circovirus type 2a open reading frame 2 (ORF2) protein, Inactivated recombinant chimeric porcine circovirus type 1 containing the porcine circovirus type 2b ORF2 protein

ATC code QI09AL08

QI09AL08

Marketed by Zoetis Belgium

Zoetis Belgium

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Patient Information leaflet Patient Information leaflet Bulgarian 01-01-1970
Summary of Product characteristics Summary of Product characteristics Bulgarian 01-01-1970
Public Assessment Report Public Assessment Report Bulgarian 01-01-1970
Patient Information leaflet Patient Information leaflet Spanish 01-01-1970
Summary of Product characteristics Summary of Product characteristics Spanish 01-01-1970
Public Assessment Report Public Assessment Report Spanish 01-01-1970
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