CircoMax Myco

Country: European Union

Language: Romanian

Source: EMA (European Medicines Agency)

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Download Patient Information leaflet (PIL)
01-01-1970
Download Summary of Product characteristics (SPC)
01-01-1970
Download 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:

Porci (pentru îngrășare)

Therapeutic area:

Imunologii pentru 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:

Autorizat

Authorization date:

2020-12-09

Patient Information leaflet

                                17
B.PROSPECT
18
PROSPECT
CIRCOMAX MYCO EMULSIE INJECTABILĂ PENTRU PORCI
1.
NUMELE ŞI ADRESA DEŢINĂTORULUI AUTORIZAŢIEI DE COMERCIALIZARE
ŞI A DEŢINĂTORULUI AUTORIZAŢIEI DE FABRICARE, RESPONSABIL PENTRU
ELIBERAREA SERIILOR DE PRODUS, DACĂ SUNT DIFERITE
Deținătorul autorizației de comercializare și producătorul
responsabil pentru eliberarea seriei:
Zoetis Belgium SA
Rue Laid Burniat 1
1348 Louvain-la-Neuve
BELGIA
2.
DENUMIREA PRODUSULUI MEDICINAL VETERINAR
CircoMax Myco emulsie injectabilă pentru porci
3.
DECLARAREA (SUBSTANŢEI) SUBSTANŢELOR ACTIVE ŞI A ALTOR
INGREDIENTE (INGREDIENŢI)
2 ml conțin:
SUBSTANȚE ACTIVE:
Circovirus porcin recombinat chimeric inactivat tip 1 care conține
proteina
1,5 – 4,9 PR*
cadre de citire deschise 2 (ORF2) de circovirus porcin tip 2a
Circovirus porcin recombinat chimeric inactivat tip 1 care conține
proteina
1,5 – 5,9 PR*
ORF2 de circovirus porcin tip 2b
_ _
_Mycoplasma hyopneumoniae _
inactivată, tulpina P-5722-3
1,5 – 4,7 PR*
ADJUVANȚI:
Scualan
0,4% (v/v)
Poloxamer 401
0,2% (v/v)
Polisorbat 80
0,032% (v/v)
EXCIPIENT:
Tiomersal
0,2 mg
*Unitatea relativă de potență determinată prin cuantificare
antigenică ELISA (test de potență
_in vitro_
)
comparativ cu un vaccin de referință.
Emulsie alba omogenă.
4.
INDICAŢIE (INDICAŢII)
Imunizarea activă a porcilor împotriva circovirusului porcin de tip
2 pentru a reduce încărcătura virală
din sânge și din țesuturile limfoide, eliminarea de virus în
materiile fecale și leziunile din țesuturile
limfoide asociate cu infecția cu PCV2. S-a demonstrat protecție
împotriva circovirusului porcin de tip
2a, 2b și 2d. Imunizarea activă a porcilor împotriva
_Mycoplasma hyopneumoniae_
pentru a reduce
leziunile pulmonare asociate cu infecția cu
_Mycoplasma hyopneumoniae_
.
Debutul imunității (ambele scheme de vaccinare): la 3 săptămâni
după (ultima) vaccinare.
19
Durata imunității (ambele scheme de vaccinare): 23 de săptămâni
după (ultima) vaccinare.
În plus, a fost demonstrat că vac
                                
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Summary of Product characteristics

                                1
ANEXA I
REZUMATUL CARACTERISTICILOR PRODUSULUI
2
1.
DENUMIREA PRODUSULUI MEDICINAL VETERINAR
CircoMax Myco emulsie injectabilă pentru porci
2.
COMPOZIŢIA CALITATIVĂ ŞI CANTITATIVĂ
2 ml conțin:
SUBSTANȚE ACTIVE:
Circovirus porcin recombinat chimeric inactivat tip 1 care conține
proteina
1,5 – 4,9 PR*
cadre de citire deschise 2 (ORF2) de circovirus porcin tip 2a
Circovirus porcin recombinat chimeric inactivat tip 1 care conține
proteina
1,5 – 5,9 PR*
ORF2 de circovirus porcin tip 2b
_ _
_Mycoplasma hyopneumoniae _
inactivată, tulpina P-5722-3
1,5 – 4,7 PR*
ADJUVANȚI:
Scualan
0,4% (v/v)
Poloxamer 401
0,2% (v/v)
Polisorbat 80
0,032% (v/v)
EXCIPIENT:
Tiomersal
0,2 mg
*Unitatea relativă de potență determinată prin cuantificare
antigenică ELISA (test de potență
_in vitro_
)
comparativ cu un vaccin de referință.
Pentru lista completă a excipienților, vezi secțiunea 6.1.
3.
FORMA FARMACEUTICĂ
Emulsie injectabilă.
Emulsie alba omogenă.
4.
PARTICULARITĂŢI CLINICE
4.1
SPECII ȚINTĂ
Porci (pentru îngrășat).
4.2
INDICAȚII PENTRU UTILIZARE, CU SPECIFICAREA SPECIILOR ȚINTĂ
Imunizarea activă a porcilor împotriva circovirusului porcin de tip
2 pentru a reduce încărcătura virală
din sânge și din țesuturile limfoide, eliminarea de virus în
materiile fecale și leziunile din țesuturile
limfoide asociate cu infecția cu PCV2. S-a demonstrat protecție
împotriva circovirusului porcin de tip
2a, 2b și 2d.
Imunizarea activă a porcilor împotriva
_Mycoplasma hyopneumoniae_
pentru a reduce leziunile
pulmonare asociate cu infecția cu
_Mycoplasma hyopneumoniae_
.
Debutul imunității (ambele scheme de vaccinare): la 3 săptămâni
după (ultima) vaccinare.
Durata imunității (ambele scheme de vaccinare): 23 de săptămâni
după (ultima) vaccinare.
3
În plus, a fost demonstrat că vaccinarea reduce pierderile de
creștere în greutate corporală în condiții
de teren.
4.3
CONTRAINDICAȚII
Nu există.
4.4
ATENȚIONĂRI SPECIALE PENTRU FIECARE SPECIE ȚINTĂ
Vaccinați doar animalele
                                
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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
Patient Information leaflet Patient Information leaflet Czech 01-01-1970
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Public Assessment Report Public Assessment Report Czech 01-01-1970
Patient Information leaflet Patient Information leaflet Danish 01-01-1970
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