CircoMax Myco

Country: European Union

Language: Danish

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:

Svin (slagtekyllinger)

Therapeutic area:

Immunologiske stoffer til 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:

autoriseret

Authorization date:

2020-12-09

Patient Information leaflet

                                17
B. INDLÆGSSEDDEL
18
INDLÆGSSEDDEL
CIRCOMAX MYCO
INJEKTIONSVÆSKE, EMULSION TIL SVIN
1.
NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN
SAMT PÅ DEN INDEHAVER AF VIRKSOMHEDSGODKENDELSE, SOM ER
ANSVARLIG FOR BATCHFRIGIVELSE, HVIS FORSKELLIG HERFRA
Indehaver af markedsføringstilladelsen og fremstiller ansvarlig for
batchfrigivelse:
Zoetis Belgium SA
Rue Laid Burniat 1
1348 Louvain-la-Neuve
BELGIEN
2.
VETERINÆRLÆGEMIDLETS NAVN
CircoMax Myco Injektionsvæske, emulsion til svin
3.
ANGIVELSE AF DE(T) AKTIVE STOF(FER) OG ANDRE INDHOLDSSTOFFER
2 ml indeholder:
AKTIVE STOFFER:
Inaktiveret, rekombinant kimært porcint circovirus type 1 med porcint
circovirus type 2a åben læseramme 2 (ORF2) -protein
Inaktiveret, rekombinant kimært porcint circovirus type 1 med porcint
circovirus type 2b ORF2-protein
Inaktiveret
_Mycoplasma hyopneumoniae_
, stamme P-5722-3
_ _
1,5-4,9 RP*
1,5-5,9 RP*
1,5-4,7 RP*
ADJUVANS:
Squalan
Poloxamer 401
Polysorbat 80
0,4 % (v/v)
0,2 % (v/v)
0,032 % (v/v)
HJÆLPESTOF:
Thiomersal
0,2 mg
*Relativ styrke påvist vha. ELISA antigentest (
_in vitro_
styrketest) ved sammenligning med en
referencevaccine.
Hvid, homogen emulsion.
4.
INDIKATIONER
Aktiv immunisering af svin mod porcint circovirus type 2 til reduktion
af virusmængden i blod og
lymfevæv, udskillelse i afføring og læsioner i lymfevæv, der er
forbundet med infektion med PCV2.
Der er påvist beskyttelse mod porcint circovirus type 2a, 2b og 2d.
Aktiv immunisering af svin mod
_Mycoplasma hyopneumoniae_
for at reducere lungelæsioner i
forbindelse med infektion med
_Mycoplasma hyopneumoniae. _
Indtræden af immunitet (begge vaccinationsprogrammer): 3 uger efter
(den sidste) vaccination.
Varighed af immunitet (begge vaccinationsprogrammer): 23 uger efter
(den sidste) vaccination.
19
Derudover har vaccination vist sig at reducere fald i
vægtforøgelseunder besætningsforhold.
5.
KONTRAINDIKATIONER
Ingen.
6.
BIVIRKNINGER
En forbigående stigning i kropstemperatur på højest 2,1°C er meget
almindelig efter vaccination og
nor
                                
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Summary of Product characteristics

                                1
BILAG I
PRODUKTRESUMÉ
2
1.
VETERINÆRLÆGEMIDLETS NAVN
CircoMax Myco Injektionsvæske, emulsion til svin
2.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING
2 ml indeholder:
AKTIVE STOFFER:
Inaktiveret, rekombinant kimært porcint circovirus type 1 med porcint
circovirus type 2a åben læseramme 2 (ORF2) -protein
Inaktiveret, rekombinant kimært porcint circovirus type 1 med porcint
circovirus type 2b ORF2-protein
Inaktiveret
_Mycoplasma hyopneumoniae_
, stamme P-5722-3
_ _
1,5-4,9 RP*
1,5-5,9 RP*
1,5-4,7 RP*
ADJUVANS:
Squalan
Poloxamer 401
Polysorbat 80
HJÆLPESTOF:
0,4 % (v/v)
0,2 % (v/v)
0,032 % (v/v)
Thiomersal
0,2 mg
*Relativ styrke påvist vha. ELISA antigentest (
_in vitro_
styrketest) ved sammenligning med en
referencevaccine.
Alle hjælpestoffer er anført under pkt. 6.1.
3.
LÆGEMIDDELFORM
Injektionsvæske, emulsion.
Hvid, homogen emulsion.
4.
KLINISKE OPLYSNINGER
4.1
DYREARTER, SOM LÆGEMIDLET ER BEREGNET TIL
Svin (til opfedning).
4.2
TERAPEUTISKE INDIKATIONER MED ANGIVELSE AF DYREARTER, SOM LÆGEMIDLET
ER BEREGNET TIL
Aktiv immunisering af svin mod porcint circovirus type 2 til reduktion
af virusmængden i blod og
lymfevæv, udskillelse i afføring og læsioner i lymfevæv, der er
forbundet med infektion med PCV2.
Der er påvist beskyttelse mod porcint circovirus type 2a, 2b og 2d.
Aktiv immunisering af svin mod
_Mycoplasma hyopneumoniae_
for at reducere lungelæsioner i
forbindelse med infektion med
_Mycoplasma hyopneumoniae. _
Indtræden af immunitet (begge vaccinationsprogrammer): 3 uger efter
(den sidste) vaccination.
Varighed af immunitet (begge vaccinationsprogrammer): 23 uger efter
(den sidste) vaccination.
Derudover har vaccination vist sig at reducere fald i vægtforøgelse
under besætningsforhold.
3
4.3
KONTRAINDIKATIONER
Ingen.
4.4
SÆRLIGE ADVARSLER FOR HVER ENKELT DYREART, SOM LÆGEMIDLET ER
BEREGNET TIL
Kun raske dyr må vaccineres.
4.5
SÆRLIGE FORSIGTIGHEDSREGLER VEDRØRENDE BRUGEN
Særlige forsigtighedsregler vedrørende brug til dyr
Der foreligger ingen oplysninger om sikkerheden af denn
                                
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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 German 01-01-1970
Summary of Product characteristics Summary of Product characteristics German 01-01-1970
Public Assessment Report Public Assessment Report German 01-01-1970
Patient Information leaflet Patient Information leaflet Estonian 01-01-1970
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Public Assessment Report Public Assessment Report Estonian 01-01-1970
Patient Information leaflet Patient Information leaflet Greek 01-01-1970
Summary of Product characteristics Summary of Product characteristics Greek 01-01-1970
Public Assessment Report Public Assessment Report Greek 01-01-1970
Patient Information leaflet Patient Information leaflet English 01-01-1970
Summary of Product characteristics Summary of Product characteristics English 01-01-1970
Public Assessment Report Public Assessment Report English 01-01-1970
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Public Assessment Report Public Assessment Report Slovak 01-01-1970
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