CircoMax Myco

Country: European Union

Language: Latvian

Source: EMA (European Medicines Agency)

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:

Cūkas (nobarošanas)

Therapeutic area:

Imunoloģiskie līdzekļi 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:

Autorizēts

Authorization date:

2020-12-09

Patient Information leaflet

                                17
B. LIETOŠANAS INSTRUKCIJA
18
LIETOŠANAS INSTRUKCIJA
CIRCOMAX MYCO EMULSIJA INJEKCIJĀM CŪKĀM
1.
REĢISTRĀCIJAS APLIECĪBAS ĪPAŠNIEKA UN RAŽOŠANAS LICENCES
TURĒTĀJA, KURŠ ATBILD PAR SĒRIJAS IZLAIDI, NOSAUKUMS UN ADRESE, JA
DAŽĀDI
Reģistrācijas apliecības īpašnieks un par sērijas izlaidi
atbildīgais ražotājs:
Zoetis Belgium SA
Rue Laid Burniat 1
1348 Louvain-la-Neuve
BELĢIJA
2.
VETERINĀRO ZĀĻU NOSAUKUMS
CircoMax Myco emulsija injekcijām cūkām
3.
AKTĪVO VIELU UN CITU VIELU NOSAUKUMS
2 ml satur:
AKTĪVĀS VIELAS:
Inaktivēts, rekombinants himērisks cūku 1. tipa cirkovīruss, kas
satur cūku
2.a tipa cirkovīrusa atvērtā nolasīšanas rāmja (ORF2) proteīnu
Inaktivēts, rekombinants himērisks cūku 1. tipa cirkovīruss, kas
satur cūku
2.b tipa cirkovīrusa ORF2 proteīnu
Inaktivētas
_Mycoplasma hyopneumoniae_
, celms P-5722-3
1,5 – 4,9 RP*
1,5 – 5,9 RP*
1,5 – 4,7 RP*
ADJUVANTI:
Skvalāns
Poloksamērs 401
Polisorbāts 80
0,4% (v/v)
0,2% (v/v)
0,032% (v/v)
PALĪGVIELAS:
Tiomersāns
0,2 mg
*
Relatīvās potences vienība noteikta, kvantitatīvi nosakot
antigēnu ar ELISA (
_in vitro_
potences tests),
salīdzinot ar references vakcīnu.
Balta, viendabīga emulsija.
4.
INDIKĀCIJA(-S)
Cūku aktīvai imunizācijai pret cūku cirkovīrusu 2. tipu, lai
samazinātu vīrusa daudzumu asinīs un
limfātiskajos audos, izdalīšanos ar fekālijām un limfātisko audu
bojājumus, ko izraisa inficēšanās ar
PCV2. Tika pierādīta aizsardzība pret 2.a, 2.b un 2.d tipa cūku
cirkovīrusiem. Cūku aktīvai
imunizācijai pret
_Mycoplasma hyopneumoniae_
, lai mazinātu plaušu bojājumus, ko izraisa inficēšanās
ar
_Mycoplasma hyopneumoniae_
.
Imunitātes iestāšanās (abas vakcinācijas shēmas): 3 nedēļas
pēc (pēdējās) vakcinācijas.
Imunitātes ilgums (abas vakcinācijas shēmas): 23 nedēļas pēc
(pēdējās) vakcinācijas.
19
Turklāt ir pierādīts, ka vakcinācija samazina ķermeņa svara
pieauguma zudumu lauka apstākļos.
5.
KONTRINDIKĀCIJAS
Nav.
6.
IESPĒJAMĀS BLAKU
                                
                                Read the complete document

Summary of Product characteristics

                                1
I PIELIKUMS
VETERINĀRO ZĀĻU APRAKSTS
2
1.
VETERINĀRO ZĀĻU NOSAUKUMS
CircoMax Myco emulsija injekcijām cūkām
2.
KVALITATĪVAIS UN KVANTITATĪVAIS SASTĀVS
2 ml satur:
AKTĪVĀS VIELAS:
Inaktivēts, rekombinants himērisks cūku 1. tipa cirkovīruss, kas
satur cūku
2.a tipa cirkovīrusa atvērtā nolasīšanas rāmja (ORF2) proteīnu
Inaktivēts, rekombinants himērisks cūku 1. tipa cirkovīruss, kas
satur cūku
2.b tipa cirkovīrusa ORF2 proteīnu
Inaktivētas
_Mycoplasma hyopneumoniae, _
celms P-5722-3
_ _
1,5 – 4,9 RP*
1,5 – 5,9 RP*
1,5 – 4,7 RP*
ADJUVANTS:
Skvalāns
Poloksamērs 401
Polisorbāts 80
0,4% (v/v)
0,2% (v/v)
0,032% (v/v)
PALĪGVIELAS:
Tiomersāns
0,2 mg
*
Relatīvās potences vienība noteikta, kvantitatīvi nosakot
antigēnu ar ELISA (
_in vitro_
potences tests),
salīdzinot ar references vakcīnu.
Pilnu palīgvielu sarakstu skatīt 6.1. apakšpunktā.
3.
ZĀĻU FORMA
Emulsija injekcijām.
Balta, viendabīga emulsija.
4.
KLĪNISKĀ INFORMĀCIJA
4.1.
MĒRĶA SUGAS
Cūkas (nobarojamās).
4.2.
LIETOŠANAS INDIKĀCIJAS, NORĀDOT MĒRĶA SUGAS
Cūku aktīvai imunizācijai pret cūku cirkovīrusu 2. tipu, lai
samazinātu vīrusa daudzumu asinīs un
limfātiskajos audos, izdalīšanos ar fekālijām un limfātisko audu
bojājumus, ko izraisa inficēšanās ar
PCV2. Tika pierādīta aizsardzība pret 2.a, 2.b un 2.d tipa cūku
cirkovīrusiem.
Cūku aktīvai imunizācijai pret
_Mycoplasma hyopneumoniae,_
lai mazinātu plaušu bojājumus, ko izraisa
inficēšanās ar
_Mycoplasma hyopneumoniae._
Imunitātes iestāšanās (abas vakcinācijas shēmas): 3 nedēļas
pēc (pēdējās) vakcinācijas.
Imunitātes ilgums (abas vakcinācijas shēmas): 23 nedēļas pēc
(pēdējās) vakcinācijas.
Turklāt ir pierādīts, ka vakcinācija samazina ķermeņa svara
pieauguma zudumu lauka apstākļos.
3
4.3.
KONTRINDIKĀCIJAS
Nav.
4.4.
ĪPAŠI BRĪDINĀJUMI KATRAI MĒRĶA SUGAI
Vakcinēt tikai klīniski veselus dzīvniekus.
4.5.
ĪPAŠI PIESARDZĪBAS PASĀKUMI LIETOŠANĀ
Īpaši piesardzības pasākumi,
                                
                                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

Documents in other languages

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
Summary of Product characteristics Summary of Product characteristics Czech 01-01-1970
Public Assessment Report Public Assessment Report Czech 01-01-1970
Patient Information leaflet Patient Information leaflet Danish 01-01-1970
Summary of Product characteristics Summary of Product characteristics Danish 01-01-1970
Public Assessment Report Public Assessment Report Danish 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
Summary of Product characteristics Summary of Product characteristics Estonian 01-01-1970
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
Patient Information leaflet Patient Information leaflet French 01-01-1970
Summary of Product characteristics Summary of Product characteristics French 01-01-1970
Public Assessment Report Public Assessment Report French 01-01-1970
Patient Information leaflet Patient Information leaflet Italian 01-01-1970
Summary of Product characteristics Summary of Product characteristics Italian 01-01-1970
Public Assessment Report Public Assessment Report Italian 01-01-1970
Patient Information leaflet Patient Information leaflet Lithuanian 01-01-1970
Summary of Product characteristics Summary of Product characteristics Lithuanian 01-01-1970
Public Assessment Report Public Assessment Report Lithuanian 01-01-1970
Patient Information leaflet Patient Information leaflet Hungarian 01-01-1970
Summary of Product characteristics Summary of Product characteristics Hungarian 01-01-1970
Public Assessment Report Public Assessment Report Hungarian 01-01-1970
Patient Information leaflet Patient Information leaflet Maltese 01-01-1970
Summary of Product characteristics Summary of Product characteristics Maltese 01-01-1970
Public Assessment Report Public Assessment Report Maltese 01-01-1970
Patient Information leaflet Patient Information leaflet Dutch 01-01-1970
Summary of Product characteristics Summary of Product characteristics Dutch 01-01-1970
Public Assessment Report Public Assessment Report Dutch 01-01-1970
Patient Information leaflet Patient Information leaflet Polish 01-01-1970
Summary of Product characteristics Summary of Product characteristics Polish 01-01-1970
Public Assessment Report Public Assessment Report Polish 01-01-1970
Patient Information leaflet Patient Information leaflet Portuguese 01-01-1970
Summary of Product characteristics Summary of Product characteristics Portuguese 01-01-1970
Public Assessment Report Public Assessment Report Portuguese 01-01-1970
Patient Information leaflet Patient Information leaflet Romanian 01-01-1970
Summary of Product characteristics Summary of Product characteristics Romanian 01-01-1970
Public Assessment Report Public Assessment Report Romanian 01-01-1970
Patient Information leaflet Patient Information leaflet Slovak 01-01-1970
Summary of Product characteristics Summary of Product characteristics Slovak 01-01-1970
Public Assessment Report Public Assessment Report Slovak 01-01-1970
Patient Information leaflet Patient Information leaflet Slovenian 01-01-1970
Summary of Product characteristics Summary of Product characteristics Slovenian 01-01-1970
Public Assessment Report Public Assessment Report Slovenian 01-01-1970
Patient Information leaflet Patient Information leaflet Finnish 01-01-1970
Summary of Product characteristics Summary of Product characteristics Finnish 01-01-1970
Public Assessment Report Public Assessment Report Finnish 01-01-1970
Patient Information leaflet Patient Information leaflet Swedish 01-01-1970
Summary of Product characteristics Summary of Product characteristics Swedish 01-01-1970
Public Assessment Report Public Assessment Report Swedish 01-01-1970
Patient Information leaflet Patient Information leaflet Norwegian 01-01-1970
Summary of Product characteristics Summary of Product characteristics Norwegian 01-01-1970
Patient Information leaflet Patient Information leaflet Icelandic 01-01-1970
Summary of Product characteristics Summary of Product characteristics Icelandic 01-01-1970
Patient Information leaflet Patient Information leaflet Croatian 01-01-1970
Summary of Product characteristics Summary of Product characteristics Croatian 01-01-1970
Public Assessment Report Public Assessment Report Croatian 01-01-1970

Search alerts related to this product

Alerts CircoMax Myco Inactivated Mycoplasma hyopneumoniae, strain

CircoMax Myco Inactivated Mycoplasma hyopneumoniae, strain

View documents history

Documents history Documents history

CircoMax Myco