Suvaxyn Circo+MH RTU
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
03-11-2021
Produktets egenskaber
(SPC)
03-11-2021
Offentlige vurderingsrapport
(PAR)
15-06-2017
Aktiv bestanddel:
Inactivated recombinant chimeric porcine circovirus type 1 containing the porcine circovirus type 2 ORF2 protein, Inactivated Mycoplasma hyopneumoniae, strain P-5722-3
Tilgængelig fra:
Zoetis Belgium SA
ATC-kode:
QI09AL
INN (International Name):
Porcine circovirus and porcine enzootic pneumonia vaccine (inactivated)
Terapeutisk gruppe:
Pigs
Terapeutisk område:
Inactivated viral and inactivated bacterial vaccines
Terapeutiske indikationer:
For active immunisation of pigs from 3 weeks of age against porcine circovirus type 2 (PCV2) to reduce viral load in blood and lymphoid tissues and fecal shedding caused by infection with PCV2.For active immunisation of pigs over the age of 3 weeks against Mycoplasma hyopneumoniae to reduce lung lesions caused by infection with M. hyopneumoniae.
Produkt oversigt:
Revision: 7
Autorisation status:
Authorised
Autorisation dato:
2015-11-06
Indlægsseddel
15
B. PACKAGE LEAFLET
16
PACKAGE LEAFLET:
SUVAXYN CIRCO+MH RTU EMULSION FOR INJECTION FOR PIGS
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorization holder and manufacturer responsible for batch
release:
Zoetis Belgium SA
Rue Laid Burniat 1
1348 Louvain-la-Neuve
BELGIUM
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Suvaxyn Circo+MH RTU emulsion for injection for pigs
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each dose (2 ml) contains:
ACTIVE SUBSTANCES:
Inactivated recombinant chimeric porcine circovirus type 1 containing
the
porcine circovirus type 2 ORF2 protein
Inactivated
_Mycoplasma hyopneumoniae, _
strain P-5722-3
_ _
2.3 – 12.4 RP*
1.5 – 3.8 RP*
ADJUVANT:
Squalane
Poloxamer 401
Polysorbate 80
0.4% (v/v)
0.2% (v/v)
0.032% (v/v)
EXCIPIENTS:
Thiomersal
0.2 mg
*
Relative potency unit determined by ELISA antigen quantification (
_in vitro _
potency test) compared
to a reference vaccine.
White homogenous emulsion.
4.
INDICATION(S)
For active immunisation of pigs from 3 weeks of age against Porcine
Circovirus type 2 (PCV2) to
reduce viral load in blood and lymphoid tissues and fecal shedding
caused by infection with
PCV2.
For active immunization of pigs from 3 weeks of age against
_Mycoplasma hyopneumoniae _
to reduce
lung lesions caused by infection with
_M. hyopneumoniae_
.
Onset of immunity: 3 weeks after vaccination.
Duration of immunity: 23 weeks after vaccination.
17
5.
CONTRAINDICATIONS
None.
6.
ADVERSE REACTIONS
A transient increase in body temperature (on average 1 °C) was very
commonly observed during the first
24 hours after vaccination in laboratory and field trials. In
individual pigs the temperature increase
compared to pre-treatment may commonly exceed 2 °C. This resolves
spontaneously within 48 hours
without treatment.
Local tissue reactions in the form of swelling at the injection site,
which may be associated with local
heat, redness and pain at palpatio
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Suvaxyn Circo+MH RTU emulsion for injection for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose (2 ml) contains:
ACTIVE SUBSTANCES:
Inactivated recombinant chimeric porcine circovirus type 1 containing
the
porcine circovirus type 2 ORF2 protein
Inactivated
_Mycoplasma hyopneumoniae, _
strain P-5722-3
_ _
2.3 – 12.4 RP*
1.5 – 3.8 RP*
ADJUVANT:
Squalane
Poloxamer 401
Polysorbate 80
EXCIPIENTS:
0.4% (v/v)
0.2% (v/v)
0.032% (v/v)
Thiomersal
0.2 mg
*
Relative potency unit determined by ELISA antigen quantification (
_in vitro _
potency test) compared to
a reference vaccine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Emulsion for injection.
White homogenous emulsion.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs (for fattening).
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of pigs from 3 weeks of age against Porcine
Circovirus type 2 (PCV2) to
reduce viral load in blood and lymphoid tissues and fecal shedding
caused by infection with PCV2.
For active immunization of pigs from the age of 3 weeks against
_Mycoplasma hyopneumoniae _
to
reduce lung lesions caused by infection with
_M. hyopneumoniae_
.
Onset of immunity: 3 weeks after vaccination.
Duration of immunity: 23 weeks after vaccination.
4.3
CONTRAINDICATIONS
None.
3
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate only healthy animals.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
No information is available on the safety of this vaccine in breeding
boars. Do not use in breeding
boars.
Special precautions to be taken by the person administering the
veterinary medicinal product to animals
In case of accidental self-injection, seek medical advice immediately
and show the package leaflet or the
label to the physician.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
A transient increase in body temperature (on average 1 °C) was very
commonly observed during the
firs
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