Suvaxyn PCV
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
15-04-2020
Karatteristiċi tal-prodott
(SPC)
15-04-2020
Rapport ta 'Valutazzjoni Pubblika
(PAR)
15-04-2020
Ingredjent attiv:
porcine circovirus recombinant virus (CPCV) 1-2, inactivated
Disponibbli minn:
Zoetis Belgium SA
Kodiċi ATC:
QI09AA07
INN (Isem Internazzjonali):
adjuvanted inactivated vaccine against porcine circovirus type 2 in piglets
Grupp terapewtiku:
Pigs (piglets)
Żona terapewtika:
Immunologicals
Indikazzjonijiet terapewtiċi:
Active immunisation of pigs over the age of three weeks against porcine circovirus type 2 (PCV2) to reduce viral load in blood and lymphoid tissues, and the lesions in lymphoid tissues associated with PCV2 infection, as well as to reduce clinical signs - including loss of daily weight gain, and mortality associated with post-weaning multisystemic wasting syndrome.
Sommarju tal-prodott:
Revision: 13
L-istatus ta 'awtorizzazzjoni:
Withdrawn
Data ta 'l-awtorizzazzjoni:
2009-07-24
Fuljett ta 'informazzjoni
Medicinal product no longer authorised
16
B. PACKAGE LEAFLET
Medicinal product no longer authorised
17
PACKAGE LEAFLET:
SUVAXYN
PCV SUSPENSION 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 authorisation holder:
Zoetis Belgium SA
Rue Laid Burniat 1
1348 Louvain-la-Neuve
BELGIUM
Manufacturer responsible for batch release:
Zoetis Manufacturing & Research Spain, S.L.
Ctra. Camprodón s/n "la Riba"
17813 Vall de Bianya
Girona
SPAIN
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Suvaxyn PCV suspension for injection for pigs
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
One dose of 2 ml contains:
ACTIVE SUBSTANCE:
Inactivated recombinant Porcine Circovirus type 1 expressing the
Porcine Circovirus type 2 ORF2 protein
1.6
≤
RP*
≤
5.3
ADJUVANTS:
Sulfolipo-cyclodextrin (SLCD)
4 mg
Squalane
64 mg
EXCIPIENTS:
Thiomersal
0.1 mg
*
Relative Potency unit determined by ELISA antigen quantification (
_in vitro_
potency test) compared
to a reference vaccine.
A milky white to pink opaque liquid, free from visible particles
4.
INDICATION(S)
Active immunisation of pigs over the age of 3 weeks against Porcine
Circovirus Type 2 (PCV2) to
reduce viral load in blood and lymphoid tissues, and the lesions in
lymphoid tissues associated with
PCV2 infection, as well as to reduce clinical signs - including loss
of daily weight gain, and mortality
associated with Post-Weaning Multisystemic Wasting Syndrome (PMWS).
Onset of immunity: from 3 weeks post-vaccination.
Duration of immunity: 19 weeks post-vaccination
Medicinal product no longer authorised
18
5.
CONTRAINDICATIONS
None.
6.
ADVERSE REACTIONS
A transient increase in body temperature (up to 1.7 °C) is very
common during the first 24 hours after
vaccination. This resolves spontaneously within 48 hours without
treatment.
Local tissue reactions in the form of swelling at the injection site
are very common and may last for up
to 26 days. The
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Karatteristiċi tal-prodott
Medicinal product no longer authorised
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Suvaxyn PCV suspension for injection for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose of 2 ml contains:
ACTIVE SUBSTANCE:
Inactivated recombinant Porcine Circovirus type 1 expressing the
Porcine Circovirus type 2 ORF2 protein
1.6
≤
RP*
≤
5.3
ADJUVANTS:
Sulfolipo-cyclodextrin (SLCD)
4 mg
Squalane
64 mg
EXCIPIENTS:
Thiomersal
0.1 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
Suspension for injection
A milky white to pink opaque liquid, free from visible particles
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs (piglets) from 3 weeks of age.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Active immunisation of pigs over the age of 3 weeks against Porcine
Circovirus type 2 (PCV2) to
reduce viral load in blood and lymphoid tissues, and the lesions in
lymphoid tissues associated with
PCV2 infection, as well as to reduce clinical signs - including loss
of daily weight gain, and mortality
associated with Post-Weaning Multisystemic Wasting Syndrome (PMWS).
Onset of immunity: from 3 weeks post-vaccination.
Duration of immunity: 19 weeks post-vaccination.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
Do not use in breeding boars.
Medicinal product no longer authorised
3
The benefit of the vaccination of pigs with very high levels of
maternally-derived antibodies, e.g. due
to vaccination of their mothers, has not been demonstrated.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Avoid stress in the animals before and after the time of vaccination.
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals
In case of accidental self-injection, seek medical
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