Porcilis PCV M Hyo
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
18-06-2020
Charakterystyka produktu
(SPC)
18-06-2020
Sprawozdanie z oceny publicznego
(PAR)
04-09-2018
Składnik aktywny:
Porcine circovirus type 2 (PCV2) ORF2 subunit antigen, Mycoplasma hyopneumoniae J strain inactivated
Dostępny od:
Intervet International B.V.
Kod ATC:
QI09AL08
INN (International Nazwa):
porcine circovirus type 2 ORF2 subunit antigen, Mycoplasma hyopneumoniae inactivated
Grupa terapeutyczna:
Pigs (for fattening)
Dziedzina terapeutyczna:
Immunologicals for suidae, Inactivated viral and inactivated bacterial vaccines
Wskazania:
For the active immunisation of pigs to reduce viraemia, virus load in lungs and lymphoid tissues, virus shedding caused by porcine circovirus type 2 (PCV2) infection, and severity of lung lesions caused by Mycoplasma hyopneumoniae infection. To reduce the loss of daily weight gain during the finishing period in face of infections with Mycoplasma hyopneumoniae and/or PCV2 (as observed in field studies)
Podsumowanie produktu:
Revision: 7
Status autoryzacji:
Authorised
Data autoryzacji:
2014-11-06
Ulotka dla pacjenta
18
B. PACKAGE LEAFLET
19
PACKAGE LEAFLET:
PORCILIS PCV M HYO 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 authorisation holder and manufacturer responsible for batch
release:
Intervet International BV
Wim de Körverstraat 35
5831 AN Boxmeer
The NETHERLANDS
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Porcilis PCV M Hyo emulsion for injection for pigs
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
2 ml contains:
ACTIVE SUBSTANCES:
Porcine circovirus type 2 (PCV2) ORF2 subunit antigen
≥
2,828 AU
1
_Mycoplasma hyopneumoniae _
J strain inactivated
≥
2.69 RPU
2
ADJUVANTS:
Light mineral oil
0.268 ml
Aluminium (as hydroxide)
2.0 mg.
1
Antigenic units as determined in the
_in vitro_
potency test (ELISA).
2
Relative potency units defined against a reference vaccine.
Homogenous white to nearly white emulsion after shaking.
4.
INDICATION(S)
For the active immunisation of pigs to reduce viraemia, virus load in
lungs and lymphoid tissues, virus
shedding caused by porcine circovirus type 2 (PCV2) infection, and
severity of lung lesions caused by
_Mycoplasma hyopneumoniae_
infection. To reduce the loss of daily weight gain during the
finishing
period in face of infections with
_Mycoplasma hyopneumoniae_
and/or PCV2 (as observed in field
studies).
Onset of immunity with single dose vaccination:
PCV2: 2 weeks after vaccination.
_M. hyopneumoniae:_
4 weeks after vaccination.
Onset of immunity with two dose vaccination:
PCV2: 18 days after the first vaccination.
_M. hyopneumoniae_
: 3 weeks after the second vaccination.
Duration of immunity (both vaccination schedules):
PCV2: 22 weeks after (the last) vaccination.
_M. hyopneumoniae_
: 21 weeks after (the last) vaccination.
20
5.
CONTRAINDICATIONS
None.
6.
ADVERSE REACTIONS
In laboratory studies and field trials:
A transient increase in body temperature very commonly occurs on the
day of vaccination (mean
±1 °C, in ind
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Porcilis PCV M Hyo emulsion for injection for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
2 ml contains:
ACTIVE SUBSTANCES:
Porcine circovirus type 2 (PCV2) ORF2 subunit antigen
≥
2,828 AU
1
_Mycoplasma hyopneumoniae_
J strain inactivated
≥
2.69 RPU
2
ADJUVANTS:
Light mineral oil
0.268 ml
Aluminium (as hydroxide)
2.0 mg.
1
Antigenic units as determined in the
_in vitro_
potency test (ELISA).
2
Relative potency units defined against a reference vaccine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Emulsion for injection.
Homogenous white to nearly white emulsion after shaking.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs for fattening
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the active immunisation of pigs to reduce viraemia, virus load in
lungs and lymphoid tissues, virus
shedding caused by porcine circovirus type 2 (PCV2) infection, and
severity of lung lesions caused by
_Mycoplasma hyopneumoniae_
infection. To reduce the loss of daily weight gain during the
finishing
period in face of infections with
_Mycoplasma hyopneumoniae_
and/or PCV2 (as observed in field
studies).
Onset of immunity with single dose vaccination:
PCV2: 2 weeks after vaccination
_M. hyopneumoniae_
: 4 weeks after vaccination.
Onset of immunity with two dose vaccination:
PCV2: 18 days after first vaccination
_M. hyopneumoniae_
: 3 weeks after the second vaccination.
Duration of immunity (both vaccination schedules):
PCV2: 22 weeks after (the last) vaccination
_M. hyopneumoniae_
: 21 weeks after (the last) vaccination.
4.3
CONTRAINDICATIONS
3
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Not applicable.
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals
To the user:
This veterinary medicinal product contains mineral oil. Accidental
injecti
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