Ingelvac PCV FLEX
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
30-11-2017
Charakterystyka produktu
(SPC)
30-11-2017
Sprawozdanie z oceny publicznego
(PAR)
08-06-2017
Składnik aktywny:
porcine circovirus type 2 ORF2 protein
Dostępny od:
Boehringer Ingelheim Vetmedica GmbH
Kod ATC:
QI09AA07
INN (International Nazwa):
Porcine circovirus vaccine (inactivated)
Grupa terapeutyczna:
Pigs
Dziedzina terapeutyczna:
Immunologicals for suidae
Wskazania:
For active immunisation of pigs with no PCV2 maternally derived antibodies from the age of 2 weeks against porcine circovirus type 2 (PCV2),
Podsumowanie produktu:
Revision: 2
Status autoryzacji:
Withdrawn
Data autoryzacji:
2017-05-24
Ulotka dla pacjenta
16
B. PACKAGE LEAFLET
17
PACKAGE LEAFLET:
INGELVAC PCV FLEX 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 and manufacturer responsible for batch
release:
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Ingelvac PCV FLEX suspension for injection for pigs
3.
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS
Each dose (1 ml) contains:
Porcine circovirus type 2 ORF2 protein: RP* 1.0–3.75
* Relative potency (ELISA test) by comparison with a reference
vaccine.
Adjuvant: Carbomer 1 mg.
Clear to slightly opalescent, colourless to yellowish suspension for
injection.
4.
INDICATIONS
For active immunisation of pigs with no PCV2 maternally derived
antibodies from the age of 2 weeks
against porcine circovirus type 2 (PCV2).
Under experimental challenge conditions in which only seronegative
animals were included, it was
demonstrated that vaccination reduces mortality, clinical signs and
lesions in lymphoid tissues
associated with PCV2 related diseases (PCVD). In addition, vaccination
has been shown to reduce
PCV2 nasal shedding, viral load in blood and lymphoid tissues, and
duration of viraemia.
Onset of immunity:
2 weeks post vaccination
Duration of immunity:
at least 17 weeks.
5.
CONTRAINDICATIONS
None.
6.
ADVERSE REACTIONS
A mild and transient hyperthermia very commonly occurs on the day of
vaccination.
On very rare occasions anaphylactic reactions may occur and should be
treated symptomatically.
The frequency of adverse reactions is defined using the following
convention:
-
very common (more than 1 in 10 animals treated displaying adverse
reactions)
-
common (more than 1 but less than 10 animals in 100 animals treated)
-
uncommon (more than 1 but less than 10 animals in 1,000 animals
treated)
-
rare (more than 1 but less than 10 animals in 10,000 animals treated)
18
-
very rare (less than 1
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Ingelvac PCV FLEX suspension for injection for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose (1 ml) contains:
ACTIVE SUBSTANCE:
Porcine circovirus type 2 ORF2 protein
RP* 1.0–3.75
* Relative potency (ELISA test) by comparison with a reference vaccine
ADJUVANT:
Carbomer
1 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
Clear to slightly opalescent, colourless to yellowish suspension for
injection.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of pigs with no PCV2 maternally derived
antibodies from the age of 2 weeks
against porcine circovirus type 2 (PCV2).
Under experimental challenge conditions in which only seronegative
animals were included, it was
demonstrated that vaccination reduces mortality, clinical signs and
lesions in lymphoid tissues
associated with PCV2 related disease (PCVD).
In addition, vaccination has been shown to reduce PCV2 nasal shedding,
viral load in blood and
lymphoid tissues, and duration of viraemia.
Onset of immunity:
2 weeks post vaccination
Duration of immunity:
at least 17 weeks.
4.3
CONTRAINDICATIONS
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.
3
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals
Not applicable.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
A mild and transient hyperthermia very commonly occurs on the day of
vaccination.
On very rare occasions anaphylactic reactions may occur and should be
treated symptomatically.
The frequency of adverse reactions is defined using the following
convention:
-
very common (more than 1 in 10 animals treated displaying adverse
reactions)
-
common (more than 1 but less than 10 animals in 100 animals treated)
-
uncommon (m
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