Respiporc Flu3
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
18-09-2020
Charakterystyka produktu
(SPC)
18-09-2020
Sprawozdanie z oceny publicznego
(PAR)
16-02-2021
Składnik aktywny:
inactivated influenza-A virus / swine
Dostępny od:
CEVA Santé Animale
Kod ATC:
QI09AA03
INN (International Nazwa):
inactivated influenza-A virus, swine
Grupa terapeutyczna:
Pigs
Dziedzina terapeutyczna:
Immunologicals
Wskazania:
Active immunisation of pigs from the age of 56 days onwards, including pregnant sows, against swine influenza caused by subtypes H1N1, H3N2 and H1N2 to reduce clinical signs and viral lung load after infection.Onset of immunity: 7 days after primary vaccinationDuration of immunity: 4 months in pigs vaccinated between the age of 56 and 96 days and 6 months in pigs vaccinated for the first time at 96 days and above.Active immunisation of pregnant sows after finished primary immunisation by administration of a single dose 14 days prior to farrowing to develop high colostral immunity, which provides clinical protection of piglets for at least 33 days after birth.
Podsumowanie produktu:
Revision: 5
Status autoryzacji:
Authorised
Data autoryzacji:
2010-01-14
Ulotka dla pacjenta
18
B. PACKAGE LEAFLET
19
PACKAGE LEAFLET:
RESPIPORC FLU3
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
Ceva Santé Animale
10 av. de La Ballastière
33500 Libourne
France
Manufacturer responsible for batch release:
IDT Biologika GmbH
Am Pharmapark
06861 Dessau-Rosslau
Germany
Ceva-Phylaxia Veterinary Biologicals Co. Ltd.
Szállás u. 5.
1107 Budapest
Hungary
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Respiporc FLU3 suspension for injection for pigs
3.
STATEMENT OF THE ACTIVE SUBSTANCES AND OTHER INGREDIENTS
Each dose of 2 ml contains:
ACTIVE SUBSTANCES:
Strains of inactivated Influenza A virus/swine/
Bakum/IDT1769/2003 (H3N2)
≥ 10.53 log
2
GMNU
1
Haselünne/IDT2617/2003 (H1N1)
≥ 10.22 log
2
GMNU
1
Bakum/1832/2000 (H1N2)
≥ 12.34 log
2
GMNU
1
1
GMNU = Geometric mean of neutralizing units induced in Guinea pigs
after twice immunisation with 0.5
ml of this vaccine
ADJUVANT:
Carbomer 971 P NF
2.0 mg
20
EXCIPIENT:
Thiomersal
0.21 mg
Clear, yellowish orange to pink coloured suspension for injection.
4.
INDICATION(S)
Active immunisation of pigs from the age of 56 days onwards including
pregnant sows against swine
influenza caused by subtypes H1N1, H3N2 and H1N2 to reduce clinical
signs and viral lung load after
infection.
Onset of immunity:
7 days after primary vaccination
Duration of immunity:
4 months in pigs vaccinated between the age of 56 and 96 days and
6 months in pigs vaccinated for the first time at 96 days and above.
Active immunisation of pregnant sows after finished primary
immunisation by administration of a single
dose 14 days prior to farrowing to develop high colostral immunity
which provides clinical protection of
piglets for at least 33 days after birth.
5.
CONTRAINDICATIONS
None.
6.
ADVERSE REACTIONS
A transient slight swelling may occur on very rare occasions after
vaccination at the site of injection,
regressing within 2 days. On
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Respiporc FLU3 suspension for injection for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 2 ml contains:
ACTIVE SUBSTANCES:
Strains of inactivated Influenza A virus/swine/
Bakum/IDT1769/2003 (H3N2)
≥ 10.53 log
2
GMNU
1
Haselünne/IDT2617/2003 (H1N1)
≥ 10.22 log
2
GMNU
1
Bakum/1832/2000 (H1N2)
≥ 12.34 log
2
GMNU
1
1
GMNU = Geometric mean of neutralizing units induced in Guinea pigs
after twice immunisation with
0.5 ml of this vaccine
ADJUVANT:
Carbomer 971 P NF
2.0 mg
EXCIPIENT:
Thiomersal
0.21 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Clear, yellowish orange to pink coloured suspension for injection.
4.
CLINICAL PARTICULARS
4.1.
TARGET SPECIES
Pigs
4.2.
INDICATION FOR USE, SPECIFYING THE TARGET SPECIES
Active immunisation of pigs from the age of 56 days onwards including
pregnant sows against swine
influenza caused by subtypes H1N1, H3N2 and H1N2 to reduce clinical
signs and viral lung load after
infection.
Onset of immunity:
7 days after primary vaccination
Duration of immunity:
4 months in pigs vaccinated between the age of 56 and 96 days and
6 months in pigs vaccinated for the first time at 96 days and above.
3
Active immunisation of pregnant sows after finished primary
immunisation by administration of a single
dose 14 days prior to farrowing to develop high colostral immunity
which provides clinical protection of
piglets for at least 33 days after birth.
4.3.
CONTRAINDICATIONS
None.
4.4.
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
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
In case of accidental self-injection only a minor injection site
reaction is expected.
4.6.
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
A transient slight swelling may occur on very rare occasions after
vaccination at the site of injection,
reg
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