Gripovac 3
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
04-09-2018
Charakterystyka produktu
(SPC)
04-09-2018
Sprawozdanie z oceny publicznego
(PAR)
04-09-2018
Składnik aktywny:
inactivated influenza-A virus, swine
Dostępny od:
Merial S.A.S.
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 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.
Podsumowanie produktu:
Revision: 1
Status autoryzacji:
Withdrawn
Data autoryzacji:
2010-01-14
Ulotka dla pacjenta
Medicinal product no longer authorised
16
B. PACKAGE LEAFLET
Medicinal product no longer authorised
17
PACKAGE LEAFLET FOR:
GRIPOVAC 3
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:
MERIAL
29 avenue Tony Garnier
69007 Lyon,
France
Manufacturer responsible for batch release
:
IDT Biologika GmbH
Am Pharmapark
06861 Dessau-Rosslau
Germany
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Gripovac 3 suspension for injection for pigs
3.
STATEMENT OF THE ACTIVE SUBSTANCES AND OTHER INGREDIENTS
Clear, yellowish orange to pink colored suspension for injection.
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 (H1N
2
)
≥ 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
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.
Medicinal product no longer authorised
18
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 wit
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Charakterystyka produktu
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
Gripovac 3 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 colored 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.
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.
Medicinal product no longer authorised
3
4.3.
CONTRAINDICATIONS
None.
4.4.
SPECIAL WARNINGS FOR THE 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 SERIOUSNES
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