Suvaxyn Aujeszky 783 + O/W
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
22-02-2021
Charakterystyka produktu
(SPC)
22-02-2021
Sprawozdanie z oceny publicznego
(PAR)
22-07-2013
Składnik aktywny:
live attenuated Aujeszky's disease virus
Dostępny od:
Zoetis Belgium SA
Kod ATC:
QI09AA01
INN (International Nazwa):
live attenuated Aujeszky's disease virus
Grupa terapeutyczna:
Pigs
Dziedzina terapeutyczna:
Immunologicals
Wskazania:
Active immunisation of pigs from the age of 10 weeks to prevent the mortality and clinical signs of Aujeszky's disease and to reduce the excretion of Aujeszky's disease field virus. Passive immunisation of the progeny of vaccinated gilts and sows to reduce mortality and clinical signs of Aujeszky's disease and to reduce the excretion of Aujeszky's disease field virus.
Podsumowanie produktu:
Revision: 15
Status autoryzacji:
Authorised
Data autoryzacji:
1998-08-07
Ulotka dla pacjenta
18
B. PACKAGE LEAFLET
19
PACKAGE LEAFLET:
SUVAXYN AUJESZKY 783 + O/W, LYOPHILISATE AND SOLVENT FOR 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:
Zoetis Belgium SA
Rue Laid Burniat 1
1348 Louvain-la-Neuve
BELGIUM
Manufacturer responsible for batch release:
Zoetis Manufacturing & Research Spain, S.L.
Ctra. de Camprodón, s/n°
Finca La Riba
Vall de Bianya
Gerona, 17813
SPAIN
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Suvaxyn Aujeszky 783 + O/W, lyophilisate and solvent for emulsion for
injection for pigs
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each dose (2 ml contains:
Lyophilisate:
ACTIVE SUBSTANCE:
Live attenuated Aujeszky’s disease virus, strain NIA
3
-783
≥
10
5.2
CCID
50
*
*CCID
50
– the quantity of virus, which infects 50 % of the cell cultures
inoculated.
Solvent:
Aluminium hydroxide, Mineral oil (Marcol 52), Mannide mono oleate
(Arlacel A), Polysorbate 80
(Tween 80), Thiomersal.
Appearance of the veterinary medicinal product before reconstitution:
Solvent: White, non-transparent liquid
Lyophilisate: Cream coloured lyophilisate
4.
INDICATION(S)
Active immunisation of pigs from the age of 10 weeks to prevent the
mortality and clinical signs of
Aujeszky’s disease and to reduce the excretion of Aujeszky’s
disease field virus.
Passive immunisation of the progeny of vaccinated gilts and sows to
reduce mortality and clinical
signs of Aujeszky’s disease and to reduce the excretion of
Aujeszky’s disease field virus.
Onset of immunity: 3 weeks after basic vaccination.
Duration of immunity 3 months after basic vaccination.
20
5.
CONTRAINDICATIONS
None.
6.
ADVERSE REACTIONS
Slight, transient and local reactions up to 2 cm in diameter after
first vaccination and up to 5 cm after
second vaccination have been very commonly reported to occur in up to
50% of the pigs in laboratory
studies and field trials. In general, thes
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Suvaxyn Aujeszky 783 + O/W, lyophilisate and solvent for emulsion for
injection for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose (2 ml) contains:
Lyophilisate:
ACTIVE SUBSTANCE:
Live attenuated Aujeszky’s disease virus, strain NIA
3
-783
≥
10
5.2
CCID
50
*
*CCID
50
– the quantity of virus, which infects 50 % of the cell cultures
inoculated.
Solvent:
ADJUVANTS
:
Aluminium hydroxide
2.1 mg
Mineral oil (Marcol 52)
425
µ
l
Mannide mono oleate (Arlacel A)
46
µ
l
Polysorbate 80 (Tween 80)
17
µ
l
EXCIPIENT:
Thiomersal
0.15 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate and solvent for emulsion for injection.
Appearance of the veterinary medicinal product before reconstitution:
Solvent: White, non-transparent liquid
Lyophilisate: Cream coloured lyophilisate
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Active immunisation of pigs from the age of 10 weeks to prevent the
mortality and clinical signs of
Aujeszky’s disease and to reduce the excretion of Aujeszky’s
disease field virus. Passive
immunisation of the progeny of vaccinated gilts and sows to reduce
mortality and clinical signs of
Aujeszky’s disease and to reduce the excretion of Aujeszky’s
disease field virus.
Onset of immunity: 3 weeks after basic vaccination.
Duration of immunity: 3 months after basic vaccination.
3
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
The presence of maternal antibodies against Aujeszky’s disease virus
may have a negative influence
on the result of vaccination.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Each piglet of vaccinated gilts or sows should ingest a sufficient
quantity of colostrum and milk.
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals
Wash and disinfect hands and
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