Suvaxyn Aujeszky 783 + O/W, lyophilisate and solvent for emulsion for injection for pigs

Land: Bretland

Tungumál: enska

Heimild: VMD (Veterinary Medicines Directorate)

Virkt innihaldsefni:

Aujeszky's disease virus

Fáanlegur frá:

Zoetis UK Limited

ATC númer:

QI09AD01

INN (Alþjóðlegt nafn):

Aujeszky's disease virus

Lyfjaform:

Lyophilisate and solvent for emulsion for injection

Gerð lyfseðils:

POM-V - Prescription Only Medicine – Veterinarian

Meðferðarhópur:

Pigs

Lækningarsvæði:

Live Viral Vaccine

Leyfisstaða:

Authorized

Leyfisdagur:

1998-08-07

Vara einkenni

Revised: March 2021
AN: 01256/2020
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
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

l
Mannide mono oleate (Arlacel A)
46

l
Polysorbate 80 (Tween 80)
17

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.
Revised: March 2021
AN: 01256/2020
Page 2 of 6
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.
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 admin