Poulvac SHS Vaccine lyophilisate for suspension for spray, eye drop or nose drop administration for chickens

Land: Bretland

Tungumál: enska

Heimild: VMD (Veterinary Medicines Directorate)

Virkt innihaldsefni:

Avian pneumovirus

Fáanlegur frá:

Zoetis UK Limited

ATC númer:

QI01AD01

INN (Alþjóðlegt nafn):

Avian pneumovirus

Lyfjaform:

Lyophilisate for oculonasal suspension

Gerð lyfseðils:

POM-V - Prescription Only Medicine – Veterinarian

Meðferðarhópur:

Chickens

Lækningarsvæði:

Live Viral Vaccine

Leyfisstaða:

Expired

Leyfisdagur:

1998-01-14

Vara einkenni

Revised: August 2020
AN: 00620/2020
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Poulvac SHS Vaccine lyophilisate for suspension for spray, eye drop or
nose drop
administration for chickens.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose contains:
ACTIVE SUBSTANCE:
Attenuated Avian Pneumovirus, strain clone K 10
3.2
- 10
4.5
*CCID
50
* CCID50 = Cell Culture Infectious Dose 50%
EXCIPIENTS:
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate for suspension for spray, eye drop or nose drop
administration
Cream coloured lyophilisate
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Chickens.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of broiler chickens to reduce clinical signs
associated with
infection with avian pneumovirus.
Onset of immunity: Immunity to challenge has been demonstrated 4 weeks
after
vaccination.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only
4.5
SPECIAL PRECAUTIONS FOR USE
Revised: August 2020
AN: 00620/2020
Page 2 of 5
Special precautions for use in animals
In order to prevent risks of dissemination of the vaccine in the site,
all the birds at
the same site should be correctly vaccinated.
There is a possibility that the virus may be disseminated to other
avian species
and care should be taken to avoid contact with other birds.
Special
precautions
to
be
taken
by
the
person
administering
the
veterinary
medicinal product to animals
If the vaccine is administered by spray, personal protective equipment
consisting
of safety goggles and a dust mask or a helmet with filtered air
circulation should
be worn.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
None.
4.7
USE DURING PREGNANCY, LACTATION OR LAY
Do not use in chickens in lay.
4.8
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Safety and efficacy data are available which demonstrate that this
vaccine can be
administered on the same day but not mixed with