Poulvac TRT Vaccine, Lyophilisate for Suspension for Spray, Eye Drop or Nose Drop administration for Turkeys.

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: VMD (Veterinary Medicines Directorate)

Nunua Sasa

Shusha Tabia za bidhaa (SPC)
18-07-2023

Viambatanisho vya kazi:

Avian pneumovirus

Inapatikana kutoka:

Zoetis UK Limited

ATC kanuni:

QI01CD01

INN (Jina la Kimataifa):

Avian pneumovirus

Dawa fomu:

Lyophilisate for oculonasal suspension

Dawa ya aina:

POM-V - Prescription Only Medicine – Veterinarian

Kundi la matibabu:

Turkeys

Eneo la matibabu:

Live Viral Vaccine

Idhini hali ya:

Authorized

Idhini ya tarehe:

1997-11-05

Tabia za bidhaa

                                Revised: July 2021
AN: 00427/2021 & 00428/2021
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Poulvac TRT vaccine, lyophilisate for suspension for spray, eye drop
or nose drop
administration for turkeys.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose contains:
ACTIVE SUBSTANCE:
Attenuated turkey rhinotracheitis virus, strain clone K
10
3.2
- 10
4.5
*CCID
50
* CCID
50
= 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
Turkeys.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of turkeys to reduce clinical signs associated
with infection
with TRT.
Onset of immunity: Immunity to challenge has been demonstrated 3 weeks
after
vaccination
Duration of immunity: 14 weeks.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
Revised: July 2021
AN: 00427/2021 & 00428/2021
Page 2 of 6
The use of the vaccine in turkeys older than 10 days does not induce
sufficient
protection due to the resistance against TRT increasing with age.
4.5
SPECIAL PRECAUTIONS FOR USE
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.
Do not vaccinate in mixed breeding farms where turkeys and other avian
species,
except chickens, are raised. The virus contained in the vaccine was
shown to spread
for approximately 10 days. This spreading appeared to be without any
consequence
for chickens.
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 
                                
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