Avishield IBD Plus, Lyophilisate for Use in Drinking Water, for Chickens

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: VMD (Veterinary Medicines Directorate)

קנה את זה

הורד מאפייני מוצר (SPC)
13-12-2022

מרכיב פעיל:

Infectious bursal disease virus

זמין מ:

Genera Inc.

קוד ATC:

QI01AD09

INN (שם בינלאומי):

Infectious bursal disease virus

טופס פרצבטיות:

Lyophilisate for use in drinking water

סוג מרשם:

POM-V - Prescription Only Medicine – Veterinarian

קבוצה תרפויטית:

Chickens

איזור תרפויטי:

Live Viral Vaccine

מצב אישור:

Authorized

תאריך אישור:

2020-06-10

מאפייני מוצר

                                Issued: June 2020
AN: 00262/2019
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Avishield IBD Plus, lyophilisate for use in drinking water, for
chickens
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose contains
ACTIVE SUBSTANCE:
Attenuated live Infectious Bursal Disease virus,
Intermediate plus strain G6
10
1.9
- 10
3.2
EID
50
*
*EID
50
= 50% embryo infective dose
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate for use in drinking water.
Cream to red-brown coloured lyophilisate.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Chickens (broilers, future layers and breeders).
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of chickens (broilers, future layers and
breeders) with
maternally derived antibodies (break-through titre: ≤500 IDEXX ELISA
units) to
reduce clinical disease and bursal lesions due to infection caused by
Avian Infectious
Bursal Disease (IBD) viruses.
Chickens can be vaccinated from 10 days of age.
Onset of immunity: 2 weeks after vaccination
Duration of immunity: 5 weeks after vaccination
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
See section 4.9.
Vaccinate healthy animals only.
Issued: June 2020
AN: 00262/2019
Page 2 of 6
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
The
vaccine
strain
can
spread
to
susceptible,
unvaccinated
chickens
following
vaccination for at least 5 days. The spread does not induce clinical
signs.
It is possible that the vaccine virus spreads to non-target
susceptible species.
Care
should
be
taken
to
ensure
that
the
vaccine
virus
does
not
spread
to
unvaccinated birds. Therefore, all birds in a flock should be
vaccinated at the same
time to reduce the risk of bird to bird transmission. Vaccinated birds
should not be
mixed with unvaccinated birds. Hygiene measures should be taken to
prevent spread
to other flocks. Vaccination of all chickens on the premises is
recommended.
Housing needs to be disi
                                
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