POULVAC IBMM + ARK Lyophilisate for suspension for spray administration for chickens

Երկիր: Իռլանդիա

Լեզու: անգլերեն

Աղբյուրը: HPRA (Health Products Regulatory Authority)

Ակտիվ բաղադրիչ:

Avian infectious bronchitis virus strain massachusetts 1263; Avian infectious bronchitis virus strain arkansas 3168

Հասանելի է:

Zoetis Belgium S.A.

ATC կոդը:

QI01AD07

INN (Միջազգային անվանումը):

Avian infectious bronchitis virus strain massachusetts 1263; Avian infectious bronchitis virus strain arkansas 3168

Դոզան:

.

Դեղագործական ձեւ:

Lyophilisate for suspension for spray administration

Ռեկվիզորի տեսակը:

POM: Prescription Only Medicine as defined in relevant national legislation

Թերապեւտիկ խումբ:

Chickens

Թերապեւտիկ տարածք:

avian infectious bronchitis virus

Թերապեւտիկ ցուցումներ:

Immunological - Live Vaccine

Լիազորման կարգավիճակը:

Authorised

Հաստատման ամսաթիվը:

2013-12-09

Ապրանքի հատկությունները

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
POULVAC IBMM + ARK
Lyophilisate for suspension for spray administration for chickens.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose contains:
ACTIVE SUBSTANCES:
Live avian infectious bronchitis virus
10
3.3 –
10
5.8
EID
50
*
(Strain Massachusetts1263 and Strain Arkansas 3168)
*EID
50
: Embryo infective dose 50%
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate for suspension for spray administration.
Off-white to cream coloured lyophilisate.
Upon reconstitution, transparent to white opaque suspension (depending
on the volume of water used).
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Chickens (broilers).
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the active immunisation of broilers to reduce the severity of
upper respiratory tract infections caused
by Massachusetts and 793/B/91-type strains of avian infectious
bronchitis virus.
Onset of immunity: 21 days after vaccination
Duration of immunity: 6 weeks after vaccination
Protection has also been demonstrated in the presence of maternally
derived antibodies.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Do not re-vaccinate birds.
Spray vaccination should not be used if an intercurrent infection is
suspected.
Avian infectious bronchitis virus strains Massachusetts and Arkansas
may spread to in contact birds. The
duration of spreading of the vaccine virus is for up to 30 days
following vaccination.
It is recommended that all chickens on a site be vaccinated with this
product.
Do not use on mixed sites of broilers and breeders.
The product should only be used where it has been established that
793/B/91 like avian infectious
bronchitis virus serotypes are epidemiologically relevant in the area.
Special precautions should be taken to avoid spread of the vaccine
virus from vaccinates to pheasants
Special precautions to be taken by