GALLIVAC IB88 NEO EFFERVESCENT TABLET FOR SUSPENSION FOR NEBULISATION FOR CHICKENS

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Kaufe es jetzt

Fachinformation Fachinformation (SPC)
15-04-2017

Wirkstoff:

LIVE ATTENUATED CORONAVIRUS, CR88121 STRAIN

Verfügbar ab:

Merial Animal Health Limited

ATC-Code:

QI01AD07

INN (Internationale Bezeichnung):

LIVE ATTENUATED CORONAVIRUS, CR88121 STRAIN

Dosierung:

4.0 %

Darreichungsform:

Tablets Effervescent

Verschreibungstyp:

POM

Therapiegruppe:

Fowl - Chicken

Therapiebereich:

Avian infectious bronchitis virus vaccine

Anwendungsgebiete:

Immunological - Live Vaccine

Berechtigungsstatus:

Authorised

Berechtigungsdatum:

2016-02-19

Fachinformation

                                SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
GALLIVAC IB88 NEO effervescent tablet for suspension for nebulisation
for chickens
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose contains:
Attenuated Infectious Bronchitis coronavirus, strain CR88121 (793B),
at least
4.0 log
10
EID
50
Excipient
…………………………………………………………
q.s. 1 dose
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Effervescent tablet for suspension for nebulisation.
Light beige, mottled, round tablets.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Broiler chickens from 14 days of age.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Reduces clinical signs and lesions of respiratory disease caused by
the coronavirus variant, strain CR88 (793B) in
broiler chickens.
Immunity has been demonstrated 17 days after vaccination, and the
duration of immunity is at least 5 weeks.
4.3 CONTRAINDICATIONS
In the absence of trial data, future layers or breeders and chickens
in lay must not be vaccinated.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
GALLIVAC IB88 NEO vaccination does not replace the vaccination
schedule against classical Infectious Bronchitis.
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_D_
_a_
_t_
_e_
_ _
_P_
_r_
_i_
_n_
_t_
_e_
_d_
_ _
_3_
_1_
_/_
_0_
_3_
_/_
_2_
_0_
_1_
_7_
_C_
_R_
_N_
_ _
_7_
_0_
_2_
_5_
_6_
_2_
_5_
_p_
_a_
_g_
_e_
_ _
_n_
_u_
_m_
_b_
_e_
_r_
_:_
_ _
_1_
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Only healthy birds sho
                                
                                Lesen Sie das vollständige Dokument