GALLIMUNE 303 ND+IB+ART Emulsion for injection

Երկիր: Իռլանդիա

Լեզու: անգլերեն

Աղբյուրը: HPRA (Health Products Regulatory Authority)

Ակտիվ բաղադրիչ:

Inactivated newcastle disease virus, ulster 2c strain; Inactivated infectious bronchitis virus, mass41 strain; Inactivated avian rhinotracheitis virus (swollen head syndrome), vco3 strain

Հասանելի է:

Boehringer Ingelheim Vetmedica GmbH

ATC կոդը:

QI01AA21

INN (Միջազգային անվանումը):

Inactivated newcastle disease virus, ulster 2c strain; Inactivated infectious bronchitis virus, mass41 strain; Inactivated avian rhinotracheitis virus (swollen head syndrome), vco3 strain

Դոզան:

.

Դեղագործական ձեւ:

Emulsion for injection

Ռեկվիզորի տեսակը:

POM: Prescription Only Medicine as defined in relevant national legislation

Թերապեւտիկ տարածք:

avian infectious bronchitis virus + newcastle disease virus / paramyxovirus + avian rhinotracheitis virus

Լիազորման կարգավիճակը:

Authorised

Հաստատման ամսաթիվը:

2005-11-25

Ապրանքի հատկությունները

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Gallimune 303 ND+IB+ART emulsion for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 0.3 ml dose contains:
ACTIVE SUBSTANCES:
Inactivated Newcastle disease virus, Ulster 2C strain, at least
..................................................... 50 PD
50
1
Inactivated infectious bronchitis virus, Mass41 strain, at least
..................................................... 18 HI.U
Inactivated turkey rhinotracheitis virus
2
, VCO3 strain, at least
................................................ 0.76 ODD
The concentrations are expressed by the antibody titre obtained during
the potency test. One unit (U)
corresponding to an antibody titre of 1.
HI: haemagglutination inhibiting - ODD : optical density difference
1
Minimum protective dose according to monograph 0870 of Ph. Eur.
2
Previously referred to as avian rhinotracheitis (ART) virus which is
the triggering pathogen in
swollen head syndrome in chickens.
ADJUVANT:
Paraffin oil
...........................................................................................................................
170 to 186 mg
EXCIPIENTS:
QUALITATIVE COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
QUANTITATIVE COMPOSITION IF THAT INFORMATION
IS ESSENTIAL FOR PROPER ADMINISTRATION OF THE
VETERINARY MEDICINAL PRODUCT
Thiomersal
30 μg
Formaldehyde
at most 45 µg
Ester of fatty acids and of polyols
Ester of fatty acids and of ethoxylated polyols
Water for injections
Whitish homogeneous emulsion.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Chickens (breeder and layer pullets).
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
Booster immunisation of breeder and layer pullets after vaccination
with live vaccines against:
-
Newcastle disease virus in order to reduce egg drop linked to
Newcastle disease infection,
-
Infectious bronchitis virus in order to reduce egg drop linked to
infectious bronchitis infection
caused by the Mass 41 strain,
-
Avian pneumovirus in order to reduce respiratory signs linked to avian
pneumovirus infectio