GALLIMUNE 302 ND+IB+EDS

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

INACTIVATED NEWCASTLE DISEASE VIRUS, ULSER 2C STRAIN, AT LEAST, INACTIVATED INFECTIOUS BRONCHITIS VIRUS, MASS41 STRAIN, AT LEAST, INACTIVATED EGG DROP SYNDROME VIRUS (EDS76), V127 STRAI, AT LEAST

Tilgængelig fra:

Merial Animal Health Limited

ATC-kode:

QI01AA13

INN (International Name):

INACTIVATED NEWCASTLE DISEASE VIRUS, ULSER 2C STRAIN, AT LEAST, INACTIVATED INFECTIOUS BRONCHITIS VIRUS, MASS41 STRAIN, AT LEAST

Dosering:

50

Lægemiddelform:

Emulsion for Injection

Recept type:

POM

Terapeutisk gruppe:

Fowl - Chicken

Terapeutisk område:

Newcastle disease virus / paramyxovirus vaccine + Avian infectious bronchitis virus vaccine + Avian

Terapeutiske indikationer:

Immunological - Inactivated vaccine

Autorisation status:

Authorised

Autorisation dato:

2005-11-25

Produktets egenskaber

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
GALLIMUNE 302 ND+IB+EDS
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Water-in oil emulsion for injection.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Chickens (breeder and layer pullets).
Each 0.3-ml dose of vaccine contains:
ACTIVE SUBSTANCES:
Inactivated Newcastle Disease virus, Ulster 2C strain, at least
50PD
50
1
Inactivated Infectious Bronchitis virus, Mass41 strain, at least
18 HI.U
Inactivated Egg Drop Syndrome virus (EDS76), V127 strain, at least
180 HI.U
The concentrations are expressed by the antibody titre obtained during the potency test. One unit
(U) corresponding to an antibody titre of 1.
HI: haemaglutination inhibiting
[1]: Minimum protective dose according to monograph 0870 of Ph. Eur.
ADJUVANT(S):
Paraffin oil
170 to 186 mg
EXCIPIENT(S):
Thiomersal, at most
30 µg
Formaldehyde, at most
43.2 µg
For a full list of excipients, see section 6.1.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 21/11/2016_
_CRN 7023943_
_page number: 1_
4.2 INDICATIONS FOR USE, SPECIFYING THE 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 Mass41
strain.
Active immunisation of breeder and layer pullets in order to reduce egg drop linked to infection with Egg Drop Syndrome virus
EDS76 without priming.
Onset of immunity: 4 weeks after vaccination.
Duration of immunity: one laying period.
4.3 CONTRAINDICATIONS
None.
4.4 SPECIAL WARNINGS FOR EA