GALLIMUNE 407 ND+IB+EDS+ART Emulsion for injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Inactivated newcastle disease virus, ulser 2C strain, at least ; Inactivated infectious bronchitis virus, mass41 strain, at least; Inactivated egg drop syndrome virus (EDS76), V127 strain, at least; Inactivated avian rhinotracheitis virus (swollen head syndrome), vc03 strain, at least

Available from:

Boehringer Ingelheim Vetmedica GmbH

ATC code:

QI01AA18

INN (International Name):

Inactivated newcastle disease virus, ulser 2C strain, at least ; Inactivated infectious bronchitis virus, mass41 strain, at least; Inactivated egg drop syndrome virus (EDS76), V127 strain, at least; Inactivated avian rhinotracheitis virus (swollen head syndrome), vc03 strain, at least

Dosage:

.

Pharmaceutical form:

Emulsion for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

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

Authorization status:

Authorised

Authorization date:

2005-11-25

Summary of Product characteristics

Health Products Regulatory Authority
07 December 2018
CRN008MPY
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
GALLIMUNE 407 ND+IB+EDS+ART Emulsion for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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
Inactivated Avian Rhinotracheitis virus (Swollen Head Syndrome),
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 - OOD : Optical Density Difference
(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
90 µg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Whitish homogeneous emulsion for injection.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Chickens (breeder and layer pullets).
Health Products Regulatory Authority
07 December 2018
CRN008MPY
Page 2 of 6
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,
-Avian pneumovirus in order to reduce respiratory signs linked to
avian pneumovirus
infection (Avian Rhinotracheitis).
Active immunisation of breeder and layer pullets in order to reduce
egg drop linked
to infection with Egg Drop Syndrome virus EDS76 without priming.
Newcastle Disease, Infectious Bronchitis and Egg Drop Syndrome
components:
-onset of immunity: 4 weeks after vaccination,
-d