GALLIMUNE 407 ND+IB+EDS+ART
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
06-12-2016
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
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 STRAI, AT LEAST, INACTIVATED AVIAN RHINOTRACHEITIS VIRUS (SWOLLEN HEAD SYNDROME), VC03 STRAIN, AT LEAST
Available from:
Merial Animal Health Limited
ATC code:
QI01AA18
INN (International Name):
INACTIVATED NEWCASTLE DISEASE VIRUS, ULSER 2C STRAIN, AT LEAST, INACTIVATED INFECTIOUS BRONCHITIS VIRUS, MASS41 STRAIN, AT LEAST
Dosage:
50
Pharmaceutical form:
Emulsion for Injection
Prescription type:
POM
Therapeutic group:
Fowl - Chicken
Therapeutic area:
Avian infectious bronchitis virus vaccine + Newcastle disease virus / paramyxovirus vaccine + Avian
Therapeutic indications:
Immunological - Inactivated vaccine
Authorization status:
Authorised
Authorization date:
2005-11-25
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
GALLIMUNE 407 ND+IB+EDS+ART
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
Inactivated Avian Rhinotracheitis virus (Swollen Head Syndrome), VCO3 strain, at least
60 IP.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: haemagglutination inhibiting - IP: interference percentage
(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 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,
-
Avian pneumovirus in order to reduce respiratory signs linked to avian pneumovirus infection (Avian Rhinotracheitis).
Active immunisation of breeder and layer pullet
Read the complete document
