Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
INACTIVATED NEWCASTLE DISEASE VIRUS, ULSTER 2C STRAIN, INACTIVATED INFECTIOUS BRONCHITIS VIRUS, MASS41 STRAIN, INACTIVATED AVIAN RHINOTRACHEITIS VIRUS (SWOLLEN HEAD SYNDROME), VCO3 STRAIN
Merial Animal Health Limited
QI01AA21
INACTIVATED NEWCASTLE DISEASE VIRUS, ULSTER 2C STRAIN, INACTIVATED INFECTIOUS BRONCHITIS VIRUS, MASS41 STRAIN, INACTIVATED AVIAN
Per Cent
Emulsion for Injection
POM
Fowl - Chicken
Avian infectious bronchitis virus vaccine + Newcastle disease virus / paramyxovirus vaccine + Avian
Immunological - Inactivated vaccine
Authorised
2005-11-25
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT GALLIMUNE 303 ND+IB+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). 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). Newcastle Disease and Infectious Bronchitis components: - onset of immunity: 4 weeks after vaccination, - duration of immunity: one laying period. Avian Rhinotracheitis component: Immunity has been demonstrated by challenge 14 weeks after vaccination and persists until the end of the laying period. 4.3 CONTRAINDICATIONS None Each 0.3-ml dose of vaccine contains: ACTIVE SUBSTANCE(S): Inactivated Newcastle Disease virus, Ulster 2C strain, at least 50PD 50 1 Inactivated Infectious Bronchitis virus, Mass41 strain, at least 18 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 45 µg For a full list of excipients, see sectio Lire le document complet