Ülke: İrlanda
Dil: İngilizce
Kaynak: 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
.
Emulsion for injection
POM: Prescription Only Medicine as defined in relevant national legislation
Chickens
avian infectious bronchitis virus + newcastle disease virus / paramyxovirus + avian rhinotracheitis virus
Immunological - Inactivated Vaccine
Authorised
2005-11-25
Health Products Regulatory Authority 30 May 2018 CRN000WPS Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 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 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 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. ADJUVANT(S): Paraffin oil 170 to 186 mg EXCIPIENT(S): Thiomersal, at most 30 μg Formaldehyde, at most 45 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 30 May 2018 CRN000WPS Page 2 of 5 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 Mass 41 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: - onset of immunity: 14 weeks after vaccination - duration of immunity: one laying period. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Vaccinate healthy animals Belgenin tamamını okuyun