Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
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
Merial Animal Health Limited
QI01AA13
INACTIVATED NEWCASTLE DISEASE VIRUS, ULSER 2C STRAIN, AT LEAST, INACTIVATED INFECTIOUS BRONCHITIS VIRUS, MASS41 STRAIN, AT LEAST
50
Emulsion for Injection
POM
Fowl - Chicken
Newcastle disease virus / paramyxovirus vaccine + Avian infectious bronchitis virus vaccine + Avian
Immunological - Inactivated vaccine
Authorised
2005-11-25
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 Read the complete document