Krajina: Írsko
Jazyk: angličtina
Zdroj: 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, INACTIVATED AVIAN RHINOTRACHEITIS VIRUS (SWOLLEN HEAD SYNDROME), VC03 STRAIN, AT LEAST
Merial Animal Health Limited
QI01AA18
INACTIVATED NEWCASTLE DISEASE VIRUS, ULSER 2C STRAIN, AT LEAST, INACTIVATED INFECTIOUS BRONCHITIS VIRUS, MASS41 STRAIN, AT LEAST
50
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 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 Prečítajte si celý dokument