GALLIMUNE 303 ND+IB+ART
Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Caracteristicilor produsului
(SPC)
06-12-2016
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Ingredient activ:
INACTIVATED NEWCASTLE DISEASE VIRUS, ULSTER 2C STRAIN, INACTIVATED INFECTIOUS BRONCHITIS VIRUS, MASS41 STRAIN, INACTIVATED AVIAN RHINOTRACHEITIS VIRUS (SWOLLEN HEAD SYNDROME), VCO3 STRAIN
Disponibil de la:
Merial Animal Health Limited
Codul ATC:
QI01AA21
INN (nume internaţional):
INACTIVATED NEWCASTLE DISEASE VIRUS, ULSTER 2C STRAIN, INACTIVATED INFECTIOUS BRONCHITIS VIRUS, MASS41 STRAIN, INACTIVATED AVIAN
Dozare:
Per Cent
Forma farmaceutică:
Emulsion for Injection
Tip de prescriptie medicala:
POM
Grupul Terapeutică:
Fowl - Chicken
Zonă Terapeutică:
Avian infectious bronchitis virus vaccine + Newcastle disease virus / paramyxovirus vaccine + Avian
Indicații terapeutice:
Immunological - Inactivated vaccine
Statutul autorizaţiei:
Authorised
Data de autorizare:
2005-11-25
Caracteristicilor produsului
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
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