GALLIMUNE 407 ND+IB+EDS+ART

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

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

Dostupné s:

Merial Animal Health Limited

ATC kód:

QI01AA18

INN (Mezinárodní Name):

INACTIVATED NEWCASTLE DISEASE VIRUS, ULSER 2C STRAIN, AT LEAST, INACTIVATED INFECTIOUS BRONCHITIS VIRUS, MASS41 STRAIN, AT LEAST

Dávkování:

50

Léková forma:

Emulsion for Injection

Druh předpisu:

POM

Terapeutické skupiny:

Fowl - Chicken

Terapeutické oblasti:

Avian infectious bronchitis virus vaccine + Newcastle disease virus / paramyxovirus vaccine + Avian

Terapeutické indikace:

Immunological - Inactivated vaccine

Stav Autorizace:

Authorised

Datum autorizace:

2005-11-25

Charakteristika produktu

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