GALLIMUNE 303 ND+IB+ART
Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
Tabia za bidhaa
(SPC)
06-12-2016
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Tuma ombi.
Viambatanisho vya kazi:
INACTIVATED NEWCASTLE DISEASE VIRUS, ULSTER 2C STRAIN, INACTIVATED INFECTIOUS BRONCHITIS VIRUS, MASS41 STRAIN, INACTIVATED AVIAN RHINOTRACHEITIS VIRUS (SWOLLEN HEAD SYNDROME), VCO3 STRAIN
Inapatikana kutoka:
Merial Animal Health Limited
ATC kanuni:
QI01AA21
INN (Jina la Kimataifa):
INACTIVATED NEWCASTLE DISEASE VIRUS, ULSTER 2C STRAIN, INACTIVATED INFECTIOUS BRONCHITIS VIRUS, MASS41 STRAIN, INACTIVATED AVIAN
Kipimo:
Per Cent
Dawa fomu:
Emulsion for Injection
Dawa ya aina:
POM
Kundi la matibabu:
Fowl - Chicken
Eneo la matibabu:
Avian infectious bronchitis virus vaccine + Newcastle disease virus / paramyxovirus vaccine + Avian
Matibabu dalili:
Immunological - Inactivated vaccine
Idhini hali ya:
Authorised
Idhini ya tarehe:
2005-11-25
Tabia za bidhaa
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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