NOBILIS RISMAVAC + CA126
Land: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Vara einkenni
(SPC)
15-10-2014
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Senda beiðni.
Virkt innihaldsefni:
LIVE CHICKEN HERPES VIRUS, STRAIN CVI 988 (SEROTYPE1), LIVE TURKEY HERPES VIRUS, STRAIN FC 126 (SEROTYPE3)
Fáanlegur frá:
Intervet Ireland Limited
ATC númer:
QI01AD03
INN (Alþjóðlegt nafn):
LIVE CHICKEN HERPES VIRUS, STRAIN CVI 988 (SEROTYPE1), LIVE TURKEY HERPES VIRUS, STRAIN FC 126 (SEROTYPE3)
Skammtar:
PFU
Lyfjaform:
Concentrate for Soln for Inj
Gerð lyfseðils:
POM
Meðferðarhópur:
Fowl - Chicken
Lækningarsvæði:
Avian herpes virus vaccine (Mareks disease)
Ábendingar:
Immunological - Live Vaccine
Leyfisstaða:
Authorised
Leyfisdagur:
2003-08-06
Vara einkenni
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobilis Rismavac + CA126
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
* pfu = plaque forming units in chicken embryo fibroblasts
3 PHARMACEUTICAL FORM
Concentrate for solution for injection.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Chickens
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the active immunisation of 18-day embryonated eggs or day-old chickens to reduce mortality, clinical signs and
lesions after infection with Marek’s Disease virus.
Duration of immunity is unknown
.
4.3 CONTRAINDICATIONS
None
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
A good immune response is reliant on the reaction of an immunogenic agent and a fully competent immune system.
Immunogenicity of the vaccine antigen will be reduced by poor storage or inappropriate administration. Immuno-competence of
the animal may be compromised by a variety of factors including poor health, nutritional status, genetic factors, concurrent drug
therapy and stress. Under certain conditions, for example extreme disease pressure, fully immune birds may succumb to disease.
Therefore, successful vaccination may not be synonymous with full protection in the face of a disease challenge.
ACTIVE SUBSTANCE
PER DOSE
Live Turkey Herpes virus strain FC126
> 3.0 log
10
pfu*
Live Chicken Herpes virus strain CVI-988
> 3.0 log
10
pfu
EXCIPIENTS
For a full list of excipients, see section 6.1
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 30/09/2014_
_CRN 7017104_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Do not use in unhealthy birds. Sick or weak birds will not develop adequate immunity following vaccinat
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