NOBILIS TRT LIVE
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
24-02-2016
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Active ingredient:
TURKEY RHINOTRACHEITIS VIRUS STRAIN BUT1#8544
Available from:
Intervet Ireland Limited
ATC code:
QI01AD01
INN (International Name):
TURKEY RHINOTRACHEITIS VIRUS STRAIN BUT1#8544
Dosage:
Unknown
Pharmaceutical form:
Lyophilisate for suspension
Prescription type:
POM
Therapeutic group:
Fowl - Chicken, Fowl - Turkey
Therapeutic area:
Avian rhinotracheitis virus vaccine
Therapeutic indications:
Immunological - Live Vaccine
Authorization status:
Authorised
Authorization date:
2002-12-16
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobilis TRT Live
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE
Live turkey rhinotracheitis (TRT) virus, strain BUT 1#8544
10
2.5
TCID
50
* per dose
* TCID
50
: 50 % tissue culture infective dose
EXCIPIENTS
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Lyophilisate for suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Chickens (broilers) and turkeys.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the active immunisation of broilers and turkeys from one day of age to reduce clinical signs of rhinotracheitis virus
infection.
Onset of immunity: 3 weeks after vaccination.
Duration of immunity: 6 – 9 weeks after vaccination.
4.3 CONTRAINDICATIONS
None.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Only vaccinate healthy birds. Sick or weak birds will not develop adequate immunity following vaccination.
A good immune response is reliant on the reaction of an immunogenic agent and a fully competent immune system.
Immunocompetence 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.
Immunogenicity of the vaccine antigen will be reduced by poor storage or inappropriate administration.
Do not use chlorinated water.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 09/02/2016_
_CRN 7022595_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions
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