NOBILIS IB MA5
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
10-09-2016
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Active ingredient:
LIVE ATTENUATED IB VIRUS STRAIN MA5
Available from:
Intervet Ireland Limited
ATC code:
QI01AD07
INN (International Name):
LIVE ATTENUATED IB VIRUS STRAIN MA5
Dosage:
Unknown
Pharmaceutical form:
Lyophilisate for solution
Prescription type:
POM
Therapeutic group:
Fowl - Chicken
Therapeutic area:
Avian infectious bronchitis virus vaccine
Therapeutic indications:
Immunological - Live Vaccine
Authorization status:
Authorised
Authorization date:
2003-02-19
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobilis IB Ma5
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
_______________________________
*
EID
50
= 50% Embryonic Infective Dose
3 PHARMACEUTICAL FORM
Lyophilisate for suspension.
Vials: off-white/cream coloured pellet
Cups: off-white predominantly sphere shaped
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Chickens.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
To reduce mortality and clinical signs of Massachusetts or serologically related types of infectious bronchitis.
A single vaccination gives protective immunity that lasts at least through the normal broiler rearing period (5 – 7
weeks). Where appropriate, e.g. in layers and breeders, revaccination at approximately 6 week intervals is advised.
4.3 CONTRAINDICATIONS
None.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
The vaccine virus may spread from vaccinates to non-vaccinated birds and appropriate care should be taken to separate
vaccinates from non-vaccinates.
ACTIVE SUBSTANCE(S)
PER DOSE
Live avian infectious bronchitis virus strain Ma5
10
3.5
EID
50
*
EXCIPIENTS
For the full list of excipients, see section 6.1
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 26/08/2016_
_CRN 7021825_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Only healthy chickens should be vaccinated.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Wash and disinfect hands after use.
When spraying the vaccine, to avoid hay-fever like reactions in some individuals, operators should wear respiratory and
eye protection conforming to current European Standards.
4.6 ADVERSE REACTIONS (FREQUENCY AND
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