CEVAC MASS L lyophilisate for oculonasal suspension for chickens

国: アイルランド

言語: 英語

ソース: HPRA (Health Products Regulatory Authority)

有効成分:

Live attenuated infectious bronchitis disease virus, Massachusetts type, strain B48

から入手可能:

CEVA-Phylaxia Veterinary Biologicals Co. Ltd

ATCコード:

QI01AD07

INN（国際名）:

Live attenuated infectious bronchitis disease virus, Massachusetts type, strain B48

投薬量:

.

医薬品形態:

Lyophilisate for oculonasal suspension/use in drinking water

処方タイプ:

POM: Prescription Only Medicine as defined in relevant national legislation

治療群:

Chickens

治療領域:

avian infectious bronchitis virus

適応症:

Immunological - Live Vaccine

認証ステータス:

Authorised

承認日:

2016-05-20

製品の特徴

Health Products Regulatory Authority
05 February 2021
CRN009Y1R
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
CEVAC MASS L lyophilisate for oculonasal suspension for chickens
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose (0.2 ml) contains:
ACTIVE SUBSTANCE:
Live, attenuated infectious bronchitis virus (IBV), Massachusetts B-48
strain10
2.8
- 10
4.3
EID
50
*
*EID
50
= 50% embryo infective dose
EXCIPIENTS
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Lyophilisate for oculonasal suspension.
Yellowish pellet.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Chickens (broilers and future layers)
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the active immunisation of broilers and future layers against
infectious bronchitis (Massachusetts serotype), in order to
reduce respiratory clinical signs, detrimental effect on the ciliary
activity and presence of virus in the trachea.
Protection was demonstrated by challenge with the Massachusetts M41
strain.
Onset of immunity: 3 weeks following vaccination.
Duration of immunity: 9 weeks following vaccination.
4.3 CONTRAINDICATIONS
None.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Vaccinated chickens may excrete the vaccine strain for up to 28 days
following vaccination.
During this time, special precautions should be taken to avoid
spreading of the vaccine strain to unvaccinated chickens and to
other bird species, if any are close by.
All chickens within the same farm should be vaccinated before or when
entering the premises.
Special precautions to be taken by the person administering the
veterinary medicinal product to animals
Care should be taken when reconstituting and administering the
vaccine. Wash and disinfect hands and equipment after
administration of the vaccine. When spraying the vaccine, personal
protective equipment consisting of a mask with eye
protection should be worn by the ope