CEVAC MASS L lyophilisate for oculonasal suspension for chickens

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

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

제공처:

CEVA-Phylaxia Veterinary Biologicals Co. Ltd

ATC 코드:

QI01AD07

INN (국제 이름):

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

복용량:

.

약제 형태:

Lyophilisate for oculonasal suspension/use in drinking water

처방전 유형:

POM: Prescription Only Medicine as defined in relevant national legislation

치료 그룹:

Chickens

치료 영역:

avian infectious bronchitis virus

치료 징후:

Immunological - Live Vaccine

승인 상태:

Authorised

승인 날짜:

2016-05-20

제품 특성 요약

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