Versican Plus Bb Oral Lyophilisate and Solvent for Oral Suspension for Dogs

국가: 영국

언어: 영어

출처: VMD (Veterinary Medicines Directorate)

유효 성분:

Bordetella bronchiseptica

제공처:

Zoetis UK Limited

INN (International Name):

Bordetella bronchiseptica

약제 형태:

Lyophilisate for Oral Suspension

처방전 유형:

POM-V - Prescription Only Medicine – Veterinarian

치료 그룹:

Dogs

치료 영역:

Live Bacterial Vaccine

승인 상태:

Authorized

승인 날짜:

2019-08-21

제품 특성 요약

Revised: December 2020
AN: 00300/2020
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Versican Plus Bb Oral Lyophilisate and Solvent for Oral Suspension for
Dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 1 ml contains:
ACTIVE SUBSTANCE:
Lyophilisate:
_Live attenuated Bordetella bronchiseptica_, strain 92B 1.4 x 10
8
- 5.5 x 10
9
CFU*/dose
* CFU: colony forming unit
EXCIPIENT:
Solvent:
Purified water
1 ml
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate and solvent for oral suspension.
Lyophilisate: Uniform off-white colour freeze-dried powder.
Solvent: clear colourless liquid
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunization of dogs of 8 weeks of age or older to reduce
clinical signs
and excretion following infection with _Bordetella bronchiseptica._
Onset of immunity: 3 weeks
Duration of immunity: 12 months
4.3
CONTRAINDICATIONS
None
Revised: December 2020
AN: 00300/2020
Page 2 of 6
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
The product contains live bacteria and must be administered by the
oral route only.
Parenteral administration can generate abscesses and cellulitis.
Vaccinated dogs may shed the vaccine strain of _Bordetella
bronchiseptica _for up to
35 days oronasally and for at least 70 days in faeces.
Due to the attenuated nature of the vaccine strain it is not necessary
to keep
unvaccinated dogs separate from vaccinated animals, however during
this time it is
advised that any immunocompromised dogs should avoid contact with
vaccinated
dogs.
The _Bordetella bronchiseptica_ in the vaccine has been shown to be
safe in pigs
exposed to the vaccine strain (e.g. from contact with vaccinated
dogs)._ _Cats exposed
to the vaccine strain (e.g. from contact with vaccinated dogs) may
show moderate
clinical signs such as sneezing, nasal and ocul