Canigen Bb Suspension for Injection for Dogs

Երկիր: Միացյալ Թագավորություն

Լեզու: անգլերեն

Աղբյուրը: VMD (Veterinary Medicines Directorate)

Ակտիվ բաղադրիչ:

Bordetella bronchiseptica

Հասանելի է:

MSD Animal Health UK Limited

ATC կոդը:

QI07AB03

INN (Միջազգային անվանումը):

Bordetella bronchiseptica

Դեղագործական ձեւ:

Suspension for injection

Ռեկվիզորի տեսակը:

POM-V - Prescription Only Medicine – Veterinarian

Թերապեւտիկ խումբ:

Dogs

Թերապեւտիկ տարածք:

Inactivated Bacterial Vaccine

Լիազորման կարգավիճակը:

Authorized

Հաստատման ամսաթիվը:

2021-11-16

Ապրանքի հատկությունները

Amended: December 2021
AN: 00853/2021
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Canigen Bb Suspension for Injection for Dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose (1 ml) contains:
ACTIVE SUBSTANCE:
_Bordetella bronchiseptica_ fimbriae
1
:
88 - 399 U
2
1
Purified from strain Bb7 92932
2
Antigenic mass ELISA units
ADJUVANT:
dl-

-tocopheryl acetate:
74.7 mg
EXCIPIENT:
Thiomersal:
0.15 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
Aqueous, white to nearly white suspension, mild creaming.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of dogs against _Bordetella bronchiseptica_ to
reduce clinical
signs of upper respiratory tract disease and bacterial shedding post
infection.
Onset of immunity:
2 weeks.
Duration of immunity:
7 months after primary vaccination.
1 year after re-vaccination.
Amended: December 2021
AN: 00853/2021
Page 2 of 5
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
Not applicable.
Special precautions to be taken by the person administering the
veterinary medicinal
product to animals
Not applicable.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
A transient swelling at the site of injection (

2 cm), which can occasionally be firm,
may very commonly be present for up to 25 days post-vaccination. A
medium size
transient swelling at the site of injection (

3.5 cm) may occur in common cases and
can be painful. The swelling may uncommonly last for up to 35 days
post-
vaccination.
The frequency of adverse reactions is defined using the following
convention:
- very common (more than 1 in 10 animals treated displaying adverse
reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 anim