Nobivac Respira 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:

2020-08-14

Ապրանքի հատկությունները

Revised: March 2023
AN: 00551/2022
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobivac Respira 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
EXCIPIENTS:
QUALITATIVE COMPOSITION OF EXCIPIENTS
AND OTHER CONSTITUENTS
QUANTITATIVE COMPOSITION IF THAT
INFORMATION IS ESSENTIAL FOR PROPER
ADMINISTRATION OF THE VETERINARY
MEDICINAL PRODUCt
Thiomersal
0.15 mg
Sodium chloride
Disodium hydrogen phosphate dihydrate
Sodium dihydrogen phosphate dihydrate
Polysorbate 80
Water for injections
Aqueous, white to nearly white suspension, mild creaming.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Dogs.
3.2
INDICATIONS FOR USE FOR EACH 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 revaccination.
Revised: March 2023
AN: 00551/2022
Page 2 of 6
3.3
CONTRAINDICATIONS
None.
3.4
SPECIAL WARNINGS
Vaccinate healthy animals only.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
Not applicable.
Special precautions to be taken by the person administering the
veterinary medicinal
product to animals:
Not applicable.
Special precautions for the protection of the environment:
Not applicable.
3.6
ADVERSE EVENTS
Dogs:
Very common
(> 1 animal / 10 animals
treated):
Injection site swelling (≤ 2 cm, occasionally firm,
may be present up to 25 days post-vaccination).
Common
(1 to 10 animals / 100
animals treated):
Injection site swelling (≤ 3.5 cm, may be present up
to 25 days post-vaccination
1
, and can be painful).
Very rare
(< 1 animal / 10,000 animals
treated, including isolated
reports):
Hypers