Nobivac Respira Bb suspension for injection in pre-filled syringe for dogs

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

Bordetella Bronchiseptica Fimbriae

Предлага се от:

Intervet Ireland Limited

АТС код:

QI07AB03

INN (Международно Name):

Bordetella Bronchiseptica Fimbriae

дозиране:

.

Лекарствена форма:

Suspension for injection in pre-filled syringe

Вид предписание :

POM: Prescription Only Medicine as defined in relevant national legislation

Терапевтична област:

bordetella

Статус Оторизация:

Authorised

Дата Оторизация:

2020-08-25

Данни за продукта

2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobivac Respira Bb suspension for injection in pre-filled syringe for
dogs
Nobivac Respira Bb vet. suspension for injection in pre-filled syringe
for dogs (DK, FI, IS, NO, SE)
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_ _
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.
3.3
CONTRAINDICATIONS
None.
3.4
SPECIAL WARNINGS
Vaccinate healthy animals only.
3.5
SPECIAL PRECAUTIONS FOR USE
3
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):
Hypersensitivity reaction
2
1
The swelling may uncommonly last for up to 35 days post-vaccination.
2
If hypersensitivity reaction occurs, a