Nobivac Rabies

Země: Velká Británie

Jazyk: angličtina

Zdroj: VMD (Veterinary Medicines Directorate)

Aktivní složka:

Rabies virus

Dostupné s:

MSD Animal Health UK Limited

ATC kód:

QI07AA02

INN (Mezinárodní Name):

Rabies virus

Léková forma:

Suspension for injection

Druh předpisu:

POM-V - Prescription Only Medicine – Veterinarian

Terapeutické skupiny:

Cats, Dogs

Terapeutické oblasti:

Inactivated Viral Vaccine

Stav Autorizace:

Authorized

Datum autorizace:

2005-10-25

Charakteristika produktu

Revised December 2021
AN: 00974/2021
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobivac Rabies Suspension for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml dose contains:
ACTIVE SUBSTANCE:
Inactivated rabies virus strain Pasteur RIV:
≥ 0.95 AIU* equivalent to ≥ 2 IU**
_ * Batch control is performed with an in vitro potency test according
to Ph. Eur. monograph 451._
_ AIU = rabies antigenic mass AlphaLISA International Units._
_** Corresponding potency in the in vivo mouse challenge test
according to Ph. Eur. Monograph 451._
ADJUVANT:
Aluminium phosphate (adjuvant)
0.60 - 0.88 mg Al
3+
EXCIPIENTS:
Thiomersal (preservative)
0.1 mg
For the full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
Light yellow/orange to slightly red/purple with a whitish sediment.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs and cats.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the active immunisation against rabies to reduce clinical signs
and mortality.
Onset of immunity:
an adequate serological response (

0.5 IU) has been
demonstrated 2 to 3 weeks after vaccination.
Duration of immunity: 3 years.
4.3
CONTRAINDICATIONS
None.
Revised December 2021
AN: 00974/2021
Page 2 of 5
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
The
vaccine may
not
be effective
in
animals
incubating
the
disease
at
the
time
of
vaccination.
Some animals may be immunologically incompetent and fail to respond to
vaccination. A
good immune response is reliant on the reaction of an immunogenic
agent and a fully
competent immune system. Immunocompetence of the animal may be
compromised by a
variety of factors including poor health, nutritional status, genetic
factors, concurrent drug
therapy and stress.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
The presence of maternal antibodies can interfere with the response to
vaccination.
This product should not be administered for at least one mo