Canigen Rabies

Ülke: Birleşik Krallık

Dil: İngilizce

Kaynak: VMD (Veterinary Medicines Directorate)

Aktif bileşen:

Rabies virus

Mevcut itibaren:

MSD Animal Health UK Limited

ATC kodu:

QI07AA02

INN (International Adı):

Rabies virus

Farmasötik formu:

Suspension for injection

Reçete türü:

POM-V - Prescription Only Medicine – Veterinarian

Terapötik grubu:

Cats, Dogs

Terapötik alanı:

Inactivated Viral Vaccine

Yetkilendirme durumu:

Authorized

Yetkilendirme tarihi:

2005-10-25

Ürün özellikleri

Revised: December 2021
AN: 00973/2021
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Canigen 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: 00973/2021
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 m