Rabisin

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Rabies virus

Available from:

Boehringer Ingelheim Animal Health UK Ltd

ATC code:

QI07AA02

INN (International Name):

Rabies virus

Pharmaceutical form:

Suspension for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cats, Dogs

Therapeutic area:

Inactivated Viral Vaccine

Authorization status:

Authorized

Authorization date:

2005-10-28

Summary of Product characteristics

Amended Pages: October 2020
AN: 01166/2019
Page 1 of 4
SUMMARY OF PRODUT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
RABISIN
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml dose of vaccine contains:
ACTIVE SUBSTANCES:
Inactivated rabies virus, G52 strain
≥ 2.09 log
10
OD
50
* and ≥ 1 IU**
ADJUVANT:
Aluminium (as hydroxide)
1.7 mg
EXCIPIENTS:
Excipient
q.s.
1 ml
* when batch control is performed with an _in vitro_ ELISA test
** when batch control is performed according to Ph. Eur. monograph 451
For full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs and cats.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of dogs and cats, to reduce mortality and
clinical signs
due to rabies infection.
Immunity has been demonstrated 1 month after primary vaccination, and
has
been shown to persist up to the first booster dose, (1 year after
primary
vaccination) and up to 3 years following booster vaccination.
4.3
CONTRA-INDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Do not vaccinate unhealthy animals.
Amended Pages: October 2020
AN: 01166/2019
Page 2 of 4
4.5
SPECIAL PRECAUTIONS FOR USE INCLUDING SPECIAL PRECAUTIONS TO BE TAKEN
BY
THE PERSON ADMINISTERING THE MEDICINAL PRODUCT TO ANIMALS
i)
Special precautions for use in animals
Where a dog or a cat was vaccinated before 12 weeks of age, the
primary vaccination scheme should be completed by an injection
given at 12 weeks of age or older.
ii)
Special precautions to be taken by the person administering the
veterinary medicinal product to the animals
In
the
case
of
accidental
self-injection,
seek
medical
advice
immediately and show the package leaflet or label to the physician.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Vaccination may sometimes induce a local reaction, as a small and
transient
swelling at the injection site (usually 2 – 3 cm diameter,
persisting mostly up to 2
weeks, rarely up to 4 weeks).
Vaccinatio