Revised: September 2014
NAME OF THE VETERINARY MEDICINAL PRODUCT
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1-ml dose of vaccine contains
Rabies virus glycoproteins 1 IU
Aluminium (as hydroxide) 1.7 mg
Excipient q.s. 1 ml
For full list of excipients, see section 6.1.
Suspension for injection.
Dogs and cats.
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.
Special warnings for each target species
Do not vaccinate unhealthy animals.
Special precautions for use including special precautions to be taken by the person administering the medicinal product to animals
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.
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.
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).
Vaccination may exceptionally induce an anaphylactoid (hypersensitivity) reaction. In such a case, symptomatic treatment should be provided.
Use during pregnancy, lactation or lay
Can be used during pregnancy.
Interaction with other medicinal products and other forms of interaction
Safety and efficacy data are available which demonstrate that this vaccine can be administered the same day but not mixed with Merial’s PUREVAX non-adjuvanted vaccines for cats.
In the case of products administered parenterally, the products should be given at different sites.
No information is available on the safety and efficacy of this vaccination when used with any other veterinary medicinal product except the products mentioned above. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be decided on a case by case basis.
Amounts to be administered and administration route
Inject one dose of 1 ml subcutaneously according to the following schedule:
Primary vaccination: 1 injection from 12 weeks of age,
Booster vaccination: 1 year after primary vaccination, then at intervals of up to 3 years.
UK Pet Travel Scheme (PETS): Animals intended for vaccination under the UK Pet Travel Scheme (PETS) must be identified by a permanently numbered microchip. The microchip number must be recorded on the pet passport or official third country veterinary certificate at the time of rabies vaccination.
Overdose (symptoms, emergency procedures, antidotes), if necessary
No other signs than those described under section 4.6 have been observed after the administration of an overdose of vaccine.
Inactivated vaccine in adjuvant against rabies.
After administration, the vaccine stimulates active immunity against rabies.
ATCVet Code: QI07AA02
List of excipients
Do not mix with any other veterinarymedicinalproduct.
Shelf-life of the veterinary medicinal product as packaged for sale: 36 months.
Use immediately after opening.
Special precautions for storage
Store between +2C and + 8C, protected from light. Do not freeze.
Nature and composition of immediate packaging
Type I glass vials with butyl-elastomer closure.
Bottle (glass) of 1 dose of suspension, box of 1 bottle
Bottle (glass) of 1 dose of suspension, box of 10 bottles
Bottle (glass) of 1 dose of suspension, box of 100 bottles
Not all pack sizes may be marketed.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if appropriate
Any unused veterinary medicinal product or waste material derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
MARKETING AUTHORISATION HOLDER
Merial Animal Health Ltd
PO Box 327
Harlow Business Park
MARKETING AUTHORISATION NUMBER
DATE OF FIRST AUTHORISATION
Date:28 October 2005
DATE OF REVISION OF THE TEXT
ANY OTHER INFORMATION REQUIRED BY THE SECRETARY OF STATE
04 September 2014
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