SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Nobivac Rabies

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active ingredient: per dose of 1 ml

Inactivated Rabies virus strain Pasteur RIV: 2 IU as measured in the Ph.Eur. potency test.

Excipients

Aluminium phosphate (adjuvant) 0.60 - 0.88 mg Al³⁺

Thiomersal (Preservative) 0.1 mg

For a 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 the active immunisation against rabies to reduce clinical signs and mortality.

Onset of immunity: an adequate serological response (0.5 I.U.) has been demonstrated 2 to 3 weeks after vaccination.

Duration of immunity: 3 years.

4.3 Contraindications

Do not use in unhealthy animals. 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 (see further information). Animals that have received the corresponding anti-serum or immunosuppressive drugs should not be vaccinated until an interval of at least 4 weeks has elapsed.

4.4 Special warnings for each target species

None.

4.5 Special precautions for use

Special precautions for use in animals

The presence of maternal antibodies can interfere with the response to vaccination.

Special precautions to be taken by the person administering the medicinal product to animals

None

4.6 Adverse Reactions (frequency and seriousness)

Transient local reactions such as non-painful diffuse to firm swellings of approximately 1 cm in diameter may be observed for up to 3 weeks after subcutaneous vaccination.

In the rare event of a hypersensitivity reaction following vaccination, administer an antihistamine, corticosteroid or adrenaline, without delay and by the most immediate route.

4.7 Use during pregnancy and lactation

Can be used during pregnancy in dogs. There are no laboratory data on use during pregnancy in other species, but on basis of field experience, such use is expected to be safe.

4.8 Interactions with other medicinal products and other forms of interaction.

Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with vaccines of the Nobivac range containing one or more of the following: live canine distemper, canine adenovirus, canine parvovirus and canine parainfluenza and inactivated canine leptospirosis antigens Leptospira canicola and icterohaemorrhagiae or live feline viral rhinotracheitis virus, feline calicivirus and feline panleucopenia virus.

No information is available on the safety and efficacy of this vaccine 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 made on a case by case basis.

This product should not be given for at least one month following the administration of hyperimmune serum or immunosuppressant drugs.

4.9 Amount to be administered and administration route

A single dose inoculation of 1 ml is sufficient irrespective of size, species or breed of animal. Sterile equipment should be used for administration. Avoid contamination of vaccine with traces of chemical sterilising agents. Do not use chemicals such as disinfectant or spirit to disinfect the skin prior to inoculation.

Primary course and booster vaccination

Dogs & cats

Primary vaccination age* 3 months or older

Booster vaccination every 3 years

Route of administration intramuscularly or subcutaneously

* Primary vaccination may be administered at an earlier age (minimum in dogs and cats of 4 weeks of age), but then a repeat vaccination must be given at the age of 3 months.

Health regulations and requirements in certain countries specify that dogs must be revaccinated annually against rabies.

Further information

Limited safety data for ferretsare available from monitoring post vaccination reactions. Ferrets can be vaccinated subcutaneously from 3 months of age. An adequate serological response (0.5 I.U.) has been demonstrated 1 month after vaccination and they should receive a booster vaccination every 18 months.

A good immune response is reliant on the reaction of an immunogenic agent and a fully competent immune system. Immunogenicity of the vaccine antigen will be reduced by poor storage or inappropriate administration. Immuno-competence of the animal may be compromised by a variety of factors including poor health, nutritional status, genetic factors, concurrent drug therapy and stress.

Pet Travel Scheme (PETS)

Animals intended for vaccination under the Pet Travel Scheme (PETS) must be identified by a permanent numbered microchip. This microchip number must be recorded on the record of the dog, cat and ferret vaccination at the time of rabies vaccination.

4.10 Overdose (symptoms, emergency procedures, antidotes) (if necessary)

No effects other than those in section 4.6.

4.11 Withdrawal period(s)

Not applicable.

5. IMMUNOLOGICAL PROPERTIES

ATCVet code: QI07A A02

The vaccine contains inactivated antigens to stimulate active immunity against rabies.

6. PHARMACEUTICAL PRECAUTIONS

6.1 List of excipients

Aluminium phosphate, di-Sodium hydrogen phosphate 2 H2O, Sodium dihydrogen phosphate 2 H2O, Thiomersal, Water for injections.

6.2 Incompatibilities

Do not mix with any other veterinary medicinal products apart from those listed in section 4.8.

6.3 Shelf-life

Shelf life of the veterinary medicinal product as packaged for sale: 4 years.

6.4 Special precautions for storage

Store in a refrigerator (2 °C - 8 °C). Do not freeze.

6.5 Nature and composition of immediate packaging

Glass Type I (Ph.Eur ) vials.

- Cardboard box with 1, 10 or 50 vials or

- PET plastic tray with 10 or 50 vials

with 1 ml with a rubber stopper and aluminium cap.

Not all presentations may be marketed.

6.6 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 product should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Intervet UK Ltd

Walton Manor

Walton

Milton Keynes

Buckinghamshire

MK7 7AJ

8. MARKETING AUTHORISATION NUMBER

Vm 01708/4325

9. DATE OF FIRST AUTHORISATION

25 October 2005

10. DATE OF REVISION OF THE TEXT

October 2016

20 October 2016