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:

Rabies virus, strain Pasteur RIV, inactivated: ≥ 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 0.60 - 0.88 mg Al³⁺

Excipients:

Qualitative composition of excipients and other constituents	Quantitative composition if that information is essential for proper administration of the veterinary medicinal product
Thiomersal (preservative)	0.1 mg
Disodium hydrogen phosphate dihydrate
Sodium dihydrogen phosphate dihydrate
Water for injections

Light yellow/orange to slightly red/purple with a whitish sediment.

3. CLINICAL INFORMATION

3.1 Target species

Dogs and cats.

3.2 Indications for use for each 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.

3.3 Contraindications None.

3.4 Special warnings

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.

3.5 Special precautions for use

Special precautions for safe use in the target species:

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

This veterinary medicinal product should not be administered for at least one month following the administration of hyperimmune serum (anti-serum) or immunosuppressant drugs.

Immunogenicity of the vaccine antigen will be reduced by poor storage or inappropriate administration.

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

In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

Special precautions for the protection of the environment: Not applicable.

3.6 Adverse events

Very rare (< 1 animal / 10 000 animals treated, including isolated reports):

Injection site swelling[1] Hypersensitivity reaction (e.g. facial oedema, vomiting, pruritus, diarrhoea)2 Immune-mediated haemolytic anaemia, immunemediated thrombocytopenia, immune-mediated polyarthritis. Lethargy3 Anorexia3 Hyperthermia 3

² Such reaction may evolve to a more severe condition (anaphylaxis), which may be life-threatening with additional signs like dyspnoea, collapse, ataxia, muscle tremor and convulsion. If such reaction occurs, appropriate treatment is recommended. ³ Mild.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

3.7 Use during pregnancy, lactation or lay

Pregnancy:

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.

3.8 Interaction 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 in the Canigen range containing one or more of the following components: live canine distemper, canine adenovirus, canine parvovirus and canine parainfluenza or live feline viral rhinotracheitis virus, feline calicivirus and feline panleucopenia virus.

Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but not mixed with Canigen vaccines containing canine Leptospira interrogans serogroups Canicola and Icterohaemorrhagiae antigens.

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.

3.9 Administration routes and dosage

Intramuscular or subcutaneous route. Administer 1 dose (1 ml).

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 administration.

Primary vaccination and revaccination in dogs and cats

Primary vaccination age 12* weeks or older

Revaccination every 3 years

*The primary vaccination may be administered at an earlier age, but a second dose must then be administered at the age of 12 weeks. Minimum vaccination age in dogs and cats: 4 weeks.

Further information

Limited safety data are available for ferrets from monitoring post vaccination reactions. Ferrets can be vaccinated subcutaneously from 12 weeks of age.

An adequate serological response (≥ 0.5 IU) has been demonstrated 1 month after vaccination.

Ferrets should be revaccinated every 18 months.

3.10 Symptoms of overdose (and where applicable, emergency procedures and antidotes)

No clinical signs other than those in section 3.6.

3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance

Not applicable.

3.12 Withdrawal periods

Not applicable.

4. IMMUNOLOGICAL INFORMATION

4.1 ATCvet code: QI07AA02

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

5. PHARMACEUTICAL PARTICULARS

5.1 Major incompatibilities

Do not mix with any other veterinary medicinal products except components recommended for use in section 3.8 above.

5.2 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 4 years. Shelf life after first opening the immediate packaging: once broached use immediately.

5.3 Special precautions for storage

Store in a refrigerator (2 °C – 8 °C).

Do not freeze.

Protect from light.

5.4 Nature and composition of immediate packaging

Type I (Ph.Eur.) clear glass vial with halogenobutyl rubber stopper, sealed with a colour-coded aluminium cap.

Pack sizes:

Cardboard box with 1 x 1 ml, 10 x 1 ml or 50 x 1 ml vials Not all pack sizes may be marketed.

5.5 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

Medicines should not be disposed of via wastewater or household waste.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

6. NAME OF THE MARKETING AUTHORISATION HOLDER

Intervet International B.V.

7. MARKETING AUTHORISATION NUMBER

Vm 06376/4109

8. DATE OF FIRST AUTHORISATION

25 October 2005

9. DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS

July 2026

10. CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product subject to prescription.

Find more product information by searching for the ‘Product Information Database’ on www.gov.uk.

Approved 22 July 2026