Summary of Product Characteristics

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Canigen DHPPi

2. Qualitative and quantitative composition

Active ingredients: per dose

Canine distemper virus  10^4.0 TCID₅₀

Canine adenovirus type 2  10^4.0 TCID₅₀

Canine parvovirus  10^7.0 TCID₅₀

Canine parainfluenza virus  10^5.5 TCID₅₀

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Lyophilisate for suspension for injection.

4. Clinical particulars

4.1 Target species

Dogs.

4.2 Indications for use, specifying the target species

For active immunisation of dogs to prevent mortality and clinical signs caused by canine distemper virus infection. To reduce clinical signs of infectious hepatitis and viral excretion due to canine adenovirus type 1 infection. To prevent mortality, clinical signs and viral excretion following canine parvovirus infection. To reduce clinical signs and viral excretion caused by canine parainfluenza virus infection and to reduce clinical signs of respiratory disease and viral excretion following adenovirus type 2 infection.

Specific claims:

An onset of immunity to the canine distemper virus, canine adenovirus and canine parvovirus vaccine components of 1 week and an onset of immunity of 4 weeks to the canine parainfluenza virus vaccine component has been demonstrated following use of the vaccine.

A duration of immunity of at least three years has been established for the canine distemper virus, canine adenovirus and canine parvovirus vaccine components. The duration of immunity for the canine parainfluenza virus component has not been demonstrated, but an anamnestic response is produced in dogs given a revaccination one year after basic vaccination. Annual revaccination with the canine parainfluenza virus vaccine component is recommended.

4.3 Contraindications

Only healthy dogs should be vaccinated. The vaccine may not be effective in dogs incubating the disease at the time of vaccination.

Some animals may be immunologically incompetent and fail to respond to vaccination. 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

The efficacy of the CDV, CAV2, CPV and CPi components of the vaccine may be reduced due to maternal antibody interference. However, the vaccine has been proved to be of benefit against virulent challenge in the presence of maternal antibody levels to CDV, CAV2, CPV and CPi that are likely to be encountered under field conditions.

4.5 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

Only healthy dogs should be vaccinated.

The canine parvovirus vaccine strain may be shed at very low levels for up to 8 days after inoculation. However there is no evidence of any reversion to virulence of the vaccine strain and therefore no need to separate unvaccinated dogs from contact with recently vaccinated individuals.

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

None.

4.6 Adverse reactions (frequency and seriousness)

A diffuse swelling, up to 5 mm in diameter, may be observed at the site of injection. Occasionally this swelling may be hard and painful and last for up to 3 days post injection.

After subcutaneous administration with an Virbac vaccine containing Rabies and/or Lepto 2 antigens, a transient palpable nodule may occasionally occur at the site of injection.

In the rare event of a hypersensitivity reaction occurring 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 in pregnant bitches which have previously been vaccinated with the CDV (strain Onderstepoort), CAV2 (strain Manhattan LPV3), CPV (strain 154) and CPi (strain Cornell) antigens included in the Canigen vaccine series.

4.8 Interaction with other medicaments and other forms of interaction

Safety and efficacy data are available which demonstrate that this vaccine can be mixed with vaccines of the Canigen range containing Inac. Leptospira interrogans serogroup canicola strain Ca-12-000and serogrup icterohaemorrhagiae, strain 820K and/or Inactivated Rabies virus strain Pasteur RIV. These can be used to reconstitute the freeze-dried Canigen DHPPi.

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.

Consult product leaflets before administering products simultaneously.

4.9 Amounts to be administered and administration route

The contents of one vial of reconstituted vaccine should be injected subcutaneously. Reconstitute immediately prior to use by the addition of the contents of one vial (1 ml) of Canigen Lepto 2 (canine leptospirosis vaccine), Canigen Rabies, or Canigen Solvent.

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 vaccination:

A single injection should establish active immunity to canine distemper, infectious canine hepatitis and disease caused by canine parvovirus infection in dogs of 10 weeks of age or older. Where earlier protection is required a first dose may be given to puppies from 6 weeks of age, but because maternally derived passive antibody can interfere with the response to vaccination a final dose at 10 weeks of age or older is generally recommended. For an optimal response to the parainfluenza component, animals should be vaccinated twice, 2 - 4 weeks apart with the final vaccination at 10 weeks of age or more.

In the event that the initial primary course dose of Canigen DHPPi is delayed to 10 weeks of age or older, a single dose of Canigen Pi at 12 weeks of age or older should suffice to establish immunity for this component.

Booster vaccination:

It is recommended that dogs be revaccinated with canine distemper virus, canine adenovirus and canine parvovirus every 3 years and against canine parainfluenzavirus every year.

It was not possible to produce clinical signs of kennel cough by parainfluenza challenge in adult dogs and duration of immunity could not therefore be demonstrated, but an anamnestic response was seen in dogs given a booster one year after primary vaccination. Revaccination against parainfluenza is recommended prior to exposure to high risk environments (such as kennelling, showing or mixing with dogs of unknown vaccination history).

Further information

Experience has shown that the maternal antibody status of pups within a litter varies greatly and reliance should not be placed on serological examination of the bitch alone.

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

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

Similar in nature to that from a single dose (see section 4.6). In some dogs the swelling may be more painful or may be observed for a longer period.

4.11 Withdrawal periods

Not applicable.

5. Immunological properties

ATC code: QI07AD04

The vaccine contains attenuated antigens to stimulate active immunity against canine distemper, canine parvovirus disease, canine infectious hepatitis caused by canine adenovirus type 1 and respiratory disease caused by canine adenovirus type 2 and canine parainfluenza virus.

6. Pharmaceutical particulars

6.1 List of excipients

Stabiliser solution

6.2 Incompatibilities

Do not mix with any other veterinary medicinal product except the diluent Canigen Solvent or Canigen Lepto 2 or Canigen Rabies recommended for use with this product.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

Shelf life after dilution or reconstitution according to directions: 30 minutes.

6.4 Special precautions for storage

Store in a refrigerator (2 C - 8 C).

Protect from light.

Do not freeze.

Care should be taken to avoid prolonged or repetitive exposure to high ambient temperatures following withdrawal from the refrigerator prior to use - in hot summer conditions vaccine potency can be severely reduced within a few hours.

6.5 Nature and composition of immediate packaging

Clear, Glass Type I (Ph.Eur.) single vials with halogenobutyl rubber stopper, closed with a colour coded aluminium cap.

Cardboard or plastic boxes containing 10 or 50 vials

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 materials derived from such veterinary medicinal products 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 01708/4519

9. Date of FIRST AUTHORISATION

20 October 2005

10. Date of revision of the text

August 2015

Approved: 27 August 2015