Lyophilisate and solvent for suspension for injection.

Each single dose vial contains Canine distemper virus, strain Onderstepoort³ 104.0 TCID50,

Canine adenovirus 2, strain Manhattan LPV3³ 104.0 TCID50, Canine parvovirus, strain 154³ 107.0 TCID50.

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

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

Onset of immunity: one week.

Duration of immunity: three years.

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

Subcutaneous use. Reconstitute immediately prior to use by the addition of the contents of one vial (1.0 ml) of the dilutent provided or the vaccines Canigen Lepto 4, Canigen Lepto 2 or Canigen Rabies.

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.

A single injection should establish active immunity 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 should be given 2-4 weeks later i.e. at 10 weeks of age or older.

To maintain protection a single booster dose is recommended every three years.

None

The efficacy of the CDV, CAV2 and CPV 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 and CPV that are likely to be encountered under field conditions.

Only healthy dogs should be vaccinated. Dogs should not be exposed to unnecessary risk of infection within the first 2 weeks after completion of the vaccination regimen. While the canine parvovirus vaccine strain may be shed at very low levels for up to 8 days after inoculation, there is no evidence that this results in clinical symptoms if nonvaccinated animals are infected.

In the case of accidental self-injection, wash the area immediately with water. If symptoms develop, seek medical attention showing a copy of package leaflet.

A common reaction after subcutaneous administration with the diluent provided is a diffuse swelling up to 5 mm in diameter at the site of injection. Occasionally this swelling may be hard and painful and last for up to 3 days post injection.

In rare cases a transient rise in body temperature and/or a transient acute hypersensitivity reaction (anaphylaxis) - with signs that may include lethargy, facial oedema, pruritus, dyspnoea, vomiting, diarrhoea or collapse - may occur shortly after vaccination.

Clinical signs of immune-mediated haemolytic anaemia, immune-mediated thrombocytopenia or immune-mediated polyarthritis have been reported in very rare cases.

Can be used in pregnant bitches which have previously been vaccinated with the Canigen DHPPi, DHP, Parvo-C or Pi.

Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with the inactivated vaccines of the Canigen range against canine leptospirosis caused by all or some of the following serovars: L. interrogans serogroup Canicola serovar Canicola, L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni, L. interrogans serogroup Australis serovar Bratislava, and L. kirschneri serogroup Grippotyphosa serovar Bananal/Liangguang.

After administration with one of the leptospirosis vaccines, a mild and transient increase in body temperature (≤ 1 °C) may occur for a few days after vaccination, with some pups showing less activity and/or a reduced appetite. A small transient swelling (≤ 4 cm), which can occasionally be firm and painful on palpation, may be observed at the site of injection. Any such swelling will either have disappeared or be clearly diminished by 14 days postvaccination.

After mixed administration of an overdose of Canigen DHP and an overdose of the leptospirosis vaccines of the Canigen range, transient local reactions such as diffuse to firm swellings from 1 to 5 cm in diameter may be observed, usually these will persist no longer than 5 weeks, however some may take a little longer to completely disappear.

Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with the inactivated vaccine of the Canigen range against rabies. After administration with the rabies vaccine, where this product is authorised, transient local reactions such as diffuse to firm swellings from 1 to 4 cm in diameter may be observed for up to 3 weeks after vaccination. The swellings may be painful for up to 3 days post dosing.

Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day, but not mixed, with the live vaccine for intranasal administration of the Canigen range against infectious tracheobronchitis caused by Bordetella bronchiseptica and/or canine parainfluenza virus.

Safety and efficacy data are available which demonstrate that this vaccine can be administered at the same time but not mixed with the inactivated vaccine of the Canigen range against Bordetella bronchiseptica.

When Canigen DHP is used with any of the other Canigen vaccines referred to above, the minimum vaccination age for each vaccine must be taken into account such that at the time of vaccination, the dogs are at or older than the oldest minimum vaccination age for the individual vaccines.

Consult product leaflets before administering products simultaneously.

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.

Not applicable.

For animal treatment only. Keep out of reach and sight of children.

Do not mix with any other veterinary medicinal product except the solvent or the vaccines of the Canigen range listed under contra-indications, warnings, etc.

Shelf life of the veterinary medicinal product as packaged for sale: 24 months.

Shelf life after reconstitution: 30 minutes.

Store in a refrigerator (2 °C – 8 °C). Do not freeze. Protect from light.

Store in a refrigerator at 2 °C – 8 °C with care being taken to avoid prolonged or repetitive exposure to high ambient temperature following withdrawal from the refrigerator prior to use.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Canigen DHP may be presented in cardboard or plastic boxes containing 10 or 50 single dose vials. The solvent may be packed with the vaccine or separately. Not all pack sizes may be marketed.

Sorbitol

Gelatine

Pancreatic digest of casein

Disodium phosphate dihydrate

Potassium dihydrogen phosphate

Water for injections.