Summary of Product Characteristics

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Canigen Pi

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Vaccine: per dose (1 ml)

Active substance(s)

live attenuated canine parainfluenza virus

(CPi) strain Cornell: ≥ 10^5.5and ≤ 10^7.3TCID₅₀.

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 from the age of 8 weeks onward to reduce clinical signs of canine para-influenza infection and to reduce viral shedding.

Onset of immunity: 4 weeks after vaccination.

Duration of immunity: has not been demonstrated, but an anamnestic response is produced in dogs given a revaccination one year after basic vaccination.

4.3 Contraindications

None.

4.4 Specific warnings for each target species

A protective antibody titre is not accomplished in all vaccinated dogs.

As maternally derived passive antibodies can interfere with the response to vaccination in very young animals, a final dose at 10 weeks of age or older is recommended.

4.5 Special precautions for use

Vaccinate only healthy dogs.

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

4.6 Adverse reactions (frequency and seriousness)

Some dogs may show discomfort during injection.

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 the lepto and/or rabies vaccines of the Canigen series (where these products and their combined use are authorised), a diffuse swelling may be observed at the injection site in most puppies. Occasionally this swelling may be hard and painful but this will diminish gradually and disappear after 2 - 3 weeks.

4.7 Use during pregnancy, lactation or lay

Canigen Pi has been shown to be safe for use in pregnant bitches that have been vaccinated before pregnancy with the Pi vaccine of the Canigen series.

4.8 Interaction with other medicinal products and other forms of interaction

Safety and efficacy data are available which demonstrate that this vaccine can be mixed with vaccines of the Canigen range containing Inac. Leptospira interrogansserogroup canicola strain Ca-12-000and serogrup icterohaemorrhagiae, strain 820K and/or Inactivated Rabies virus strain Pasteur RIV. These liquid vaccines can be used to reconstitute the freeze-dried Canigen Pi, where these products and their combined use are authorised.

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

One ml solvent must be used to reconstitute the freeze-dried Canigen Pi vaccine.

One ml of the reconstituted vaccine should be given by subcutaneous injection.

Vaccination schedule:

Basic vaccination:

Before the age of 12 weeks:

Two vaccinations, each with a single dose: the first vaccination from the age of 8 weeks onwards and the second vaccination 2-4 weeks later.

From the age of 12 weeks onwards:

A single vaccination, with one dose per animal

Revaccination:

Every year with a single dose.

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

Not different from a single dose. In some dogs the swelling may be more painful or may be observed for a longer period.

4.11 Withdrawal period(s)

Not applicable.

5. IMMUNOLOGICAL PROPERTIES

ATC vet code:QI07AD08.

Pharmacotherapeutic group: Immunologicals for canidae, live viral vaccines.

Induction of active immunity against canine parainfluenza virus.

Under laboratory conditions, antibody response, reduction of clinical signs and/or reduction of virus excretion have been observed after challenge with CPi virus 4 weeks after vaccination.

It was not possible to produce clinical signs by CPi challenge in adult dogs and duration of immunity could therefore not be demonstrated, but an anamnestic response was seen in dogs given a revaccination one year after basic vaccination.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Stabiliser

6.2 Incompatibilities

Do not mix with any other veterinary medicinal product except with the diluent supplied with the product or with the lepto and/or rabies vaccines of the Canigen series.

6.3 Shelf- life

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

Shelf life after reconstitution according to directions 30 minutes

6.4 Special precautions for storage

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

Do not freeze.

Protect from light.

Care should be taken to avoid prolonged or repetitive exposure to high ambient temperatures following withdrawal from the refrigerator prior to use.

6.5 Nature and contents of container

Carton or plastic box with 5, 10, 25 or 50 vials of hydrolytical class type I (Ph. Eur.) glass, containing 1 dose of the vaccine. The vial is closed with a halogenobutyl rubber bung and sealed with a coded aluminium cap.

Not all presentations may be marketed.

6.6 Special precautions for the disposal of unused medicinal product or waste materials, if any

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

Vm01708/4491

9. Date of first authorisation

26 August 2003

10. Date of revision of the text

August 2015

Approved: 26 August 2015