Revised: August 2015
Summary of Product Characteristics
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Vaccine: per dose (1 ml)
live attenuated canine parainfluenza virus
(CPi) strain Cornell: ≥ 105.5and ≤ 107.3TCID50.
3. PHARMACEUTICAL FORM
Lyophilisate for suspension for injection.
4. CLINICAL PARTICULARS
4.1 Target species
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.
4.4 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
Special precautions for use in animals
Vaccinate only healthy dogs.
Special precautions to be taken by the person administering the medicinal product to animals
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.
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
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)
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
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
8. Marketing Authorisation number
9. Date of first authorisation
26 August 2003
10. Date of revision of the text
Approved: 26 August 2015
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