NOAH Compendium

Printed from NOAH Compendium (https://www.noahcompendium.co.uk). (c) Copyright NOAH Compendium 2024. All Rights Reserved.
Date: Wednesday, May 22, 2024 20:03

Description: Virbac 2013
Release 2.141
Canigen Pi
 
Species: Dogs
Therapeutic indication: Immunological veterinary medical products: For dogs
Active ingredient: Vaccine Antigens
Product:Canigen Pi
Product index: Canigen Pi
Incorporating:
Presentation
Pharmaceutical form
Lyophilisate and solvent for suspension for injection.
Lyophilisate: Off-white or cream-coloured pellet.
Solvent: clear colourless solution.
Reconstituted product: off-pink or pink suspension.
Qualitative and quantitative composition
Each 1 ml dose of reconstituted vaccine contains:
Active substance:
Live attenuated canine parainfluenza virus (CPi) strain Cornell at ≥ 105.5 and ≤ 107.3 TCID50.*.
*TCID50 = median Tissue Culture Infective Dose
Solvent (1 ml per vial):
Phosphate buffered saline.
List of excipients
Lyophilisate:
Sorbitol
Hydrolysed gelatin
Pancreatic digest of casein
Disodium phosphate dihydrate
Solvent:
Disodium phosphate dihydrate
Potassium dihydrogen phosphate
Water for injections.
Uses
Target species
Dogs.
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.
Contraindications
None.
Dosage and administration
One ml (1 ml) solvent or 1 ml (1 dose) of inactivated vaccine (as specified in 'Interactions') must be used to reconstitute the freeze-dried Canigen Pi vaccine. One dose (1 ml) of the reconstituted vaccine should be administered 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: single vaccination, with one dose per animal.
Revaccination
Every year with a single dose
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.
Contra-indications, warnings, etc
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.
Special precautions for use
Special precautions for use in animals
Vaccinate only healthy dogs.
Sterile equipment should be used for administration.
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.
Adverse reactions (frequency and seriousness)
In very rare cases, some dogs may show discomfort during injection.
In very rare cases, 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.
In very rare cases, hypersensitivity reactions may occur. In the event of an anaphylactic reaction appropriate treatment such as adrenaline should be administered without delay. .
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.
Interaction with other medicinal products and other forms of interaction
Safety and efficacy data (viral excretion) 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.
The product information of the relevant Canigen vaccines should be consulted before administration of the mixed product. When mixed with Canigen leptospirosis vaccines at annual revaccination, it has been established that there is no interference with the anamnestic response induced by the injectable canine parainfluenza virus component.
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 post-vaccination.
After mixed administration of an overdose of Canigen Pi and an overdose of the leptospirosis vaccines in 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 in the Canigen range against rabies or the inactivated vaccine against rabies and leptospirosis, where applicable. After administration with the rabies containing vaccines 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 data are available which demonstrate that this vaccine can be administered at the same time but not mixed with the inactivated vaccine in the Canigen range against Bordetella bronchiseptica.
When this vaccine is administered in association with the inactivated vaccine in the Canigen range against Bordetella bronchiseptica, the demonstrated antibody response data of this vaccine are the same as when this vaccine is administered alone.
When Canigen Pi 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.
No information is available on the compatibility 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.
Pharmaceutical precautions
Incompatibilities
Do not mix with any other veterinary medicinal product, except the Canigen dog vaccines mentioned above.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years
Shelf life after reconstitution according to directions 30 minutes
Special precautions for storage
Vaccine:
Store in a refrigerator (2 oC – 8 oC).
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.
Solvent:
Store below 25 °C if stored independently from the vaccine.
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.
Nature and contents of container
Vaccine:
Vial of hydrolytical class type I (Ph. Eur.) glass closed with a halogenobutyl rubber stopper and aluminium cap.
Solvent:
Vial of hydrolytical class type I (Ph. Eur.) glass closed with a halogenobutyl rubber stopper and aluminium cap.
Pack sizes:
Carton or plastic box with 5, 10, 25 or 50 single dose vials.
The solvent may be packed with the vaccine or separately.
Not all pack sizes may be marketed
Legal category
Legal category: POM-V
Packaging quantities
Carton or plastic box with 5, 10, 25 or 50 vials containing 1 dose of the vaccine. Not all pack sizes may be marketed.
Further information
List of excipients
Sorbitol
Gelatin
Pancreatic digest of casein
Disodium phosphate dehydrate
Water for injections
Marketing Authorisation Number
Vm 01708/4491
Significant changes
GTIN
GTIN description:Canigen Pi (10 Doses)
GTIN:8713184050694