Special warnings
Vaccinate healthy animals only.
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 to be taken by the person administering the veterinary medicinal product to animals:
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Adverse events
Dogs:
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Discomfort1. Injection site swelling2. Hypersensitivity reaction3. |
1 During injection.
2 Diffuse up to 5 mm in diameter, which may occasionally be hard and painful and last up to 3 days post injection.
3 In the event of an anaphylactic reaction, appropriate treatment such as adrenaline should be administered without delay.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
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 in 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 this vaccine 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 this vaccine 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 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.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
No adverse events other than those mentioned in 'Adverse events', except that the swelling may be more painful or may be observed for a longer period, were observed after administration of a 10-fold overdose of the vaccine.