Target species
Dogs
Indications for use, specifying the target species
Active immunisation of dogs from 7 weeks of age to prevent or reduce mortality, clinical signs, infection, bacterial excretion, renal carriage and renal lesions caused by:
•Leptospira interrogans serogroup Canicola serovar Canicola,
•Leptospira interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae,
•Leptospira kirschneri serogroup Grippotyphosa serovar Grippotyphosa, and
•Leptospira interrogans serogroup Australis serovar Bratislava.
•
| | | | | | |
Canicola / Canicola | Prevention* | Prevention* | Reduction | Reduction | Reduction | Reduction |
Icterohaemorrhagiae / Icterohaemorrhagiae | Prevention** | Prevention** | Reduction | Reduction | Reduction | Reduction |
Grippotyphosa / Grippotyphosa | Prevention** | Prevention** | Reduction | Reduction | Reduction | Reduction |
Australis / Bratislava | Prevention | Prevention | Prevention | Prevention | Prevention | Prevention |
* For Leptospira interrogans serovar Canicola, no mortality and clinical signs occurred in the vaccinated and control groups during challenge experiment for duration of immunity.
**For Leptospira interrogans serovar Icterohaemorrhagiae and Leptospira kirschneri serovar Grippotyphosa, no mortality occurred in the vaccinated and control groups during challenge experiments for duration of immunity and the prevention of clinical signs was not statistically significant.
Onset of immunity:
2 weeks after the second injection of the primary vaccination course for all strains.
Duration of immunity:
at least one year after the second injection of the primary vaccination course for all strains.
Contraindications
None
Special warnings for each target species
Vaccinate healthy animals only
Special precautions for use
i). Special precautions for safe use in the target species
Apply usual aseptic procedures
ii). 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 label to the physician.
iii). Other precaution
Adverse reactions (frequency and seriousness)
| |
Very common (>1 animal / 10 animals treated): | Swelling at the injection site¹, transient pruritus, heat and pain at the injection site² |
Common (1 to 10 animals / 100 animals treated): | Transient lethargy, anorexia and emesis. |
Uncommon (1 to 10 animals / 1,000 animals treated): | Diarrhoea, muscle tremor, vocalisation, hyperthermia, tachycardia and tachypnoea |
Rare (1 to 10 animals / 10,000 animals treated): | Hypersensitivity reactions (facial oedema, anaphylactic shock, urticaria), some of which are life-threatening³. |
Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established during pregnancy.
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 Boehringer Ingelheim live attenuated vaccines against distemper, adenovirosis, parvovirosis and parainfluenza type 2 respiratory infections.
Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day as, but not mixed with, Boehringer Ingelheim's rabies vaccine in dogs from 12 weeks of age.
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.
Amount(s) to be administered and administration route
When Eurican L4 is used alone, inject a 1 ml dose subcutaneously.
When Eurican L4 is used as a diluent of a Boehringer Ingelheim freeze-dried vaccine against distemper, adenovirosis, parvovirosis and parainfluenza type 2, aseptically reconstitute the contents of the lyophilisate with the Eurican L4 vaccine suspension. Mix well before use. The entire contents of the reconstituted vial should be administered as a single dose.
The following schedule should be followed:
Primary vaccination: Two injections separated by an interval of 4 weeks from 7 weeks of age.
Revaccination: Administer one dose 12 months after completion of the primary vaccination course. Dogs should be revaccinated with a single booster dose on an annual basis.
Overdose (symptoms, emergency procedures, antidotes), if necessary
No adverse events other than those mentioned in section 4.6 were observed after administration of a 2-fold overdose.
Withdrawal period(s)
Not applicable