Target species
Dogs
Indications for use for each 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 |
Contraindications
None.
Special warnings
Vaccinate healthy animals only.
Special precautions for use
Special precautions for safe use in the target species:
Apply usual aseptic procedures.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
None.
Special precautions for the protection of the environment:
Not applicable.
Adverse events
Dogs:
| |
Very Common (>1 animal / 10 animals treated): | Injection site swelling¹, pruritus², injection site pain and warmth⁴. |
Common (1 to 10 animals / 100 animals treated): | Lethargy³, anorexia² and emesis². |
Uncommon (1 to 10 animals / 1,000 animals treated): | Diarrhoea, muscle tremor, vocalisation, hyperthermia⁵, tachycardia and tachypnoea. |
Rare (1 to 10 animals / 10,000 animals treated): | Hypersensitivity reactions (facial oedema, urticaria)⁶. |
¹ less than 6 cm, disappearing within 8 days
² disappearing within 2 days
³ disappearing within 3 days
⁴ disappearing within 4 days
⁵ maximum 39.8 °C, disappearing within 1 day.
⁶ including anaphylactic shock, which may be life threatening. If such a reaction occurs, appropriate treatment 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 section “contact details” of the package leaflet.
Use during pregnancy, lactation or lay
Safety data in pregnant bitches vaccinated with Boehringer Ingelheim’s trivalent leptospirosis vaccine containing Leptospira Canicola, Leptospira Icterohaemorrhagiae and Leptospira Grippotyphosa are available and demonstrate that it can be used during pregnancy. For Eurican L4, which contains an additional inactivated strain, Leptospira Australis, no safety data in pregnant bitches are available.
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 Eurican DAP or Eurican DAPPi / Eurican DHPPi.
Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day as, but not mixed with Rabisin 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.
Administration routes and dosage
When Eurican L4 is used alone, inject a 1 ml dose subcutaneously.
When Eurican L4 is used as a diluent of Eurican DAP or Eurican DAPPi / Eurican DHPPi, 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.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
No adverse events other than those mentioned in section 3.6 were observed after administration of a 2-fold overdose. Swelling and pain at the injection site may persist longer after an overdose. These symptoms disappear within at most 22 days and 10 days respectively.
Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance
Not applicable.
Withdrawal periods
Not applicable.