Target species
Dog.
Indications for use, specifying the target species
For active immunisation of dogs from 8 weeks of age to:
- prevent mortality and reduce infection, clinical signs, kidney colonisation, renal lesions and urine shedding of Leptospira Canicola;
- reduce infection, clinical signs, kidney colonisation and urine shedding of Leptospira Icterohaemorrhagiae;
Onset of immunity:
The onset of immunity has been demonstrated from 5 weeks for Leptospira Canicola and 2 weeks for Leptospira Icterohaemorrhagiae.
Duration of immunity:
The duration of immunity lasts for one year after the primary vaccination for all components.
In the one-year duration of immunity studies there was no significant difference between vaccinated and control dogs in reduction of kidney colonisation for Leptospira Canicola and Leptospira Icterohaemorrhagiae, nor in renal lesions and urine shedding for Leptospira Canicola.
Contraindications
None.
Special warnings for each target species
Vaccinate healthy animals only.
Special precautions for use
Special precautions for use in animals:
None.
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 reactions (frequency and seriousness)
A transient swelling (≤ 4 cm) or slight diffuse local oedema in rare cases associated with pain or pruritus was commonly observed in safety studies. Any such local reaction resolves spontaneously within 1 to 2 weeks.
Some transient post-vaccinal lethargic states were commonly observed in clinical studies.
Transient hyperthermia or digestive disturbances such as anorexia, diarrhoea or vomiting were rarely observed from spontaneous reports.
Hypersensitivity reactions (e.g. anaphylaxis, skin manifestations such as oedema/swelling, erythema, pruritus) have been reported in very rare cases from spontaneous reports. In case of such an allergic or anaphylactic reaction, appropriate symptomatic treatment should be administered.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Use during pregnancy, lactation or lay
Do not use during pregnancy and lactation.
Interaction with other medicinal products and other forms of interaction
Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with Virbac’s vaccines against canine distemper virus (CDV), canine adenovirus (CAV), canine parvovirus (CPV), canine parainfluenza virus (CPiV) and rabies, if available.
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 decided on a case-by-case basis.
Amounts to be administered and administration route
Shake gently and administer immediately one dose of 1 ml subcutaneously according to the following vaccination schedule:
Primary vaccination course:
- first injection from 8 weeks of age,
- second injection 3 or 4 weeks later.
When active immunisation against CDV, CAV, CPV and CPiV is required, one dose of the product can be used to reconstitute one dose of Virbac’s freezedried vaccines containing CDV, CAV-2, CPV and CPiV components. After reconstitution, shake gently (the reconstituted product is slightly pinkish beige) and administer immediately one dose of 1 ml subcutaneously according to the same vaccination schedule: 2 injections 3 to 4 weeks apart from 8 weeks of age.
When active immunisation against rabies is also required, and if Virbac’s rabies vaccine is available, 1 dose of the product alone or mixed as above can be mixed with 1 dose of Virbac’s rabies vaccine and 2 ml of mixed vaccines can be administered immediately subcutaneously. Refer to the Virbac’s rabies vaccine product information regarding vaccination scheme against rabies.
Annual re-vaccination:
One booster injection of a single dose should be given 1 year after the second injection and annually thereafter.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Not applicable.