Target species
Dogs
Indications for use, specifying the target species
Active immunisation of dogs to:
•prevent mortality and clinical signs caused by canine distemper virus (CDV),
•prevent mortality and clinical signs caused by infectious canine hepatitis virus (CAV-1),
•reduce viral excretion during respiratory disease caused by canine adenovirus type 2 (CAV-2),
•prevent mortality, clinical signs and viral excretion caused by canine parvovirus (CPV)*.
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 and at least 2 years after the first annual booster for all strains.
Current available challenge and serological data show that protection for distemper virus, adenovirus and parvovirus* lasts for 2 years after primary vaccination course followed by a first annual booster. Any decision to adapt the vaccination schedule of this veterinary medicinal product needs to be made on a case by case basis, taking into account the vaccination history of the dog and the epidemiological context.
*Protection has been demonstrated against canine parvovirus type 2a, 2b and 2c either by challenge (type 2b) or serology (type 2a and 2c).
Contraindications
None.
Special warnings for each target species
Vaccinate healthy animals only.
Special precautions for use
Special precautions for use in animals
Apply usual aseptic procedures.
After vaccination, the live CAV-2 and CPV vaccine strains can transiently be shed without adverse consequence for in-contact animals.
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 slight swelling (≤ 2 cm) at the injection site may commonly be observed immediately after injection. It usually regresses within 1-6 days. This can, on some occasions, be accompanied by slight pruritus, heat and pain at the injection site. Transient lethargy and emesis may also be commonly observed.
Anorexia, polydipsia, hyperthermia, diarrhoea, muscle tremor, muscle weakness and injection site cutaneous lesions may uncommonly be observed.
Hypersensitivity reactions (facial oedema, anaphylactic shock, urticaria) may rarely occur, some of which are life-threatening. Appropriate symptomatic treatment should promptly be provided.
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
Can be used 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 administered with Eurican LR, Eurican L Eurican Lmulti or Eurican L4 vaccines (used as solvent) where available.
Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but not mixed with Rabisin vaccine.
When administered with Boehringer Ingelheim's vaccines containing rabies, the minimum age for vaccination is 12 weeks of age.
When mixed with the Eurican LR vaccine a small and transient nodule (maximum size 1.5 cm) at the injection site may be induced due to the presence of aluminium hydroxide and a slight swelling (~4 cm) may occur after the injection at injection site, regressing generally within 1-4 days.
When mixed with the Eurican L4 vaccine a swelling (less than 6 cm) may very commonly occur at the injection site, disappearing within 8 days, anorexia may commonly occur and vocalisation, tachycardia and tachypnoea may uncommonly be observed. For Eurican L4, no safety data in pregnant bitches are available for the additional inactivated strain, Leptospira Australis.
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.
Amounts to be administered and administration route
Aseptically reconstitute the contents of the lyophilisate with either solvent for Eurican DAP/DAPPi or a compatible Boehringer Ingelheim vaccine (Eurican LR, Eurican L, Eurican Lmulti or Eurican L4) where available. Shake well before use. The entire contents of the reconstituted vial should be administered as a single dose.
The reconstituted content shall be an opalescent yellow to orange suspension.
Inject a 1-ml dose subcutaneously according to the following schedule:
Primary vaccination:
Two injections separated by an interval of 4 weeks from 7 weeks of age.
When administered with Boehringer Ingelheim's vaccines containing rabies, the minimum age for vaccination is 12 weeks of age.
In cases where high levels of maternally derived antibodies are suspected by the veterinarian and the primary vaccination course was completed before 16 weeks of age, a third injection is recommended from 16 weeks of age, at least 3 weeks after the second injection.
Revaccination: Administer one dose 12 months after completion of the primary vaccination course.
Dogs should be revaccinated with a single booster dose every two years after the first annual booster.
Overdose (symptoms, emergency procedures, antidotes), if necessary
No adverse reactions other than those mentioned in section 4.6 were observed after administration of a 10-fold overdose of the lyophilisate.
Withdrawal period(s)
Not applicable.