Name of the veterinary medicinal product
Eurican DAPPi lyophilisate and solvent for suspension for injection
2. Composition
Each dose of 1 ml vaccine contains:
Lyophilisate:
Active substances:107.1DICC50*
Attenuated Parainfluenza virus type 2, strain 104.7 DICC50* 107.1DICC50*
CGF 2004/75
*DICC50: 50% infectious dose on cell cultures
Solvent:
Water for injections3. Target species Dogs
4. Indications for use
Active immunisation of dogs, for the purpose of:
- prevention of mortality and clinical signs caused by Canine Distemper Virus (CDV),
- prevention of mortality and clinical signs caused by Canine Infectious Hepatitis Virus (CAV-1),
- reduction of viral excretion during respiratory disease caused by Canine Adenovirus Type 2 (CAV-2),
- prevention of mortality, clinical signs and viral excretion caused by Canine Parvovirus (CPV)*,
- reduction of viral excretion caused by Canine Parainfluenza Virus Type 2 (CpiV).
Onset of immunity: 2 weeks after the second injection of the first vaccination.
Duration of immunity: at least one year after the second injection of the first vaccination.
Available data from serological and challenge testing demonstrate that protection against distemper, adenovirus and parvovirus* lasts for at least 2 years after the first annual revaccination.
Any decision to adapt the vaccination schedule of this veterinary medicinal product should be made on a case-by-case basis, taking into account the vaccination history of the dog and the epidemiological context.
*Protection against canine parvovirus types 2a, 2b and 2c has been demonstrated either by challenge testing (type 2b) or by serology (type 2a and 2c).
5. Contraindications
None.
6. Special warnings
Special warnings:
Vaccine only healthy animals.
Special precautions for safe use in the target species:
Usual aseptic procedures should be followed.
After vaccination, live vaccine strains CAV-2 and CPV may be temporarily transmitted by vaccinated animals without undesirable consequences to animals with which they come into contact.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
In case of accidental injection/self-injection with this product, seek medical advice immediately and show the label or package leaflet to the physician.
Pregnancy: Can be used during pregnancy.
Interaction with other veterinary medicinal products and other forms of interaction:
Safety and efficacy data are available that demonstrate that this vaccine can be administered with Eurican LR, Eurican L, Eurican Lmulti or Eurican L4 vaccines (used as a solvent) where available.
Safety and efficacy data are available that demonstrate that this vaccine can be administered on the same day but not mixed with Rabisin.
When administered with Boehringer Ingelheim rabies vaccines, the minimum age for vaccination is 12 weeks.
When administered mixed with Eurican LR vaccine, a small temporary nodule (maximum size 1.5 cm) and a slight swelling (~4 cm) may form at the injection site due to the aluminum hydroxide, which generally regresses within 1-4 days.
When administered mixed with Eurican L4 vaccine, very commonly, a swelling (less than 6 cm) may appear at the injection site, which will disappear within a maximum of 8 days, anorexia may occur frequently and vocalization, tachycardia and tachypnea may occur less frequently. For Eurican L4, which contains an additional inactivated strain, Leptospira Australis, no data are available on the safety of pregnant females.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except those mentioned above. A decision to use this vaccine before or after any other veterinary medicinal product should be made on a case by case basis.
Overdose:
No adverse events have been observed except those mentioned in the “adverse events” section after administration of an overdose of 10 times the dose of the lyophilisate.
Major incompatibilities:
Do not mix with other veterinary medicinal products except the solvent for Eurican DAP/DAPPi intended for use with this veterinary medicinal product and except those mentioned in the “Interaction” subsection above.
7. Adverse events
Dogs:
Common (1 to 10 animals/100 animals treated):
Injection site inflammation1, injection site pruritus, injection site pain. Lethargy2. Emesis2.
Uncommon (1 to 10 animals/1,000 animals treated):
Anorexia, polydipsia, hyperthermia. Diarrhoea. Muscle tremors. Muscle weakness. Warmth at the injection site, skin lesions at the injection site3
Rare (1 to 10 animals/10,000 animals treated):
Hypersensitivity reactions (facial oedema, anaphylactic shock, urticaria)4
1 Mild (≤ 2 cm) immediately after inoculation. Usually resolves within 1 - 6 days.
2 Temporary.
3 Cutaneous.
4 Some of these may be life-threatening. They require immediate appropriate symptomatic treatment.
8. Dosage for each species, route of administration and methods of administration
After reconstitution, 1 dose of 1 ml is injected subcutaneously according to the following schedule:
First vaccination: Two injections at an interval of 4 weeks, starting from 7 weeks of age.
When administered together with Boehringer Ingelheim rabies vaccines, the minimum age for vaccination is 12 weeks.
In cases where the veterinarian assumes a high level of maternally derived antibodies and the primary vaccination is completed before 16 weeks of age, a third injection with a Boehringer Ingelheim distemper, adenovirus and parvovirus vaccine is recommended, starting at 16 weeks of age, at least 3 weeks after the second injection.
Revaccination: One dose is administered 12 months after the primary vaccination. Dogs should be revaccinated with a single booster dose annually.
9. Recommendations for correct administration
The lyophilisate is reconstituted aseptically with either the solvent for Eurican DAP/DAPPi or a compatible vaccine (Eurican LR, Eurican L, Eurican Lmulti or Eurican L4) from Boehringer Ingelheim, where available. Shake well before use. After reconstitution, the entire contents of the vial should be administered as a single dose.
The reconstituted vaccine will be an opalescent yellow-orange suspension.
10. Withdrawal periods
Not applicable.
11. Special precautions for storage
Keep out of the sight and reach of children.
Lyophilisate and solvent:
Store and transport at 2°C-8°C.
Do not freeze.
Protect from light.
Do not use this veterinary medicinal product after the expiry date which is stated on the label after “EXP”.
Shelf life after reconstitution according to directions: use immediately.
12. Special precautions for disposal
Medicinal products should not be disposed of via wastewater or household waste.
Use systems for the return of unused veterinary medicinal products or waste materials derived from such products, in accordance with local requirements and applicable national collection systems. These measures should contribute to the protection of the environment.
13. Classification of veterinary medicinal products
Veterinary medicinal product subject to prescription.