14

authorised

no

Medicinal

Medicinal product no longer authorised

PACKAGE LEAFLET

1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

   
   

   Intervet International B.V. Wim de Körverstraat 35 NL - 5831 AN Boxmeer

   
   

2. NAME OF THE VETERINARY MEDICINAL PRODUCT

   
   

   Nobivac Piro lyophilisate and solvent for suspension for injections for dogs

   
   

3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS

   
   

   Per 1 ml dose of the reconstituted product:

   606 (301-911) total antigenic mass units of soluble parasite antigen (SPA) from Babesia canis and

   Babesia rossi cultures

   Adjuvant: 250 (225-275) μg saponin (from the solvent)

   
   

4. INDICATION(S)

   
   

   For active immunisation of dogs of 6 months of age or older against Babesia canis to reduce the severity of clinical signs associated with acute Babesiosis (B. canis) and anaemia as measured by Packed Cell Volume (PCV).

   Onset of immunity: Three weeks after the basic vaccination course. Duration of immunity: 6 months after the last (re-)vaccination .

   
   

5. CONTRAINDICATIONS

   
   

   Do not use in pregnant or lactating bitches.

   
   

6. ADVERSE REACTIONS

   
   

   Commonly reported post-vaccination reactions are a diffuse swelling and/or hardened nodule, accompanied by pain, at the site of vaccination. In general this disappears within 4 days. In rare cases, the reactions after the second dose of vaccine may remain for 14 days. In addition, systemic signs, such as lethargy and a reduction in appetite may also commonly occur, sometimes accompanied by pyrexia and a stiff gait. These reactions should disappear within 2-3 days.

   If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.

   
   

7. TARGET SPECIES

   
   

   Dogs

   Medicinal product no longer authorised

8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

   
   

   1 ml reconstituted vaccine, via subcutaneous injection.

   
   

   Vaccination scheme:

   Basic vaccination course: First injection from 6 months of age, second injection 3-6 weeks later. Revaccination: Single dose, every six months after the last (re-) vaccination.

   
   

9. ADVICE ON CORRECT ADMINISTRATION

   
   

   Allow the solvent to reach room temperature (15 - 25°C). Aseptically add the solvent to the lyophilisate. DO NOT SHAKE, but swirl gently.

   Make sure that the lyophilisate is completely dissolved before use

   Withdraw the entire contents of the reconstituted vaccine into a sterile syringe and administer the whole contents subcutaneously.

   
   

10. WITHDRAWAL PERIOD

    
    

    Not applicable.

    
    

11. SPECIAL STORAGE CONDITIONS, IF ANY

    
    

    Store and transport refrigerated (2°C - 8°C). Protect from light. Keep out of reach and sight of children.

    Do not use after the expiry date which is stated on the label.

    
    

12. SPECIAL WARNINGS

    
    

    Only healthy dogs should be vaccinated. In particular, chronic asymptomatic carriers should be identified and treated before vaccination, with substances that do not compromise immunological responsiveness.

    
    

    It is recommended that vaccinations are given at least one month before the tick season.

    
    

    As active Babesia infection might interfere with the development of protective immunity it is recommended to reduce exposure to ticks during the period of vaccination.

    
    

    Currently there is only evidence of the efficacy of the vaccine against challenge with B. canis. There is a possibility that vaccinated dogs facing a challenge with other babesia's may develop disease and require treatment.

    
    

    Vaccination with Nobivac Piro does not prevent infection. As a consequence a milder form of disease caused by B. canis can occur. If mild babesia-like symptoms arise which last for more than 2 days veterinary advice should be sought.

    
    

    No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. 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.

    
    

    In the absence of compatibility studies, do not mix with any other veterinary medicinal product except the solvent supplied for use with the vaccine.

    Medicinal product no longer authorised

    In case of accidental self-injection, seek medical advice immediately and show the package insert or the label to the physician.

    
    

13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

    
    

    Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with the local requirements.

    
    

14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

    
    

    16 July 2009

    
    

15. OTHER INFORMATION

Pack sizes:

Cardboard box containing 1 vial of lyophilisate and 1 vial of solvent. Cardboard box containing 5 vials of lyophilisate and 5 vials of solvent.

Cardboard box containing 10 vials of lyophilisate and 10 vials of solvent.

Not all pack sizes may be marketed.

For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.

For animal treatment only.