PACKAGE LEAFLET:

Ecoporc SHIGA suspension for injection for pigs

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

   
   

   Marketing authorisation holder:

   
   

   Ceva Santé Animale 10 av. de La Ballastière 33500 Libourne

   France

   
   

   Manufacturer responsible for batch release:

   
   

   IDT Biologika GmbH
   Am Pharmapark
   06861 Dessau-Rosslau
   Germany

   
   

   Ceva-Phylaxia Veterinary Biologicals Co. Ltd. Szállás u. 5.

   1107 Budapest

   Hungary

   
   

2. NAME OF THE VETERINARY MEDICINAL PRODUCT

   
   

   Ecoporc SHIGA suspension for injection for pigs

   
   

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

   
   

   Each dose of 1 ml contains:

   
   

   Active substances:

   Genetically modified recombinant Stx2e antigen: ≥ 3.2 x 106 ELISA units

   
   

   Adjuvant:

   Aluminium (as hydroxide) max. 3.5 mg

   
   

   Excipient:

   Thiomersal max. 0.115 mg

   
   

   Appearance after shaking: yellowish to brownish, homogenous suspension.

   
   

4. INDICATION(S)

   
   

   Active immunisation of piglets from the age of 4 days, to reduce the mortality and clinical signs of oedema disease caused by Stx2e toxin produced by E. coli (STEC).

   
   

   Onset of immunity: 21 days after vaccination Duration of immunity: 105 days after vaccination

5. CONTRAINDICATIONS

   
   

   Do not use in case of hypersensitivity to the active substance, to the adjuvant or to any of the excipients.

   
   

6. ADVERSE REACTIONS

   
   

   Commonly very small local reactions such as mild swelling at the injection site (maximum of 5 mm) may be observed, but these reactions are transient and subside within a short time (up to seven days) without treatment.

   Commonly a slight rise in body temperature (maximum of 1.7 °C) may occur after injection. But these reactions subside within a short time (maximum of two days) without treatment.

   Clinical signs such as temporary mild behavioural disturbances can uncommonly be observed after

   application of Ecoporc SHIGA.

   
   

   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).

     
     

     If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.

     
     

7. TARGET SPECIES

   
   

   Pigs.

   
   

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

   
   

   Prior to administration, shake the vaccine carefully.

   A single intramuscular injection (1 ml) to pigs from the age of 4 days. The preferred application site is the neck muscle behind the ear.

   
   

9. ADVICE ON CORRECT ADMINISTRATION

   
   

   It is recommended to use a needle appropriate for the age of the piglets (preferred size 21G length 16 mm).

   
   

10. WITHDRAWAL PERIOD(S)

    
    

    Zero days.

    
    

11. SPECIAL STORAGE PRECAUTIONS

    Keep out of the sight and reach of children. Store in a refrigerator (2 °C – 8 °C).

    Do not freeze.

    Protect from light.

    Shelf life after first opening the container: 24 hours (store at 2 °C – 8 °C). Between the withdrawals the vaccine should be stored at 2 °C – 8 °C.

    
    

    Do not use this veterinary medicinal product after the expiry date which is stated on the label or carton.

    
    

12. SPECIAL WARNING(S)

    
    

    Special precautions for use in animals:

    
    

    Only vaccinate healthy animals.

    
    

    Special precautions to be taken by the person administering the veterinary medicinal product to animals:

    
    

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

    
    

    Pregnancy and lactation:

    
    

    The safety of the veterinary medicinal product has not been established during pregnancy and lactation. The use is not recommended during pregnancy and lactation.

    
    

    Interaction with other medicinal products and other forms of interaction:

    
    

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

    A decision about using this vaccine before or after any other veterinary medicinal product therefore needs to be made by the responsible veterinarian on a case by case basis.

    
    

    Major incompatibilities:

    Do not mix with any other veterinary medicinal product.

    
    

    Overdose (symptoms, emergency procedures, antidotes):

    
    

    Following the administration of a double dose of vaccine no adverse reactions other than those described in section 6 have been observed.

    
    

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

    
    

    Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.

    
    

14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

    
    

    ).

    
    

15. OTHER INFORMATION

PET bottle containing 50 ml or 100 ml closed with a bromobutyl rubber stopper and sealed with an aluminium tear-off cap.

Pack sizes:

Cardboard box with 1 PET bottle of 50 doses (50 ml) or 100 doses (100 ml).

Not all pack sizes may be marketed.