16

Medicinal product no longer authorised

PACKAGE LEAFLET FOR:

BTVPUR AlSap 1 suspension for injection for sheep and cattle

authorised

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

   
   

   Marketing authorisation holder: MERIAL

   29 avenue Tony Garnier 69007 Lyon,

   France

   
   

   Manufacturer responsible for batch release: MERIAL

   Laboratory of Lyon Porte des Alpes Rue de l’Aviation,

   69800 Saint-Priest France

   
   

2. NAME OF THE VETERINARY MEDICINAL PRODUCT

   
   

   BTVPUR AlSap 1 suspension for injection for sheep and cattle

   
   

   no

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

   
   

   Each dose of 1 ml of vaccine (homogeneous milky white suspension) contains:

   
   

   Active substance:

   .Inactivated Bluetongue Virus Serotype 1...............................................................≥ 1.9 log10 pixels *

   (*) Antigen content (VP2 protein) by immuno-assay

   
   

   Adjuvants:

   .Al3+ (as hydroxide) .................................................................................................................. 2.7 mg

   .Saponin.................................................................................................................................. 30 HU**

   Medicinal

   (**)Haemolytic units

   
   

4. INDICATION(S)

   
   

   Active immunisation of sheep and cattle to prevent viraemia* and to reduce clinical signs caused by Bluetongue Virus Serotype 1.

   *(below the level of detection by the validated RT-PCR method at 3.68 log10 RNA copies/ml, indicating no infectious virus transmission).

   
   

   Onset of immunity has been demonstrated 3 weeks after the primary vaccination course. The duration of immunity for cattle and sheep is 1 year after the primary vaccination course.

   
   

5. CONTRAINDICATIONS

   
   

   None.

6. ADVERSE REACTIONS

   
   

   In very rare cases it has been observed a small local swelling at the injection site (at most 32 cm² in cattle and 24 cm² in sheep) which becomes residual 35 days later (≤ 1 cm2).

   In very rare cases it has been observed a transient increase in body temperature, normally not

   authorised

   exceeding an average of 1.1 °C, may occur within 24 hours after vaccination.

   
   

   The frequency of adverse reactions is defined using the following convention:

   • Very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment).

   • Common (more than 1 but less than 10 animals in 100 animals).

   • Uncommon (more than 1 but less than 10 animals in 1,000 animals).

   • Rare (more than 1 but less than 10 animals in 10,000 animals).

   • Very rare (less than 1 animal in 10,000 animals, including isolated reports).

     
     

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

     
     

7. TARGET SPECIES

   
   

   Sheep and cattle.

   
   

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

   
   

   no

   Administer one dose of 1 ml subcutaneously according to the following vaccination scheme:

   
   

   • Primary vaccination

     In sheep

     • 1st injection: from 1 month of age in naive animals (or from 2.5 months of age in young animals born to immune sheep).

     • 2nd injection: after 3-4 weeks

       
       

       In cattle

     • 1st injection: from 1 month of age in naive animals (or from 2.5 months of age in young animals born to immune cattle).

     • 2nd injection: after 3-4 weeks.

     
     

     Medicinal

   • Revaccination

   Annual.

   
   

9. ADVICE ON CORRECT ADMINISTRATION

   
   

   Apply usual aseptic procedures.

   Shake gently immediately before use. Avoid bubble formation, as this can be irritating at the site of injection. The entire content of the bottle should be used immediately after broaching and during the

   same procedure. Avoid multiple vial broaching.

   
   

10. WITHDRAWAL PERIOD

    
    

    Zero days.

11. SPECIAL STORAGE PRECAUTIONS

    authorised

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

    Do not freeze.

    Protect from light.

    
    

    Shelf life after first opening the immediate packaging: immediately

    Do not use this veterinary medicinal product after the expiry date which is stated on the carton after EXP:

    
    

12. SPECIAL WARNINGS

    
    

    Special warnings for each target species:

    If used in other domestic and wild ruminant species that are considered at risk of infection, its use in these species should be undertaken with care and it is advisable to test the vaccine on a small number of animals

    prior to mass vaccination. The level of efficacy for other species may differ from that observed in sheep and cattle.

    
    

    Special precautions for use in animals: Vaccinate healthy animals only.

    
    

    Pregnancy and lactation:

    Can be used during pregnancy in ewes. Can be used during pregnancy and lactation in cows

    
    

    no

    Fertility:

    The safety and the efficacy of the vaccine have not been established in breeding males. In this category of animals the vaccine should be used only according to the benefit/risk assessment by the responsible veterinarian and/ or national Competent Authorities on the current vaccination policies against Bluetongue Virus (BTV).

    
    

    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 to use this vaccine before or after any other veterinary

    medicinal product therefore needs to be decided on a case by case basis.

    
    

    Medicinal

    Overdose (symptoms, emergency procedures, antidotes):

    Very rare and transient apathy can be observed after the administration of a double-dose of the vaccine. No other adverse reactions except those mentioned in section ‘Adverse Reactions’ were

    observed.

    
    

    Incompatibilities:

    Do not mix with any other veterinary medicinal product.

    
    

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

    
    

    Medicines should not be disposed of via wastewater or household waste.

    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

    
    

    authorised

    Detailed information on this product is available on the website of the European Medicines Agency

    /.

    
    

15. OTHER INFORMATION

The vaccine contains inactivated Bluetongue Virus Serotype 1 with aluminium hydroxide and saponin adjuvants. It induces an active and specific immunity against Bluetongue Virus Serotype 1 in the vaccinated animal.

Not all pack sizes may be marketed Box of 1 bottle of 10 doses (1 x 10 ml)

Box of 1 bottle of 50 doses (1 x 50 ml)

Box of 10 bottles of 50 doses (10 x 50 ml)

Box of 1 bottle of 100 doses (1 x 100 ml)

Box of 10 bottles of 100 doses (10 x 100 ml)

Medicinal

no

The manufacture, import, possession, sale, supply and/or use of BTVPUR AlSap 1 may be prohibited in a certain Member State on the whole or part of their territory pursuant to national legislation. Any person intending to manufacture, import, possess, sell, supply and/or use BTVPUR AlSap 1 must consult the relevant Member State’s competent authority on the current vaccination policies prior to the manufacture, import, possession, sale, supply and/or use.