Porcilis Pesti - Patient leaflet, side effects, dosage

PROHIBITION OF SALE, SUPPLY AND/OR USE

The import, sale, supply and/or use of Porcilis Pesti is only allowed under the particular conditions established by European Community legislation on the control of CSF (Council Directive 80/217/EEC, as amended). Any person intending to import, sell, supply and/or use the veterinary medicinal product must be authorised by the competent authority of the Member State.

MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE

• B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE

• C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION

WITH REGARD TO SAFE AND EFFECTIVE USE

STATEMENT OF T RLs

• A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND

MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH

RELEASE

Manufacturer of the biological active substance:

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

The Netherlands

Manufacturer responsible for batch release

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

The Netherlands

• B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE

To be supplied only on veterinary prescription.

According to Community Legislation on Classical swine fever (Council Directive 80/217/EEC, as amended), in the European Union:

The use of classical swine fever vaccines is prohibited. However, the use of vaccines may be

authorised in the framework of an emergency vaccination plan, implemented by the competent authority of a Member State following confirmation of disease, in accordance with Community Legislation on control and eradication of classical swine fever;

• b) The storage, supply, distribution and sale of classical swine fever vaccines must be carried out under the control of and in accordance with the eventual instructions established by the competent authority of the Member State;

• c) Special provisions regulate the movement of pigs from areas where classical swine fever vaccine is being or has been used and the marking of pig meat from vaccinated pigs.

  
  

• C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT

According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council, Member States prohibit or/ may prohibit the import, sale, supply and/or use of Porcilis Pesti on the whole or part of their territory if it is established that:

• a) the administration of the product to animals will interfere with the implementation of national programmes for the diagnosis, control and elimination of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals

• b) the disease to which the product is intended to confer immunity is largely absent from the territory.

  D.

  
  

  STATEMENT OF THE MRLs

  
  

  The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.

  The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for

  
  

The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.

SPECIAL WARNING(S), IF NECESSARY

Accidental self-injection is dangerous

MINIMUM PARTICULARS TO APPEAR ON Bottle Label {50ml/100ml/250ml }

• 1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Porcilis Pesti emulsion for injection for pigs

• 2. QUANTITY OF THE ACTIVE SUBSTANCE(S) 120 Elisa Units CSF E2 antigen/2ml.

  
  

  3. CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES

  
  

  For animal treatment only.

  
  
  
  

PACKAGE LEAFLET

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

Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Porcilis Pesti emulsion for injection for pigs

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

  
  

Each dose of 2 ml contains:

120 Elisa Units Classical Swine Fever Virus-E2 subunit antigen Liquid paraffin as adjuvant: 941.4 mg

• 4. INDICATION(S)

Active immunisation of pigs from the age of 5 weeks onwards to prevent mortality and to reduce clinical signs of Classical Swine Fever, as well as to reduce infection with and excretion of CSF field virus.

The onset of protection is 2 weeks.

The duration of protection is 6 months.

None

6. ADVERSE REACTIONS

A local and in most cases transient swelling at the injection site may occur up to 4 weeks after administration of each dose of the vaccine. Transient hyperthermia may occur post the second dose.

Abscesses may be observed at the injection site. Since safety after giving both inoculations at the same site has not been examined, it is advised to carry out the second vaccination at a different site than the first

y serious side effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.

• 8. DOSAGE FOR EACH SPECIES, ROUTES AND METHOD OF ADMINISTRATION

Administer one dose (2 ml) by deep intramuscular injection in the neck area behind the ear.

Vaccination scheme:

Basic vaccination: Inject one dose per pig followed by a second injection 4 weeks after the first injection.

Re-vaccination: Every 6 months, using a single dose.

• 9. ADVICE ON CORRECT ADMINISTRATION

Shake well before use.

Before use, allow the vaccine to reach room temperature.

Use sterile syringes and needles.

It is recommended to use a closed multiject vaccination system.

• 10. WITHDRAWAL PERIOD

  
  
  
  

Zero days

• 11. SPECIAL STORAGE PRECAUTIONS

Keep out of the reach and sight of children.

Store in a refrigerator (2°C to 8°C).

Do not freeze.

Shelf-life after first broaching the bottle: 3 hours. Do not use after the expiry date which is stated on t

Vaccinate only healthy animals.

ccidental injection/self injection may result in severe pain and a joint or finger, and in rare cases could result in the loss of the affected finger if prompt medical attention is not given.

If you are accidentally injected with this product, seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you.

If pain persists for more than 12 hours after medical examination, seek medical advice again.

To the physician:

This product contains mineral oil. Even if small amounts have been injected, accidental injection with this product can cause intense swelling, which may, for example, result in ischaemic necrosis and even the loss of a digit. Expert, PROMPT, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.

The product can be used during pregnancy but may not prevent transplacental transmission of Classical swine fever field virus from the sow to foetuses.

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.

After administration of an overdose, local reactions at the injection site may be more pronounced.

Do not mix with any other veterinary medicinal product.

The import, sale, supply and/or use of this veterinary medicinal product is only allowed under the particular conditions established by European Community legislation on the control of CSF (Council Directive 80/217/EEC, as amended). Any person intending to import, sell, supply and/or use the veterinary medicinal product must be authorised by the competent authority of the Member State.

• 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 local requirements.

• 14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

Detailed information on this product is available on the website of the European Medicines Agency (EMA).

• 15. OTHER INFORMATION