Advasure - patient leaflet, side effects, dosage

A. 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

D. STATEMENT OF THE MRLs

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

Name and address of the manufacturer(s) of the biological active substance(s)

ID-DLO

Edelhertweg 15, P.O. Box 65

8200 AB Lelystad

The Netherlands

Name and address of the manufacturer(s) responsible for batch release

Bayer AG

Business Group Animal Health

Osterather Strasse 1a

D-50739 Köln

Germany

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

Veterinary medicinal product subject to prescription.

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

• a) The use of classical swine fever vaccines is prohibited. However, the use of vaccines may be authorized 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 pigmeat 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 4 of Council Directive 90/677/EEC Member States prohibit or/ may prohibit the

  
  

According to Article 4 of Council Directive 90/677/EEC Member States prohibit or/ may prohibit the import, sale, supply and/or use of Advasure 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.

LABELLING AND PACKAGE LEAFLET

PARTICULARS TO APPEAR ON THE OUTER PACKAGE

BOX CONTAINING 54 Vials / 35 Vials / 12 Vials / 10 Vials

For intramuscular use.

Read the package leaflet before use.

8. WITHDRAWAL PERIOD

Withdrawal period: zero days

16. MARKETING AUTHORISATION NUMBER(S)

EU/2/00/025/001

EU/2/00/025/002

EU/2/00/025/003

EU/2/00/025/004

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

20 ml Vial/ 50 ml Vial / 100 ml Vial / 250 ml Vial

Not currently manufactured.

7. EXPIRY DATE

EXP (MONTH/YEAR)

Once broached, use within 8 hours if stored at 2°C-8°C

Active immunisation of pigs, over the age of 2 weeks, against Classical Swine Fever (CSF), to prevent mortality, reduce clinical signs of the disease and the excretion of field virus.

The onset of protection is 2 weeks.

The duration of protection is 6 months.

• 5. CONTRAINDI­CATIONS

None

• 6. ADVERSE REACTIONS

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

• 7. TARGET SPECIES

Pigs ♦ wO

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

The dosage for pigs, over 2 weeks, is 2 ml of the vaccine

Intramuscular injection

• 9. ADVICE ON CORRECT ADMINISTRATION

The vaccine is to be administered aseptically by intramuscular injection closely behind the ear of the pig.

The pigs should be vaccinated in time before the expected exposure to the field virus, preferably prior to housing (crowding) or transfer to new groups. It is strongly recommended to vaccinate all pigs in the herd.

The dosage for pigs, over the age of 2 weeks, is 2 ml of the vaccine.

In emergency situations the basic immunisation consists of one intramuscular injection with one dose (2 ml) for all pigs over the age of 2 weeks, irrespective of the level of maternal antibodies.

Depending on the infection pressure and the disease situation sows and piglets over the age of 2 weeks (irrespective of the level of maternal antibodies) may be vaccinated twice with one dose (2 ml), 4–6 weeks apart. For fattening pigs over the age of 10 weeks, however, one intramuscular injection with one dose is administered.

Re-vaccination: one dose (2 ml) at 6 months intervals.

Can be used during pregnancy. The vaccine has been shown to prevent transplacental transmission of low virulence strains after two vaccinations of the sow. However it may not prevent transplacental transmission of highly virulent strains from the sow to the foetuses.

Zero days

SPECIAL STORAGE PRECAUTIONS

Store out of reach and sight of children.

Store at 2°C – 8°C Do not freeze. Protect from light. Do not use after the expiry date stated on the label.

• 12. SPECIAL WARNING(S)

The use of immunosuppressive veterinary medicinal products (e.g. corticosteroids) or modified live Porcine Reproductive and Respiratory Syndrome (PRRS) vaccines within 7 days before and 7 days after application of Advasure may interfere with the induction of immunity and should therefore be avoided.

Do not mix with any other vaccine/immuno­logical product.

To the user:

This product contains mineral oil. Accidental injection/self injection may result in severe pain and swelling, particularly if injected into 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 insert 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 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

ordance with local requirements.

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