Country: Եվրոպական Միություն
language: անգլերեն
source: EMA (European Medicines Agency)
Classical Swine Fever Virus (CSFV) -E2 subunit antigen
Intervet International BV
QI09AD04
Adjuvanted vaccine against classical swine fever
Pigs
Immunologicals for suidae
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.
Revision: 12
Withdrawn
2000-06-09
B. PACKAGE LEAFLET 14/17 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 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. 5. CONTRAINDICATIONS 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 vaccination. If you notice any serious side effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon. 7. TARGET SPECIES Pigs 15/17 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. WIT read_full_document
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1/17 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Porcilis Pesti emulsion for injection for pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 2 ml contains: ACTIVE SUBSTANCE: Classical Swine Fever Virus (CSFV) -E2 subunit antigen: 120 Elisa Units (EU) ADJUVANT: 941.4 mg liquid paraffin EXCIPIENTS: For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Emulsion for injection. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES 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. _ _ 4.3 CONTRAINDICATIONS None 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Vaccinate only healthy animals. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS To the user: 2/17 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 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 the read_full_document