Land: Europese Unie
Taal: Engels
Bron: EMA (European Medicines Agency)
Live Recombinant E2 gene-deleted bovine viral diarrhoea virus containing classical swine fever virus E2 gene (CP7_E2alf)
Zoetis Belgium SA
QI09AD04
classical swine fever vaccine (live recombinant)
Pigs
Live viral vaccines, Immunologicals for suidae
For active immunisation of pigs from 7 weeks of age onwards to prevent mortality and reduce infection and disease caused by classical swine fever virus (CSFV).Onset of immunity: 14 days after vaccinationDuration of immunity: at least 6 months after vaccinationFor active immunisation of breeding females to reduce transplacental infection caused by CSFV.Onset of immunity: 21 days after vaccinationDuration of immunity has not been demonstrated.
Revision: 4
Authorised
2015-02-10
15 B. PACKAGE LEAFLET 16 PACKAGE LEAFLET: SUVAXYN CSF MARKER LYOPHILISATE AND SOLVENT FOR 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 and manufacturer responsible for batch release: Zoetis Belgium SA Rue Laid Burniat 1 1348 Louvain-la-Neuve BELGIUM 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Suvaxyn CSF Marker lyophilisate and solvent for suspension for injection for pigs 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) ACTIVE SUBSTANCE: LYOPHILISATE Live recombinant E2 gene-deleted bovine viral diarrhoea virus containing classical swine fever virus E2 gene (CP7_E2alf) 10 4.8 * to 10 6.5 TCID** 50 * min 100 PD 50 ** Tissue culture infectious dose SOLVENT: Sodium chloride 9 mg/ml Water for injections q.s.p. 1 ml Lyophilisate: Off-white pellet Solvent: Clear colourless liquid After reconstitution, the suspension should be slightly pink clear liquid. 4. INDICATION(S) For active immunisation of pigs from 7 weeks of age onwards to prevent mortality and reduce infection and disease caused by classical swine fever virus. Onset of immunity: 14 days after vaccination Duration of immunity: at least 6 months after vaccination For active immunisation of breeding females to reduce transplacental infection caused by CSFV. Onset of immunity: 21 days after vaccination Duration of immunity has not been demonstrated. 17 5. CONTRAINDICATIONS None. 6. ADVERSE REACTIONS In laboratory safety studies in pregnant animals, the following adverse reactions were observed: A local and transient tissue reaction in the form of swelling of up to 5 mm in diameter at the injection site was very common and lasted for up to 1 day. A transient increase in body temperature of 2.9 °C was observed commonly 4 hours after vaccination. This resolved spontaneously within 1 day after vaccination. The frequency of adverse reactions is defined using the following convention: - Lees het volledige document
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Suvaxyn CSF Marker lyophilisate and solvent for suspension for injection for pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 1 ml contains: ACTIVE SUBSTANCE: LYOPHILISATE : Live recombinant E2 gene-deleted bovine viral diarrhoea virus containing classical swine fever virus E2 gene (CP7_E2alf) 10 4.8 * to 10 6.5 TCID** 50 * min 100 PD 50 ** Tissue culture infectious dose SOLVENT: Sodium chloride 9 mg/ml Water for injections q.s.p. 1 ml For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Lyophilisate and solvent for suspension for injection. Lyophilisate: Off-white pellet Solvent: Clear colourless liquid After reconstitution, the suspension should be slightly pink clear liquid. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For active immunisation of pigs from 7 weeks of age onwards to prevent mortality and reduce infection and disease caused by classical swine fever virus (CSFV). Onset of immunity: 14 days after vaccination Duration of immunity: at least 6 months after vaccination For active immunisation of breeding females to reduce transplacental infection caused by CSFV. Onset of immunity: 21 days after vaccination Duration of immunity has not been demonstrated. 4.3 CONTRAINDICATIONS None. 3 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Vaccinate healthy animals only. Documentation provided for this vaccine supports that it is only to be used in an outbreak situation in herds within restricted control zones. Protection against transplacental transmission of CSFV was shown 21 days after vaccination when challenge was applied in 6 pregnant sows with a moderately virulent CSFV strain. Partial protection against transplacental transmission of CSFV was observed when challenge was applied in 6 pregnant sows with a highly virulent CSFV strain. Birth of persistently infected immunotolerant piglets represent a very high risk since they are sh Lees het volledige document