Country: Perancis
Bahasa: Inggeris
Sumber: HMA (Heads of Medicines Agencies)
pasteurella multocida 65 % protection, pasteurella multocida 80 % protection
Ceva-Phylaxia Veterinary Biologicals Co. Ltd.
QI01BB
Emulsion for injection
Inactivated bacterial vaccines (including Mycoplasma, Toxoid and Chlamydia)
Other
2012-03-21
FINAL PRODUCT SPECIFICATIONS 2 PRODUCT SPECIFICATIONS Bulk vaccine: Appearance: off-white homogeneous emulsion Type of emulsion: water in oil Stability of the emulsion: stable after centrifugation at 3000 rpm for 30 minutes Viscosity < 200 mPAS Finished product: Appearance: off-white homogeneous emulsion Filling volume (> 52 ml for 50-ml presentation, > 503 ml for 500-ml presentation) Identification / quantification of A1 component (SOP in appendix 8/1, p.406) Administration SC at 12 and 15 weeks of age of 1 dose of vaccine to 20 seronegative chickens + 10 controls. At the age of 17 weeks (2 weeks after V2), challenge with _P.multocida_ A1 (strain X-73). Record of death and clinical signs for 14 days; post-mortem examination and re-isolation of _P.multocida_ : at least 70% of controls die or show clinical signs of infection at least 80% of vaccinates are protected from mortality and morbidity Re-test if more than 50% of control birds die before the 3 rd day of observation, or if less than 70% of controls die or show clinical signs of infection 14 days after challenge. Identification / quantification of A3 component Administration SC at 6 and 9 weeks of age of 1 dose of vaccine to 20 seronegative broiler turkeys + 10 controls. At the age of 11 weeks (2 weeks after V2), challenge with _P.multocida_ A3 (strain P-1059). Record of death and clinical signs for 14 days; post-mortem examination and re-isolation of _P.multocida_ : at least 70% of controls die or show clinical signs of infection at least 65% of vaccinates are protec Baca dokumen lengkap
FINAL SPC 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT CEVAC LANDAVAX SC 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _Pasteurella multocida_, A1 inactivated, strain X73 ≥80 % clinically protected chicken* _Pasteurella multocida_, A1 inactivated, strain P-1059 ≥65 % clinically protected turkey* Oil adjuvant 0.3 ml Thiomersal 0.035 mg Exipient QSP 1 dose of 0.5 ml (*) In the vaccinated birds (chicken and turkey and for the release control test) after challenge. For a full list of excipients, see section “List of excipients”. 3. PHARMACEUTICAL FORM Emulsion for injection 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Ducks (mulard ducks). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES In mulard ducks: -Active immunization in order to reduce mortality, morbidity and clinical signs associated with infection caused by _Pasteurella multocida_ capsule type A, serovars 1 and 3. Onset of clinical protection: 3 weeks following the administration of second injection. Duration of immunity: 10 weeks after the second injection. 4.3 CONTRAINDICATIONS Do not vaccinate sick birds. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES No information is available on the possible interferences from the presence of maternal antibodies on the response to vaccination. 3 4.5 SPECIAL PRECAUTIONS FOR USE I) SPECIAL PRECAUTIONS FOR USE IN ANIMALS None. II) SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS To the user: This product contains mineral oil. Accidental injection/self injection may result in severe pain and swelling, particularly Baca dokumen lengkap