국가: 아일랜드
언어: 영어
출처: HPRA (Health Products Regulatory Authority)
AUJESZKYS DISEASE VIRUS STRAIN BARTHA K/61 LIVE
Fort Dodge Animal Health Limited
QI09AD01
Pdr+Solv for Soln for Inj
Immunological - Live Vaccine
Porcine
2002-09-18
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Freeze dried vaccine: Suvaxyn® Aujeszky Diluent: Suvaxyn® Aujeszky Diluent 2 QUALITATIVE AND QUANTITATIVE COMPOSITION For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Powder and Solvent for Solution for Injection. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Fattening pigs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For active immunization of pigs to reduce mortality, clinical signs, virus excretion and infection caused by Aujeszky’s Disease Virus. Onset of immunity occurs 1 week after vaccination with duration of immunity lasts 13 weeks. 4.3 CONTRAINDICATIONS Do not vaccinate unhealthy pigs. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Animals that have received immunosuppressive drugs (e.g. glucocorticoids) should not be vaccinated until an interval of at least 4 weeks has elapsed. Maternally derived antibody (MDA) can interfere with development of active immunity. Where it is likely that recent field infection or vaccination of the dam has stimulated a high antibody titre and consequently a high level of MDA, the timing of the vaccination programme should be planned accordingly. Per dose (2 ml) Active Ingredient Live Aujeszky’s Disease virus, not less than 10 5.2 TCID 50 strain Bartha K61 (gE glycoprotein deletion). Gentamicin sulphate maximum 5.2 µg Diluent: Excipients q.s. 2 ml (which include Phenol Red) IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 16/11/2006_ _CRN 7002459_ _page number: 1_ 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS None. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS Avoid accident 전체 문서 읽기