País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
CONCENTRATE OF ACTINOBACILLUS PLEUROPNEUMONIAE ANTIGENS CONTAINING, OMP (OUTER MEMBRANE PROTEIN), APXI (105 KILODALTON TYPE I TOXOID), APXII (105 KILODALTON TYPE II TOXOID), APXIII (120 KILODALTON MACROPHAGE TOXOID)
Intervet Ireland Limited
QI09AB07
CONCENTRATE OF ACTINOBACILLUS PLEUROPNEUMONIAE ANTIGENS CONTAINING, OMP (OUTER MEMBRANE PROTEIN), APXI (105 KILODALTON TYPE I TO
%v/v
Suspension for Injection
POM(E)
Porcine
Actinobacillus/Haemophilus vaccine
Immunological - Inactivated vaccine
Authorised
2014-01-31
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Porcilis APP Suspension for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Suspension for injection. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs (weaned piglets). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the active immunization of weaned piglets to reduce mortality, clinical signs and lesions of pleuropneumonia caused by _Actinobacillus pleuropneumoniae._ Onset of immunity: 2 weeks after completion of the vaccination scheme. Duration of immunity: 11 weeks after completion of the vaccination scheme. 4.3 CONTRAINDICATIONS None. Each 2 ml dose contains: ACTIVE SUBSTANCE(S): 600 mg _Actinobacillus pleuropneumoniae _antigen concentrate containing: OMP [outer membrane protein] 50 units* Apx I toxoid 50 units Apx II toxoid 50 units Apx III toxoid 50 units *units relative to an internal standard determined to be efficacious in pigs. ADJUVANT dl- -tocopherol 150 mg EXCIPIENTS Formaldehyde (preservative) 0.02 % w/v For a full list of excipients, see section 6.1 HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 01/12/2014_ _CRN 7019273_ _page number: 1_ 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Only healthy animals should be vaccinated. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals It is not advisable to vaccinate animals immediately before and after feeding. Special precautions to be taken by the person administering the veterinary medicinal product to animals In the case of accidental self-injection or ingestion seek medical advice immediately and show the package leaflet or the label to the physician. If spilled on the skin, wash with soap and water. 4.6 ADVE Llegiu el document complet