Land: Ierland
Taal: Engels
Bron: 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 toxoid); Apxii (105 kilodalton type ii toxoid); Apxiii (120 kilodalton macrophage toxoid)
.
Suspension for injection
POM (E): Prescription Only Exempt as defined in relevant national legislation
Pigs
actinobacillus/haemophilus vaccine
Immunological - Inactivated Vaccine
Authorised
2014-01-31
Health Products Regulatory Authority 21 March 2019 CRN000YQ2 Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Porcilis APP suspension for injection for pigs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 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-α-tocopherol 150 mg EXCIPIENT: Formaldehyde (preservative) 0.02 % w/v For the full list of excipients, see section 6.1 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 immunisation 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. 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 Health Products Regulatory Authority 21 March 2019 CRN000YQ2 Page 2 of 4 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 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) In laboratory studies and field trials: Mild to moderate injection site reactions may very commonly occur in some animals, these resolve within 5 days post-vaccination. Anorexia and decreased activity/depre Lees het volledige document