Riik: Suurbritannia
keel: inglise
Allikas: VMD (Veterinary Medicines Directorate)
Actinobacillus pleuropneumoniae
MSD Animal Health UK Limited
QI09AB07
Actinobacillus pleuropneumoniae
Suspension for injection
POM-V - Prescription Only Medicine – Veterinarian
Pigs
Inactivated Bacterial Vaccine
Authorized
2014-02-11
Revised: August 2020 AN: 00299/2020 Page 1 of 5 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. Revised: August 2020 AN: 00299/2020 Page 2 of 5 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Vaccinate healthy animals only. 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 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/depression may be very commonly observed after vaccination. Lugege kogu dokumenti