Country: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
MYCOPLASMA HYOPNEUMONIAE STRAIN 11 INACTIVATED WHOLE CELL CONCENTRATE
Intervet Ireland Limited
QI09AB13
MYCOPLASMA HYOPNEUMONIAE STRAIN 11 INACTIVATED WHOLE CELL CONCENTRATE
Unknown
Suspension for Injection
POM
Porcine
Mycoplasma vaccine
Immunological - Inactivated vaccine
Authorised
2005-12-21
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Porcilis M Hyo, suspension for injection. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Per dose of 2 ml ACTIVE SUBSTANCE Inactivated whole cell concentrate of _Mycoplasma hyopneumoniae _strain 11: 7.0 log 2 Ab titre * Mean antibody titre (Ab) obtained after inoculation of mice with a 1/20 pig dose. ADJUVANT 150 mg dl- -tocopheryl acetate For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Suspension for injection; white or nearly white. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Pig (finishing pigs). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For finishing pigs: For the active immunisation of pigs to reduce pulmonary lesions due to infection by _Mycoplasma hyopneumoniae._ Onset of immunity: 2 weeks after the second injection Duration of immunity: at least 20 weeks after the second injection. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 30/03/2012_ _CRN 7012230_ _page number: 1_ 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Vaccinate only healthy animals. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS In case of accidental self-injection, seek medical advice immediately and show the package insert or label to the physician. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) A mean transient temperature increase in body temperature of about 0.3 ° C, in individual pigs up to 2.0 ° C, may occur on the first 1 to 2 days after vaccination. The animals return to normal the next day. A transient swelling/redness (max. diameter 5 cm) may occu Aqra d-dokument sħiħ