Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
ERYSIPELOTHRIX RHUSIOPATHIAE STRAIN M2 (SEROTYPE 2)
Intervet Ireland Limited
QI09AB
ERYSIPELOTHRIX RHUSIOPATHIAE STRAIN M2 (SEROTYPE 2)
Unknown
Suspension for Injection
LM-Licensed Merchant
Porcine
Inactivated bacterial vaccines (including Mycoplasma, Toxoid and Chlamydia vaccines)
Immunological - Inactivated vaccine
Authorised
2001-04-10
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Porcilis ERY. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Per dose (2 ml) ACTIVE SUBSTANCE: _Erysipelothrix rhusiopathiae _strain M2 (serotype 2) > 1 ppd* *ppd = pig protective dose, determined by reference to a standard vaccine batch Adjuvant: dl- -tocopherol acetate 150.0 mg Excipients: Formaldehyde 0.05% 3 PHARMACEUTICAL FORM Suspension for injection. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs (sows, gilts, boars and growing pigs). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the active immunisation of healthy pigs to reduce clinical signs and lesions caused by erysipelas disease. To maintain protection, animals should be re-vaccinated at no more than six monthly intervals. 4.3 CONTRAINDICATIONS Do not vaccinate unhealthy animals. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None 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 In the case of accidental self-injection, seek medical advice immediately and show the package insert or the label to the physician. If spilled on the skin, wash with soap and water. If ingested, drink water. If symptoms develop, seek medical advice. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 18/07/2012_ _CRN 7012940_ _page number: 1_ 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) Vaccination reactions normally consist of a slight (0.5 ° C), transient (normal within 24 hours) rise in body temperature. A mild local swelling (less than 5 cm in diameter, normal within 3 days) and some reluctance to move may be seen in a very small proportion (<5 Prečítajte si celý dokument