Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
Erysipelothrix rhusiopathiae strain m2 (serotype 2)
Intervet Ireland Limited
QI09AB
Erysipelothrix rhusiopathiae strain m2 (serotype 2)
.
Suspension for injection
LR: Licensed Retailer as defined in national legislation
Pigs
Inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia)
Immunological - Inactivated Vaccine
Authorised
2001-04-10
1. NAME OF THE VETERINARY MEDICINAL PRODUCT Porcilis Ery suspension for injection for pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 2 ml dose contains: ACTIVE SUBSTANCE: Inactivated lysed antigen concentrate of _Erysipelothrix rhusiopathiae_ strain M2 (serotype 2): ≥ 1ppd* *ppd = pig protective dose, determined by reference to a standard vaccine batch. ADJUVANT: dl- -tocopherol acetate: 150mg EXCIPIENTS: For the full list of excipients, see Section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection. Aqueous white or nearly white liquid. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs (sows, gilts, boars and growing pigs). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For 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 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 Not applicable. 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 leaflet 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. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) Transient increases in body temperature (0.5°C) within 24 hours may very commonly occur. A mild transient local swelling (less than 5cm in diameter, normally within 3 days) may very commonly occur. Transient reluctance to move may commonly occur. In post marketing experience: In very rare cases, a hypersensitivity reaction may occur. The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 Preberite celoten dokument