国: ドイツ
言語: 英語
ソース: HMA (Heads of Medicines Agencies)
erysipelothrix rhusiopathiae 1 ppd
Intervet Intenational BV
QI09AB03
Suspension for injection
Erysipelothrix vaccine
Pigs Other
2012-02-28
Registration file / July 2008 SUMMARY OF PRODUCT CHARACTERISTICS Registration file / July 2008 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Porcilis Ery 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: Per dose of 2 ml Inactivated lysed antigen concentrate of _Erysipelothrix rhusiopathiae_ strain M2 (serotype 2): ≥ 1pig protective dose (ppd) as measured in the Ph. Eur. Potency test. ADJUVANT: 150 mg dl- -tocopherol acetate EXCIPIENT: 0.02 - 0.05% formaldehyde For a 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 Pig 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For active immunisation of pigs to prevent clinical signs of Erysipelas disease caused by all relevant _Erysipelothrix rhusiopathiae_ serotypes (serotype 1 and 2). Onset of immunity: 3 weeks Duration of immunity: 6 months 4.3 CONTRAINDICATIONS None 4.4 SPECIAL WARNINGS None 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Sick and weak animals should not be vaccinated. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS Registration file / July 2008 In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) Vaccination reactions are restricted to a slight, transient rise (0.5 °C) in body temperature within 24 hours, an occasional mild tr 完全なドキュメントを読む