Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
E.rhusiopathiae strain m2; Porcine parvo virus; Leptospira canicola; Leptospira icterohaemorrhagiae; Leptospira australis; Leptospira grippotyphosa; Leptospira pomona; Leptospira tarassovi
Intervet International BV
QI09AL07
E.rhusiopathiae strain m2; Porcine parvo virus; Leptospira canicola; Leptospira icterohaemorrhagiae; Leptospira australis; Leptospira grippotyphosa; Leptospira pomona; Leptospira tarassovi
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Suspension for injection
LM: Licensed Merchant as defined in relevant national legislation
Pigs
porcine parvovirus + erysipelothrix + leptospira
Immunological - Inactivated Vaccine
Authorised
2016-12-16
Health Products Regulatory Authority 25 June 2019 CRN0094HY Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Porcilis Ery+Parvo+Lepto suspension for injection for pigs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 2 ml contains: ACTIVE SUBSTANCES: Inactivated strains of: _Erysipelothrix rhusiopathiae_, serotype 2 (strain M2) ≥ 1 ppd 1 Porcine parvovirus (strain 014) ≥ 130 U 2 _Leptospira interrogans_ serogroup Canicola serovar Portland-Vere (strain Ca-12-000) ≥ 2816 U 2 _Leptospira interrogans_ serogroup Icterohaemorrhagiae serovar Copenhageni (strain Ic-02-001) ≥ 210 U 2 _Leptospira interrogans_ serogroup Australis serovar Bratislava (strain As-05-073) ≥ 1310 U 2 _Leptospira kirschneri _serogroup Grippotyphosa serovar Dadas (strain Gr-01-005) ≥ 648 U 2 _Leptospira interrogans_ serogroup Pomona serovar Pomona (strain Po-01-000) ≥ 166 U 2 __ _Leptospira santarosai_ serogroup Tarassovi serovar Gatuni (strain S1148/02) ≥ 276 U 2 ADJUVANT: dl-α-tocopheryl acetate 150 mg EXCIPIENT: Formaldehyde (preservative) 0.4 - 1 mg 1 Pig protective dose as compared to a reference preparation known to be protective in pigs. 2 As determined in the _in vitro _antigenic mass ELISA potency test. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Suspension for injection. Homogenous white to nearly white suspension after shaking. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Pig for reproduction. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the active immunization of pigs: - to reduce clinical signs (skin lesions and fever) of swine erysipelas caused by_ Erysipelothrix rhusiopathiae_, serotype 1 and serotype 2. - to reduce transplacental infection, viral load and foetal mortality caused by Porcine parvovirus. - to reduce clinical signs (increase of body temperature and reduction in feed intake or activity), infection and bacterial exc Läs hela dokumentet