Država: Irska
Jezik: engleski
Izvor: 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 Ireland Limited
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
LR: Licensed Retailer as defined in national legislation
porcine parvovirus + erysipelothrix + leptospira
Authorised
2016-12-16
1. NAME OF THE VETERINARY MEDICINAL PRODUCT Porcilis Ery+Parvo+Lepto suspension for injection for pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 2 ml dose 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- -tocopheryl acetate 150 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. EXCIPIENTS: QUALITATIVE COMPOSITION OF EXCIPIENTS AND OTHER CONSTITUENTS Polysorbate 80 Simethicone Sodium chloride Potassium chloride Potassium dihydrogen phosphate Disodium phosphate dihydrate Water for injections Homogenous white to nearly white suspension after shaking. 3. CLINICAL INFORMATION 3.1 TARGET SPECIES Pigs for reproduction. 3.2 INDICATIONS FOR USE FOR EACH TARGET SPECIES For the active immunisation 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 fetal mortality caused by Porcine parvovirus. -to reduce clinical signs (increase of body temperature and reduction in feed intake or activity), infection and bacterial excretion caused by _ L. interrogans _ serogroup Canicola serovar Canicola. -to reduce clinical signs (increase of body temperature and reduction Pročitajte cijeli dokument