Država: Velika Britanija
Jezik: angleščina
Source: VMD (Veterinary Medicines Directorate)
Erysipelothrix rhusiopathiae, Leptospira australis, Leptospira canicola, Leptospira grippotyphosa, Leptospira icterohaemorrhagiae, Leptospira pomona, Leptospira tarassovi, Porcine parvovirus
Intervet International BV
QI09AL07
Erysipelothrix rhusiopathiae, Leptospira australis, Leptospira canicola, Leptospira grippotyphosa, Leptospira icterohaemorrhagiae, Leptospira pomona, Leptospira tarassovi, Porcine parvovirus
Suspension for injection
POM-V - Prescription Only Medicine – Veterinarian
Pigs
Inactivated Viral and Bacterial Vaccine
Authorized
2016-12-22
Revised: September 2019 AN: 01758/2018 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- -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: 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. Page 1 of 5 Revised: September 2019 AN: 01758/2018 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 excretion caused by_ L. interrogans _ serogroup Canicola serovar Canicola. - to reduce clinical signs (increase of body Preberite celoten dokument