Država: Velika Britanija
Jezik: engleski
Izvor: VMD (Veterinary Medicines Directorate)
Erysipelothrix rhusiopathiae, Leptospira australis, Leptospira canicola, Leptospira grippotyphosa, Leptospira icterohaemorrhagiae, Leptospira pomona, Leptospira tarassovi, Porcine parvovirus
MSD Animal Health UK Limited
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: October 2023 AN: 02973/2022 Page 1 of 6 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 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: For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Homogenous white to nearly white suspension after shaking. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs for reproduction. Revised: October 2023 AN: 02973/2022 Page 2 of 6 4.2 INDICATIONS FOR USE, SPECIFYING THE 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 red Pročitajte cijeli dokument