देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: 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, LEPTO
Suspension for Injection
LM-Licensed Merchant
Porcine
Inactivated Porcine parvovirus vaccine + inactivated Erysipelothrix vaccine + inactivated Leptospira
Immunological - Inactivated vaccine
Authorised
2016-12-16
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) 1704 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 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. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 16/12/2016_ _CRN 7021236_ _page number: 1_ 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 पूरा दस्तावेज़ पढ़ें