Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
ERYSIPELOTHRIX RHUSIOPATHIAE STRAIN M2 (SEROTYPE 2)
Intervet Ireland Limited
QI09AL01
ERYSIPELOTHRIX RHUSIOPATHIAE STRAIN M2 (SEROTYPE 2)
Unknown
Suspension for Injection
LM-Licensed Merchant
Porcine
Inactivated Porcine parvovirus vaccine + inactivated Erysipelothrix vaccine
Immunological - Inactivated vaccine
Authorised
2001-05-04
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Porcilis Ery + Parvo 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCES: Per dose of 2 ml: - Inactivated porcine parvovirus (PPV) strain 014: 552 EU as determined in the final product by antigenic mass ELISA - Inactivated lysed antigen concentrate of _Erysipelothrix rhusiopathiae _strain M2 (serotype 2): 1 pig protective dose (ppd) as measured in the Ph. Eur. potency test Adjuvant: dl- Tocopherol acetate 150 mg Preservative: Formaldehyde 0.02 - 0.05% For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Suspension for injection. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs (sows and gilts) 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the active immunisation of sows and gilts to reduce clinical signs and lesions caused by erysipelas disease and to prevent or reduce mortality and clinical signs of parvovirus infection on embryos and foetuses during pregnancy. 4.3 CONTRAINDICATIONS None. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 05/11/2015_ _CRN 7022311_ _page number: 1_ 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Only healthy animals should be vaccinated. After vaccination with Porcilis Ery + Parvo, animals may seroconvert and detectable levels of antibody to PPV may persist. PPV infection is not the only cause of reproductive failure in pigs. A good immune response is reliant on the reaction of an immunogenic agent and a fully competent immune system. Immunogenicity of the vaccine antigen will be reduced by poor storage or inappropriate administration. Immunocompetence of the animal may be compromised by a variety of factors including poor health, nutritional Lugege kogu dokumenti