国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
INACTIVATED PORCINE REPRODUCTIVE AND RESPIRATORY SYNDROME (PRRS) VIRUS, P120 STRAIN
Merial Animal Health Limited
QI09AA05
INACTIVATED PORCINE REPRODUCTIVE AND RESPIRATORY SYNDROME (PRRS) VIRUS, P120 STRAIN
%v/v
Emulsion for Injection
POM
Porcine
Porcine reproductive and respiratory syndrome (PRRS) virus vaccine
Immunological - Inactivated vaccine
Authorised
2003-06-06
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Progressis Emulsion for injection for pigs (sows and gilts) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 2-ml dose of vaccine contains: ACTIVE SUBSTANCE: Inactivated Porcine Reproductive and Respiratory Syndrome (PRRS) virus, P120 strain ................................................................................................ 2.5 log 10 IF* units. *IF units: ImmunoFluorescence antibody titre obtained after 2 injections in pigs under specific laboratory conditions. ADJUVANT: O/w oily excipient (containing hydrogenated polyisobutene as adjuvant) .... q.s. 1 dose of 2 ml. EXCIPIENT(S): For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Emulsion for Injection. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs (sows and gilts). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Reduction of the reproductive disorders caused by Porcine Reproductive and Respiratory Syndrome virus (European strain) in a contaminated environment: vaccination reduces the number of early farrowings and the number of still- births. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES In PRRS infected herds, viral infection is heterogeneous and varies over time. In such context, the implementation of a vaccination program is a tool to improve the reproductive parameters and may contribute to the disease control in conjunction with sanitary measures. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 14/06/2016_ _CRN 7023400_ _page number: 1_ 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Vaccinate only healthy animals. Apply usual procedures for the handling of animals. SPECIAL PRECAUTIONS 阅读完整的文件