Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
Inactivated e.coli serotype 09; Inactivated e.coli serotype 08; Inactivated e.coli serotype 015; Inactivated e.coli serotype 078; Inactivated e.coli serotype 0101; Inactivated e.coli serotype 00117; Inactivated e.coli (antigen k99); Inactivated e.coli (antigen y); Inactivated e.coli (antigen 31a)
Boehringer Ingelheim Vetmedica GmbH
QI02AC; QI04AC
Inactivated e.coli serotype 09; Inactivated e.coli serotype 08; Inactivated e.coli serotype 015; Inactivated e.coli serotype 078; Inactivated e.coli serotype 0101; Inactivated e.coli serotype 00117; Inactivated e.coli (antigen k99); Inactivated e.coli (antigen y); Inactivated e.coli (antigen 31a)
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Suspension for injection
LM: Licensed Merchant as defined in relevant national legislation
Inactivated bacterial vaccines and antisera; Inactivated bacterial vaccines and antisera
Authorised
2003-08-06
Health Products Regulatory Authority 29 May 2020 CRN009PHD Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT IMOCOLIBOV 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of vaccine contains _E. coli _somatic serotypes 09, 08, 015, 078, 0101, 0117, expressing virulence factors: Active substances: Antigen K99 of _E. coli_ >1.22 SA.U* Antigen Y of _E. coli_ >1.80 SA.U* Antigen 31A of _E. coli_ >1.27 SA.U* E coli serotype 078 >1.14 OD Units ** Adjuvants: Saponin Aluminium hydroxide (expressed in A1 +++ ) 0.3 mg 0.7 mg Formaldehyde, at most 1.5 mg Excipient, q.s 1 ml * 1 SA.U: q.s. to obtain an agglutinating antibody titre of 1 log 10 in guinea-pigs after two administrations of vaccine. ** OD – Optical Density For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Suspension for injection. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Pregnant cows or pregnant ewes 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Pregnant cows or pregnant ewes. Passive immunisation against neonatal _Escherichia coli _infections by administration of the vaccine to pregnant cows or ewes. Reduction of diarrhoea and mortality caused by enterotoxic _E. coli_ strains in both lambs and calves. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Vaccinate only healthy animals. Health Products Regulatory Authority 29 May 2020 CRN009PHD Page 2 of 4 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS None. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) The vaccine may cause the formation of a transient nodule at the site of injection (at most 2 cm) disappearing three to four weeks after vaccination. Hypersensitivity reactions may occur. In such cases, symptomatic treatment should be provided. The vaccination may c Đọc toàn bộ tài liệu