Country: Bretland
Tungumál: enska
Heimild: VMD (Veterinary Medicines Directorate)
Clostridium perfringens, Escherichia coli
Intervet UK Ltd
QI09AB08
Clostridium perfringens, Escherichia coli
Expired
Revised: December 2011 AN: 01181/2011 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Porcilis Coli 6C 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ ACTIVE SUBSTANCES PER 5 ML DOSE Cell-free pilus antigen of K88ab 100-135 units Cell-free pilus antigen of K88ac 100-135 units Cell-free pilus antigen of K99 190-250 units Cell-free pilus antigen of 987P 2900-3100 units Purified toxoids of _Cl. perfringens_ Type B, C and D together contributing equivalents beta toxoid and equivalents of epsilon toxoid ≥ 300 IU ≥ 200 IU Aluminium Hydroxide (Adjuvant) ≤ 15mg A1 Thiomersal (Preservative) 0.01% w/v 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 A combined _E. coli_ and _Cl. perfringens_ Types B, C and D vaccine for pigs. For the passive protection of piglets by the active immunisation of breeding sows and gilts to prevent neonatal colibacillosis caused by K99 bearing strains of _E. coli; _reduce neonatal colibacillosis caused by K88ab, K88ac and 987P bearing strains of _E.coli_ and _Cl. perfringens_ Type C necrotising infectious enteritis. 4.3 CONTRA-INDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Vaccinate only healthy animals. Page 1 of 4 Revised: December 2011 AN: 01181/2011 4.5 SPECIAL PRECAUTIONS FOR USE i. Special precautions for use in animals Occasional hypersensitivity reactions may occur. Prompt subcutaneous administration of adrenaline may relieve the condition. Syringes and needles should be sterilised before use and injection should be made through an area of clean, dry skin, taking precautions against contamination. ii. Special precautions to be taken by the person administering the veterinary medicinal product to animals None 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) In most pigs, a slight to moderate swelling (up to 6 cm) may be seen at the injection site after vaccination. The Lestu allt skjalið