देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
E.COLI K88AB ANTIGEN, E.COLI K88AC ANTIGEN, E.COLI K99 ANTIGEN, E.COLI 987P ANTIGEN, CLOSTRIDIUM PERFRINGENS TYP B, CLOSTRIDIUM PERFRINGENS TYPE C TOXOID, CLOSTRIDIUM PERFRINGENS TYPE D TOXOID
Zoetis Ireland Limited
QI09AB08
E.COLI K88AB ANTIGEN, E.COLI K88AC ANTIGEN, E.COLI K99 ANTIGEN, E.COLI 987P ANTIGEN, CLOSTRIDIUM PERFRINGENS TYP B, CLOSTRIDIUM
Unknown
Suspension for Injection
LM-Licensed Merchant
Porcine
Escherichia vaccine + Clostridium vaccine
Immunological - Inactivated vaccine
Authorised
2013-08-29
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT GLETVAX 6 2 QUALITATIVE AND QUANTITATIVE COMPOSITION For a full list of excipients, see section 6.1. * Antibody titre obtained in the potency test in mice in accordance with Ph. Eur. 962 ** IU = International Unit 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 reduce mortality and clinical signs due to neonatal colibacillosis and enteritis. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Vaccinate only healthy animals. ACTIVE SUBSTANCES PER 5 ML DOSE Cell-free pilus antigen of _E.coli _K88ab 14.6 log 2 antibody titre* Cell-free pilus antigen of _E.coli _K88ac 15.5 log 2 antibody titre * Cell-free pilus antigen of _E.coli _K99 12.2 log 2 antibody titre * Cell-free pilus antigen of _E.coli _987p 13.1 log 2 antibody titre * Purified toxoids of _Cl. Perfringens _Type B and purified toxoids of Types C and D Together contributing not less than 300 IU** equivalents beta toxoid and not less than 200 IU** equivalents of epsilon toxoid. ADJUVANT Aluminium hydroxide Less than 15 mg aluminium PRESERVATIVE Thiomersal Less than 0.575 mg HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 31/08/2016_ _CRN 7022827_ _page number: 1_ 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN IN ANIMALS None. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS: None. 4. पूरा दस्तावेज़ पढ़ें