País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
florfenicol
Zoetis Ireland Limited
QJ01BA90
200 Mg/Ml
Granules for use in drinking water
Porcine
Antibiotics
Authorised
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT COLFEN 200 SP, 200 mg/g granules for use in drinking water for pigs. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Granules for use in drinking water. White to cream waxy granules. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of swine respiratory disease associated with _Pasteurella multocida _susceptible to florfenicol. 4.3 CONTRAINDICATIONS Do not administer to boars intended for breeding purposes. Do not administer in cases of previous allergic reactions to florfenicol or any of the excipients. Do not use in piglets less than 6 weeks old. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES If there is no significant improvement after 3 days of treatment, the diagnosis should be reviewed and if necessary the treatment should be changed_._ Each g contains: ACTIVE SUBSTANCE: Florfenicol 200.0 mg EXCIPIENT(S): Butylhydroxytoluene (E321) 1.0 mg For a full list of excipients, see section 6.1 IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 19/07/2013_ _CRN 7012445_ _page number: 1_ 4.5 SPECIAL PRECAUTIONS FOR USE i) Special precautions for use in animals The veterinary medicinal product should be used in conjunction with susceptibility testing. Official, national and regional antimicrobial policies should be taken into account when the product is used. Inappropriate use of the veterinary medicinal product may increase the prevalence of bacteria resistant to florfenicol. Treatment should not exceed 5 days. ii) Special precautions for the person administering the veterinary medicinal product to animals Avoid skin and eye contact with product. Do Llegiu el document complet