Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Florfenicol
Huvepharma N.V.
QJ01BA90
Florfenicol
Granules for use in drinking water
POM-V - Prescription Only Medicine – Veterinarian
Pigs
Antimicrobial
Expired
2013-06-24
Revised July 2018 AN: 01612/2017 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT AMPHEN, 200 mg/g granules for use in drinking water for pigs. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each g contains: ACTIVE SUBSTANCE: Florfenicol 200.0 mg EXCIPIENT(S): Butylhydroxytoluene (E321) 1.0 mg Disodium edetate 1.0 mg For the full list of excipients, see section 6.1 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 use in cases of hypersensitivity to the active substance or to 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_._ In case of insufficient water intake, animals should be treated parenterally Revised July 2018 AN: 01612/2017 Page 2 of 6 4.5 SPECIAL PRECAUTIONS FOR USE i) Special precautions for use in animals Use of the product should be based on susceptibility testing of the bacteria isolated from the animal. It this not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria. Official and local antimicrobial policies should be taken into account when the product is used. Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to florfenicol and may decrease the effectiveness of treatment with amphenicols due to the potential for cross-resistance. Treatment should not exceed 5 days. ii) Special precautions for the person administering the veterinary medicinal product to animal Read the complete document