Pays: Allemagne
Langue: anglais
Source: HMA (Heads of Medicines Agencies)
florfenicol 50 mg/ml
ANDERSEN, S.A.
QJ01BA90
Oral solution
florfenicol
Pigs Food
2013-05-29
PACKAGE LEAFLET FLOXYME 50 MG/ML SOLUTION FOR USE IN DRINKING WATER 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT MARKETING AUTHORIZATION HOLDER: Andersen S.A. Avda. de la Llana, 123 08191 Rubí (SPAIN) MANUFACTURER FOR THE BATCH RELEASE: Laboratorios Maymó S.A. Polígono Industrial Can Pelegrí C/ Ferro, 9. 08755 Castellbisbal (SPAIN) 2. NAME OF THE VETERINARY MEDICINAL PRODUCT FLOXYME 50 mg/ml SOLUTION FOR USE IN DRINKING WATER 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS Florfenicol 50 mg/ml Macrogol 300. 4. INDICATIONS In Pigs: Treatment and prevention at the group level where clinical signs are present of swine respiratory disease associated with _Actinobacillus pleuropneumoniae_ and _Pasteurella _ _multocida_ susceptible to florfenicol. The presence of the disease should be established in the herd before initiating preventive treatment. 5. CONTRAINDICATIONS Do not use in boars intended for breeding purposes. _Do not use in case of previous allergic reactions to florfenicol or to any of the _ _excipients_. “Do not use in case of hypersensitivity to the active substance or to any of the excipients.” 6. ADVERSE REACTIONS A slight reduction of water consumption by the animals, dark brown faeces and constipation may be observed during treatment. Commonly observed adverse effects are diarrhoea and/or peri-anal and rectal erythema/oedema which may affect approximately 40% of the animals. These effects are Lire le document complet
FLOXYME 50 MG/ML SOLUTION FOR USE IN DRINKING WATER 1. NAME OF THE VETERINARY MEDICINAL PRODUCT FLOXYME 50 mg/ml SOLUTION FOR USE IN DRINKING WATER 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: Florfenicol 50 mg/ml For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for use in drinking water. Clear, colourless 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES (Pigs) 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES In swine: Treatment and prevention at the group level where clinical signs are present of swine respiratory disease associated with _Actinobacillus pleuropneumoniae_ and _Pasteurella _ _multocida_ susceptible to florfenicol. The presence of the disease should be established in the herd before initiating preventive treatment. 4.3 CONTRAINDICATIONS Do not use in boars intended for breeding purposes. _Do not use in case of previous allergic reactions to florfenicol or to any of the _ _excipients_. “Do not use in case of hypersensitivity to the active substance or to any of the excipients.” 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None 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. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria. Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to florfenico Lire le document complet