Страна: Испания
Язык: английский
Источник: HMA (Heads of Medicines Agencies)
florfenicol 23 mg/ml
Novartis Animal Health UK Limited
QJ01BA
Concentrate for oral solution
Amphenicols
Pigs
2012-06-27
Issued: December 2012 AN: 00715/2011 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Florvio 23 mg/ml solution for use in drinking water for pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Florfenicol 23 mg EXCIPIENTS: For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for use in drinking water. Clear, colourless to yellow, slightly viscous solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pig 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES 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 treatment. 4.3 CONTRAINDICATIONS Do not use in boars intended for breeding purposes. Do not administer in cases of previous allergic reactions to florfenicol. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES The treated pigs should be placed under special observation. On each of the five days of treatment, untreated drinking water should not be given until the full daily amount of medicated drinking water has been ingested by the pigs. If there is no significant improvement after 3 treatment days, the diagnosis should be reviewed and if necessary the treatment should be changed. Issued: December 2012 AN: 00715/2011 Page 2 of 7 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE Прочитать полный документ