Nazione: Spagna
Lingua: inglese
Fonte: HMA (Heads of Medicines Agencies)
florfenicol 30 %
SP Veterinaria S.A
QJ01BA90
Solution for injection
florfenicol
Cattle, Pigs
2011-10-26
Issued: December 2011 AN: 00749/2010 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Mycoflor 300 mg/ml solution for injection for pigs Florfenicol 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains Active substance: Florfenicol. 300mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for Injection Clear, light yellow to yellow solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Pigs: Treatment of acute outbreaks of respiratory disease caused by strains of _Actinobacillus pleuropneumoniae _and_ Pasteurella multocida_ _susceptible to _ _florfenicol_ 4.3 CONTRAINDICATIONS Do not use in adult boars intended for breeding purposes. Do not administer to animals with known hypersensitivity to florfenicol or to any of the excipients of the product Do not use in case of known resistance to florfenicol Do not administer intravenously Refer to section 4.11 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Do not exceed the recommended treatment dose or the recommended duration of treatment Issued: December 2011 AN: 00749/2010 Page 2 of 5 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS The product should only be used in piglets of less than 2kg after a benefit:risk assessment by a veterin ary surgeon’. The product should be used in conjunction with susceptibility testing and take into account official and local a Leggi il documento completo