Advocin porcine 2,5% 100 ml

ADVOCATION SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT ADVOCIN INJECTABLE SOLUTION   2. QUALITATIVE AND QUANTITATIVE COMPOSITION     Active principle: Danofloxacin mesylate 31,73a mg/ml Equivalent to 25 mg danofloxacin/ml. Excipients: Phenol 2,5 mg as preservative Other excipients, csp 1 ml   3. PHARMACEUTICAL FORM Injectable solution.  5. CLINICAL DATA 5.1 Target species Pigs and cattle, including lactating dairy cows. 5.2 Indications for use Treatment of respiratory diseases in cattle caused by Pasteurella haemolytica y P. multocida and treatment of enteric infections caused by E. coli in cattle. Treatment of respiratory diseases caused by Pasteurella multocida y Actinobacillus pleuropneumoniae and treatment of enteric infections caused by E. coli in swine. 5.3 Contraindications They have not been described. 5.4 Adverse reactions (frequency and seriousness) Its intramuscular application can cause irritation at the point of inoculation. 5.5 Special precautions for use When using this product, the recommendations should be taken into account. officials on the use of antimicrobials. The use of fluoroquinolones should be reserved for the treatment of those clinical cases that have responded poorly, or are expected to respond poorly, to other classes of antimicrobials. Whenever possible, fluoroquinolones should be used after perform a sensitivity test. The use of the product in conditions other than those recommended in the Sheet technique can increase the prevalence of bacteria resistant to fluoroquinolones and decrease the efficacy of treatment with other quinolones due to to cross resistances. Use sterile injection equipment. 5.6 Use during pregnancy and lactation It can be used in pregnant cows and in lactating cows whose milk is intended for for human consumption. The effect of danofloxacin on reproductive function and on pregnancy in swine, has not been fixed, therefore do not use in these periods. 5.7 Interactions with other medicinal products and other forms of interaction They have not been described. 5.8 Posology and method of administration In cattle, ADVOCIN SOLUTION FOR INJECTION can be administered via intramuscularly, or intravenously at a dose of 1,25 mg of danofloxacin per kg of live weight (1 ml per 20 kg of live weight). Three treatments with 24 hours apart from each other. Treatment can be extended for an additional period two days, in animals that have not fully recovered after three days of initial treatment. For the treatment of bovids that weigh more from 400 kg, the dose should be divided so that no more than 20 ml is administered at the same point of application. In pigs, ADVOCIN SOLUTION FOR INJECTION will be administered via intramuscularly at a dose of 1,25 mg of danofloxacin per kg of body weight (1 ml per every 20 kg of live weight). Three treatments 24 hours apart are required each other. For the treatment of pigs weighing more than 100 kg, the dose should be divided in such a way that no more than 5 ml are administered at any one point of application. 5.9 Overdose (symptoms, emergency procedures, antidotes) In cattle, a safety margin of at least 5 times the recommended dose for the intramuscular route and 3 times for the intravenous route. In pigs, with a dose 10 times higher than the recommended one, it appears reduced mobility, change in stool consistency, depression and perianal erythema. 5.10 Special warnings for each target species For the treatment of cattle weighing more than 400 kg, the dose should be divided so that no more than 20 ml is administered at the same point of application. For the treatment of pigs weighing more than 100 kg, the dose should be divided so that no more than 5 ml are administered at the same point of application. 5.11 Timeout Animals must not be slaughtered for human consumption during the period of treatment. Cattle: Meat, intramuscular or intravenous route: 5 days from the last injection Milk: 48 hours after the last injection. Pigs: 3 days. 5.12 Specific safety precautions to be taken by the person who administers or handles the medication Wash hands after using the medication. 6. PHARMACEUTICAL DATA 6.1 Incompatibilities (important) They have not been described. 6.2 Period of validity, when necessary after the reconstitution of the medicinal product or when the first opening of the container 5 years for closed vials. Once the vial is opened, the product must be used within 4 weeks. 6.3 Special precautions for storage Store below 28ºC. 6.4 Nature and contents of container 100 or 250 ml Type II amber rounded glass vial with snap closure West 4416/50 butylated rubber stopper and lacquered aluminum seal in one part. 6.5 Special precautions to be observed in disposing of the unused medication and/or containers Any unused veterinary medicinal product or residues derived from it must be disposed of in accordance with current regulations. 7 NAME OR COMPANY NAME AND ADDRESS OR BUSINESS HEADQUARTERS OF THE HOLDER THE MARKETING AUTHORIZATION PFIZER SA Europa Avenue nº 20-B La Moraleja Business Park 28108 Alcobendas (Madrid). Spain FINAL INFORMATION – Marketing authorization number: 1243 ESP- Date of authorization/renewal: February 23, 1999 / April 24, 2007 – Last revision of the text: June 02, 2008. – Dispensation: Subject to veterinary prescription ADVOCATION See technical sheet