Authorisation For The Medicinal Product For Usoveterinario «Unisol 25 Mg/ml. "

Original Language Title: Autorizzazione all'immissione in commercio del medicinale per usoveterinario «Unisol 25 mg/ml».

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Decree No 24 of February 24, 2015 mutual recognition procedure # IE/V/0216/002/E/002.
Veterinary medicinal product UNISOL 25 mg/ml oral solution for calves.
A.I.C. Holder: Vetpharma Animal Health Company, S.L. Les Corts, 23-08028 Barcelona-Spain.
Manufacturer responsible for batch release: an establishment Laboratorios Karizoo, S.A. Poligono Industrial La Borda, Mas Pujades, 11-12-08140 Caldes de Montbui (Barcelona) Spain.
Authorised pack sizes and numbers of 250 ml bottle-A.I.C.: A.I.C. 500 ml bottle # 104750017-1 liter bottle-A.I.C. A.I.C. # 104750029 # 104750031 composition: each ml contains: active ingredient: Enrofloxacin 25.0 mg excipients: as indicated in pharmaceutical techniques acquired to acts.
Target species: calfs (calves pre-ruminants).
Medical indications: in calves: treatment of respiratory disease by Pasteurella multocida and Mannheimia haemolytica;
gastro-intestinal dysfunctions by Escherichia coli.
To be used where the clinical indications or tests of sensitivity indicates enrofloxacin as the drug of choice.
Validity: the veterinary medicinal product as packaged for sale: 2 years;
After first opening the immediate packaging: 28 days;
period of validity after dilution according to directions: 24 hours.
Waiting time: meat and offal: 11 days.
Dispensing scheme: to be supplied only upon presentation of medical-veterinary prescription in triplicate not repeatable.
Date of Decree: immediate effect.