Authorisation For The Medicinal Product For Usoveterinario «Filolinc», 400 400 Mg/g Powder For Oral Solution For Pigs, Broiler (Except Hens Eggs Are Produced For Human Alconsumo).

Original Language Title: Autorizzazione all'immissione in commercio del medicinale per usoveterinario «Filolinc 400», 400 mg/g polvere per soluzione orale persuini, broiler (escluso galline che producono uova destinate alconsumo umano).

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-05-18&atto.codiceRedazionale=15A03570&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Decree n. 61 of April 21, 2015 veterinary medicine: FILOLINC 400, 400 mg/g powder for oral solution for pigs, broiler (excluding chickens which produce eggs for human consumption).
A.I.C. holder: Filozoo S.r.l., Carpi (MO)-Via del Commercio, 28/30-Italy.
Manufacturer responsible for batch release: Filozoo S.r.l., Carpi (MO)-Via del Commercio, 28/30-Italy.
Authorised pack sizes and numbers of A.I.C.: 1 kg jar-A.I.C. # 104734013;
5 kg bag-A.I.C. # 104734025.
Composition: A g contains: active ingredient: Lincomycin (in the form of hydrochloride) 400.0 mg;
excipients: so as stated in the documentation of pharmaceutical techniques acquired to acts.
Target species: pigs and broilers (excluding chickens which produce eggs for consumption).
Medical indications: infections caused by microbial agents and Mycoplasma susceptible to lincomycin, as for example: Brachyspira hyodysenteriae and enzootic pneumonia caused by Mycoplasma pneumonia and necrotic enteritis caused by Clostridium perfringens.
Waiting time: pigs: meat and offal: 0 days.
Broilers: meat and offal 5 days.
Eggs: do not use in hens producing eggs for human consumption.
Validity: validity of the veterinary medicinal product as packaged for sale: 2 years;
Period of validity after first opening the immediate packaging: 6 months;
Period of validity after dissolving in water: 24 hours.
Dispensing scheme: to be supplied only upon presentation of medical veterinary prescription non-repeatable in triplicate.
Effectiveness of the Decree: from the day of its publication in the official journal of the Italian Republic.