Autorizzazione all'immissione in commercio della specialita' medicinale per uso veterinario
Decreto n. 61 del 12 luglio 2006
Specialita' medicinale per uso veterinario PARACILLINA P.S. - A.I.C. n. 100045.
E' confermata l'autorizzazione all'immissione in commercio della specialita' medicinale per uso veterinario «Paracillina P.S.» alle condizioni di seguito specificate:
Titolare A.I.C.: Intervet International B.V. - Boxmeer (Olanda), rappresentata in Italia dalla Intervet Italia Srl. con sede legale in Peschiera Borromeo (MI) - via Walter Tobagi n. 7 - codice fiscale n. 01148870155.
Produttore: sia presso lo stabilimento dell societa' Intervet Productions S.r.l. sito in Aprilia (Latina) - via Nettunense km 20,300 sia presso lo stabilimento della societa' PenCef GmbH sito in Berlino (Germania).
Confezioni autorizzate e numeri di A.I.C.:
barattolo da 100 g - A.I.C. n. 100045018;
barattolo da 250 g - A.I.C. n. 100045020;
barattolo da 1 kg - A.I.C. n. 100045032.
Composizione: 1 g di prodotto contiene:
Principio attivo: amoxicillina triidrato (pari ad amoxicillina 697 mg) 800 mg;
Eccipienti: cosi' come indicato nella tecnica farmaceutica acquisita agli atti.
Specie di destinazione: suini e polli (ad esclusione delle galline ovaiole che producono uova per il consumo umano).
Indicazioni terapeutiche: Paracillina PS e' indicata per il trattamento delle infezioni causate da batteri sensibili all'amoxicillina in suini e polli, escluse le galline che depongono uova per il consumo umano. L'amoxicillina ha dimostrato in vitro di essere battericida nei confronti di un gran numero di batteri Gram-positivi e Gram-negativi che causano comunemente malattie nei polli (quali: stafilococci, Streptococci, Pasteurella spp., Clostridium spp., Salmonella spp., Haemophilus paragallinarum ed E. coli penicillino-sensibili) e nei suini (quali: Actinobacillus pleuropneumoniae, Actinomyces pyogenes, Bordetella bronchiseptica, Erysipelothrix rhusiopathiae, Streptococci suis, Staphylococci, Streptococci, Pasteurella...
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