Modificazione dell'autorizzazione all'immissione in commercio, secondo procedura di mutuo riconoscimento, della specialita' medicinale per uso veterinario .
Estratto provvedimento n. 18 del 7 febbraio 2007
Procedura mutuo riconoscimento n. UK/V/0172/001/II/007.
Specialita' medicinale per uso veterinario ORBESEAL (subnitrato di bismuto) infusione endomammaria non antibiotica per vacche in asciutta, nelle confezioni:
confezione da 24 siringhe - A.I.C. n. 103593012;
confezione da 60 siringhe - A.I.C. n. 103593024;
confezione da 120 siringhe - A.I.C. n. 103593036.
Titolare A.I.C.: Pfizer Italia S.r.l., con sede legale e domicilio fiscale in Borgo San Michele (Latina), SS 156, Km 50 - codice fiscale 06954380157.
Oggetto: variazione tipo II: modifica delle indicazioni d'uso al punto 5.2 del SPC e revisione del punto 5.8 del SPC.
E' autorizzata, per la specialita' medicinale per uso veterinario indicata in oggetto, la variazione tipo II concernente la modifica del sommario delle caratteristiche del prodotto, al punto 5.2 - ´Indicazioni per l'uso, specificando le specie target e il tipo di trattamento (preventivo, curativo o scopi diagnostici)ª - che ora e' il seguente:
´per la prevenzione delle nuove infezioni intramammarie durante tutto il periodo dell'asciutta.
Nelle bovine presumibilmente non affette da mastite subclinica, Orbeseal puo' essere utilizzato da solo per la gestione dell'asciutta e per il controllo delle mastiti.
La selezione delle bovine da sottoporre al singolo trattamento con Orbeseal dovrebbe essere basata sulla valutazione clinica del veterinario. I criteri di selezione possono essere basati sulla anamnesi relativa a mastiti e conteggi individuali di cellule somatiche o a test riconosciuti per la diagnosi di mastiti subcliniche...
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