COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso veterinario «Clindabactin 55 mg» compresse masticabili per cani e gatti, «Clindabactin 220 mg» compresse masticabili per cani e «Clindabactin 440 mg» compresse masticabili per cani. (19A05641)
Estratto decreto n. 120 del 29 agosto 2019 Procedura decentrata n. UK/V/0678/001-003/DC Medicinale veterinario CLINDABACTIN 55 mg compresse masticabili per cani e gatti, CLINDABACTIN 220 mg compresse masticabili per cani e CLINDABACTIN 440 mg compresse masticabili per cani;
Titolare A.I.C.: Dechra Regulatory B.V. - Handelsweg 25, 5531 AE Bladel , Paesi Bassi;
Produttore responsabile rilascio lotti: Stabilimento Lelypharma B.V., Zuiveringweg 42, Lelystad, 8243 PZ, Paesi Bassi;
Confezioni autorizzate e numeri di A.I.C.: Clindabactin 55 mg : blister da 10 compresse A.I.C. numero 105224036;
Clindabactin 220 mg: blister da 10 compresse A.I.C. numero 105224012;
Clindabactin 440 mg: blister da 10 compresse A.I.C. numero 105224024;
Composizione: Clindabactin 55 mg: ogni compressa contiene: Principio attivo: Clindamicina (come clindamicina cloridrato) 55mg Clindabactin 220 mg: ogni compressa contiene: Principio attivo: Clindamicina (come clindamicina cloridrato) 220 mg Clindabactin 440 mg: ogni compressa contiene: Principio attivo: Clindamicina (come clindamicina cloridrato) 440 mg;
Eccipienti: cosi' come indicato nella documentazione di tecnica farmaceutica acquisita agli atti. Indicazioni terapeutiche: Clindabactin 55 mg: Cani Trattamento delle ferite infette, degli ascessi e delle infezioni del cavo orale, parodontite inclusa, causate o associate a Staphylococcus spp., Streptococcus spp. (eccetto Streptococcus faecalis), Bacteroides spp., Fusobacterium necrophorum e Clostridium perfringens sensibili alla clindamicina. Trattamento del pioderma superficiale associato a Staphylococcus pseudintermedius sensibile alla clindamicina. Trattamento...
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