Authorisation For The Medicinal Product For Usoveterinario «Miprepol» Oily Suspension For Cats And Dogs.

Original Language Title: Autorizzazione all'immissione in commercio del medicinale per usoveterinario «Miprepol» sospensione oleosa per cani e gatti.

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-02-16&atto.codiceRedazionale=15A01001&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Decree No. 9 of January 22, 2015 decentralised procedure # IT/V/0130/001/DC veterinary medicine MIPREPOL oily suspension for dogs and cats Owner A.I.C.: ELI LILLY Italy S.p.A. Via Gramsci 731-733-500190Sesto Fiorentino (FI)-Italy manufacturer responsible for batch release: JANSSEN Pharmaceutica NV-Turnhoutseweg 30, 2340 Beerse (Belgium) B-;
Authorised pack sizes and numbers of A.I.C.: 15 ml bottle-30 ml bottle # 104,700,012-A.I.C. A.I.C. # 104,700,024 15 ml bottle with child resistant cap-A.I.C. # 104,700,036 30 ml bottle with child resistant cap-A.I.C. # 104,700,048 composition: one ml contains: active ingredients: miconazole (as nitrate) 20 mg Prednisolone (as acetate) 4.48 mg polymyxin B sulfate 0.5293 mg excipients: as stated in the documentation of pharmaceutical techniques acquired to acts.
Target species: dogs cats medical indications: dogs and cats: external ear infections and treatment of dermatitis incurred by following sensitive microorganisms: yeast and fungus Microsporum spp.
Trichophyton spp.
Candida spp.
Malassezia pachydermatis gram-positive Staphylococcus spp.
Streptococcus spp.
Gram negative bacteria Pseudomonas spp.
Escherichia coli In case of otitis externa supported by ear mites (Otodectes cynotis), the effect of the product is due to a physical action of the excipient and not to the intrinsic activity of the active ingredients contained in this product. Use the product for this indication, only in cases where there is a secondary infection caused by susceptible organisms.
The product has also Antiinflammatory and antipruritic activity wait times: not applicable.
Validity:-period of validity of the veterinary medicinal product as packaged for sale: 2 years-period of validity after first opening the immediate packaging: 3 months.
Dispensing scheme: to be supplied only upon presentation of medical veterinary repeatable recipe.
Effectiveness of the Decree: immediate effect.