Review Product Marketing Authorisation For Veterinary Use ' 10% ' Findol Solution For Injection.

Original Language Title: Modifica dell'autorizzazione all'immissione in commercio delmedicinale per uso veterinario «Findol 10%» soluzione iniettabile.

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-04-27&atto.codiceRedazionale=15A02959&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Extract from the measure # 186 of March 24, 2015 veterinary medicinal product 10% FINDOL solution for injection.
Packaging: 100 ml glass bottle-A.I.C. # 100191042;
200 ml glass vial-A.I.C. # 100191055;
bottle 100 ml-A.I.C. PP # 100191067;
bottle 200 ml-A.I.C. PP # 100191079.
A.I.C. holder: Ceva animal health S.p.A. with offices in via Colleoni # 15-20864 Agrate Brianza (MB).
The object of the measure: extension pursuant to annex I of the Reg (EC) No 1234/2008: permission of intravenously for bovine and equine in producing milk for human consumption, with determination of their waiting time.
You authorize the addition of intravenous route of Administration for bovine and equine's administration of the product that produce milk for human consumption, with the relevant waiting periods set forth below.
Therefore changes the following paragraphs of the summary of product characteristics (SMPC) and its other printed leaflets.
4.9-dosage and route of Administration: horses and pigs: unchanged;
cattle: serving size: 3 mg active ingredient/kg bodyweight (equivalent to m1/3 100 kg);
Administration: by e.v. or i.m. 1 time per day for 3 consecutive days deep in case of respiratory infections, for the duration of antibiotic therapy in cases of acute mastitis.
4.11-waiting time: pigs: unchanged;
cattle: after intravenous administration: meat and offal: 0 days. Milk: 0 hours after intramuscular: meat and offal: 4 days. Milk: 0 hours equines: meat and offal: 4 days. Milk: 0 hours.
Lots already products may be marketed until their expiry date.
This abstract will be published in the official journal of the Italian Republic, and its decision will be notified to the undertaking in question.