Review Of The Marketing Authorisation For Veterinary Dellapremiscela Premix For Medicated «Tylosin200».

Original Language Title: Modifica dell'autorizzazione all'immissione in commercio dellapremiscela per alimenti medicamentosi per uso veterinario «Tylosin200 premix».

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-01-30&atto.codiceRedazionale=15A00552&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved 10 January 8, 2015 # measure the subject: «Tylosin 200 premix» premix for medicated feed for broilers, pigs.
A.I.C. # 103387.
Owner: Chemifarma S.p.A. with registered office and tax domicile in Forli ', via Don Eugenio Servadei, 16-VAT # 00659370407.
Type IB variation.
You authorize the changes as described below: adjustment of the summary of product characteristics to the guideline EMEA/CVMP/SAGAM/383441/2005 revised guideline on the spc for antimicrobial products.
The effect of this change in printed matter must be modified with the addition of the sentences below: 1. Name of the veterinary medicinal product: «premix» Tylosin 200 200 mg/g premix for medicated feed for broilers, pigs. 4.2. Indications for use, specifying the target species.
Pigs: necrotic enteritis, enzootic pneumonia, incurred by pathogens susceptible to tylosin.
For information regarding swine dysentery see section 4.5.
Broiler: respiratory chronic disease, supported by pathogens susceptible to tylosin. .3. Contraindications: do not use in animals with known hypersensitivity to tylosin or any of the excipients. 4.4. Special warnings for the target species: repeated or prolonged use should be avoided by improving management practices and by cleaning and disinfection. 4.5. Special precautions during use.
Special precautions for use in animals: the use of the product should be based on testing of sensitivity towards the bacteria isolated from animals. If this is not possible the therapy should be based on local (regional) epidemiological information about the sensitivity of target bacteria. Misuse of the product may increase the prevalence of tylosin-resistant bacteria and reduce the effectiveness of the treatments with other antimicrobials because they may experience cross-resistance.
Special precautions to be taken by the person administering the veterinary medicinal product to animals: people with known hypersensitivity to tylosin should avoid contact with the veterinary medicinal product 4.9. Dosage and administration route: to avoid underdosing body weight should be determined by the most accurate possible.
Medicated water consumption depends on the clinical conditions of the animals. In order to get the proper dosage, the concentration of Tylosin should be calculated accordingly. 5.1. pharmacodynamic properties: the MIC values reported for Mycoplasma gallisepticum are outside the range µ g/ml, -1 0.125 to 0.25 µ g/ml Mycoplasma synoviae between -1, Clostridium perfringens between 0.125-4 µ g/ml. 5.2. pharmacokinetic properties: the main pharmacokinetic parameters following oral administration of Tylosin in broilers are: Cmax: 1.2 µ g/ml, 1.5 hours, T1/2 Tmax: 2.07 hours, in pigs: Cmax: 1.0 µ g/ml, Tmax: 1.2 hours, T1/2 4.5 hours.
Lots already products can be marketed until the expiration date printed on the package.
This abstract will be published in the official journal of the Italian Republic, and its decision will be notified to the undertaking in question.