Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-01-30&atto.codiceRedazionale=15A00543&elenco30giorni=false&atto.tipoProvvedimento=DECRETO
Retrieved 9 January 8, 2015 # measure the subject: «Chemifarma» 20% liquid Tylosin 200 mg/ml, oral solution for pigs, broilers and dairy calves AIC # 103385.
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: «Chemifarma» 20% liquid Tylosin 200 mg/ml, oral solution for pigs, broilers and dairy calves.
4.3. Controndicazioni: do not use in animals with known hypersensitivity to tylosin or any of the excipients.
4.4. Special warnings for each target species: repeated or prolonged use should be avoided by improving management practices and by cleaning and disinfection.
4.5. Special precautions for 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.
4.9. dosage and route of administration.
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.
Do not mix in feed solids.
5.1. Pharmacodynamic information: 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 particulars: 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, into the calf: Cmax: 2.7 µ g/ml, 2.0 hours, T1/2 Tmax: 1.2 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.
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