Review Product Marketing Authorisation For Veterinary Use ' Roxacin Soluzioneiniettabile 100 Mg/ml For Cattle And Pigs ".

Original Language Title: Modifica dell'autorizzazione all'immissione in commercio delmedicinale per uso veterinario «Roxacin 100 mg/ml soluzioneiniettabile per bovini e suini».

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-03-21&atto.codiceRedazionale=15A02126&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Measure # 89 of February 10, 2015 veterinary medicinal product ROXACIN 100 mg/ml solution for injection 100 ml Bottle for cattle and pigs-250 ml Bottle # A.I.C. 104264027-Calier A.I.C. A.I.C. Holder # 104264015: Laboratorios S.A. based in Barcelones 26 (P.la of Ramassa ') Les Franqueses del Valles (Barcelona)-Spain.
Purpose of review: type IA Variations, C.I. 1. to View the European Commission implementing decision ' C (2014) the 1 St September 2014 final» 6268 on, pursuant to article 35 of Directive 2001/82/EC of the European Parliament and of the Council to the marketing authorisations for veterinary medicinal products "Baytril Baytril injectable solution 2.5% solution for injection, 5%, 10% and Baytril injectable solution associated names» and regarding veterinary medicinal products containing the active substance «enrofloxacin».
Seen the Decree # 100 of September 19, 2014 (Gazzetta Ufficiale-serie generale n. 228 of 1° October 2014).
You authorize changes to the summary of product characteristics and patient handouts.
As a result of those decisions of the European Commission, the amendments to the printed leaflets of the product in question are mentioned below: target species cattle and pigs indications for use with specification of the target species are now as follows: Cattle treatment of respiratory tract infections caused by susceptible strains of Pasteurella multocida and Mannheimia haemolytica to enrofloxacin, Mycoplasma spp.
Treatment of severe acute mastitis caused by susceptible strains of Escherichia coli to enrofloxacin.
Treatment of gastrointestinal tract infections caused by susceptible strains of Escherichia coli to enrofloxacin.
Treatment of septicemia caused by susceptible strains of Escherichia coli to enrofloxacin.
Treatment of acute arthritis associated with Mycoplasma, caused by susceptible strains of Mycoplasma bovis in cattle to enrofloxacin age less than 2 years.
Pigs respiratory tract infections caused by susceptible strains to enrofloxacin Pasteurella multocida, Mycoplasma spp. Actinobacillus pleuropneumoniae and.
Treatment of urinary tract infections caused by susceptible strains of Escherichia coli to enrofloxacin.
Treatment of postpartum disgalassia syndrome (PDS, or MMA syndrome) caused by susceptible strains of Escherichia coli and Klebsiella spp to enrofloxacin.
Treatment of gastrointestinal tract infections caused by susceptible strains of Escherichia coli to enrofloxacin.
Treatment of septicemia caused by susceptible strains of Escherichia coli to enrofloxacin.
Contraindications: do not use in horses during the growth period due to the possible damage to the articular cartilage.
Special precautions for use precautions for use in animals Add in calves treated orally with 30 mg/kg body weight/day for 14 days enrofloxacin was observed degenerative articular cartilage.
Dosage and route of Administration is now as follows: intravenous, subcutaneous or intramuscular injection.
Repeated injections should be performed in different injection sites.
To ensure the correct dose, body weight should be determined by the most accurate as possible in order to avoid underdosing.
Cattle enrofloxacin 5 mg/kg bw, equivalent to 1 ml per 20 kg of body weight once a day for 3-5 days.
Acute arthritis associated with Mycoplasma caused by Mycoplasma bovis strains susceptible to enrofloxacin, age less than 2 years in cattle: 5 mg enrofloxacin/kg bw, equivalent to 1 ml per 20 kg of body weight once a day for 5 days.
The medication can be administered by slow intravenous injection or subcutaneous injection.
Acute mastitis caused by Escherichia coli: enrofloxacin 5 mg/kg bw, equivalent to 1 ml per 20 kg of body weight, by slow intravenous injection once daily for 2 consecutive days.
The second dose can be administered subcutaneously. In this case, the waiting time after subcutaneous injection.
In each site by subcutaneous injection should not be given more than 10 ml.
Pigs 2.5 mg enrofloxacin/kg bw, equivalent to 20 0.5 ml/kg of body weight once a day for 3 days by intramuscular injection.
Gastrointestinal tract infection or septicemia caused by Escherichia coli: enrofloxacin 5 mg/kg bw, equivalent to 1 ml per 20 kg of body weight once a day for 3 days by intramuscular injection.
In pigs, the injection should be made in the neck at the base of the ear.
In each site for intramuscular injection should not be given more than 3 ml.
Waiting period (s) are now as follows: bovine animals After intravenous injection: meat and offal: 5 days.
Milk: 3 days after subcutaneous injection: meat and offal: 12 days.
Milk: 4 days Pigs meat and offal: 13 days.
Pharmacodynamic properties Replace with text: mode of action two essential enzymes in the replication and transcription of DNA, DNA gyrase and topoisomerase IV, have been identified as targets of fluoroquinolones. Inhibition of these targets is mediated by non-Covalent bonds fluoroquinolone molecules with these enzymes. Translational replication forks and are unable to proceed beyond these enzyme-DNA-fluoroquinolone complexes and the inhibition of the synthesis of DNA and mRNA triggers events that lead to a quick-and concentration-dependent bactericidal effect of medication of pathogenic bacteria. The mode of action of enrofloxacin is bactericidal and bactericidal activity is concentration-dependent.
Antibacterial spectrum recommended therapeutic doses, enrofloxacin is active against many Gram negative bacteria, such as Escherichia coli, Klebsiella spp., Actinobacillus pleuropneumoniae, Mannheimia haemolytica, Pasteurella spp. (eg. Pasteurella multocida, Bordetella spp.), Proteus spp, Pseudomonas spp., against Gram positive bacteria such as Staphylococcus spp. (eg. Staphylococcus aureus) and against Mycoplasma spp.
Types and mechanisms of resistance

It has been reported that the fluoroquinolone resistance derives from five causes: (i) point mutations in the genes coding for DNA gyrase or topoisomerase IV, which lead to alterations of the respective enzyme; (ii) alterations of drug permeability in Gram-negatives; (iii) efflux mechanisms; (iv) plasmid-mediated resistance; (v) protective proteins of gyrase. All mechanisms lead to a reduced sensitivity of bacteria to Fluoroquinolones. Cross resistance is common within the class of antimicrobials of fluoroquinolones.
This excerpt will be publish in the official journal of the Italian Republic, and its decision will be notified to the company concerned.