Extract from the measure # 92 of February 11, 2015 subject: veterinary medicinal product GELLIFLOX 50 mg/ml solution for injection for cattle, pigs, cats and dogs.
Mutual recognition procedure change number IE/V/xxxx/IA/035/G type IA variation for the following medicinal product: packaging: Bottle 250 ml-100 ml Bottle # 104124021-A.I.C. A.I.C. # 104124019 Holder A.I.C.: Chanelle Pharmaceuticals Manufacturing Ltd., based in Loughrea, co. Galway, Ireland.
You authorize changes to the summary of product characteristics and patient handouts.
Due to the above mentioned variation handouts of the veterinary medicinal product as indicated in question must be modified as follows: indications for use with specification of the target species are now as follows: Calves respiratory tract infections caused by susceptible strains of Pasteurella multocida and Mannheimia haemolytica to enrofloxacin, Mycoplasma spp.
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 Mycoplasma bovis strains susceptible to enrofloxacin.
Pigs respiratory tract infections caused by susceptible strains of Pasteurella multocida to enrofloxacin, Mycoplasma spp. Actinobacillus pleuropneumoniae and.
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.
Dogs treat infections of the gastrointestinal tract, respiratory and urogenital (including prostatitis and additional antibiotic therapy for pyometra), wound and skin infections, otitis (external/media) caused by susceptible strains to enrofloxacin of Staphylococcus spp., Escherichia coli, Pasteurella spp., Klebsiella spp., Bordetella spp, Pseudomonas spp. and Proteus spp.
Cats treatment of infections of the gastrointestinal tract, respiratory and urogenital (as additional antibiotic therapy for pyometra), skin infections and wounds, caused by susceptible strains to enrofloxacin such as Staphylococcus spp, Escherichia coli, Pasteurella spp., Klebsiella spp., Bordetella spp, Pseudomonas spp. and Proteus spp.
Dosage and route of administration are now as follows: intravenous, subcutaneous or intramuscular injection.
Repeated injections should be performed in different injection sites.
To ensure the correct dose, body weight (BW) should be determined by the most accurate as possible in order to avoid underdosing.
Calves: enrofloxacin 5 mg/kg b.w., corresponding to 1 ml/10 kg bw once daily for 3-5 days.
Acute arthritis associated with Mycoplasma, caused by susceptible strains of Mycoplasma bovis: 5 mg to enrofloxacin enrofloxacin/kg b.w., corresponding to 1 ml/10 kg bw once daily for 5 days.
The medication can be administered by slow intravenous injection or subcutaneous injection.
In each site by subcutaneous injection should not be given more than 10 ml.
Pigs: 2.5 mg enrofloxacin/kg b.w. (corresponding to 0.5 ml/10 kg b.w.) Once a day for 3 days by intramuscular injection.
Gastrointestinal tract infection or septicemia caused by Escherichia coli: enrofloxacin 5 mg/kg b.w., corresponding to 1 ml/10 kg bw once daily 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.
Dogs and cats: enrofloxacin 5 mg/kg b.w. (corresponding to 1 ml/10 kg b.w.) Once a day up to 5 days by injection under the skin.
Waiting period (s) are now as follows: Calves After intravenous injection: meat and offal: 5 days.
After subcutaneous injection: meat and offal: 12 days.
Unauthorized use in animals producing milk for human consumption.
Pigs meat and offal: 13 days.
This abstract will be published in the official journal of the Italian Republic, and its decision will be notified to the undertaking in question.