Extract from the measure # 93 of February 11, 2015 subject: veterinary medicinal product GELLIFLOX 100 mg/ml. Solution for injection for cattle and pigs.
Mutual recognition procedure change number IE/V/xxxx/IA/035/G type IA variation for the following medicinal product: pack size: 250 ml bottle-A.I.C. # 104123029;
bottle 100 ml-A.I.C. # 104123017.
A.I.C. holder: 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 the following: treating bacterial infections caused by susceptible strains to enrofloxacin.
Cattle: treatment of 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, cattle of age under 2 years.
Pigs: respiratory tract infections caused by susceptible strains of Pasteurella multocida to enrofloxacin, 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.
Enrofloxacin should be used when clinical experience, confirmed where possible causal agent sensitivity tests, indicates enrofloxacin as the drug of choice.
Dosage and route of administration.
Are now as follows: intravenous, subcutaneous or intramuscular injection.
Repeated injections must be done at 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.
Cattle: enrofloxacin 5 mg/kg b.w., corresponding to 1 ml per 20 kg bw once daily 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/kg bw enrofloxacin, corresponding to 1 20 ml/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 bw, equivalent to 20 0.5 ml/kg bw once daily 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 per 20 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.
Waiting period (s) are now as follows: cattle: 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.
This abstract will be published in the official journal of the Italian Republic, and its decision will be notified to the undertaking in question.