Fenoflox 50 mg/ml Solution for Injection for Cattle, Pigs, Dogs and Cats

fluoroquinolones or to any of the excipients.
Dogs under 1 year of age should not be treated with Enrofloxacin as damage to the
articular cartilage may occur during the period of rapid growth, specifically in large
breeds of dog. As a precaution very large breeds of dog should not be treated with
Enrofloxacin until they are 18 months of age because of their longer growth period.
Do not use in cats less than 8 weeks of age.
Do not use for prophylaxis.
Do not use in growing horses because of possible deleterious damage on articular
cartilage.
4.4 Special warnings for each target species
Cattle (calves), pigs:
None
Cats:
Retinotoxic effects including blindness can occur when the recommended dose is
exceeded.
Dogs:
Occasionally skin reactions have been seen after administration to kennelled
greyhounds.
4.5 Special precautions for use
Special precautions for use in animals
Do not exceed the recommended dosage.
Repeat injections should be made at different sites.
Official and local antimicrobial policies should be taken into account when the product
is used.
Fluoroquinolones should be reserved for the treatment of clinical conditions which
have responded poorly, or are expected to respond poorly, to other classes of
antimicrobials.
Whenever possible, fluoroquinolones should only be used based on susceptibility
testing.

Revised: August 2015
AN: 00612/2015
Use of the product deviating from the instructions given in the SPC may increase the
prevalence of bacteria resistant to the fluoroquinolones and may decrease the
effectiveness of treatment with other quinolones due to the potential for cross
resistance.
Enrofloxacin should be used with caution in epileptic animals or animals affected by
renal dysfunction.
Degenerative changes of articular cartilage were observed in calves treated orally
with 30 mg enrofloxacin/kg bw during 14 days.
Special precautions to be taken by the person administering the veterinary
medicinal product to animals
The product is an alkaline solution. Wash any splashes from skin and eyes
immediately with water. Direct contact with the skin should be avoided because of
sensitisation, contact dermatitis and possible hypersensitivity reactions. Wear gloves.
Do not eat, drink or smoke whilst using the product. Care should be taken to avoid
accidental self-injection. In case of accidental injection, seek medical advice
immediately and show the package leaflet or the label to the physician.
4.6 Adverse reactions (frequency and seriousness)
During the period of rapid growth, enrofloxacin may affect articular cartilage.
Local tissue reactions may occasionally occur at the injection site.
Normal sterile precautions should be taken.
In cattle and dogs, gastrointestinal disturbances may occasionally occur.
4.7 Use during pregnancy, lactation or lay
There is no restriction on the use of this product during pregnancy and lactation.
4.8 Interaction with other medicinal products and other forms of interaction
Combination of enrofloxacin with cloramphenicol, macrolide antibiotics or
tetracyclines may produce antagonistic effects.
Enrofloxacin may interfere with the metabolism of theophylline, decreasing
theophylline clearance resulting in increased plasma levels of theophylline.
Care should be taken during the concomitant use of flunixin and enrofloxacin in dogs to
avoid adverse drug reactions. The decrease in drug clearances as a result of co-
administration of flunixin and enrofloxacin indicates that these substances interact
during the elimination phase. Thus, in dogs, the co-administration of enrofloxacin and
flunixin increased the AUC and the elimination half-life of flunixin and increased the
elimination half-life and reduced the Cmax of enrofloxacin.
4.9 Amounts to be administered and administration route
Intravenous, subcutaneous or intramuscular use.
Repeated injections should be made at different injection sites.
To ensure a correct dosage, body weight (bw) should be determined as accurately as
possible to avoid underdosing.
Calves:

Revised: August 2015
AN: 00612/2015
5 mg of enrofloxacin/kg bw, corresponding to 1 ml/10 kg bw, once daily for 3-5 days.
Acute mycoplasma-associated arthritis due to enrofloxacin susceptible strains of
Mycoplasma bovis: 5 mg of enrofloxacin/kg bw, corresponding to 1 ml/10 kg bw,
once daily for 5 days.
The product can be administered by slow intravenous or subcutaneous
administration.
Not more than 10 ml should be administered at the one subcutaneous injection site.
Pigs:
2.5 mg enrofloxacin per kg bodyweight (corresponding to 0.5 ml/10 kg bw) once daily
by intramuscular injection for 3 days.
Alimentary tract infection or septicaemia caused by Escherichia coli: 5 mg of
enrofloxacin/kg bw, corresponding to 1 ml/10 kg bw, once daily by intramuscular
injection for 3 days.
In pigs, the injection should be made in the neck at the ear base.
Not more than 3 ml should be administered at one intramuscular injection site.
Dogs and Cats:
5mg of enrofloxacin per kg bodyweight (corresponding to 1 ml/10 kg bw) daily by
subcutaneous injection for up to 5 days.
Treatment may be initiated with injectable product and maintained with enrofloxacin
tablets. Duration of treatment should be based on the duration of treatment approved
for the appropriate indication in the SPC of the tablet product.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
In dogs and cats, lack of appetite and nausea may occur following overdose.
Overdose may result in CNS and renal dysfunction. In dogs, 10-fold over dosage
results in neurological symptoms such as ataxia, tremor, nystagmus or convulsions.
These symptoms are reversible on cessation of treatment.
No signs of over dosage were observed in pigs following administration of the
product at five times the recommended therapeutic dose.
In target animal studies, cats have been shown to suffer ocular damage after receiving
doses of more than 15mg/kg once daily for 21 consecutive days. Doses of 30mg/kg
given once daily for 21 consecutive days have been shown to cause irreversible ocular
damage. At 50mg/kg given once daily for 21 consecutive days, blindness can occur.
In accidental overdose, there is no antidote and treatment should be symptomatic.
4.11 Withdrawal period(s)
Calves:
Following intravenous injection: Meat and offal: 5 days.
Following subcutaneous injection: Meat and offal: 12 days.
Not authorised for use in animals producing milk for human consumption.
Pigs:
Meat and offal: 13 days
5.