Fenoflox 100 mg/ml Solution for Injection for Cattle and Pigs

fluoroquinolones or to any of the excipients
Do not use in growing horses because of possible deleterious damage on articular
cartilage.
4.4 Special warnings for each target species
None known.
4.5 Special precautions for use
Special precautions for use in animals
Do not exceed the recommended dose.
Repeat injections should be made at different sites.
The safety of the product has not been established in pigs or calves when
administered by the intravenous route and use of this route of administration is not
recommended in these animal groups.
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.
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 or eyes
immediately with water.
Do not eat, drink or smoke whilst using the product. Direct contact with the skin
should be avoided because of sensitisation, contact dermatitis and possible
hypersensitivity reactions. Wear gloves.
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.

Revised: August 2015
AN: 00612/2015
4.6 Adverse reactions (frequency and seriousness)
Local tissue reactions may occasionally occur at the injection site. Normal sterile
precautions should be taken.
In cattle, 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
Antagonistic effects due to concurrent administration of macrolides, and tetracyclines
may occur. Enrofloxacin may interfere with the metabolism of theophylline,
decreasing theophylline clearance resulting in increased plasma levels of
theophylline.
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.
Cattle:
5 mg of enrofloxacin/kg bw, corresponding to 1 ml/20 kg bw, once daily for 3-5 days.
Acute mycoplasma-associated arthritis due to enrofloxacin susceptible strains of
Mycoplasma bovis in cattle less than 2 years old: 5 mg of enrofloxacin/kg bw,
corresponding to 1 ml/20 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 any one subcutaneous injection site.
Pigs:
2.5 mg of enrofloxacin/kg bw, corresponding to 0.5 ml/20 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/20 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 any one intramuscular injection site.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Do not exceed the recommended dose.
In accidental overdose (lethargy, anorexia) there is no antidote and treatment should
be symptomatic.
No signs of over dosage were observed in pigs following administration of the
product at five times the recommended therapeutic dose.
4.11 Withdrawal period(s)

Revised: August 2015
AN: 00612/2015
Cattle: Following intravenous injectionMeat and offal: 5 days.Milk:3 daysFollowing subcutaneous injection:Meat and offal: 12 days. Milk: 4 days.Pigs: Intramuscular UseMeat and offal:13 days.
5.