Enrofloxacin FP 5% , 50 mg/ml

COMPOSITION
1 ml of solution for injection contains:
Active substance:
Enrofloxacin …………………………………………………………………………….50 mg
Excipients:
n-butyl alcohol, potassium hydroxide, water for injections.
INDICATIONS
Treatment of respiratory tract infections caused by enrofloxacin
sensitive strains of Pasteurella multocida, Mannheimia haemolytica
and Mycoplasma spp..
Treatment of digestive tract infections caused by enrofloxacin
sensitive strains of Escherichia coli. Treatment of septicemia caused
by enrofloxacin sensitive strains of Escherichia coli.
Treatment of arthritis associated with acute mycoplasmosis caused
by enrofloxacin sensitive strains of Mycoplasma bovis.
Sheep: Treatment of digestive tract infections caused by enrofloxacin
sensitive strains of Escherichia coli. Treatment of sepsis caused by
enrofloxacin sensitive strains of Escherichia coli.
Treatment of mastitis caused by enrofloxacin sensitive strains of
Staphylococcus aureus and Escherichia coli.
Goats: Treatment of certain respiratory tract infections of
enrofloxacin sensitive strains of Pasteurella multocida, Mannheimia
haemolytica and Mycoplasma spp.
Treatment of digestive tract infections caused by enrofloxacin
sensitive strains of Escherichia coli. Treatment of sepsis caused by
enrofloxacin sensitive strains of Escherichia coli.
Treatment of mastitis determined by enrofloxacin sensitive strains
of Staphylococcus aureus and Escherichia coli.
Pigs: Treatment of certain respiratory tract infections of enrofloxacin
sensitive strains of Pasteurella multocida, Mycoplasma spp. and
Actinobacillus pleuropneumoniae.
Treatment of digestive tract infections caused by enrofloxacin
sensitive strains of Escherichia coli. Treatment of sepsis determined
by enrofloxacin sensitive strains of Escherichia coli.
Dogs: Treatment ofdigestive tract, respiratory and urogenital
infections (including prostatitis, adjuvant antibiotic therapy for
pyometra), skin and wound infections, otitis (externa / media),
caused by enrofloxacin sensitive strains of: Staphylococcus spp.,
Escherichia coli, Pasteurella spp., Klebsiella spp., Bordetella spp.,
Pseudomonas spp. and Proteus spp.
Cats: Treatment of digestive tract, respiratory and urogenital
infections (as adjuvant therapy with antibiotics for pyometra), skin
and wound infections, caused by enrofloxacin sensitive strains of:
Staphylococcus spp., Escherichia coli, Pasteurella spp., Klebsiella
spp., Bordetella spp., Pseudomonas spp. and Proteus spp.
CONTRAINDICATIONS
Do not administer to dogs with a history of epilepsy. Do not
administer to dogs under 8 months of age (small dogs), under 12
months (for those of medium size) and 18 months (for those of
large size). Do not use in cats under 8 weeks of age. Do not use it in
growing horses because it can cause possible
conditions of the articular cartilage. Do not administer in case of
hypersensitivity to the active substance or to any of the excipients.
ADVERSE REACTIONS
Occasionally, in some animals there may be recorded: urticaria,
gastrointestinal disorders (vomiting, diarrhea). Very rarely the
product can cause some behavioral changes (restlessness).
Young animals treated with enrofloxacin may suffer joint
cartilage damage. Transient edema may occur at the inoculation
site.
TARGET SPECIES
Cattle (calves), sheep, goats, pigs, dogs, cats.
ADMINISTRATION
Intravenous, subcutaneous or intramuscular administration.
Repeated injections should be performed at different injection
sites.
Calves: 5 mg enrofloxacin/kg b.w., which corresponds to 1 ml/10
kg b.w., once a day for 3-5 days.
Arthritis associated with acute mycoplasmosis caused by
enrofloxacin- sensitive strains of Mycoplasma bovis: 5 mg
enrofloxacin/kg b.w., which corresponds to 1 ml/10 kg b.w.,
once a day, for 5 days. The product can be administered by slow
intravenous or subcutaneous injection.
No more than 10 ml at a single subcutaneous injection site
should be administered.
Sheep and goats: 5 mg enrofloxacin / kg b.w., which corresponds
to 1 ml/10 kg b.w., once a day by subcutaneous injection, for
3 days. No more than 6 ml should be administered at a single
subcutaneous injection site.
Pigs: 2.5 mg enrofloxacin/kg b.w., which corresponds to 0.5
ml/10 kg b.w., once a day by intramuscular injection, for 3 days.
Infections of the digestive tract or sepsis caused by Escherichia
coli: 5 mg enrofloxacin/kg body weight, which corresponds to 1
ml/10 kg b.w., once a day by intramuscular injection, for 3 days.
In pigs, the injection should be carried out in the neck area at the
base of the ear. Not more than 3 ml should be administered at a
single intramuscular injection site.
Dogs and cats: 5 mg enrofloxacin / kg body weight, which
corresponds to 1 ml/10 kg body weight, daily, by subcutaneous
injection, up to 5 days.
Treatment can be started with the product for injection and
can be maintained with enrofloxacin tablets. The duration of
the treatment should be based on the duration of the approved
treatment for the corresponding indication in the product
information of the tablet product.
RECOMMENDATIONS FOR PROPER ADMINISTRATION
To ensure correct dosage, body weight (b.w.) should be
determined as precisely as possible to avoid underdosing.

SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Degenerative changes in the joint cartilage have been observed in
calves treated orally with 30 mg enrofloxacin/kg body weight for 14 days.
The use of enrofloxacin in growing lambs, in the recommended
dose, for 15 days, has caused histological changes in the joint
cartilage, which are not associated with clinical signs. Official and
local policies regarding the use of antimicrobial products should be
taken into account when using the product. Fluoroquinolones should
be reserved for the treatment of clinical conditions that have an
insufficient response or are expected to have an insufficient response
to other classes of antimicrobials.
Whatever if possible, fluoroquinolones should be used only after
susceptibility testing. Use of the product that deviates from the
instructions provided in the SPC may increase the prevalence
of bacteria resistant to fluoroquinolones and may decrease the
effectiveness of the treatment with other quinolones due to the
potential for cross-resistance.
USE DURING PREGNANCY, LACTATION
Do not administer to bitches and cats that are pregnant and/or in
the lactation period.
INTERACTIONS WITH OTHER MEDICINAL PRODUCTS OR OTHER
FORMS OF INTERACTION
The administration of antacids prevents the absorption of
enrofloxacin. It has antagonistic action with chloramphenicol,
macrolide antibiotics, tetracyclines and non-steroidal antiinflammatorie drugs. Caution must be taken when co-administering
flunixin and enrofloxacin to dogs, to avoid adverse reactions.
The decreased clearance of these substances due to the
simultaneous administration of flunixin and enrofloxacin indicates
that these substances interact during the elimination phase. Thus,
in dogs, concomitant administration of enrofloxacin and flunixin has
increased the AUC and plasma half-life of flunixin and has increased
the plasma half-life and decreased Cmax of enrofloxacin.
OVERDOSE
Due to the low toxicity of enrofloxacin, the risk of overdose is
minimal. However, sometimes symptoms of anorexia and vomiting
may occur. There is no specific antidote. Treatment is symptomatic.
WITHDRAWAL PERIOD
Calves: After intravenous injection: meat and offal: 5 days. After
subcutaneous injection: meat and offal: 12 days. It is not authorized
for use in animals producing milk for human consumption. Sheep:
Meat and offal: 4 days. Milk: 3 days. Goats: Meat and offal: 6 days.
Milk: 4 days. Pigs: Meat and offal: 13 days.
STORAGE
Store at a temperature below 25o
C. Protect from direct light and
frost. Store in a dry place.

PRESENTATION
Bottles x 100 ml