Enrotron 100 mg/ml Solution for injection for cattle, sheep, goats and pigs

1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Enrotron 100 mg/ml Solution for injection for cattle, sheep, goats and pigs
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active Substance
Enrofloxacin 100.0 mg
Excipients
1-Butanol 30.0 mg
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Solution for injection.
Clear, slightly yellowish to yellowish orange solution.
4. CLINICAL PARTICULARS
4.1 Target Species
Cattle
Sheep
Goats
Pigs
4.2 Indications for use, specifying the target species
Cattle
Treatment of infections of the respiratory tract caused by enrofloxacin susceptible
strains of Pasteurella multocida, Mannheimia haemolytica and Mycoplasma spp.
Treatment of acute severe mastitis caused by enrofloxacin susceptible strains of
Escherichia coli.
Treatment of infections of the alimentary tract caused by enrofloxacin susceptible
strains of Escherichia coli.
Treatment of septicaemia caused by enrofloxacin susceptible strains of Escherichia
coli.
Treatment of acute mycoplasma-associated arthritis due to enrofloxacin susceptible
strains of Mycoplasma bovis in cattle less than 2 years old.
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Sheep
Treatment of infections of the alimentary tract caused by enrofloxacin susceptible
strains of Escherichia coli.
Treatment of septicaemia caused by enrofloxacin susceptible strains of Escherichia
coli.
Treatment of mastitis caused by enrofloxacin susceptible strains of Staphylococcus
aureus and Escherichia coli.
Goats
Treatment of infections of the respiratory tract caused by enrofloxacin susceptible
strains of Pasteurella multocida and Mannheimia haemolytica.
Treatment of infections of the alimentary tract caused by enrofloxacin susceptible
strains of Escherichia coli.
Treatment of septicaemia caused by enrofloxacin susceptible strains of Escherichia
coli.
Treatment of mastitis caused by enrofloxacin susceptible strains of Staphylococcus
aureus and Escherichia coli.
Pigs
Treatment of infections of the respiratory tract caused by enrofloxacin susceptible
strains of Pasteurella multocida, Mycoplasma spp. and Actinobacillus
pleuropneumoniae.
Treatment of infections of the urinary tract caused by enrofloxacin susceptible strains
of Escherichia coli.
Treatment of post-partum dysgalactiae syndrome, PDS (MMA syndrome) caused by
enrofloxacin susceptible strains of Escherichia coli and Klebsiella spp.
Treatment of infections of the alimentary tract caused by enrofloxacin susceptible
strains of Escherichia coli.
Treatment of septicaemia caused by enrofloxacin susceptible strains of Escherichia
coli.
4.3 Contraindications
Do not use for prophylaxis.
Do not use in cases of known hypersensitivity to fluoroquinolones or to any of the
excipients.
Do not use when resistance / cross resistance to (fluoro)quinolones is known to
occur.
Refer to section 4.5.
Do not use in growing horses because of possible deleterious damage on articular
cartilage.
4.4 Special warnings for each target species
None.
4.5 Special precautions for use
Special precautions for use in animals
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.
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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, fluoroquinoones 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.
The use of enrofloxacin in growing lambs at the recommended dose for 15 days
caused histological changes in the articular cartilage, not associated with clinical
signs.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals
The product is an alkaline solution. Direct contact with skin should be avoided due to
sensitisation, contact dermatitis and possible hypersensitivity reactions to
(fluoro)quinolones. Wear gloves. In case of eye or skin contact, rinse immediately
with water. Do not eat, drink or smoke whilst handling the product.
Care should be taken to avoid accidental self-injection. If accidental self injection
occurs seek medical advice immediately and show the package leaflet or the label to
the physician.
Other precautions
None known.
4.6 Adverse reactions (frequency and seriousness)
Digestive tract disorders (e.g. diarrhoea) may occur in very rare cases. These signs
are generally mild and transient.
Intravenous treatment of cattle can cause shock reactions in very rare cases,
presumably as a result of circulatory impairment.
Local reactions at injection site
In pigs, after intramuscular administration of the product, inflammatory reactions may
occur. They may persist up to 28 days after the injection.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
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- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
4.7 Use during pregnancy or lactation
Cattle
The safety of the veterinary medicinal product has been established in pregnant cows
during the 1st quarter of pregnancy. The product can be used in pregnant cows
during the 1st quarter of pregnancy.
The use of the product in cows during the 3 last quarters of pregnancy should be
based on a benefit-risk assessment by the responsible veterinarian.
The product can be used in cows during lactation.
Sheep and goats
The safety of the veterinary medicinal product has not been established during
pregnancy and lactation. Use only accordingly to the benefit-risk assessment by the
responsible veterinarian.
Pigs
The safety of the veterinary medicinal product has not been established during
pregnancy. Use only accordingly to the benefit-risk assessment by the responsible
veterinarian.
The product can be used in sows during lactation.
4.8 Interaction with other medicinal products and other forms of interaction
Antagonistic effects due to concurrent administration of macrolides, tetracyclines and
phenicols 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.
Acute mastitis caused by Escherichia coli: 5 mg enrofloxacin/kg bw, corresponding to
1 ml/20 kg bw, by slow intravenous injection once daily for two consecutive days.
The second dose may be administered by the subcutaneous route. In this case, the
withdrawal period following subcutaneous injection applies.
Not more than 10 ml should be administered at one subcutaneous injection site.
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Sheep and goats
5 mg of enrofloxacin/kg bw, corresponding to 1 ml/20 kg bw, once daily by
subcutaneous injection for 3 days. Not more than 6 ml should be administered at 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 one intramuscular injection site.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Do not exceed the recommended dosage. In accidental overdose 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. In cattle, sheep and goats,
overdose has not been documented.
4.11 Withdrawal Period(s)
Cattle:
Following intravenous injection:
Meat and offal: 5 days.
Milk: 3 days.
Following subcutaneous injection:
Meat and offal: 12 days.
Milk: 4 days.
Sheep:
Meat and offal: 4 days.
Milk: 3 days.
Goats:
Meat and offal: 6 days.
Milk: 4 days.
Pigs:
Meat and offal: 13 days.
Revised: March 2025
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5. PHARMACOLOGICAL OR IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: antibacterials for systemic use, fluoroquinolones
ATC Vet Code: QJ01MA90.
5.1 Pharmacodynamic properties
Mode of action
Two enzymes essential in DNA replication and transcription, DNA gyrase and
topoisomerase IV, have been identified as the molecular targets of fluoroquinolones.
Target inhibition is caused by noncovalent binding of fluoroquinolone molecules to
these enzymes. Replication forks and translational complexes cannot proceed
beyond such enzyme-DNA-fluoroquinolone complexes, and inhibition of DNA and
mRNA synthesis triggers events resulting in a rapid, drug concentration-dependent
killing of pathogenic bacteria. The mode of action of enrofloxacin is bactericidal and
bactericidal activity is concentration dependent.
Antibacterial spectrum
Enrofloxacin is active against many Gram-negative bacteria such as Escherichia coli,
Klebsiella spp.,
Actinobacillus pleuropneumoniae, Mannheimia haemolytica, Pasteurella spp. (e.g.
Pasteurella multocida), against Gram-positive bacteria such as Staphylococcus spp.
(e.g. Staphylococcus aureus)
and against Mycoplasma spp. at the recommended therapeutic doses.
Types and mechanisms of resistance
Resistance to fluoroquinolones has been reported to arise from five sources, (i) point
mutations in the genes encoding for DNA gyrase and/or topoisomerase IV leading to
alterations of the respective
enzyme, (ii) alterations of drug permeability in Gram-negative bacteria, (iii) efflux
mechanisms, (iv) plasmid mediated resistance and (v) gyrase protecting proteins. All
mechanisms lead to a reduced susceptibility of the bacteria to fluoroquinolones.
Cross-resistance within the fluoroquinolone class of antimicrobials is common.
5.2 Pharmacokinetic particulars
Enrofloxacin is rapidly absorbed after parenteral injection. Bioavailability is high
(approximately 100% in pigs and cattle) with a low to moderate plasma protein
binding (approximately 20 to 50%). Enrofloxacin is metabolised to the active
substance ciprofloxacin at approximately 40% in ruminants and less than 10% in
pigs.
Enrofloxacin and ciprofloxacin distribute well into all target tissues, e.g. lung, kidney,
skin and liver, reaching 2- to 3-fold higher concentrations than in plasma. Parent
substance and active metabolite are cleared from the body via urine and faeces.
Accumulation in plasma does not occur following a treatment interval of 24 h.
In milk, most of drug activity relates to ciprofloxacin.
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Overall drug concentrations peak at 2 hours after treatment showing an
approximately 3-fold higher total exposure over the 24 hours dosing interval
compared to plasma.
Pigs Pigs Cattle Cattle
Dose rate (mg/kg bw) 2.5 5 5 5
Route of administration IM IM IV SC
Tmax (h) 2 2 - 3.5
Cmax (µg/ml) 0.7 1.6 - 0.733
AUC (µg x h/ml) 6.6 15.9 9.8 5.9
Terminal half-life (h) 13.12 8.10 - 7.8
Elimination half-life (h) 7.73 7.73 2.3 -
F (%) 95.6 - - 88.2
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
1-Butanol
Potassium Hydroxide (excipient and for pH adjustment)
Hydrochloric acid (for pH adjustment)
Water for Injections
6.2 lncompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be
mixed with other veterinary medicinal products.
6.3 Shelf life
Shelf life of the product as packaged for sale: 3 years.
Shelf life after first opening the immediate packaging: 28 days.
6.4 Special precautions for storage
Keep the vial in the outer carton in order to protect from light.
6.5 Nature and composition of immediate packaging
Pack Size:
100 ml clear glass vial type I with Teflon coated rubber stopper sealed with an
aluminium cap.
Cartons of 1 x 100 ml or 12 x 100 ml are available.
Not all pack sizes may be marketed.
6.6 Special precautions for the disposal of unused veterinary medicinal
products or waste materials
Any unused veterinary medicinal product or waste materials derived from such
veterinary medicinal products should be disposed of in accordance with local
requirements