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POM-V Prescription Required

Enrotron 100 mg/ml Solution for Injection for Cattle, Sheep, Goats and Pigs

Active ingredient: Enrofloxacin

Form

Injection

Species

Cattle Goats Pigs Sheep

Manufacturer

aniMedica GmbH

VMD MA No.

24745/3004

What it's used for

Treatment of acute severe mastitis caused by enrofloxacin susceptible strains of Escherichia coli. Treatment of infections of the alimentary tract caused b...

Full indications, dosage and side effects ↓
View official SPC (PDF)

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Clinical information

Enrotron 100 mg/ml Solution for Injection for Cattle, Sheep, Goats and Pigs — SPC Details

Source: VMD Summary of Product Characteristics (SPC). Last updated 27 Mar 2026.

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.
AN: 02463/2024, 02464/2024, 03236/2024 & 03236/2024
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 multocidaMannheimia 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
Repeated injections should be made at different injection sites.
To ensure a correct dosage, body weight (bw) should be determined as accurately as
possible.
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
AN: 02463/2024, 02464/2024, 03236/2024 & 03236/2024
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 veterinary medicinal product can be administered by slow intravenous or
subcutaneous administration.
Acute mastitis caused by
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.
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.
The stopper may be safely punctured up to 125 times. For multiple vial entry, an
aspirating needle or multi-dose syringe is recommended to avoid excessive
broaching of the stopper.
Do not use for prophylaxis.
Do not use in cases of hypersensitivity to the active substance or to any of the
excipients.
Do not use when resistance / cross resistance to (fluoro)quinolones is known to
occur.
Refer to section 3.5.
Do not use in growing horses because of possible deleterious damage on articular
cartilage.
Cattle, sheep, goats, pigs:
Very rare
(<1 animal / 10,000 animals treated,
including isolated reports):
Shock
Digestive tract disorder (e.g. Diarrhoea)
Undetermined frequency, (cannot be
estimated from the available data):
Injection site inflammation
1
In cattle after intravenous administration, presumably as a result of circulatory
impairment.
Generally mild and transient.
AN: 02463/2024, 02464/2024, 03236/2024 & 03236/2024
In pigs, after intramuscular administration, may persist up to 28 days after the
injection.
Reporting adverse events is important. It allows continuous safety monitoring of a
veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to
either the marketing authorisation holder or its local representative or the national
competent authority via the national reporting system. See the package leaflet for
respective contact details.
None.

Special precautions for safe use in the target species:
The safety of the veterinary medicinal product has not been established in pigs or
calves when administered by the intravenous route and use of this route of
AN: 02463/2024, 02464/2024, 03236/2024 & 03236/2024
administration is not recommended in these animal groups.
Official and local antimicrobial policies should be taken into account when the
veterinary medicinal 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 veterinary medicinal 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 veterinary medicinal 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
veterinary medicinal 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.
Special precautions for the protection of the environment:
Not applicable.
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.
Keep the vial in the outer carton in order to protect from light.
Not more than 10 ml should be administered at one subcutaneous injection site.
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.
The stopper may be safely punctured up to 125 times. For multiple vial entry, an
aspirating needle or multi-dose syringe is recommended to avoid excessive
broaching of the stopper.
3.10 Symptoms of overdose (and where applicable, emergency procedures and
antidotes)
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
veterinary medicinal product at five times the recommended therapeutic dose. In
cattle, sheep and goats, overdose has not been documented.
3.11 Special restrictions for use and special conditions for use, including
restrictions on the use of antimicrobial and antiparasitic veterinary
medicinal products in order to limit the risk of development of resistance
Not applicable.
3.12 Withdrawal periods
Cattle:
Following intravenous injection:
Meat and offal: 5 days.
Milk: 3 days.
Following subcutaneous injection:
Meat and offal: 12 days.
AN: 02463/2024, 02464/2024, 03236/2024 & 03236/2024
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.

This information is sourced from the official Summary of Product Characteristics (SPC) published by the Veterinary Medicines Directorate (VMD). It is provided for informational purposes only and does not replace professional veterinary advice. Always consult your vet before administering any medication.

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