Enrocat Flavour 25 mg/ml Oral Suspension for Cats

Composition

Each ml contains:

Active substance:

Enrofloxacin 25 mg

Excipients:

White to pale yellow suspension.

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Pharmacological properties

4.1 ATCvet code:

QJ01MA90

4.2 Pharmacodynamics

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 non-covalent 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 has antimicrobial activity against the following enrofloxacin-sensitive Gram-positive and Gram-negative bacteria: Staphylococcus spp., Escherichia coli, Haemophilus spp., and Pasteurella spp.

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. The Clinical and Laboratory Standard Institute (CLSI) has established veterinary breakpoints for enrofloxacin to enable internationally harmonised evaluation of MIC (Minimum Inhibitory Concentration) data.

For cats CLSI has established the enrofloxacin breakpoints S: ≤ 0.5 µg/ml, I: 1-2 µg/ml and R: ≥ 4 μg/ml for skin and soft tissue infections.

4.3 Pharmacokinetics

Enrofloxacin shows an overall high oral availability of >80%.

After oral administration, the maximum concentration of active substance is reached after approximately one hour.

Fluoroquinolones diffuse to a great extent into body fluids and tissues, achieving higher concentrations than those found in plasma. Moreover, they are widely distributed in skin, bones and semen, reaching the anterior and posterior eye chambers; they cross the placenta and the brain barrier. They also accumulate in phagocytes (alveolar macrophages, neutrophils). Protein binding of enrofloxacin in serum is 40%.

Metabolism varies between species and it is around 50-60%. Biotransformation of enrofloxacin at hepatic level gives rise to an active metabolite which is ciprofloxacin.

Excretion occurs via bile and the kidneys, with the latter being the main route. Renal excretion is carried out by glomerular filtration and also by active tubular secretion through organic anion pumps.

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Target species

Cats.

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Indications

For the treatment of single or mixed bacterial infections of the respiratory, digestive and urinary tract, otitis externa, skin and wound infections caused by the following enrofloxacin-sensitive Gram-positive and Gram-negative bacteria: Staphylococcus spp., Escherichia coli, Haemophilus spp. and Pasteurella spp.

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Dosage

Oral use.

The veterinary medicinal product should be administered directly onto the back of the tongue and not in the animal’s feed.

The dosage is 5 mg enrofloxacin per kg bodyweight once daily for 5 consecutive days. This is equivalent to 0.2 ml of the veterinary medicinal product per kg bodyweight once daily for 5 consecutive days.

In chronic and severe diseases, the duration of treatment can be extended up to 10 days.

Treatment should be reconsidered if no improvement of the condition is observed after 3 days of treatment.

To ensure a correct dosage, body weight should be determined as accurately as possible.

Do not exceed the recommended dosage.

Figure 1: Administration of the veterinary medicinal product

Shake well for 15 seconds before use

Draw out the appropriate dosage into the syringe

Administer directly onto the back of the tongue

In order to avoid cross-contamination, the same syringe should not be used for different animals. Thus, one syringe should only be used for one animal. After administration the syringe should be cleaned with tap water and stored in the carton box together with the veterinary medicinal product.

A 3 ml syringe with 0.1 ml graduations is supplied with every package of the veterinary medicinal product.

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Contraindications

Do not use in animals with existing impairment of cartilage growth.

Do not use in animals with a known history of seizures, since enrofloxacin may cause CNS stimulation.

Do not use in cases of hypersensitivity to the active substance or other fluoroquinolones or to any of the excipients.

Do not use in animals less than 8 weeks of age.

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Adverse reactions

Cats

Very rare (<1 animal / 10 000 animals treated, including isolated reports): Digestive tract disorders (e.g. hypersalivation, vomiting or diarrhoea)¹, Anorexia², Anaphylaxis, Neurological disorders (e.g. ataxia, seizure, tremor), Excitation

Undetermined frequency (cannot be estimated from the available data): Hypersensitivity reaction

1 Mild and transient.

2 As a result of digestive tract disorders.

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.

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Warnings

Special precautions for safe use in the target species:

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 instructions given in the SPC may increase the prevalence of bacteria resistant to fluoroquinolones and may decrease the effectiveness of treatment with other quinolones due to the potential for cross resistance.

Official and local antimicrobial policies should be taken into account when the veterinary medicinal product is used.

In cases of pyoderma, possible underlying primary disease should be identified and treated.

Enrofloxacin is partially excreted via the kidneys; as with all fluoroquinolones, excretion may therefore be delayed in individuals with existing renal damage. The veterinary medicinal product should be used with caution in animals with severe renal or hepatic impairment.

Retinotoxic effects including blindness can occur when the recommended dose is exceeded.

Do not use in cases of known resistance to quinolones or fluoroquinolones because of near-total cross-resistance to the former and complete cross-resistance to the latter.

Special precautions to be taken by the person administering the veterinary medicinal product to animals:

Enrofloxacin and sorbic acid may cause hypersensitivity (allergic reactions). People with known hypersensitivity to enrofloxacin or to any of the excipients should avoid contact with the veterinary medicinal product.

The veterinary medicinal product may be irritant to skin and eyes.

Avoid dermal and eye contact with the veterinary medicinal product. In case of accidental dermal and/or eye contact, wash any splashes from skin or eyes immediately with water.

Enrofloxacin may cause gastrointestinal effects such as abdominal pain and diarrhoea if ingested. To avoid accidental ingestion, particularly by a child, do not leave a syringe containing the solution in the sight or reach of children. The used syringe should be stored with the veterinary medicinal product in the original carton. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

Do not eat, drink or smoke while handling the veterinary medicinal product. Wash hands after use.

Special precautions for the protection of the environment:

Not applicable.

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.

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Use during pregnancy, lactation or lay

Pregnancy:

Laboratory studies in rats and chinchillas have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects.

The safety of the veterinary medicinal product has not been established during pregnancy in queens. The use is not recommended during pregnancy.

Lactation:

As enrofloxacin passes into the maternal milk, the use is not recommended during lactation.

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Interactions

Combination of the veterinary medicinal product (enrofloxacin) with chloramphenicol, macrolide antibiotics or tetracyclines may produce antagonistic effects. The concomitant administration of substances containing magnesium or aluminium may reduce the absorption of enrofloxacin. These drugs should be administered two hours apart.

Concomitant administration of theophylline requires careful monitoring as serum levels of theophylline may increase.

The concomitant use with digoxin should be avoided as fluoroquinolones can increase the bioavailability of digoxin.

Concurrent administration of fluoroquinolones may increase the action of oral anticoagulants.

Concomitant administration of fluoroquinolones in combination with non-steroidal anti-inflammatory drugs (NSAID) in animals could lead to seizures because of potential pharmacodynamic interactions in the CNS.

In animals subjected to rehydration, avoid excessive alkalinity of the urine.

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Overdose

Do not exceed the recommended dosage. In the event of overdosing digestive tract disorders (vomiting, diarrhoea or hypersalivation) or CNS alterations (mydriasis, ataxia) may occur. In severe cases it may be necessary to interrupt the treatment. Cats have been shown to suffer ocular damage after receiving doses higher than recommended. At doses of 20 mg/kg bw/day or higher, the toxic effects on the retina could lead to irreversible blindness in the cat.

To reduce the absorption of enrofloxacin taken orally the administration of antacids containing magnesium or aluminium is recommended.

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Special warnings

None.

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Withdrawal period

Not applicable.

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Incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

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Immediate packaging

High density polyethylene (HDPE) bottles sealed with a child resistant stopper made of polypropylene (PP) with thread and low density polyethylene (LDPE) plug with a polypropylene oral syringe with an HDPE plunger.

Package size:

Cardboard box of 1 bottle of 8.5ml and a 3 ml oral syringe.

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Storage

This veterinary medicinal product does not require any special storage conditions.

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Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years. Shelf life after first opening the immediate packaging: 1 month.

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Disposal of unused product

Medicines should not be disposed of via wastewater.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

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Additional information

Vm 36547/5014 (GB) Vm 36547/3014 (NI)

8 DATE OF FIRST AUTHORISATION

07 April 2020

9 DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS

February 2026

10 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product subject to prescription.

Find more product information by searching for the ‘Product Information Database’ on www.gov.uk.

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Registration holder

Industrial Veterinaria SA

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