Orniflox 25 mg/ml Concentrate for Oral Solution for Pet Rabbits, Rodents, Ornamental Birds and Reptiles

Composition

Each ml contains:

Active substances:

Enrofloxacin 25 mg

Excipients:

Clear slightly yellow solution.

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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 is active against many Gram-negative bacteria such as Escherichia coli, Klebsiella spp., Actinobacillus pleuropneumoniae, Pasteurella spp. (e.g. Pasteurella multocida), Bordetella spp., Proteus spp., Pseudomonas spp., 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.

4.3 Pharmacokinetics

The pharmacokinetics of enrofloxacin are such that both oral and parenteral administration leads to similar serum levels. Enrofloxacin possesses a high distribution volume. Tissue levels 2-3 times higher than found in the serum have been demonstrated in laboratory animals and target species. Organs in which high levels can be expected are the lungs, liver, kidney, skin, bone and lymphatic system.

Enrofloxacin also distributes into the cerebrospinal fluid, the aqueous humour and the foetus in pregnant animals.

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Target species

Rabbits (exclusively kept as pets), rodents, ornamental birds and reptiles.

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Indications

Pet rabbits

Treatment of infections of the alimentary and respiratory tracts caused by enrofloxacin susceptible strains of: Escherichia coli, Pasteurella multocida and Staphylococcus spp..

Treatment of skin and wound infections caused by enrofloxacin susceptible strains of Staphylococcus aureus.

Rodents, reptiles and ornamental birds

Treatment of infections of the alimentary and respiratory tracts where clinical experience, if possible, supported by susceptibility testing of the causal organism, indicates enrofloxacin as the substance of choice.

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Dosage

Pet rabbits, rodents and reptiles

Gastric use, by oral gavage.

Ornamental birds

In drinking water use or gastric use by oral gavage (crop needle).

Advice on correct administration

The undiluted veterinary medicinal product is strongly alkaline and, therefore to avoid caustic effects, it is essential to dilute the product with at least 4 parts water prior to administration. In the case of smaller animals (weighing less than 500 g), it may be appropriate to dilute 0.1 ml of the neat product with >4 parts water and administer a proportion of the total volume.

10 ml bottle: A 1 ml syringe is provided with the 10 ml bottle for withdrawal of small volumes of the product and to facilitate dilution prior to administration. This syringe has dosage graduations of 0.01 and 0.1 ml. The lowest volume that has been demonstrated to be accurate is 0.1 ml. Therefore, for accuracy of dosing, it is recommended to draw up a minimum of 0.1 ml of product.

50 ml bottle: A 5 ml syringe is provided with the 50 ml bottles for withdrawal of product.

The diluted solution should be mixed thoroughly prior to administration.

Medicated drinking water should be freshly prepared and supplied immediately, preferably in a glass container, and replaced every 12 hours. Any medicated drinking water solution not consumed after 12 hours should be disposed of.

The dilution prepared for direct administration should be made on a twice-daily basis immediately prior to provision , preferably in a glass container. This dilution should be administered immediately. Any unused solution should be disposed of immediately after use.

After extracting and expressing the amount of veterinary medicinal product required the syringes should be washed with lukewarm water to remove any remaining product. The syringe can subsequently be used to prepare another solution or be opened, emptied and left to dry.

Dosage

Never administer undiluted product. Ensure thorough mixing.

Owing to physiological and pharmacokinetic differences between the wide range of species for which this veterinary medicinal product is indicated, the dose rates below are for guidance only. Depending upon the species of animal and the infection to be treated, alternative doses may be appropriate using an evidence-based approach. However, any change in dosing regimen should be based on a benefit-risk assessment by the responsible veterinarian, as tolerance at higher doses has not been investigated.

To avoid inhalation of the medication, care should be taken with restraint of the animal and administration of the veterinary medicinal product.

Rodents and pet rabbits

5 mg enrofloxacin per kg bodyweight (0.2 ml per kg bodyweight), twice daily for 7 days.

Reptiles

5 mg enrofloxacin per kg bodyweight (0.2 ml per kg bodyweight), at 24-48 hour intervals for 6 days.

Reptiles are ectothermic, relying on external heat sources to maintain their body temperature at the optimum level for correct function of all body systems. Metabolism of substances and activity of the immune system are, thus, critically dependant on the body temperature. Therefore, the veterinarian must be aware of correct temperature requirements of the respective reptile species and the hydration status of the individual patient. Furthermore, it has to be considered that large differences exist in the pharmacokinetic behaviour of enrofloxacin among different species, which additionally will influence the decision about the correct dosage of the veterinary medicinal product. Therefore, the recommendations made here can only be used as a starting point for individual dose setting.

Ornamental birds

10 mg enrofloxacin per kg bodyweight (0.4 ml per kg bodyweight), twice daily for 7 days.

The uptake of medicated water depends on the clinical condition of the animals, the environment, the age and the kind of feed provided. In order to obtain the correct dosage, the concentration of enrofloxacin should be adjusted accordingly. In order to ensure consumption of the medicated water, animals should not have access to other water supplies whilst being treated.

Treatment should be re-evaluated if no improvement is seen. It is commonly advised to re-evaluate the treatment if no clinical improvement is observed within 3 days.

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Contraindications

Do not use in cases of hypersensitivity to the active substance, to other (fluoro)quinolones or to any of the excipients.

Do not use in animals that are epileptic or suffer from seizures since enrofloxacin may cause CNS stimulation.

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Adverse reactions

Rabbits (exclusively kept as pets), rodents, ornamental birds and reptiles:

1 These signs are generally mild and transient, e.g. diarrhoea.

2 during the period of rapid growth.

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:

Do not administer undiluted product. Ensure thorough mixing. Direct oral administration has been associated with buccal and pharyngeal necrosis. This veterinary medicinal product should be administered only as indicated in section 3.9 (Administration routes and dosage).

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 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.

Special caution should be taken when using enrofloxacin in animals with impaired renal function.

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

People with known hypersensitivity to fluoroquinolones, such as enrofloxacin, or to any of the excipients should avoid any contact with the veterinary medicinal product. The undiluted veterinary medicinal product is strongly alkaline and may cause irritation if it comes into contact with the skin or eyes.

Personal protective equipment consisting of impermeable gloves should be worn when handling the veterinary medicinal product.

Avoid skin and eye contact. Wash any splashes from skin or eyes immediately with large amounts of water. If irritation persists, seek medical advice and show the package leaflet or the label to the physician.

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

Special precautions for the protection of the environment:

Not applicable.

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Use during pregnancy, lactation or lay

Pregnancy and lactation:

Pet rabbits and rodents:

Laboratory studies in rats and rabbits have not produced any evidence of teratogenic effects but have shown evidence of foetotoxic effects at maternotoxic doses. The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Use only according to the benefit-risk assessment by the responsible veterinarian.

Lay:

Ornamental birds and reptiles:

The safety of the veterinary medicinal product has not been established during lay, although detrimental effects on developing eggs of avian scavengers have been reported when these birds ingest livestock meat from animals previously administered fluoroquinolones. Use only according to the benefit-risk assessment by the responsible veterinarian.

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Interactions

Do not use enrofloxacin concomitantly with antimicrobial substances acting antagonistically to quinolones (e.g. macrolides, tetracyclines or phenicols). Do not use concurrently with theophylline as the elimination of theophylline may be delayed.

The simultaneous application of substances containing aluminium, calcium or magnesium can impair the absorption of enrofloxacin.

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Overdose

In cases of accidental overdose digestive tract disorders (e.g. vomiting, diarrhoea) and neurological disorders may occur.

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Special warnings

None.

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Withdrawal period

Not authorised for use in animals producing food for human consumption.

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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

Type III amber glass bottles of 10 ml and 50 ml closed with tamper-evident HDPE screw caps with ring and colourless LDPE syringe insert. A 1 ml dosing syringe is supplied with each 10 ml bottle, a 5 ml dosing syringe is supplied with each 50 ml bottle.

Each bottle is packed in an individual carton.

Pack sizes:

1 x 10 ml, 10 x (1 x 10 ml).

1 x 50 ml, 10 x (1 x 50 ml).

Not all pack sizes may be marketed.

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Storage

Keep the bottle tightly closed.

Any remaining diluted solution should be discarded immediately after use.

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Shelf life

Shelf life of the veterinary medicinal product as packaged for sale:3 years.

Shelf life after first opening the immediate packaging:28 days.

Shelf life after dilution according to directions:

Medicated drinking water:12 hours.

Direct application (gastric use):use immediately.

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Disposal of unused product

Medicines should not be disposed of via wastewater or household waste.

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 43564/4001

8 DATE OF FIRST AUTHORISATION

2 December 2015

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

July 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.

Approved 10 August 2026

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Registration holder

Avimedical B.V.

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