Xeden 15 mg Tablet for Cats

Composition

Each tablet contains:

Active substance:

Enrofloxacin 15.0 mg

Excipients:

Qualitative composition of excipients and other constituents

Pig liver powder

Malted yeast

Cellulose microcrystalline

Croscarmellose sodium

Silica colloidal anhydrous

Magnesium stearate

Lactose monohydrate

Oblong scored beige tablet

The tablet can be divided into two equal parts.

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Pharmacological properties

4.1 ATCvet code:

QJ01MA90

4.2 Pharmacodynamics

Enrofloxacin is a synthetic fluoroquinolone antibiotic that exerts its activity by inhibiting topoisomerase II, an enzyme involved in the mechanism of bacterial replication.

Enrofloxacin exerts bactericidal activity concentration-dependant with similar values of minimal inhibit concentration and minimal bactericide concentrations. It also possesses activity against bacteria in the stationary phase by an alteration of the permeability of the outer membrane phospholipid cell wall.

In general, enrofloxacin exhibits good activity against most gram-negative bacteria, especially those of the Enterobacteriacea. Escherichia coli, Klebsiella spp., Proteus spp., and Enterobacter spp. are generally susceptible.

Pseudomonas aeruginosa is variably susceptible and, when it is susceptible, usually has a higher MIC than other susceptible organisms.

Staphylococcus aureus and Staphylococcus intermedius usually are susceptible. Streptococci, enterococci, anaerobic bacteria can generally be considered resistant.

Induction of resistance against quinolones can develop by mutations in the gyrase gene of bacteria and by changes in cell permeability towards quinolones.

4.3 Pharmacokinetics

Enrofloxacin is approximately 100% bioavailable after oral administration. It is unaffected by food. Enrofloxacin is rapidly metabolised to form an active compound, ciprofloxacin.

After oral administration of XEDEN 15 (5 mg/kg) in cats:

- The maximal plasma concentration of enrofloxacin of 2.9µg/mL was observed one hour following administration.

- The maximal plasma concentration of ciprofloxacin (0.18 µg/ml) was observed 5 hours following administration.

Enrofloxacin is widely distributed in the body. The tissue concentrations are often higher than the serum concentrations. Enrofloxacin crosses the blood-brain barrier. The degree of protein binding in serum is 8% in cats. The half-life in serum is 3-4 hours in cats (5 mg/kg). Approximately 25 % of the dose of enrofloxacin is excreted in the urine and 75 % via faeces. Approximately 15 % of the dose is excreted as unchanged enrofloxacin and the remainder as metabolites, amongst others ciprofloxacin. The total clearance is approximately 9 ml/minute/kg bodyweight.

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Target species

Cats

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Indications

In cats: treatment of upper respiratory tract infections.

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Dosage

Oral use

5 mg of enrofloxacin/kg body weight once daily for 5 to 10 consecutive days:

- either 1 tablet for 3 kg body weight as a single daily dosing.

- or ½ tablet for 1.5 kg body weight as a single daily dosing.

The treatment should be reconsidered in case of lack of clinical improvement at half of the treatment duration.

To ensure a correct dosage body weight should be determined as accurately as possible to avoid underdosing The tablets are flavoured. They may be administered directly in the mouth of the cat or added to food if necessary.

Do not exceed the recommended treatment dose.

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Contraindications

Do not use in young, growing cats, because of the possibility of the development of cartilage lesions. (cats aged less than 3 months or weighing less than 1kg)

Do not use in the case that there is resistance to quinolones, as there exists almost complete cross resistance to other quinolones and complete cross resistance to other fluoquinolones.

Do not use in cats having seizure disorders, since enrofloxacin may cause CNS stimulation.

See also section 3.7 and 3.8.

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Adverse reactions

Cat:

Rare (1 to 10 animals / 10,000 animals treated): Vomiting1, Diarrhoea1, Hypersensitivity reaction2

Very rare (<1 animal / 10,000 animals treated, including isolated reports): Neurological signs (Ataxia, Tremor, Seizure, Excitation)

1Regress spontaneously and generally do not require treatment discontinuation. 2In this case, the administration of the product should be stopped.

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 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.

Wherever possible, fluoroquinolones should be used based on susceptibility testing. Use of the 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 product is used.

Use the product with caution in cats with severe renal or hepatic impairment. The chewable tablets are flavoured. In order to avoid any accidental ingestion, store tablets out of reach of the animals.

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

People with known hypersensitivity to (fluoro)quinolones should avoid contact with the veterinary medicinal product. In case of accidental ingestion seek medical advice immediately and show the package leaflet or the label to the physician. Wash hands after handling the product. In case of contact with eyes, rinse immediately with plenty of water.

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

Use during pregnancy: Studies in laboratory animals (rat, chinchilla) have not produced any evidence of a teratogenic, foetotoxic, maternototoxic effect. Use only according to the benefit/risk assessment by the responsible veterinarian. Use during lactation: As enrofloxacin passes into maternal milk, the use is not recommended during lactation.

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Interactions

Concurrent use of flunixin should be under careful veterinary monitoring, as the interactions between these drugs may lead to adverse events related to delayed elimination.

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

Concurrent use of magnesium or aluminum containing substances (such as antacids or sucralfate) may reduce absorption of enrofloxacin. These drugs should be administered two hours apart.

Do not use with tetracyclines, phenicols or macrolides because of potential antagonistic effects.

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Overdose

Overdosing can cause vomiting and nervous signs (muscle tremor, incoordination and convulsions) which may require treatment discontinuation. In the absence of any known antidote, apply drug elimination and symptomatic treatment.

If necessary, administration of aluminium or magnesium containing antacids or activated carbon can be used to reduce absorption of enrofloxacin.

In laboratory studies, ocular adverse effects have been observed from 20 mg/kg. The toxic effects on the retina caused by overdosing may be such that they lead to irreversible blindness in the cat.

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Special warnings

None

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Withdrawal period

Not applicable

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Incompatibilities

Not applicable

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Immediate packaging

Blister complex: PVDC-TE-PVC/Aluminium heat sealed blisters with 12 tablets / blister Cardboard box with 1 blister of 12 tablets Cardboard box with 2 blisters of 12 tablets Cardboard box with 5 blisters of 12 tablets Cardboard box with 8 blisters of 12 tablets Cardboard box with 10 blisters of 12 tablets Not all pack sizes may be marketed.

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Storage

Store in the original container. Protect from light

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

Any half tablets should be returned to the original blister for storage. Any half tablets remaining after 24 hours should be discarded.

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Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale:

3 years

Shelf-of halved tablets: 24 hours

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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 15052/5089

8 DATE OF FIRST AUTHORISATION

29 October 2008

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

December 2025

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

Ceva Animal Health Ltd

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