SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Zobuxa 100 mg tablets for dogs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One tablet contains:

Active substance(s):

Enrofloxacin 100 mg

Excipients:

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Tablet

Beige-coloured, round, slightly dotted tablet with score line on both sides. The tablets can be divided into equal halves.

4. CLINICAL PARTICULARS

4.1 Target species

Dogs

4.2 Indications for use, specifying the target species

Treatment of bacterial infections of the alimentary, respiratory and urogenital tracts, skin, wound infections and otitis externa.

4.3 Contraindications

Do not use in young or growing dogs (dogs aged less than 12 months (small breed)) or less than 18 months (large breed) as the product may cause epiphyseal cartilage alterations in growing puppies.

Do not use in dogs that have seizure disorders, since enrofloxacin may cause CNS stimulation.

Do not use in dogs with known hypersensitivity to fluoroquinolones or to any of the excipients of the product.

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

Pregnant and lactating animals, please see section 4.7.

Do not use for prophylaxis.

4.4 Special warnings for each target species

None.

4.5 Special precautions for use

It is prudent to reserve the fluoroquinolones for the treatment of clinical conditions that have responded poorly, or are expected to respond poorly, to other classes of antibiotics.

Whenever possible, fluoroquinolones should only be used based on susceptibility testing.

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

Use of the product deviating from the 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.

Do not use in case of resistance to quinolones, as there exists almost complete cross resistance to other quinolones and complete cross resistance to other fluoroquinolones.

Pyoderma is mostly secondary to an underlying disease. It is advisable to determine the underlying cause and to treat the animal accordingly.

Use the product with caution in dogs with severe renal or hepatic impairment.

People with known hypersensitivity to fluoroquinolones should avoid contact with the product.

Wash hands after handling the product.

In case of contact with the eyes, wash immediately with plenty of clean water.

In case of accidental ingestion, seek medical advice immediately and show the package leaflet to the physician.

Do not smoke, eat or drink while handling the product.

4.6 Adverse reactions (frequency and seriousness)

During the period of rapid growth, Enrofloxacin may affect articular cartilage development.

Typical side effects of antimicrobials include gastrointestinal disorders such as transient and mild to moderate diarrhoea, and are also reported for fluoroquinolones for dogs. In severe cases the treatment should be discontinued.

-Hypersensitivity reactions

-Alterations in Central Nervous System

Possible joint cartilage alterations in growing puppies (see 4.3 contraindications).

In rare cases vomiting and anorexia are observed.

4.7 Use during pregnancy, lactation or lay

Use during pregnancy:

Studies in laboratory animals (rat, chinchilla) have not produced any evidence of a teratogenic, foetotoxic, maternotoxic effect. Use only according to the benefit/risk assessment by the responsible veterinarian.

Use during lactation:

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

4.8 Interaction with other medicinal products and other forms of interaction

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

Do not administer simultaneously with tetracyclines, phenicols or macrolides because of potential antagonistic affects.

Do not administer simultaneously with non-steroidal anti-inflammatory drugs, convulsions can occur.

4.9 Amounts to be administered and administration route

For oral use.

The dosage is 5 mg enrofloxacin per kg bodyweight once daily.

This is equivalent to 1 tablet per 20 kg bodyweight.

The tablets can be administered directly or with the feed.

Treatment is generally administered over 5 – 10 consecutive days.

The recommended dosage should not be exceeded.

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.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

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 methods and symptomatic treatment.

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

According to literature, signs of overdosage with enrofloxacin in dogs such as inappetence and gastrointestinal disturbance were observed at approximately 10 times the recommended dose when administered for two weeks. No signs of intolerance were observed in dogs administered 5 times the recommended dose for a month.

Do not exceed the recommended dose. In case of overdose, vomiting, diarrhoea and CNS/behavioural changes may occur, this will stop when correct dosing is resumed.

4.11 Withdrawal period(s)

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group:Antibacterials for systemic use, quinolone and quinoxaline antibacterials, fluoroquinolones, enrofloxacin.

ATC Vet Code: QJ01MA90

5.1 Pharmacodynamic properties

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., andEnterobacter 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 andStaphylococcus 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.

5.2 Pharmacokinetic particulars

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

After a dose of 5 mg/kg body weight, maximum plasma levels of approximately 0.9 µg/mL are reached in dogs.

Enrofloxacin is primarily excreted via the kidneys. A major portion of the parent drug and its metabolites is recovered in urine.

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 14% in dogs. The half-life lies between 2 to 7hours for dogs.

Approximately 25% of the dose of enrofloxacin is excreted in the urine and 75% via the faeces. Approximately 60% (dogs) of the dose is excreted as unchanged enrofloxacin in the urine and the remainder as metabolites, amongst others ciprofloxacin. The total clearance is approximately 9 mL/minute/kg bodyweight.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Lactose monohydrate

Cellulose, microcrystalline

Povidone (K-30)

Croscarmellose sodium

Silica, colloidal anhydrous

Magnesium stearate

Artificial flavour (beef)

6.2 Incompatibilities

Not applicable.

6.3 Shelf-life

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

Shelf-life of divided tablets after first opening the blister: 2 days

6.4 Special precautions for storage

Return any divided tablet to the opened blister and use within 2 days.

6.5 Nature and composition of immediate packaging

Container material: Aluminium foil blister

Container volume: Box with 10 and 100 tablets. 10 tablets per blister each.

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Elanco Europe Ltd

Lilly House

Priestley Road

Basingstoke

Hampshire

RG24 9NL

8. MARKETING AUTHORISATION NUMBER

Vm 00879/4026

9. DATE OF FIRST AUTHORISATION

28 October 2011

10. DATE OF REVISION OF THE TEXT

January 2016

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

Approved: 13 January 2016