SUMMARY OF THE PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Efex 100 mg chewable tablets for dogs

Efex vet 100 mg chewable tablets for dogs (FI, SE)

Axor vet 100 mg chewable tablets for dogs (NO)

Axor 100 mg chewable tablets for dogs (DK)

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One tablet contains:

Active substance:

Marbofloxacin 100.0 mg

Excipient(s):

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Chewable tablet

Clover-shaped scored beige tablet. The tablet can be divided into four equal parts

4. CLINICAL PARTICULARS

4.1 Target species

Dogs

4.2 Indications for use,specifying the target species

In dogs

Marbofloxacin is indicated in the treatment of:

- skin and soft tissue infections (skinfold pyoderma, impetigo, folliculitis, furunculosis, cellulitis) caused by susceptible strains of organisms.

- urinary tract infections (UTI) caused by susceptible strains of organisms associated or not with prostatitis or epididymitis.

- respiratory tract infections caused by susceptible strains of organisms.

4.3 Contraindications

Do not use in dogs aged less than 12 months, or less than 18 months for giant

breeds of dogs with a longer growth period.

Do not use in cases of hypersensitivity to (fluoro)quinolones.

4.4 Special warnings for each target species

A low urinary pH could have an inhibitory effect on the activity of marbofloxacin.

4.5 Special precautions for use

The chewable tablets are flavoured. In order to avoid any accidental ingestion, store tablets out of reach of the animals.

The fluoroquinolones have been shown to induce erosion of articular cartilage in juvenile dogs and care should be taken to dose accurately especially in young animals.

The fluoroquinolones are also known for their potential neurological side effects. Cautious use is recommended in dogs and cats diagnosed as suffering from epilepsy.

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, use of fluoroquinolones should be based on susceptibility testing. Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the fluoroquinolones and may decrease 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.

veterinary medicinal product to animals

People with known hypersensitivity to (fluoro)quinolones or other components of the formulation should avoid using this product. In case of accidental ingestion seek medical attention and show product label and/or package leaflet to the doctor. Wash hands after use.

4.6 Adverse reactions (frequency and seriousness)

Mild side effects that do not necessitate cessation of treatment such as vomiting, softening of faeces, modification of thirst or transient increase in activity may occasionally occur. These signs cease spontaneously after treatment.

4.7 Use during pregnancy, lactation or lay

Studies in laboratory animals (rat, rabbit) showed no embryotoxicity, teratogenicity and maternotoxicity with marbofloxacin at therapeutic doses.

However no specific studies have been carried out in pregnant and lactating dogs.

In pregnant and lactating animals, use only according to the benefit/risk assessment by the responsible veterinarian.

4.8 Interaction with other medicinal products and other forms of interaction

Fluoroquinolones are known to interact with orally administered cations (Aluminium, Calcium, Magnesium, Iron). In such cases, the bioavailability may be reduced.

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

4.9 Amounts to be administered and administration route

For oral administration

The recommended dose rate is 2 mg/kg/d (1 tablet for 50 kg per day) in single daily administration.

Dogs:

- in skin and soft tissue infections, treatment duration is at least 5 days. Depending on the course of the disease, it may be extended up to 40 days.

- in urinary tract infections, treatment duration is at least 10 days. Depending on the course of the disease, it may be extended up to 28 days.

- in respiratory infections, treatment duration is at least 7 days and depending on the course of the disease, it may be extended up to 21 days.

To ensure a correct dosage body weight should be determined as accurately as possible to avoid underdosing.

The chewable tablets may be accepted by dogs or can be administered directly into the mouth of the animals.

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

Overdosage may cause acute signs in the form of neurological disorders, which should be treated symptomatically.

4.11 Withdrawal period(s)

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Antibacterials for systemic use, fluoroquinolones

ATCvet code: QJ01MA93

5.1 Pharmacodynamic properties

Marbofloxacin is a synthetic, bactericidal antimicrobial, belonging to the fluoroquinolone group which acts by inhibition of topoisomerase II (DNA gyrase) and topoisomerase IV.. It has a broad-spectrum activity in vitro against Gram-positive bacteria (in particular Staphylococci,Streptococci) and, Gram-negative bacteria (Escherichia coli, Enterobacter cloacae, Proteus spp, Klebsiella spp, Shigella spp, Pasteurella spp, Pseudomonas spp) as well as Mycoplasma spp.

A report on microbiological susceptibility including two European field surveys covering hundreds of canine and feline pathogens sensitive to marbofloxacin was published on 2009

Micro-organisms	MIC (µg/ml)
Staphylococcus intermedius	0,23 - 0,25
Escherichia coli	0,125 - 0,25
Pasteurella multocida	0,04
Pseudomonas aeruginosa	0,94

Cases of resistance have been observed in Streptococcus. Strains with MIC ≤ 1 µg/ml are sensitive to marbofloxacin whereas strains with MIC ≥ 4 µg/ml are resistant to marbofloxacin.

Marbofloxacin is not active against anaerobes, yeasts or fungi.

The activity of marbofloxacin against the target bacterial species is bactericidal concentration-dependant.

Resistance to fluoroquinolones occurs by chromosomal mutation with three mechanisms: decrease of the bacterial wall permeability, expression of efflux pump or mutation of enzymes responsible for molecule binding. To date, only sporadic cases have been reported for plasmid mediated fluoroquinolone resistance in animals. Depending on the underlying resistance mechanism cross-resistance to other (fluoro)quinolones and co-resistance to other antimicrobial classes can occur.

5.2 Pharmacokinetic particulars

After oral administration in dogs at the recommended dose of 2 mg/kg, marbofloxacin is readily absorbed and reaches maximal plasma concentrations of 1.5 µg/ml within 2 hours

Its bioavailability is close to 100%.

It is weakly bound to plasma proteins (less than 10%), extensively distributed and in most tissues (liver, kidney, skin, lung, bladder, digestive tract) it achieves higher concentrations than in plasma. Marbofloxacin is eliminated slowly (t½ß = 14 h in dogs) predominantly in the active form in urine (2/3) and faeces (1/3).

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Lactose monohydrate

Copovidone

Silica, colloidal anhydrous

Croscarmellose sodium

Hydrogenated caster oil

Pig liver powder

Malted yeast

Cellulose microcrystalline

6.2 Incompatibilities

Not applicable

6.3 Shelf life

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

Blister: PVC-TE-PVDC – aluminium heat sealed: 3 years

Blister: PA-AL-PVC – aluminium heat sealed: 36 months

Shelf-life after first opening the immediate packaging: 72 hours:

6.4 Special precautions for storage

Blister: PVC-TE-PVDC – aluminium heat sealed: Do not store above 30°C

Blister: PA-AL-PVC – aluminium heat sealed: This veterinary medicinal product does not require any special temperature storage conditions.

Tablet portions should be stored in the blister pack

Any tablet portions remaining after 72 hours should be discarded

Keep the blister in the outer carton.

6.5 Nature and composition of immediate packaging

• (Polyvinyl chloride-Thermo-elast-P olyvinylidene chloride – aluminium heat sealed) containing 6 tablets per blister

• (Polyamide-Aluminium-Polyvinyl chloride – aluminium heat sealed) containing 6 tablets per blister

Cardboard box of 6 tablets containing 1 blister of 6 tablets

Cardboard box of 12 tablets containing 2 blisters of 6 tablets

Cardboard box of 120 tablets containing 20 blisters of 6 tablets

Cardboard box of 240 tablets containing 40 blisters of 6 tablets

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

Ceva Animal Health Ltd

Unit 3, Anglo Office Park

White Lion Road

Amersham

Buckinghamshire

HP7 9FB

8. MARKETING AUTHORISATION NUMBER

Vm 15052/4097

9. DATE OF FIRST AUTHORISATION

07August 2013

10. DATE OF REVISION OF THE TEXT

June 2016

14 June 2016