SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

DORAFLOX 100 mg/ml solution for injection for cattle and pigs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml contains:

	Active substance Enrofloxacin	100 mg
	Excipients Benzyl alcohol Disodium edetate	7.8 mg 10 mg

For the full list of excipients, see section 6.1.

3. PHARMAPEUTICAL FORM

Solution for injection.

Clear slightly yellowish solution.

4. CLINICAL PARTICULARS

4.1 Target species

Cattle and pigs.

4.2 Indications for use, specifying the target species

Cattle

Treatment of infections of the respiratory tract caused by enrofloxacin susceptible

strains of Pasteurella multocida, Mannheimia haemolytica and Mycoplasma spp.

Treatment of acute severe mastitis caused by enrofloxacin susceptible strains of

Escherichia coli.

Treatment of infections of the alimentary tract caused by enrofloxacin susceptible

strains of Escherichia coli.

Treatment of septicaemia caused by enrofloxacin susceptible strains of

Escherichia coli.

Treatment of acute mycoplasma-associated arthritis due to enrofloxacin

susceptible strains of Mycoplasma bovis in cattle less than 2 years old.

Pigs

Treatment of infections of the respiratory tract caused by enrofloxacin susceptible

strains of Pasteurella multocida, Mycoplasma spp. and Actinobacillus

pleuropneumoniae.

Treatment of infections of the urinary tract caused by enrofloxacin susceptible

strains of Escherichia coli.

Treatment of post-partum dysgalactiae syndrome, PDS (MMA syndrome) caused

by enrofloxacin susceptible strains of Escherichia coliand Klebsiella spp.

Treatment of infections of the alimentary tract caused by enrofloxacin susceptible

strains of Escherichia coli.

Treatment of septicaemia caused by enrofloxacin susceptible strains of

Escherichia coli.

4.3 Contra-indications

Do not use in growing horses because of possible deleterious damage on articular cartilage.

Do not use for prophylaxis.

Do not use when resistance / cross resistance to (Fluoro)quinolones is known to occur.

Refer to section 4.5. Do not use in the case of known hypersensitivity to fluoroquinolones or to any of the excipients.

4.4 Special warnings for each target species

None known.

4.5 Special precautions for use

Special precautions for use in animals

Degenerative changes of articular cartilage were observed in calves treated orally with 30 mg enrofloxacin/kg bw during 14 days.

Do not exceed the recommended dose.

Repeat injections should be administered at different sites.

Enrofloxacin should be used with caution in epileptic animals or animals affected by renal dysfunction.

Official and local antimicrobial policies should be taken into account when the 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 product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the fluoroquinolones and may decrease the effectiveness of treatment with other quinolones due to the potential for cross resistance.

The use of enrofloxacin in growing lambs at the recommended dose for 15 days caused histological changes in the articular cartilage, not associated with clinical signs.

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

The product is an alkaline solution. Wash any splashes from skin or eyes immediately with water.

Do not eat, drink or smoke whilst using the product.

Care should be taken to avoid accidental self-injection. If accidental self-injection occurs seek medical advice immediately.

Direct contact with the skin should be avoided because of sensitisation, contact dermatitis and possible hypersensitivity reactions. Wear gloves.

Other precautions

None known

4.6 Adverse reactions (frequency and seriousness)

Local tissue reactions may occasionally occur at the injection site. Normal sterile precautions should be taken.

In cattle, gastrointestinal disturbances may occasionally occur.

4.7 Use during pregnancy, lactation or lay

There is no restriction on the use of this product during pregnancy and lactation.

4.8 Interaction with other medicinal products and other forms of interaction

Antagonistic effects due to concurrent administration of macrolides, and tetracyclines may occur Enrofloxacin may interfere with the metabolism of theophylline, decreasing theophylline clearance resulting in increased plasma levels of theophylline.

4.9 Amounts to be administered and administration route

Intravenous, subcutaneous or intramuscular use.

Repeated injections should be made at different injection sites.

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

Cattle:

5 mg of enrofloxacin/kg bw, corresponding to 1 ml/20 kg bw, once daily for 3-5

days.

Acute mycoplasma-associated arthritis due to enrofloxacin susceptible strains of Mycoplasma bovis in cattle less than 2 years old: 5 mg of enrofloxacin/kg bw, corresponding to 1 ml/20 kg bw, once daily for 5 days. The product can be administered by slow intravenous or subcutaneous administration.

Acute mastitis caused by Escherichia coli: 5 mg enrofloxacin/kg bw, corresponding to 1 ml/20 kg bw, by slow intravenous injection once daily for two consecutive days.

The second dose may be administered by the subcutaneous route. In this case, the withdrawal period following subcutaneous injection applies.

Not more than 10 ml should be administered at any one subcutaneous injection

site.

Pigs:

2.5 mg of enrofloxacin/kg bw, corresponding to 0.5 ml/20 kg bw, once daily by intramuscular injection for 3 days.

Alimentary tract infection or septicaemia caused by Escherichia coli: 5 mg of enrofloxacin/kg bw, corresponding to 1 ml/20 kg bw, once daily by intramuscular injection for 3 days.

In pigs, the injection should be made in the neck at the ear base.

Not more than 3 ml should be administered at one intramuscular injection site.

The stopper should not be punctured more than 20 times.

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

Do not exceed the recommended dose.

In accidental overdose (lethargy, anorexia) there is no antidote and treatment should be symptomatic.

No signs of over dosage were observed in pigs following administration of the product at five times the recommended therapeutic dose.

4.11 Withdrawal periods

Cattle:

Following intravenous injection:

Meat and offal: 5 days

Milk: 3 days

Following subcutaneous injection:

Meat and offal: 12 days

Milk: 4 days

Pigs:

Meat and offal: 13 days

5. Pharmacological Properties

Pharmacotherapeutic group:antibacterials for systemic use, fluoroquinolones

ATCvet-code:QJ01MA90

5.1 Pharmacodynamic properties

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, Mannheimia haemolytica, Pasteurella spp. (e.g. Pasteurella multocida), 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.

5.2 Pharmacokinetic properties

Enrofloxacin possesses a high distribution volume. Tissue levels 2-3 higher than that 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.

6. pharmaceutical particulars

Benzyl alcohol

Disodium edetate

Potassium hydroxide (for pH adjustment)

Glacial acetic acid

Water for injections

6.2 Incompatibilities

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

6.3 Shelf-life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

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

6.4. Special precautions for storage

Protect from light.

Do not freeze.

6.5 Nature and composition of immediate packaging

Type II Amber glass vials of 250 ml closed with bromobutyl rubber stoppers and aluminium seals

One vial of 250 ml is available in a cardboard box.

Type II Amber glass vials of 100 ml closed with bromobutyl rubber stoppers and aluminium seals

One vial of 100 ml is available in a cardboard box.

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials

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

7. MARKETING AUTHORISATION HOLDER

Dorpharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

The Netherlands.

8. MARKETING AUTHORISATION NUMBER

Vm 28365/4009

9. DATE OF FIRST AUTHORISATION

27 June 2011

10. DATE OF REVISION OF THE TEXT

May 2016

05 May 2016