Neocell

Doraflox 100 mg/ml solution for injection for cattle and pigs.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml of solution contains:
Active Constituents mg
Enfloxacin 100

Relevant Constituents of the Excipients mg
Benzyl alcohol 7.8
Disodium edetate 10

PHARMACEUTICAL FORM
Solution for injection.
Clear slightly yellowish solution.

Target Species
Cattle and pigs.

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 coli and 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.

Contraindications
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.

Special warnings for each target species
None known.

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

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.

Use during pregnancy, lactation or lay
There is no restriction on the use of this product during pregnancy and lactation.

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.

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.

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.

Withdrawal Period(s)
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

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

Shelf-life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf life after first opening the immediate packaging: 28 days.

Special precautions for storage
Protect from light.
Do not freeze.

Nature and composition of immediate packaging
Type II Amber glass vials of 250 ml capacity closed with pink bromobutyl rubber stoppers and aluminium flip-off seals
One vial of 250 ml is available in a cardboard box.
Type II Amber glass vials of 100 ml capacity closed with grey bromobutyl rubber stoppers and aluminium flip-off seals
One vial of 100 ml is available in a cardboard box.
Not all pack sizes may be marketed.

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 products should be
disposed of in accordance with local requirements.