COMPOSITION
Active ingredient: Enrofloxacin, 100mg/ml, w/v.
Excipients: Propylene Glycol, Water for Injections.
DESCRIPTION
Solution for injection.
A clear light yellow solution.
PHARMACOLOGICAL ACTIONS
Fluoroquinolone antibacterial drug.
Enrofloxacin acts via inhibition of DNA gyrase in bacteria to inhibit DNA and RNA synthesis. It is a bactericidal with a broad spectrum of activity. In most animal species, enrofloxacin is metabolized, at least partially, to ciprofloxacin. Ciprofloxacin is an active desmethyl metabolite of enrofloxacin and may contribute in an additive fashion to the antibacterial effects.
Susceptible bacteria include Staphylococcus, Escherichia coli, Proteus, Klebsiella, and Pasteurella. Pseudomonas aeruginosa is moderately susceptible, but requires higher concentrations. Enrofloxacin has poor activity against Streptococcus and anaerobic bacteria.
TARGET SPECIES
Cattle, calves, sheep and goats.
INDICATIONS
Cattle, calves
Treatment of infections of the respiratory tract caused by enrofloxacin susceptible strains of Pasteurella multocida, Mannheimia haemolytica and Mycoplasma 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. Treatment of acute mycoplasma-associated arthritis due to enrofloxacin susceptible strains of Mycoplasma bovis.
Sheep
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 mastitis caused by enrofloxacin susceptible strains of Staphylococcus aureus and Escherichia coli.
Goats
Treatment of infections of the respiratory tract caused by enrofloxacin susceptible strains of Pasteurella multocida and Mannheimia haemolytica. 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 mastitis caused by enrofloxacin susceptible strains of Staphylococcus aureus and Escherichia coli.
ADMINISTRATION AND DOSAGE
Intravenous, subcutaneous or intramuscular use.
Repeated injections should be made at different injection sites.
Cattle, calves
5mg of enrofloxacin per kg body weight (equal to 1ml per 20 kg body weight), once daily for 3-5 days.The product can be administered by slow intravenous or subcutaneous administration. Not more than 10 ml at one subcutaneous injection site.
Sheep and goats
5mg of enrofloxacin per kg body weight (equal to 1 ml per 20 kg body weight), once daily by subcutaneous injection for 3 days.Not more than 6 ml at one subcutaneous injection site.
CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to enrofloxacin or other fluoroquinolones or to any of the excipients.
Do not use in animals that are epileptic or suffer from seizures since enrofloxacin may cause CNS stimulation.
PRECAUTIONS
Special precautions for use in animals
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 including use deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to enrofloxacin and may decrease the effectiveness of treatment with all fluoroquinolones due to the potential for cross-resistance.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
People with known hypersensitivity to fluoroquinolones should avoid any contact with the product.
Avoid skin and eye contact. Wash any splashes from skin or eyes immediately with water.
Do not eat, drink or smoke whilst handling the product.
Care should be taken to avoid accidental self-injection. If accidental self-injection occurs seek medical advice immediately.
Wash hands after use.
Keep out of the reach of children.
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
ADVERSE REACTIONS
Digestive tract disorders (e.g. diarrhoea) may occur in very rare cases. These signs are generally mild and transient.
In calves, transient local tissue reactions may occur in very rare cases and may be observed up to 14 days.
DRUG INTERACTIONS
Do not use enrofloxacin concomitantly with antimicrobial substances acting antagonistically to quinolones (e.g. macrolides, tetracyclines or phenicols).
Do not use concurrently with theophylline as the elimination of theophylline may be delayed.
WITHDRAWAL PERIOD
Cattle, calves
For meat: 5 days (intravenous injection) or 12 days (subcutaneous injection).
For milk: Do not use in animals producing milk for human consumption.
Sheep
For meat: 4 days.
For milk: 3 days.
Goats
For meat: 6 days.
For milk: 4 days.
STORAGE
Sealed and store below 30°C. Protect from light.
PACKAGE
100 ml.
SHELF LIFE
3 years.
Shelf life after opening:
28 days.
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