Floxibac 100 mg/ml Solution for Injection for Cattle and Pigs
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active substance:
Enrofloxacin 100mg
PHARMACEUTICAL FORM
Solution for injection.
Clear light yellow solution free from particulate matter.
Target species
Cattle and Pigs.
Indications for use, specifying the target species
Treatment of bacterial infections caused by strains susceptible to enrofloxacin.
Cattle:
Respiratory infections caused by Pasteurella spp. or Mycoplasma spp.
Alimentary tract infections caused by E. coli.
Pigs:
Respiratory infections caused by of Pasteurella spp. or Mycoplasma spp.
Alimentary tract infections caused by E. coli.
Enrofloxacin should be used where clinical experience, supported where possible by sensitivity testing of the causal organism, indicates enrofloxacin as the drug of choice.
Contraindications
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
Special warnings for each target species
None known.
Special precautions for use
Special precautions for use in animals
Do not exceed the recommended dose.
Repeat injections should be made at different sites.
The safety of the product has not been established in pigs or calves when administered by the intravenous route and use of this route of administration is not recommended in these animal groups.
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.
Enrofloxacin should be used with caution in epileptic animals or animals affected by renal dysfunction.
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. Direct contact with the skin should be avoided because of sensitisation, contact dermatitis and possible hypersensitivity reactions. Wear gloves.
Care should be taken to avoid accidental self-injection. If accidental self injection occurs seek medical advice immediately.
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
To ensure correct dosage, body weight should be determined as accurately as possible to avoid underdosing.
Cattle:
For respiratory and alimentary infections in cattle and secondary bacterial infections: administer by subcutaneous injection.
2.5 mg enrofloxacin per kg bodyweight daily by subcutaneous injection for 3 days (2.5 ml per 100 kg bodyweight). This rate may be doubled to 5 mg/kg bodyweight (5 ml per 100 kg) for 5 days for complicated respiratory disease.
Not more than 10 ml should be administered at any one subcutaneous injection site.
Pigs:
For respiratory and alimentary infections in pigs and secondary bacterial infections: administer by intramuscular injection.
2.5 mg enrofloxacin per kg bodyweight daily by intramuscular injection for 3 days (2.5 ml per 100 kg bodyweight). This rate may be doubled to 5 mg/kg bodyweight (5 ml per 100 kg) for 5 days for complicated respiratory disease.
Not more than 2.5 ml should be administered at any one intramuscular injection site.
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 : Subcutaneous Use
Meat and offal: 10 days.
Milk: 84 hours (7 milkings)
Pigs: Intramuscular Use
Meat and offal: 10 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: 3 years
Shelf-life after first opening the immediate packaging: 28 days.
Special precautions for storage
Do not store above 25°C.
After first opening the immediate packaging: do not store above 25°C.
Nature and composition of immediate packaging
Container material: Type I Amber Glass
Container closure: Grey teflonised chlorobutyl rubber stopper with an aluminium cap.
Container colour: Amber
Container volumes: 100ml, 250ml
Contents: Clear pale yellow sterile aqueous solution
No of containers in a carton:
1 x 100 ml, 5 x 100 ml, 10 x 100 ml, 12 x 100 ml, 15 x 100 ml, 20 x 100 ml
1 x 250 ml, 5 x 250 ml, 10 x 250 ml, 12 x 250 ml, 15 x 250 ml, 20 x 250 ml.
Not all pack sizes may be marketed
Special precautions for the disposal of unused veterinary medicinal products or waste materials
Any unused product or waste material should be disposed of in accordance with national requirements.
