QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active substance:
Enrofloxacin 50mg
PHARMACEUTICAL FORM
Solution for injection.
Clear light yellow solution free from particulate matter.
Target species
Cattle, Pigs, Dogs and Cats.
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., Actinobacillus spp. or Mycoplasma spp.
Alimentary tract infections caused by E. coli.
Dogs and Cats:
Treatment of bacterial infections of the alimentary, respiratory and urogenital tracts, skin, wound infections and otitis externa.
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 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.
Dogs under 1 year of age should not be treated with Enrofloxacin as damage to the articular cartilage
may occur during the period of rapid growth, specifically in large breeds of dog. As a precaution very
large breeds of dog should not be treated with Enrofloxacin until they are 18 months of age because of
their longer growth period.
Do not use in cats less than 8 weeks of age.
Do not use for prophylaxis.
Special warnings
Cattle, pigs:
None
Cats:
Retinotoxic effects including blindness can occur when the recommended dose is exceeded.
Dogs:
Occasionally skin reactions have been seen after administration to kennelled greyhounds.
Special precautions for use
Special precautions for use in animals
Do not exceed the recommended dosage.
Repeat injections should be made at different sites.
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 and 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 injection occurs, seek medical
advice immediately.
Adverse reactions (frequency and seriousness)
During the period of rapid growth, enrofloxacin may affect articular cartilage.
Local tissue reactions may occasionally occur at the injection site.
Normal sterile precautions should be taken.
In cattle and dogs, 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
Combination of enrofloxacin with cloramphenicol, macrolide antibiotics or tetracyclines may produce antagonistic effects.
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:
2.5 mg enrofloxacin per kg bodyweight (0.5ml/10 kg) daily by subcutaneous injection for 3 days. This rate may be doubled to 5 mg enrofloxacin per kg bodyweight (1.0 ml/10 kg) for 5 days for complicated respiratory diseases.
Not more than 10 ml should be administered at the one subcutaneous injection site.
Pigs:
2.5 mg enrofloxacin per kg bodyweight (0.5 ml/10 kg) daily by intramuscular injection for 3 days. This rate may be doubled to 5 mg enrofloxacin per kg bodyweight (1.0 ml/10 kg) for 5 days for complicated respiratory diseases.
Not more than 2.5 ml should be administered at the one intramuscular site.
Dogs and Cats:
5mg enrofloxacin per kg bodyweight (1.0 ml/10 kg) daily by subcutaneous injection once daily for up to 5 days.
Overdose (symptoms, emergency procedures, antidotes), if necessary
In dogs and cats, lack of appetite and nausea may occur following overdose.
Overdose may result in CNS and renal dysfunction. In dogs, 10-fold over dosage results in neurological symptoms such as ataxia, tremor, nystagmus or convulsions. These symptoms are reversible on cessation of treatment.
No signs of over dosage were observed in pigs following administration of the product at five times the recommended therapeutic dose.
In target animal studies, cats have been shown to suffer ocular damage after receiving doses of more than 15mg/kg once daily for 21 consecutive days. Doses of 30mg/kg given once daily for 21 consecutive days have been shown to cause irreversible ocular damage. At 50mg/kg given once daily for 21 consecutive days, blindness can occur.
In accidental overdose, there is no antidote and treatment should be symptomatic.
Withdrawal period(s)
MEAT & OFFAL
Cattle: 14 days
Pigs: 10 days
MILK: Not permitted for use in lactating animals producing milk for human consumption.
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 250C.
After first opening the immediate packaging: do not store above 250C.
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 mol, 12 x 100 ml, 15 x 100 ml, 20 x 100 ml
1 x 250 ml, 5 x 250 ml, 10 x 250 mol, 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 product or waste materials derived from the use of such products
Any unused product or waste material should be disposed of in accordance with national requirements.
