EN
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In cattle
Treatment of infections of the respiratory tract caused by Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, Mycoplasma spp.
Treatment of mastitis caused by Escherichia coli, Klebsiella pneumoniae.
In pigs
Treatment of infections of the respiratory tract caused by Mycoplasma hyopneumoniae, Pasteurella multocida, Actinobacillus pleuropneumoniae, Haemophilus parasuis, Streptococcus suis, Bordetella bronchiseptica.
Active substance:
Enrofloxacin 100 mg/ml
Excipients:
Benzyl alcohol 20 mg/ml
N-butanol 30 mg/ml
Do not use in animals with known hypersensitivity to enrofloxacin or to any of the excipients.
In rare cases, transitory inflammatory reactions (swelling, redness) can occur at the injection site. These regress within a few days without further therapeutic measures.
In very rare cases, gastrointestinal disturbances may occur in isolated cases during treatment of calves.
In very rare cases, intravenous treatment can cause shock reactions in cattle, probably as a result of circulatory disturbances.
If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Cattle
The dosage for respiratory diseases is 7.5 mg enrofloxacin per kg bodyweight (7.5 ml of the product per 100 kg bw/day), for a single treatment, by subcutaneous administration.
The dosage for the treatment of colimastitis is 5 mg enrofloxacin per kg bodyweight (5 ml of the product per 100 kg bw/day) by intravenous administration.
Pigs
The dosage for respiratory tract infections is 7.5 mg enrofloxacin per kg bodyweight (equivalent to 7.5 ml of the product per 100 kg bw/day) for a single treatment, by subcutaneous administration.
Method of administration:
For subcutaneous injection (respiratory disease) or for intravenous injection (colimastitis).
To ensure administration of the correct dosage, body weight should be determined as accurately as possible to avoid underdosing.
To ensure a correct dosage, bodyweight should be determined as accurately as possible to avoid underdosing.
Usually, one administration is enough. In case of serious or chronic respiratory disease a second injection may be required after 48 hours.
Not more than 15 ml (cattle) and 7.5 ml (pigs) should be administered at one subcutaneous injection site.
The treatment of colimastitis should be exclusively by intravenous route for 2 consecutive days.
Cattle (meat and offal): 14 days.
Milk: 72 hours.
Pigs (meat and offal): 10 days.
Do not store above 25°C. Store in the original package. Store in a dry place. Protect from direct sunlight. Keep the vial in the outer package.
Shelf-life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf-life after first opening the immediate packaging: 28 days.
Special warnings for each target species
None.
Special precautions for use
Prudent use:
Whenever possible fluoroquinolones should only be used based on susceptibility testing.
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.
Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to fluoroquinolones and may decrease the effectiveness of treatment with other quinolones due to the potential for cross-resistance.
Special precautions for use in animals
Normal sterile precautions should be taken. Do not mix with other medicinal products. For repeated injection or for injection volumes exceeding 15 ml (cattle) or 7.5 ml (pigs, calves) in divided doses, a new site must be chosen for each injection. Inject slowly by intravenous route.
If in the first 2-3 days no improvement in clinical signs is observed, additional susceptibility testing and the possibility of changing antimicrobial therapy should be considered.
Special precautions to be taken by the person administering the medicinal products to animals
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. If the pain persists for more than 12 hours after the medical examination, seek medical advice again.
People with known hypersensitivity to enrofloxacin should avoid contact with the veterinary medicinal product.
In the event of accidental splash into the eye, rinse with large amounts of clean water. If irritation occurs, seek medical advice. Do not eat, drink or smoke while handling the product.
Use during pregnancy, lactation or lay
The product may be used 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 decrease theophylline, caffeine or antipyrine excretion.
Overdose (symptoms, emergency procedures, antidotes), if necessary
In cattle a dose of 25 mg/kg bodyweight administered by the subcutaneous route for 15 consecutive days is tolerated without any clinical symptoms.
Higher doses in cattle (more than 25 mg active substance/kg bw) may cause lethargy, slight diarrhea and loss of appetite.
Incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Vials of 50 ml, 100 ml, 250 ml and 500 ml.
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