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In cattle
Treatment of respiratory infections caused by Pasteurella multocida, Mannheimia haemolytica, Mycoplasma bovis.
Treatment of acute mastitis caused by strains of Escherichia coli susceptible to marbofloxacin during the lactation period.
In pigs
Treatment of Metritis Mastitis Agalactia syndrome caused by bacterial strains susceptible to marbofloxacin.
Active substance:
Marbofloxacin 100 mg/ml
Excipients:
Disodium Edetate 0.1 mg/ml
Thioglycerol 1 mg/ml
Meta-cresol 2 mg/ml
Do not use in animals with hypersensitivity to marbofloxacin or to any of the excipients.
Administration by the intramuscular route may cause transient local reactions such as pain and swelling at the injection site and inflammatory lesions which may persist for at least 12 days after injection.
Cattle
In cases of respiratory infections, the recommended dose is 2 mg marbofloxacin/kg body weight (1 ml veterinary medicinal product/50 kg bodyweight), in a single daily injection for 3 to 5 consecutive days, by the intramuscular or subcutaneous route.
In cases of acute mastitis, the recommended dosage is 2 mg marbofloxacin/kg body weight (1 ml veterinary medicinal product/50 kg body weight) in a single daily injection, for 3 consecutive days by the intramuscular or subcutaneous route.
In cattle, the subcutaneous route of administration has been shown to be better tolerated than intramuscularly.
Pigs
The recommended dosage is 2 mg marbofloxacin/kg body weight (1 ml veterinary medicinal product/50 kg bodyweight) in a single daily injection, for 3 consecutive days by the intramuscular route.
The preferred injection site is the neck area.
To ensure a correct dosage, bodyweight should be determined as accurately as possible to avoid underdosing.
Cattle (meat and offal): 6 days.
Milk: 36 hours.
Pigs (meat and offal): 3 days.
Do not store above 250C. Do not refrigerate or freeze. Store in the original package. Store in a dry place. Protect from direct light.
Shelf-life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf-life after first opening the immediate packaging: 28 days.
Special warnings for each target species
None.
Special precautions for use
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 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.
The efficacy data showed that the product has insufficient efficacy for the treatment of acute forms of mastitis induced by Gram-positive bacteria.
Special precautions to be taken by the person administering the medicinal products to animals
Care should be taken to avoid accidental self-injection as it can induce a slight irritation.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
In case of contact with skin or eyes, rinse with plenty of water.
Wash hands after use.
Use during pregnancy, lactation or lay
Use during pregnancy: laboratory studies in rats and rabbits have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects. Bovine product safety has been demonstrated during gestation.
Use during lactation: product safety has been demonstrated in piglets and calves when the product has been used in sows and lactating cows.
Interaction with other medicinal products and other forms of interaction
None known.
Overdose (symptoms, emergency procedures, antidotes), if necessary
No signs of overdosage have been observed after administration of 3 times the recommended dose.
Signs as acute neurological disorders may occur when the dose is exceeded. These signs should be treated symptomatically.
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.
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