Target species
Cattle and Pigs (sows).
Indications for use, specifying the target species
Cattle
Treatment of respiratory infections caused by susceptible strains of Pasteurella multocida, Mannheimia haemolytica and Mycoplasma bovis.
Treatment of acute mastitis caused by Escherichia coli strains susceptible to marbofloxacin during the lactation period.
Sows
Treatment of Metritis Mastitis Agalactia Syndrome (postpartum dysgalactia syndrome, PDS) caused by bacterial strains susceptible to marbofloxacin.
Contraindications
Do not use in cases where the pathogen involved is resistant to other fluoroquinolones (cross resistance).
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Special Warnings for each target species
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 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 upon 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.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
People with known hypersensitivity to (fluoro)quinolones should avoid any contact with the veterinary medicinal product.
If the product comes into contact with skin or eyes, rinse with copious amounts of water.
Do not drink, eat or smoke whilst using the veterinary medicinal product.
Wash hands after use.
Accidental self-injection can induce slight irritation.
In case of accidental self-injection or ingestion, seek medical advice immediately and show package leaflet or the label to the physician.
Adverse reactions (frequency and seriousness)
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. However, in cattle the subcutaneous route was shown to be better tolerated locally than the intramuscular route. Therefore, the subcutaneous route is recommended in heavy cattle.
Use during pregnancy, lactation or lay
May be used in pregnant and lactating cows and sows.
Interaction with other medicinal products and other forms of interaction
None known.
Amounts to be administered and administration route
To ensure administration of a correct dose, bodyweight should be determined as accurately as possible to avoid underdosing.
The recommended dosage is 2 mg marbofloxacin/kg bodyweight (1 ml of the product/50 kg bodyweight) in a single daily injection by intramuscular, subcutaneous or intravenous routes in cattle and by intramuscular route in pigs. For the injections, the neck should be preferred in cattle and pigs.
Treatment durations are 3 days in pigs and 3 to 5 days in cattle.
The vial may be broached up to 35 times. The user should choose the most appropriate vial size according to the target species to be treated.
Overdose (symptoms, emergency procedures, antidotes), if necessary
No severe side-effects are to be expected at doses up to 3 or 5 times the recommended dose in cattle and pigs respectively.
Signs such as neurological disorders may occur when the dose is exceeded.
Such signs should be treated symptomatically.
Withdrawal period(s)
Cattle: Meat and offal: 6 days Milk: 36 hours
Pigs: Meat and offal: 4 days.