Target species
Cattle and pigs (sows).
Indications for use, specifying the target species
Cattle:
Therapeutic treatment of respiratory infections caused by sensitive strains of Pasteurella multocida, Mannheimia haemolytica and Histophilus somni.
Therapeutic treatment of acute mastitis caused by E. coli strains sensitive to marbofloxacin during the lactation period.
Sows:
Treatment of Metritis Mastitis Agalactia Syndrome caused by bacterial strains sensitive to marbofloxacin.
Contraindications
Do not use in case of known hypersensitivity to the active substance or other (fluoro)quinolones or to any of the excipients.
Do not use in case of confirmed or suspected resistance to fluoroquinolones (cross resistance).
Special warnings
None.
Special precautions for use
Special precautions for use in animals
Use of the product should be based on susceptibility testing and has to take into account official and local antimicrobial policies.
It is prudent to reserve the fluoroquinolones for the treatment of clinical conditions that have responded poorly, or are expected to respond poorly, to other classes of antibiotics.
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.
As the vial cannot be broached more than 45 times, the user should choose the most appropriate vial size according to the target species to treat.
For the injections, the neck should be preferred in cattle and pigs.
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 product.
If the product comes into contact with the skin or eyes, rinse with copious amounts of water.
Take care to avoid accidental self-injection since it can induce a slight irritation.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet to the physician.
Wash hands after use.
Adverse reactions (frequency and seriousness)
Administration by the intramuscular route may cause in cattle transient local reactions such as pain at the injection site and slight muscular inflammatory lesions (resulting in fibrosis). The process of cicatrisation starts rapidly (varying from fibrosis to synthesis of extracellular matrice and collagen) and may persist for at least 15 days after injection.
Administration by the subcutaneous route may induce slight to moderate oedema at the injection site. A moderate pain on palpation of the injection site occurred in some animals.
In pigs, administration by the intramuscular route may induce very transient slight oedema and mild inflammatory lesions at the injection site persisting for 12 days after injection.
Use during pregnancy, lactation or lay
Studies in laboratory animals (rats, rabbits) did not show any evidence of a teratogenic, embryotoxic or maternotoxic effect associated with the use of marbofloxacin.
Safety of the product at 2 mg/kg has been shown in cows during gestation and in suckling pigs and calves when used in sows and cows.
Safety of the product at 8 mg/kg has not been determined in pregnant cows or in suckling calves when used in cows. Use therefore according to the benefit/risk assessment carried out by the responsible veterinarian.
Interaction with other medicinal products and other forms of interaction
None known.
Amounts to be administered and administration route
Cattle:
Intramuscular use:- Respiratory infections: The recommended dosage is 8 mg/kg bodyweight i.e. 2 ml/25 kg bodyweight in a single injection.
If the volume to be injected is more than 20 ml, it should be divided between two or more injection sites.
Subcutaneous use:- Acute mastitis: The recommended dosage is 2 mg/kg i.e. 1 ml/50 kg bodyweight in a single daily injection, for 3 days.
The first injection may also be given by the intravenous route.
Sows:
Intramuscular use:- The recommended dosage is 2 mg/kg i.e. 1 ml/50 kg bodyweight in a single daily injection by intramuscular route, for 3 days.
To ensure a correct dosage body weight should be determined as accurately as possible to avoid underdosing.
Overdose (symptoms, emergency procedures, antidotes), if necessary
No sign of overdosage has been observed in cattle after administration of 3 times the recommended dose.
Overdosage may cause signs such as acute neurological disorders which should be treated symptomatically.
Withdrawal period(s)
Cattle:
Intramuscular: Meat and offal: 3 days - Milk: 72 hours
Subcutaneous: Meat and offal: 6 days - Milk: 36 hours
Sows:
Intramuscular: Meat and offal: 4 days