Solution for injection :
Disodium edetate…………….0.1 mg
Excipient to……………….. 1 ml
Marbofloxacin is a bactericidal anti-infectious synthesis belonging to the fluoroquinolones group. It acts by inhibition of DNA-gyrase. Its spectrum is broad, directed towards Gram positive (especially Staphylococcus), Gram negative bacteria (Escherichia coli, Pasteurella spp.) and Mycoplasma (Mycoplasma bovis and M. hyopneumoniae).
• Pharmacokinetic particulars :
After subcutaneous or intramuscular administration at the recommended dose of 2 mg/kg in cattle and pigs, Marbofloxacin is rapidly absorbed and reaches maximal plasmatic concentrations of 1,5 µg/ml in less than one hour. Bioavailability is close to 100 %.
Marbofloxacin is slightly related to plasmatic proteins (less than 10 % in the pig and less than 30 % in cattle) and is widely distributed in the entire organism. In the majority of tissues (liver, kidney, skin, lung, uterus), tissular concentrations are higher than those of plasma.
Marbofloxacin is slowly eliminated in the pre-ruminant calf (t1/2 = 5-9 hours) and in the pig (t1/2 = 8-10 hours), more rapidly in the ruminant cattle (t1/2 = 4-7 hours), and mainly in active form in the urines and faeces.
Disorders caused by germs sensitive to Marbofloxacin.
• In calves and young cattle :
Treatment of respiratory infections with strains sensitive to Pasteurella multocida, Pasteurella haemolytica and Mycoplasma bovis.
• In pigs :
Treatment of respiratory infections with strains sensitive to Actinobacillus pleuropneumoniae, Mycoplasma hyopneumoniae and Pasteurella multocida.
Control the sensitivity of strains prior to use the product.
• Calves, young cattle : IV, IM, SC routes.
2 mg of Marbofloxacin per kg (i.e. 1 ml for 10 kg of b.w.) in a daily injection by IM or SC route for 3 – 5 days. First injection can also be made by IV route.
• Pigs : IM route.
2 mg of Marbofloxacin per kg (i.e. 1 ml for 10 kg of b.w.) in a daily injection for 3 – 5 days.
• Use during pregnancy and lactation :
Studies in the animals of laboratory (rat, rabbit) have not produced any evidence of a teratogenic, foetotoxic or maternotoxic effect of Marbofloxacin.
Harmlessness of the product in the pregnant sow has not been shown. However, it can be apparently used in pregnant females without any particular inconvenience.
Harmlessness in suckling pigs during use of the product in the sow has been shown.
• Overdose :
No sign of overdose has been shown with the product after administration of 3 times the recommended dose.
In the case of overdose with Marbofloxacin, acute neurological signs occur whose treatment is symptomatic.
Do not administer in the case of bacterial infections with bacteria resistant to other fluoroquinolones.
• Calves and young cattle :
Meat and offal : 6 days.
• Pigs :
Meat and offal : 4 days.
Prescription only medicine. This drug should be stored during duration of its withdrawal period.
| Special precautions for storage
After opening, the bottle can be stored 1 month below 25° C.
1 bottle of 100 ml box
M.A. N° 676 202.4 from the 10/7/97