 |
|
|
|
Marbokem is used for the treatment of respiratory infections caused by sensitive strains of Pasteurella multocida, Mannheimia haemolytica and Histophilus somni in cattle.
|
|
Presentation
Marbokem is a clear yellow solution for injection containing 100 mg/ml marbofloxacin.
Uses
Marbokem is used for the treatment of respiratory infections caused by sensitive strains of Pasteurella multocida, Mannheimia haemolytica and Histophilus somni in cattle.
Dosage and administration
Intramuscular use.
The recommended dosage is 8 mg/kg bodyweight i.e. 2 ml/25 kg bodyweight in a single intramuscular injection. If the volume to be injected is more than 20 ml, it should be divided between two or more injection sites.
|
|
Contra-indications, warnings, etc
Do not use in animals with known hypersensitivity to fluoroquinolones.
Do not use in cases where the pathogen involved is resistant to other fluoroquinolones (cross resistance).
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 the fluoroquinolones and may decrease the effectiveness of treatment with other quinolones due to the potential for cross resistance.
Adverse effects
Fluoroquinolones are known to induce arthropathies. Nevertheless, this effect has never been observed with marbofloxacin in cattle. Administration by the intramuscular route may cause 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 matrix and collagen) and may persist for at least 15 days after injection. No other adverse injection site effects have been observed in cattle.
Overdose
No sign of overdosage has been observed after administration of 3 times the recommended dose. Overdosage may cause signs such as acute neurological disorders which should be treated symptomatically.
Use during pregnancy and lactation
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 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
None known
Special precautions to be taken by the person administering the medicinal product to animals
People with known hypersensitivity to 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.
Accidental self-injection can induce a slight irritation.
Withdrawal periods
Meat and offal: 3 days
Milk : 72 hours
|
|
Pharmaceutical precautions
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products. Use the product within 28 days after first use.
Keep the container in the outer carton in order to protect from light.
|
|
Legal category
POM-V
Packaging Quantities
Box containing 50, 100, 250 or 500 ml vial.
Not all pack sizes may be marketed.
Further information
Pharmacodynamic properties
Marbofloxacin is a synthetic, bactericidal antimicrobial, belonging to the fluoroquinolone group, which acts by inhibition of DNA gyrase. It has a broad-spectrum activity in vitro against mycoplasma, Gram-positive and Gram-negative bacteria.
The marbofloxacin in vitro activity against pathogens isolated between 2004 and 2007 from bovine respiratory diseases in Europe (France, Germany, Italy, UK, Czech Republic, Ireland and Belgium) is good: MIC values are between 0.004 and 1 µg/ml for Pasteurella multocida (MIC90= 0.06 µg/ml; MIC50= 0.01 µg/ml), between 0.015 and 0.5 µg/ml for Mannheimia haemolytica (MIC90= 0.10 µg/ml; MIC50= 0.03 µg/ml), and between 0.008 and 0.06 µg/ml for Histophilus somni (MIC90= 0.05 µg/ml; MIC50= 0.03 µg/ml).
Strains with MIC ≤ 1 µg/ml are sensitive to marbofloxacin whereas strains with MIC ≥ 4 µg/ml are resistant to marbofloxacin.
Resistance to fluoroquinolones occurs by chromosomal mutation with three mechanisms: decrease of the bacterial wall permeability, expression of efflux pump or mutation of enzymes responsible for molecule binding.
Pharmacokinetic particulars
After a single intramuscular administration in cattle at the recommended dose of 8 mg/kg, the maximum plasma concentration of marbofloxacin (Cmax) is 8 µg/ml reached in approximatively 1 hour (Tmax). Binding to plasma proteins is about 30%. Marbofloxacin is eliminated slowly (terminal T1/2 = 9.5 h), predominantly in the active form in urine and faeces.
Marketing authorisation number
Vm 15052/4043.
|
|
|
