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Marbocyl 10% Injection 100ml |
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Marbocyl 10% Injection for the use In cattle: Indicated in the treatment of respiratory infections caused by susceptible strains of organisms. It is also indicated in the treatment of acute E.coli mastitis. In pigs: Indicated in the treatment of Metritis Mastitis Agalactia syndrome caused by susceptible strains of organisms.
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Presentation
Sterile aqueous solution containing 10% w/v marbofloxacin as active ingredient, 0.1% w/v Monothioglycerol, 0.2% w/v m-Cresol as preservatives.
Uses
Marbofloxacin is a synthetic bactericidal antimicrobial belonging to the fluoroquinolone group, which acts by inhibition of DNA gyrase. It is effective against a wide range of Gram positive bacteria (in particular Staphylococci) and Gram negative bacteria (Escherichia coli, Salmonella typhimurium, Citrobacter freundii, Serratia marcesens, Morganella morganii, Proteus spp, Klebsiella spp, Shigella spp, Pasteurella spp, Haemophilus spp, Moraxella spp, Pseudomonas spp,) as well as Mycoplasma spp. In cattle Marbocyl 10% is indicated for the treatment of respiratory infections caused by susceptible strains of organisms. It is also indicated in the treatment of acute E. coli mastitis. In pigs Marbocyl 10% is indicated in the treatment of Metritis Mastitis Agalactia syndrome caused by susceptible strains of organisms.
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Dosage and administration
The recommended dose rate is 2mg/kg (1ml/50kg) daily by intramuscular, subcutaneous or intravenous injection in cattle and by intramuscular injection in pigs.
Treatment durations are 3 days in pigs and 3 to 5 days in cattle.
In order to reduce the risk of particulate contamination of the product, it is recommended that a draw-off needle be used to reduce the number of times the septum is punctured.
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Contra-indications, warnings, etc
Withdrawal periods
Milk for human consumption must not be taken during treatment. Milk for human consumption may only be taken from cattle after 36 hours from the last treatment.
Animals must not be slaughtered for human consumption during treatment. Cattle may be slaughtered for human consumption only after 6 days from the last treatment. Pigs may be slaughtered for human consumption only after 2 days from the last treatment.
Overdosage may cause acute signs in the form of neurological disorders which should be treated symptomatically.
General precautions: No severe side-effects are to be expected at doses up to 3 or 5 times the recommended dose in cattle and pigs respectively. In particular, no lesions of the articular joints are encountered. Intramuscular or subcutaneous injections are well tolerated although transitory inflammatory lesions without clinical impact can occur at the injection site.
Operator warnings
None
Pharmaceutical precautions
Do not store above 25°C and protect from light.
Following withdrawal of the first dose, use the product within 28 days. Discard unused material.
Keep out of reach of children.
Any unused product or waste material should be disposed of in accordance with national requirements.
Manure containing marbofloxacin should not be spread on the same area of land in successive years.
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Legal category
POM-V (previously POM).
Packaging Quantities
Glass vials of 20, 50, 100 and 250ml.
Further information
After subcutaneous or intramuscular administration in cattle and intramuscular administration in pigs at the recommended dose of 2mg/kg, marbofloxacin is readily absorbed and reaches maximal plasma concentrations of 1.5microgram/ml within less than 1 hour. Its bioavailability is close to 100%. It is weakly bound to plasma proteins (less than 10% in pigs and 30% in cattle), extensively distributed and in most tissues (liver, kidney, skin, lung, bladder, uterus, digestive tract) it achieves a higher concentration than in plasma.
In cattle, marbofloxacin is eliminated slowly in pre-ruminating calves (t1/2β = 5-9h) but faster in ruminant cattle (t1/2β = 4-7h) predominantly in the active form in urine (¾ in pre-ruminating calves, ½ in ruminants)
In pigs, marbofloxacin is eliminated slowly (t1/2β = 8-10h) predominantly in the active form in urine (2/3) and faeces (1/3).
Marketing authorisation number
VM 06462/4003.
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