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Date: Sunday, February 25, 2024 8:07

Release 2.234
Marbocyl™ 10% Solution for Injection
 
Species: Pigs, Cattle
Therapeutic indication: Pharmaceuticals: Antimicrobials: Injections
Active ingredient: Marbofloxacin
Product:Marbocyl™ 10% Solution for Injection
Product index: Marbocyl 10% Solution for Injection
Cattle - milk: 36 hours
Cattle - meat: 6 days
Pig - meat: 4 days
Incorporating:
Presentation
Solution for Injection. Each 100ml contains marbofloxacin 10g, monothioglycerol 0.1g, metacresol 0.2g and disodium edetate 0.01g
Uses
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.
Dosage and administration
The recommended dose rate is 2mg/kg/day (1ml/50kg) in a single daily injection by intramuscular, subcutaneous or intravenous routes in cattle and by intramuscular route 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.
Contra-indications, warnings, etc
Do not use in cases of resistance to other fluoroquinolones (cross-resistance).
Do not use in cases of hypersensitivity to the active substance, to any other quinolone or to any of the excipients.
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 prevelance of bacteria resistant to the fluoroquinolones and may decrease the effectiveness of treatment with other quinolones due to the potential for cross resistance.
Operator warnings
People with known hypersensitivity to (fluoro)quinolones should avoid using this product.
In case of contact with skin or eyes, rinse with plenty of water.
Accidental self-injection can induce a slight irritation.
In case of accidental self-injection, seek medical advice and show the label to the doctor.
Wash hands after use.
Adverse Reactions (frequency and seriousness)
Intramuscular or subcutaneous injections are well tolerated although in very rare cases transitory inflammatory lesions can occur at the injection site.
The frequency of adverse reactions is defined using the following convention:
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports)
Use during pregnancy and lactation
May be used in pregnant and lactating cows and sows.
Overdose
Overdosage may cause acute signs in the form of neurological disorders which should be treated symptomatically.
No severe side-effects are to be expected at doses up to 3 or 5 times the recommended dose in cattle and pigs respectively.
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 4 days from the last treatment.
Pharmaceutical precautions
Do not store above 25°C and protect from light.
Following withdrawal of the first dose, use the product within 28 days. Any unused material should be discarded.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Manure and slurry containing marbofloxacin should not be spread on the same area of land in successive years.
Legal category
Legal category: POM-V
Packaging quantities
Marbocyl 10% is packaged in amber type II glass vials of 20ml, 50ml, 100ml and 250ml.
The vials are closed with a chlorobutyl rubber stopper oversealed with aluminium caps. Each vial is packaged in a cardboard box.
Further information
ATC Vet code: QJ01MA93
Pharmacodynamic properties:
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, Enterobacter cloacae, Serratia marcescens, Morganella morganii, Proteus spp, Klebsiella spp, Shigella spp, Pasteurella spp, Haemophilus spp, Moraxella spp, Pseudomonas spp) as well as Mycoplasma spp.
Pharmacokinetic properties:
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) and faeces (¼ 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 Holder (if different from distributor)
Marketing Authorisation Number
Vm 08007/4149
Significant changes
GTIN
GTIN description:Marbocyl 10% 50ml
GTIN:03605870006359
GTIN description:Marbocyl 10% 100ml
GTIN:03605870006366