Marbocyl 10% solution for injection for cattle and pigs 100 ml
Treatment of respiratory infections and acute E. coli mastitis in cattle and treatment of Metritis Mastitis Agalactia syndrome in pigs
Marbocyl 10% Solution for Injection
2. MARBOCYL QUALITATIVE AND QUANTITATIVE COMPOSITION
Disodium edetate 0.01g
For a full list of excipients, see section 6.1
3. MARBOCYL PHARMACEUTICAL FORM
Solution for Injection.
4. MARBOCYL CLINICAL PARTICULARS
4.1 Target species
Cattle & pigs.
4.2 Indications for use, specifying the target species
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.
4.4 Special warnings for each target species
4.5 Special precautions for use
i. 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.
ii. Special precautions to be taken by the person administering the veterinary medicinal product to animals
People with known hypersensitivity to fluoroquinolones should avoid using this product. Wash hands after use.
4.6 Adverse reactions (frequency and seriousness)
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.
4.7 Use during pregnancy, lactation or lay
May be used in pregnant and lactating cows and sows.
4.8 Interaction with other medicinal products and other forms of interaction
4.9 Amounts to be administered and administration route
The recommended dosage 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.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Overdosage may cause acute signs in the form of neurological disorders which would have to be treated symptomatically.
4.11 Withdrawal period(s)
6 days (meat)
36 hours (milk)
4 days (meat)
5. MARBOCYL PHARMACOLOGICAL PROPERTIES
ATC Vet code: QJ01MA93
5.1 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.
5.2 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 1.5µg/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 (t½ β = 5-9h) but faster in ruminant cattle (t½ β = 4-7h) predominantly in the active form in urine (3/4 in pre-ruminating calves, 1/2 in ruminants) and faeces (1/4 in pre-ruminating calves, 1/2 in ruminants).
In pigs, marbofloxacin is eliminated slowly (t½ β = 8-10h) predominantly in the active form in urine (2/3) and faeces (1/3)
6. MARBOCYL PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Water for injections
6.3 Shelf life
Following withdrawal of the first dose, use the product within 28 days.
Any unused material should be discarded.
6.4 Special precautions for storage
Do not store above 25°C. Protect from light.
6.5 Nature and composition of immediate packaging
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.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
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.
7. MARKETING AUTHORISATION HOLDER