Marboxil 100 mg/ml,
Injectable solution for cattle and pigs
Qualitative and quantitative composition
Each milliliter contains:
Active substance:
Marbofloxacin (Marbofloxacin) ............. 100 mg
Pharmaceutical form
Injectable solution.
A clear solution ranging in color from yellow-green to yellow-brown.
Clinical particulars
Target species
Cattle and pigs.
Indications for use specifying the target species
In cattle:
Treatment of respiratory infections caused by Pasteurella multocida, Mannheimia haemolytica, and Mycoplasma bovis.
Treatment of acute mastitis caused by strains of Escherichia coli sensitive to marbofloxacin during lactation.
In pigs:
Treatment of metritis, mastitis, and agalactia syndrome caused by bacterial strains sensitive to marbofloxacin.
Contraindications
Do not use in animals with hypersensitivity to marbofloxacin or to any of the excipients.
Special warnings for each target species
None.
Special precautions for use
Special precautions for use in animals
When using this product, official and local antimicrobial policies should be taken into account.
Fluoroquinolones should be reserved for 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 in a manner deviating from the instructions given on the label may increase the prevalence of bacteria resistant to fluoroquinolones and may decrease the effectiveness of treatment with other quinolones due to the potential for cross-resistance. Data on efficacy have shown that the product is ineffective in the treatment of acute forms of mastitis caused by Gram-positive bacteria.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Care should be taken to avoid accidental self-injection, as this may cause slight irritation.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or label to the physician.
In case of contact with skin or eyes, rinse with plenty of water.
Wash hands thoroughly after use.
Adverse reactions (frequency and seriousness)
Intramuscular injection may cause transient local reactions such as pain and swelling at the injection site, as well as inflammatory lesions which may persist for at least 12 days after injection.
Use during pregnancy, lactation or lay
Use during pregnancy: laboratory studies in rats and rabbits have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects. The safety of the product has been demonstrated in cattle when used during pregnancy.
Use during lactation: the safety of the product has been demonstrated in piglets and calves when the product is used in sows and cows during lactation.
Interaction with other medicinal products and other forms of interaction
None known.
Amounts to be administered and administration route
Cattle
For respiratory infections, the recommended dose is 2 mg marbofloxacin per kg body weight (equivalent to 1 ml of veterinary medicinal product per 50 kg body weight), administered once daily for 3 to 5 consecutive days by intramuscular or subcutaneous injection.
For acute mastitis, the recommended dose is 2 mg marbofloxacin per kg body weight (equivalent to 1 ml per 50 kg body weight), administered once daily for 3 consecutive days by intramuscular or subcutaneous injection.
Administration by the subcutaneous route is generally better tolerated in cattle than intramuscular administration.
Pigs
The recommended dose is 2 mg marbofloxacin per kg body weight (equivalent to 1 ml per 50 kg body weight), administered once daily by intramuscular injection for 3 consecutive days.
The preferred injection site is the neck area.
To ensure correct dosing, body weight should be determined as accurately as possible in order to avoid underdosing or overdosing.
Overdose (symptoms, emergency procedures, antidotes), if necessary
No signs of overdose have been observed following administration of up to three times the recommended dose.
Overdose may cause symptoms such as acute neurological disorders. Treatment should be symptomatic.
Withdrawal period
Cattle (meat and offal): 6 days.
Milk: 36 hours.
Pigs (meat and offal): 3 days.
Pharmacological properties
Pharmacotherapeutic group: antibacterials for systemic use, fluoroquinolones.
ATC Vet code: QJ01MA93
Pharmaceutical particulars
List of excipients:
Disodium edetate
Thioglycerol
Meta-cresol
Gluconolactone
Water for injections
Major incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf life after first opening of the immediate packaging: 28 days.
Special precautions for storage
Do not store above 25°C.
Do not refrigerate or freeze.
Store in the original package.
Store in a dry place.
Protect from direct sunlight.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from such products
Any unused veterinary medicinal product or waste materials should be disposed of in accordance with local requirements.
Marketing authorization holder
CRIDA PHARM S.R.L.
Str. Intrarea Vagonetului, Nr. 2, Bloc 101, Ap. 47, Parter, Sector 6,
Bucharest, Romania
Tel/Fax: +4021 4304399
E-mail: office@cridapharm.ro
