Kelacyl 100 mg/ml, Solution for Injection for Cattle and Pigs.
Solution for injection.
Yellow greenish to yellow brownish, clear solution
Indications for use, specifying the target species:
- treatment of respiratory infections caused by strains of Histophilus somni, Mannheimia haemolytica, Mycoplasma bovis, Pasteurella multocida susceptible to marbofloxacin.
- treatment of acute mastitis caused by strains of Escherichia coli susceptible to marbofloxacin during the lactation period.
- treatment of Postpartum Dysgalactia Syndrome- PDS-(Metritis Mastitis Agalactia syndromw), caused by bacterial strains susceptible to marbofloxacin.
Dosage and administration
Amounts to be administered and administration route
The recommended dosage is 8 mg marbofloxacin/kg body weight (2ml product/25 kg body weight) in a single injection by intramuscular route. If the volume to be injected is more than 20 ml, it should be divided between two or more injection sites.
In cases of respiratory infections caused by Mycoplasma bovis, the recommended dose is 2 mg marbofloxacin/kg body weight (1 ml product/50 kg body weight), in a single daily injection for 3 to 5 consecutive days, by intramuscular or subcutaneous route. The first injection may be given by the intravenous route.
- Intramuscular or subcutaneous use:
The recommended dosage is 2 mg marbofloxacin/kg body weight (1 ml product/50 kg body weight) in a single daily injection, for 3 consecutive days. The first injection may also be given by the intravenous route.
The recommended dosage is 2 mg marbofloxacin/kg body weight (1 mg product/50 kg body weight) in a single daily injection,for 3 consecutive days.
To ensure administration of correct dose, body weight should be determined as accurately as possible, to avoid underdosing.
In cattle and pigs, the preferred injection site is the neck area.
The cap may be safely punctured up to 30 times. The user should choose the most appropriate vial size according to the target species to treat.
Contra-indications, warnings, etc
Do not use in cases where the pathogen involved is resistant to other fluoroquinolones (cross resistance).
Do not use in animals with known hypersensitivity to the active substance or to any other quinolone or to any of the excipients.
Special warnings for each target species
Special precautions for use
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 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.
The efficacy data showed that the product has insufficient efficacy for the treatment of acute forms of mastitis induced by gram-positive bacteria.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
People with known hypersensitivity to (fluoro)quinolones should avoid contact with the veterinary medicinal product. Care should be taken to avoid accidental self-injection as it can induce a slight irritation.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
In case of contact with skin or eyes, rinse with plenty of water.
Wash hands after use.
Adverse reactions (frequency and seriousness)
Transitory inflammatory lesions can occur at the injection site, without clinical impact, when administered via the intramuscular or subcutaneous route.
Administration by the intramuscular route may cause transient local reactions such as pain and swelling at the injection site and inflammatory lesions which may persist for at least 12 days after injection.
However, in cattle, subcutaneous route was shown to be better tolerated locally than intramuscular route. Therefore, the subcutaneous route is recommended in heavy cattle.
Use during pregnancy, lactation or lay.
Laboratory studies in rats and rabbits have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects.
Safety of the product at 2 mg/kg body weight has been established in pregnant cows and in sucking calves and piglets when used in cows and sows. Can be used during pregnancy and lactation.
Safety of the product at 8 mg/kg body weight has not been established in pregnant cows or in sucking calves when used in cows. Therefore, the dose regimen should be used only according to the benefit/risk assessment by the responsible veterinarian.
Interaction with other medicinal products and other forms of interaction
Overdose (symptoms, emergency procedures, antidotes), if necessary
No signs of overdosage have been observed after administration of 3 times the recommended dose.
Signs as acute neurological disorders may occur when the dose is exceeded. These signs should be treated symptomatically. Do not exceed the recommended dose.
8 mg/kg on single occasion (IM)
Meat and offal: 3 days
Milk: 72 hours
2 mg/kg for 3 to 5 days (IV/SC/IM)
Meat and offal: 6 days
Milk: 36 hours
2 mg/kg for 3 days (IM)
Meat and offal: 4 days
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Shelf-life of the veterinary medicinal product as packaged for sale: 3 years
Shelf-life after first opening the immediate packaging: 28 days
Special precautions for storage
Store in the original package in order to protect from light.
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 product should be disposed of in accordance with local requirements.
Amber glass type ll vial of 100ml, closed with bromobutyl rubber stopper and aluminium closure
Amber glass type ll vial of 250ml, closed with bromobutyl rubber stopper and aluminium closure
100ml and 250ml vials are individually packed in a carton box.
Six, ten or twelve vials are grouped as a clinical pack.