Description
Forcyl 160mg/ml Solution for Injection for cattle.
Presentation
Solution for injection. Clear yellow greenish to yellow brownish solution. Each ml contains 160 mg marbofloxacin and 15 mg benzyl alcohol (E 1519).
Uses
In cattle:
- Therapeutic treatment of respiratory infections in cattle caused by sensitive strains of Pasteurella multocida and Mannheimia haemolytica.
In lactating cows:
- Treatment of acute mastitis caused by sensitive strains of Escherichia coli.
Dosage and administration
- Therapeutic treatment of respiratory infections:
10 mg/kg body weight i.e. 10 ml /160 kg body weight in a single intramuscular injection.
- Treatment of acute mastitis caused by sensitive strains of Escherichia coli: 10 mg/kg body weight i.e. 10 ml/160 kg body weight in a single intramuscular or intravenous injection.
If the volume to be injected is more than 20 ml, it should be divided between two or more injection sites.
To ensure a correct dosage, bodyweight should be determined as accurately as possible to avoid underdosing.
Where there is slight cloudiness or visible particles present, such cloudiness or particles disappear when the bottle is shaken before use.
Contra-indications, warnings, etc
Do not use in animals with known hypersensitivity to fluoroquinolones or to any of the excipients.
Do not use in cases where the pathogen involved is resistant to other fluoroquinolones (cross resistance).
Special warnings
The efficacy of the product has not been tested on mastitis caused by Gram positive bacteria.
Special precautions for use in animals
Official and local antimicrobial policies should be taken into account when this 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. Wherever possible, use of the product should only be 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.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
People with known hypersensitivity to (fluoro)quinolones should avoid any contact with the product.
If the product comes into contact with the skin or eyes, rinse with copious amounts of water.
Care should be taken to avoid accidental self-injection. In the event of accidental self-administration, the user should immediately seek professional medical care.
Accidental self-injection can induce a slight irritation.
Adverse reactions (frequency and seriousness)
Administration by the intramuscular route may cause rare transient local reactions such as pain and swelling at the injection site which may persist up to 7 days after injection.
Fluoroquinolones are known to induce arthropathies. In cattle, such lesions were observed after three days of treatment with the 16% marbofloxacin solution. These lesions did not induce clinical signs and should be reversible, particularly if they were to be observed after a single administration.
No other adverse effect was observed on cattle.
Use during pregnancy, lactation or lay
Studies in laboratory animals (rats, rabbits) did not show any evidence of a teratogenic, embryotoxic or maternotoxic effect associated with the use of marbofloxacin. Safety of the product at 10 mg/kg has not been determined in pregnant cows or in suckling calves when used in cows. Use therefore according to the benefit/risk assessment carried out by the responsible veterinarian.
Interaction with other medicinal products and other forms of interaction
None known.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Lesions of the joint cartilage were observed in some animals treated at 10 mg/kg or 30 mg/kg for three times the recommended treatment duration, but did not induce clinical signs. Moreover, no sign of overdosage was observed throughout this study.
Overdosage may cause signs such as acute neurological disorders which should be treated symptomatically.
Withdrawal period(s)
Meat and offal: 5 days
Milk : 48 hours
Incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Pharmaceutical precautions
Shelf life of the veterinary medicinal product as packaged for sale: 3 years
Shelf life after first opening the immediate packaging: 28 days
This veterinary medicinal product does not require any special storage conditions.
Legal category
POM-V
Packaging Quantities
Cardboard box containing one 100 ml or 50 ml vial
Delivery
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