Contra-indications:
Do not use in adult bulls intended for breeding purposes.
Do not use in animals suffering from hepatic and renal diseases.
Do not use if there is a risk of gastrointestinal bleeding or in cases where there is evidence of altered hemostasis.
Do not use in animals suffering from cardiac diseases.
Do not use in cases of known hypersensitivity to the active substances or to any of the excipients.
Special warnings for each target species
None.
Special precautions for use
Special precautions for use in animals
Use of the product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria. Official and local antimicrobial policies should be taken into account when the product is used. Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to florfenicol.
Avoid use in dehydrated, hypovolaemic or hypotensive animals as there is a potential risk of increased renal toxicity. Concurrent administration of potentially nephrotoxic drugs should be avoided. Repeated daily dosing has been associated with abomasal erosions in the preruminant calf. The product should be used with caution in this age group. The safety of the product has not been tested in calves of 3 weeks of age or less.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
This product may cause adverse effects. Care should be taken to avoid accidental self-injection. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. This veterinary medicinal product may cause hypersensitivity reactions (allergy).
People with known hypersensitivity to propylene glycol and polyethylene glycols should avoid contact with the veterinary medicinal product. If you develop symptoms following exposure, such as skin rash, swelling of the face, lips or eyes or difficulty with breathing, you should seek medical advice immediately and show the package leaflet or the label to the physician.
Wash hands after use.
Adverse reactions (frequency and seriousness)
Subcutaneous administration of the product may result in injection site swellings that become palpable 2-3 days after injection. The duration of the injection site swellings ranged from 15-36 days post-injection. Grossly, this is associated with minimal to mild irritation of the subcutis. Extension into the underlying muscle was noted in only a few instances. By 56 days post-dosing, no gross lesions were observed that would require any trim-out at slaughter.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Use during pregnancy, lactation or lay
The effect of florfenicol on bovine reproductive performance, pregnancy and lactation has not been assessed. Use only accordingly to the benefit-risk assessment by the responsible veterinarian.
Interaction with other medicinal products and other forms of interaction
Concurrent use of other active substances that have a high degree of protein binding may compete with flunixin for binding and thus lead to toxic effects. Pre-treatment with other anti-inflammatory substances may result in additional or increased adverse effects and accordingly a treatment-free period with such drugs should be observed for at least 24 hours before the commencement of treatment. The treatment-free period, however, should take into account the pharmacokinetic properties of the products used previously.
The product must not be administered in conjunction with other NSAIDs or glucocorticosteroids. Gastrointestinal tract ulceration may be exacerbated by corticosteroids in animals given NSAIDs.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Overdose studies in the target species for 3 times the duration of treatment showed decreased food consumption in the groups given 3 and 5 times the recommended dose. Decreased body weights were observed in the 5 times overdose group (secondary to decreased food consumption). Decreased water consumption was observed in the 5 times overdose group. Tissue irritation increases with injection volume.
Treatment at 3 times the recommended treatment duration was associated with dose-related erosive and ulcerative abomasum lesions.