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.
Flunixin is toxic to avian scavengers. Do not administer to animals susceptible to enter wild fauna food chain. In case of death or sacrifice of treated animals, ensure that they are not made available to wild fauna.
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.
Laboratory studies in rabbits and rats with the excipient N-methyl pyrrolidone have shown evidence of foetotoxic effects. Women of childbearing age, pregnant women or women suspected of being pregnant should use the veterinary medicinal product with serious caution to avoid accidental self-injection.
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)
Very rare (<1 animal / 10,000 animals treated, including isolated reports): Anaphylactic-type reaction1
Undetermined frequency: Application site swelling2
1Those reactions might be fatal.
2Subcutaneous 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.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See also section 16 of the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established in Cattle during pregnancy, lactation, or in animals intended for breeding. Laboratory studies in rabbits and rats with the excipient N-methyl pyrrolidone have shown evidence of foetotoxic effects. 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.