Target species
Horses.
Indications for use
For the alleviation of inflammation and pain associated with musculoskeletal disorders in the horse.
Contraindications
Do not exceed the stated dose or duration of treatment.
Do not use in animals suffering from cardiac, hepatic or renal disease, or where there is the possibility of gastrointestinal ulceration or bleeding.
Do not use in cases of hypersensitivity to the active substance.
Do not administer steroidal or other non-steroidal anti-inflammatory drugs concurrently or within 24 hours of each other.
Do not use in hypovolaemic animals except in the case of endotoxaemia or septic shock.
Special warnings for each target species
Non-steroidal anti-inflammatory drugs are not permitted substances under the rules of racing and under rules covering other competitive events. The Royal College of Veterinary Surgeons has given guidance to the Veterinary profession regarding the use of anti-inflammatory drugs in competing horses. It states that if a veterinarian recommends the discontinuation of any such drug not less than eight days before racing he should feel sure he has catered for all but the most exceptional case.
Special precautions for use
Use in animals less than 6 weeks of age or in aged animals may involve additional risk.
If such use cannot be avoided animals may require a reduced dosage and careful clinical management.
In animals undergoing general anaesthesia it is preferable to wait until they are fully recovered before the veterinary medicinal product is administered.
NSAIDs can cause inhibition of phagocytosis. During use in the treatment of inflammatory conditions associated with bacterial infections, appropriate concurrent antimicrobial therapy should be administered.
Avoid use in dehydrated, hypovolaemic or hypersensitive animals as there is a potential risk of increased renal toxicity.
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.
Operator warnings
Avoid contact with eyes and direct contact with skin. In the case of accidental contact with eyes, rinse immediately with plenty of water and seek medical advice and show the package leaflet or the label to the physician.
The veterinary medicinal product may cause reactions in sensitive individuals. Reactions may be serious.
People with known hypersensitivity to non-steroidal anti-inflammatory products, should avoid handling the veterinary medicinal product.
Personal protective equipment consisting of gloves should be worn when handling the veterinary medicinal product during application.
Wash hands and exposed skin after use.hands and exposed skin after use.
Adverse reactions
Horses:
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Allergic reaction (e.g., allergic skin reaction, anaphylaxis) |
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 the package leaflet for respective contact details.
Use during pregnancy or lactation
Pregnancy:
The safety of the veterinary medicinal product has not been established during pregnancy.
Interactions
Concurrent administration of potentially nephrotoxic drugs should be avoided.
Some NSAIDs may be highly bound to plasma proteins and may compete with other highly bound drugs to produce an increase in non-bound pharmacologically active concentrations which can lead to toxic effects.
Amounts to be administered and administration route
Oral use. 1.1 mg flunixin per kg bodyweight once daily for up to 5 days according to clinical response.
Each 10 g syringe is sufficient for one day’s treatment for a 454 kg (1000 lb.) horse. The syringe is calibrated in 100 kg increments to facilitate dosing of horses of different weights.
Prior to first use, the syringe must be primed. Set the ring on the graduated syringe plunger to the zero (0) position. Remove the cap and press the plunger to remove air. Discard any small volume of paste that may be expelled. The syringe is now ready for use.
Overdose
Overdosage studies in the target species have shown the product to be well-tolerated. Flunixin meglumine is a non-steroidal anti-inflammatory drug. Overdosage is associated with gastrointestinal toxicity.
Withdrawal periods
Not to be used in horses intended for human consumption.
Treated horses may never be slaughtered for human consumption.
The horse must have been declared as not intended for human consumption under national horse passport legislation.