Target species
Cattle
Indications for use
For the reduction of pyrexia associated with bovine respiratory disease.
For the reduction of pyrexia associated with acute mastitis.
For the reduction of pain and lameness associated with interdigital phlegmon, interdigital dermatitis and digital dermatitis.
Contraindications
Do not use in animals suffering from cardiac, hepatic or renal disease, or where there is evidence of gastrointestinal ulceration or bleeding.
Do not use in severely dehydrated, hypovolaemic animals as there is a potential risk of increased renal toxicity.
Do not use the veterinary medicinal product within 48 hours before expected parturition in cows.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Special warnings for each target species
Apply only to dry skin and prevent exposure to wetting for at least 6 hours after application.
In case of bacterial infections, concurrent antibiotic therapy should be considered.
Special precautions for use
See also section “Use during pregnancy or lactation”.
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) are known to have the potential to delay parturition through a tocolytic effect by inhibiting prostaglandins that are important in signalling the initiation of parturition. The use of the product in the immediate post-partum period may interfere with uterine involution and expulsion of foetal membranes resulting in retained placentae.
Safety studies have not been conducted in bulls intended for breeding. Laboratory studies in rats have not shown any evidence of reproductive toxicity. Use only in accordance with a benefit/risk assessment by the responsible veterinarian.
Use in pre-ruminating and in aged animals may involve additional risk. If such use cannot be avoided, animals may require a reduced dosage and careful clinical management.
Apply only to undamaged skin.
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
Non-Steroidal Anti-inflammatory Drugs (NSAIDs) may cause hypersensitivity (allergy).
People with known hypersensitivity to NSAIDs should avoid contact with the veterinary medicinal product.
The product has been shown to cause severe and irreversible eye damage and to cause slight skin irritation. Ingestion of, or dermal contact with the product may be harmful.
Avoid contact with eyes, including hand-to-eye contact. Avoid contact with the skin. Avoid contact with the treated area (allowing for spreading of the product) without protective gloves, for at least three days or until the application site is dry (if longer). Avoid children getting access to the product or treated animals.
Personal protective equipment consisting of impermeable gloves, protective clothing and approved safety glasses should be worn when handling the veterinary medicinal product.
In case of accidental ingestion or mouth contact, immediately rinse the mouth with plenty of water, seek medical advice and show the package leaflet or the label to the physician.
In case of eye contact, rinse eyes immediately with copious amounts of clean water and seek medical advice.
In case of skin contact, wash thoroughly with soap and water.
Do not smoke, eat or drink while handling the product. Wash hands after use.
Adverse reactions
Cattle:
Common (1 to 10 animals /100 animals treated): | Application site swelling1, application site erythema1, application site dry skin (dandruff)1, application site hair change (broken/brittle hair, hair thinning)1, application site alopecia1, application site thickening1 Uncomfortable2, agitation2, irritability2 |
Very rare (< 1 animal / 10,000 animals treated, including isolated reports): | Anaphylaxis3 |
1 These changes have been reported as transient. No specific treatment is generally required.
2 Temporary signs
3 May be serious, may occur and should be treated symptomatically
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
Can be used during pregnancy and lactation except for 48 hours prior to parturition.
Due to an increased risk of retained placentae, the product should only be administered within the first 36 hours post-partum following a benefit/risk assessment performed by the responsible veterinarian and treated animals should be monitored for retained placentae.
Interactions
Do not administer other NSAIDs concurrently or within 24 hours of each other.
Some NSAIDs may be highly bound to plasma proteins and compete with other highly bound drugs which can lead to toxic effects. Concurrent administration of potentially nephrotoxic drugs should be avoided.
Amounts to be administered and administration route
Pour-on use. For single application. The recommended treatment dose is 3.33 mg flunixin/kg body weight (equivalent to 1 ml/15 kg body weight). The dosing chamber of the bottle is calibrated in kilograms of body weight. To ensure a correct dosage, body weight should be determined as accurately as possible.
Practice the administration instructions a few times to become familiar with operating the package before dosing animals.
Step 1: On first use remove cap and peelable seal from the dosing chamber. | |
Step 2: Hold the bottle upright and at eye level while slowly and gently squeezing the bottle to fill the dosing chamber to the selected mark. If the dosing chamber is overfilled follow the Overfill Reduction Instructions. | |
Step 3: Pour the measured volume on the midline of the animal's back extending from the whithers to tail head. A small amount of liquid will remain on the walls of the chamber, but the chamber is calibrated to account for this. Avoid squeezing the container section while the solution is poured from the dosing chamber. | |
Overfill reduction instructions
Step 1: Re-apply cap to dosing chamber and tighten. | |
Step 2: Tilt the bottle to allow an air pocket to form at the beginning of the transfer tube inside the bottle. | |
Step 3: Hold the bottle horizontally to allow veterinary medicinal product to cover the end of the transfer tube inside the dosing chamber. | |
Step 4: Squeeze and release the bottle repeatedly. Veterinary medicinal product will return to the bottle through the transfer tube. | |
Figure 1 - Recommended pour-on location |
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Overdose
Localised dermal inflammatory reactions and necrosis have been reported at 5 mg/kg.
Erosive and ulcerative abomasal lesions were observed in animals administered the veterinary medicinal product at 3 times the recommended treatment dose.
Occult faecal blood was observed in some animals administered the product at 5 times the recommended treatment dose.
No emergency procedures are necessary.
Withdrawal periods
Meat and offal: 7 days.
Milk: 36 hours.
Due to the possibility of cross-contamination of non-treated animals with this product due to grooming (licking), treated animals should be kept separately from non-treated animals throughout the withdrawal period. Non-compliance with this recommendation may lead to residues in non-treated animals.