Target species
Cattle, pigs and horses.
Indications for use, specifying the target species
Cattle:
- Alleviation of clinical signs of respiratory disease when used concurrently with appropriate anti-infective therapy.
Pigs:
- To support appropriate antibiotic therapy in the treatment of Mastitis-Metritis-Agalactia syndrome.
- Alleviation of fever associated with respiratory disease when used in conjunction with specific antibiotic therapy.
Horses:
- Alleviation of inflammation and pain associated with musculo-skeletal disorders.
- Alleviation of visceral pain associated with colic.
Contraindications
Do not use in animals suffering from chronic musculo-skeletal disorders.
Do not use in animals suffering from cardiac, hepatic or renal disease.
Do not use in animals with gastro-intestinal lesions (gastro-intestinal ulceration or bleeding).
Do not use in case of haemorrhagic disorders.
Do not use in case of hypersensitivity to flunixin meglumine, other NSAIDs or any of the excipients.
Do not use in animals suffering from colic caused by ileus and associated with dehydration.
Do not use the product within 48 hours before expected parturition in cows. In such cases an increase in the number of stillbirths has been observed.
Do not exceed the stated dose or the duration of treatment
See also section Use in pregnancy, lactation or lay.
Special warnings for each target species
The underlying cause of the inflammatory condition or colic must be determined and treated with appropriate concomitant therapy.
Special precautions for use
Special precautions for use in animals
Use in any animal less than 6 weeks of age (cattle and horses) or in aged animals may involve additional risk. If such use cannot be avoided, animals may require a reduced dosage and careful clinical management.
It is preferable that NSAIDs which inhibit prostaglandin synthesis are not administered to animals undergoing general anaesthesia until fully recovered.
Avoid use in any dehydrated, hypovolaemic or hypotensive animal except in the case of endotoxaemia or septic shock.
In rare cases, shock (potentially fatal), may occur after intravenous injection, due to a high quantity of propylene glycol in the veterinary medicinal product. The veterinary medicinal product must be injected slowly and at body temperature. Stop injection at the first signs of intolerance and treat for shock if necessary.
Due to its anti-inflammatory properties, flunixin may mask clinical signs and therefore possible resistance to antibiotic treatment.
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 veterinary medicinal product in the immediate post-partum period may interfere with uterine involution and expulsion of fetal membranes resulting in retained placentae.
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
See also section Use in pregnancy, lactation or lay.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Flunixin meglumine is a non-steroidal anti-inflammatory drug (NSAID). The veterinary medicinal product may cause an allergic reaction in people sensitised to NSAIDs. People with known hypersensitivity to NSAIDs should avoid contact with the veterinary medicinal product.
Hypersensitivity reactions may be serious.
This veterinary medicinal product may cause skin and eye irritation.
Avoid contact with skin or eyes.
In case of skin contact, wash exposed area with soap and plenty of water. If symptoms persist, seek medical advice.
In case of contact with the eyes, wash eyes thoroughly with clean water and seek medical advice.
Avoid risk of ingestion, do not eat or drink when using the veterinary medicinal product and wash hands after use. In case of ingestion of the veterinary medicinal product seek medical advice.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Wash hands after use.
Special precautions for the protection of the environment:
Not applicable
Adverse reactions (frequency and seriousness)
Cattle:
Rare (1 to 10 animals / 10,000 animals treated): | Anaphylaxis (with collapse)1 Death1 |
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Bleeding2, gastrointestinal irritation2, gastric ulceration2 Renal damage2 Injection site reaction3 |
Undetermined frequency (cannot be estimated from the available data) | Renal and hepatic disorders4 Delayed parturition5, increase of stillbirths5, retained placenta6 |
1mainly during rapid intravenous injection
2 mainly in dehydrated or hypovolaemic animals
3 following intramuscular injection
4 idiosyncratic effects
5 through a tocolytic effect by inhibiting prostaglandins that are important in signalling the initiation of parturition
6 in cases of the use of the veterinary medicinal product in the immediate post-partum period
Horses:
Rare (1 to 10 animals / 10,000 animals treated): | Anaphylaxis (with collapse)1 Death1 |
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Bleeding2, gastrointestinal irritation2, gastric ulceration2, blood in faeces, diarrhea (liquid) Renal damage2 |
Undetermined frequency (cannot be estimated from the available data) | Renal and hepatic disorders3 Delayed parturition4, increase of stillbirths4, retained placenta5 |
1mainly during rapid intravenous injection
2 mainly in dehydrated or hypovolaemic animals
3 idiosyncratic effects
4 through a tocolytic effect by inhibiting prostaglandins that are important in signalling the initiation of parturition
5 in cases of the use of the veterinary medicinal product in the immediate post-partum period
Pigs:
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Undetermined frequency (cannot be estimated from the available data) |
Undetermined frequency (cannot be estimated from the available data) | Renal and hepatic disorders2 Delayed parturition3, increase of stillbirths3, retained placenta4 |
1 mainly in dehydrated or hypovolaemic animals
2 idiosyncratic effects
3 through a tocolytic effect by inhibiting prostaglandins that are important in signalling the initiation of parturition
4 in cases of the use of the veterinary medicinal product in the immediate post-partum period
In case of untowards effects stop treatment and seek medical advice.
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, lactation or lay
Studies in laboratory animals have produced evidence of foetotoxicity from flunixin after oral administration (rabbit and rat) and intramuscular administration (rat) at maternotoxic doses as well as an increase in the gestation period (rat).
The safety of flunixin has not been assessed in pregnant mares, breeding stallions and bulls. Do not use in these animals.
The safety of flunixin was demonstrated in pregnant cows and sows, as well as boars. The product may be used in these animals except within the 48 hours preceding parturition (see sections Contraindications and Adverse reactions).
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.
Interaction with other medicinal products and other forms of interaction
Do not administer other NSAIDs concurrently or within 24 hours of each other, as it may increase the toxicity, mainly gastro-intestinal, even with low doses of acetylsalicylic acid.
The concurrent administration of corticoids may increase toxicity of the two products and increase the risk of gastro-intestinal ulceration. It should therefore be avoided.
Flunixin may reduce the effect of some anti-hypertensive medicinal products, such as diuretics, Angiotensin Conversion Enzyme (ACE) inhibitors, and beta blockers, by inhibition of prostaglandin synthesis.
Concurrent administration of potentially nephrotoxic drugs, particularly aminoglycosides, should be avoided.
Flunixin may reduce renal elimination of some drugs and increase their toxicity, such as aminoglycosides for example.
Amounts to be administered and administration route
Cattle: intramuscular and intravenous uses
Pigs: intramuscular use
Horses: intravenous use
The bodyweight should be accurately determined before the administration
Cattle:
2 mg of flunixin per kg bodyweight, equivalent to 2 ml of solution per 50 kg bodyweight, administered once daily by intravenous or intramuscular injection for 1 to 3 consecutive days.
Volumes greater than 20 ml should be divided and administered at least at 2 different injection sites.
Pigs:
To support appropriate antibiotic therapy in the treatment of Mastitis-Metritis-Agalactia syndrome:
2 mg of flunixin per kg bodyweight, equivalent to 2 ml of solution per 50 kg bodyweight, administered once daily for 1 to 3 consecutive days.
Alleviation of fever associated with respiratory diseases:
2 mg of flunixin per kg bodyweight, equivalent to 2 ml of solution per 50 kg bodyweight, administered once daily.
Maximum dosage volume per injection site should not exceed 5 ml. Volumes greater than 5 ml should be divided and administered at different injection sites
Horses:
Alleviation of inflammation and pain associated with musculo-skeletal disorders: 1 mg of flunixin per kg bodyweight, equivalent to 1 ml of solution per 50 kg bodyweight, administered once daily for 1 to 5 consecutive days.
Alleviation of visceral pain associated with colic:
1 mg of flunixin per kg bodyweight, equivalent to 1 ml of solution per 50 kg bodyweight, administered once daily. Treatment may be repeated once or twice if colic recurs.
The cap can be broached up to 10 times. When treating large groups of animals at one time, use an automatic dosing device.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Overdose is associated with gastrointestinal toxicity. Signs of ataxia and incoordination may also appear.
In horses, following 3 times the recommended dose (3 mg/kg bodyweight) administered by the intravenous route, a transient increase in blood pressure may be observed.
In cattle, administration of 3 times the recommended dose (6 mg/kg bodyweight) administered by the intravenous route did not induce untoward effects.
In pigs, following a dose of 2 mg flunixin/kg, administered twice a day, painful reactions at the injection site and an increase in the number of leucocytes was reported.
Withdrawal period(s)
Cattle:
Meat and offal: 10 days (IV route) / 31 days (IM route).
Milk: 24 hours (IV route) / 36 hours (IM route).
Pigs:
Meat and offal: 20 days.
Horses:
Meat and offal: 10 days.
Milk: the product is not authorised for use in lactating animals producing milk for human consumption.