Megluvet

Reduction of pyrexia.

3.3 Contraindications

– Do not use in animals suffering from heart, liver or kidney disease or in which there is a possibility of ulcers or gastrointestinal bleeding

– Do not use in cases of hypersensitivity to the active substance or any of the excipients

– Do not use if hematopoiesis or hemostasis are altered.

– Do not use in case of colic caused by ileus and associated with dehydration.

3.4 Special Warnings

None.

3.5 Special Precautions for Use

Special precautions for safe use in target species

Inject slowly as life-threatening shock symptoms may occur due to the propylene glycol content.

NSAIDs are known to have the potential to delay labor through a tocolytic effect by inhibiting prostaglandins, which are important in signaling the onset of labor. The use of the veterinary medicinal product in the immediate postpartum period may interfere with uterine involution and expulsion of fetal membranes, leading to retained placenta.

The veterinary medicinal product must be at a temperature similar to body temperature. At the onset of the first symptoms of shock, discontinue administration immediately and initiate treatment for shock, if necessary.

The use of NSAIDs in hypovolemic animals or animals in shock should be subject to a benefit/risk assessment by the responsible veterinarian due to the risk of renal toxicity. Use in very young animals (cattle, horses: less than 6 weeks of age) as well as in elderly animals may involve additional risks. If such treatment cannot be avoided, careful clinical follow-up should be performed. The underlying cause of the pain, inflammation, or colic should be determined and, when appropriate, antibiotic or rehydration treatment should be administered simultaneously.

NSAIDs can cause inhibition of phagocytosis and therefore, in the treatment of inflammatory states associated with bacterial infections, appropriate concurrent antimicrobial therapy should be established.

Specific precautions to be taken by the person administering the veterinary medicinal product to animals:

The veterinary medicinal product may cause hypersensitivity reactions (allergies) in sensitive people. People with known hypersensitivity to non-steroidal anti-inflammatory drugs such as flunixine and/or propylene glycol should avoid all contact with the veterinary medicinal product. In case of hypersensitivity reactions, consult your doctor and show the package leaflet or label.

This veterinary medicinal product may cause skin and eye irritation. Avoid contact with skin and eyes. Wash your hands after using the veterinary medicinal product.

In case of accidental contact with the skin, wash the affected area immediately with plenty of water.

In case of accidental contact with eyes, rinse immediately with plenty of water.

If skin or eye irritation persists, consult a doctor immediately and show the package leaflet or label.

Accidental self-injection can lead to sharp pain and inflammation. In case of accidental self-injection, consult a doctor immediately and show the package leaflet or label.

Laboratory studies in rats with flunixino have shown toxic effects on the fetus. Pregnant women should use the veterinary medicinal product with great caution to avoid accidental self-injection.

Precauciones especiales para la protección del medio ambiente:

El flunixino es tóxico para las aves necrófagas. No administrar a animales susceptibles de entrar en la cadena alimentaria de la fauna silvestre. En caso de muerte o sacrificio de animales tratados, asegurarse de que no queden a disposición de la fauna silvestre.

3.6   Acontecimientos adversos

Bovino:

¹ Especialmente en animales hipovolémicos e hipotensos.

² Después de la administración intravenosa. Ante la aparición de los primeros síntomas se debe suspender inmediatamente la administración y, si es necesario, iniciar un tratamiento para shock.

³ Anomalías en los recuentos sanguíneos.

⁴ Por un efecto tocolítico inducido por la inhibición de la síntesis de prostaglandinas, responsables del inicio del parto.

⁵ Si el medicamento se utiliza en el periodo posterior al parto.

Caballos:

¹ Especialmente en animales hipovolémicos e hipotensos.

² After intravenous administration. At the onset of the first symptoms, administration should be discontinued immediately and, if necessary, shock treatment should be initiated.

³ Abnormalities in blood counts.

⁴ Due to a tocolytic effect induced by the inhibition of the synthesis of prostaglandins, responsible for the onset of labor.

⁵ If the product is used in the postpartum period.

⁶ It can occur by accidental intra-arterial injection.

Reporting of adverse events is important. It allows continuous monitoring of the safety of a veterinary drug. Notifications shall preferably be sent through a veterinarian to the marketing authorisation holder or to the national competent authority through the national notification system. Please refer to the package insert for the respective contact details.

3.7 Use during pregnancy and lactation

Gestation:

The safety of the veterinary medicinal product has been demonstrated in pregnant cows. Do not use the veterinary medicinal product within 48 hours of the expected calving date in cows.

The safety of the veterinary medicinal product in pregnant mares has not been demonstrated. Do not use throughout pregnancy.

Laboratory studies in rats have demonstrated toxic effects of flunixino on the fetus following intramuscular administration at maternally toxic doses, as well as an extension of the gestation period.

The veterinary medicinal product should be administered during the first 36 hours postpartum only after a benefit/risk assessment by the responsible veterinarian and treated animals should be monitored for possible retained placenta.

Fertility:

The safety of the veterinary medicinal product in whole breeding bulls and horses has not been demonstrated. Do not use on breeding bulls or on whole breeding horses.

3.8 Interaction with other medicinal products and other forms of interaction

Do not administer other nonsteroidal anti-inflammatory drugs (NSAIDs) together, or within 24 hours after administration. Do not administer corticosteroids at the same time. The co-use of other NSAIDs or corticosteroids may increase the toxicity of both, increasing the risk of gastrointestinal ulcers.

Some nonsteroidal anti-inflammatory drugs (NSAIDs) can bind to a large extent to plasma proteins and crowd out other drugs with high affinity to bind to them, which can lead to toxic effects. This interaction is important for drugs with a narrow therapeutic range: oral anticoagulants and some anticonvulsants such as phenytoin.

The co-use of other NSAIDs or corticosteroids may increase the toxicity of both, increasing the risk of gastrointestinal ulcers.

Flunixino may decrease the effect of some hypertensive drugs by inhibiting the synthesis of prostaglandins such as diuretics, inhibitors of ACE inhibitors (the angiotensin-converting enzyme), and β-blockers.

The concomitant administration of potentially nephrotoxic drugs, including cyclosporine or aminoglycoside antibiotics, should be avoided.

3.9 Dosage and routes of administration

IV

Bovine

Adjunctive therapy in the treatment of bovine respiratory diseases, endotoxemia and acute mastitis and relief of acute inflammation and pain associated with musculoskeletal disorders

2.2 mg flunixine/kg body weight (2 ml per 45 kg) once daily. Repeat as needed at 24-hour intervals for up to 3 consecutive days.

Reduction of postoperative pain associated with dehorning in calves less than 9 weeks of age

A single administration of 2.2 mg of flunixino per kg of body weight (2 ml per 45 kg), 15-20 minutes before the procedure.

Horses

Relief of acute inflammation and pain associated with musculoskeletal disorders and reduction of pyrexia

1.1 mg flunixine/kg body weight (1 mL per 45 kg) once daily for up to 5 days based on clinical response.

Relief of visceral pain associated with colic

1.1 mg flunixine/kg body weight (1 ml per 45 kg). Repeat once or twice if colic recurs.

Concomitant therapy of endotoxemia due to or as a result of post-surgical or medical conditions or diseases that result in alterations in blood circulation in the gastrointestinal tract.

0.25 mg flunixine/kg body weight every 6-8 hours or 1.1 mg flunixine/kg body weight once a day for up to 5 consecutive days

3.10 Symptoms of overdose (and, where appropriate, emergency procedures and antidotes)

Overdose is associated with gastrointestinal toxicity. There may also be ataxia and incoordination. In case of overdose, symptomatic treatment should be administered.

Cattle:

In cattle, intravenous administration of three times the recommended dose did not cause any adverse effects.

Horses:

Foals given an overdose of 6.6 mg flunixine/kg body weight (i.e., 5 times the recommended clinical dose) had more gastrointestinal ulcers and higher cecal petechiae scores than control foals. Foals treated with 1.1 mg flunixine/kg body weight for 30 days intramuscularly developed gastric ulceration, hypoproteinaemia and renal papillary necrosis. Renal crest necrosis was observed in 1 in 4 horses treated with 1.1 mg flunixine/kg body weight for 12 days.

In horses, after an intravenous injection of three times the recommended dose, a transient increase in blood pressure may be observed.

3.11 Restrictions and special conditions of use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products, in order to reduce the risk of the development of resistance

Medicinal product administered exclusively by the veterinarian in the case of intravenous administration or under the supervision and control of the veterinarian

3.12 Timeouts

Cattle:

Meat: 4 days

Milk: 24 hours

Horses:

Meat: 5 days

Milk: Its use is not authorized in animals whose milk is used for human consumption.

4.1 ATCvet Code: QM01AG90

4.2 Pharmacodynamics

Flunixine meglumine acts as a non-selective, reversible inhibitor of cyclooxygenase (both forms, COX1 and COX2), an enzyme of the arachidonic acid cascade pathway that is responsible for the conversion of arachidonic acid to endoperoxides. Consequently, the synthesis of eicosanoids, important mediators of the inflammatory process involved in central pyrexia, pain perception and tissue inflammation, is reduced. Through its effects on the arachidonic acid cascade, flunixine also inhibits the production of thromboxane, a potent platelet proaggregator and vasoconstrictor that is released during blood clotting. Flunixino exerts its antipyretic effect by inhibiting the synthesis of prostaglandin E2 in the hypothalamus. Although flunixin has no direct effect on endotoxins after they have been produced, it reduces the production of prostaglandins and thus reduces the multiple effects of the prostaglandin cascade. Prostaglandins are part of the complex processes involved in the development of endotoxic shock. Due to the involvement of prostaglandins in other physiological processes, COX inhibition would also be responsible for different adverse reactions, such as gastrointestinal or kidney damage.

4.3 Pharmacokinetics

Following intravenous administration of flunixine meglumine to horses (horses and ponies) at a dose of 1.1 mg/kg, the kinetics of the drug conform to a bicompartmental model. It showed a rapid distribution (volume of distribution 0.16 l/kg), with a high proportion of plasma protein binding (greater than 99 %). The elimination half-life was 1 to 2 hours. An AUC 0-15h of 19.43 μg·h/ml was determined. Excretion was rapid, mainly in the urine, reaching the maximum concentration in it 2 hours after administration.

After 12 hours of intravenous injection, 61% of the dose administered had been recovered in the urine.

In cattle, after intravenous administration of a dose of 2.2 mg/kg, peak plasma concentrations of between 15 and 18 μg/ml were obtained 5-10 minutes after injection. Between 2 and 4 hours later, a second peak in plasma concentration was observed (possibly due to enterohepatic circulation), while at 24 hours concentrations were less than 0.1 μg/ml.

Flunixino meglumine is rapidly distributed to organs and body fluids (with high persistence in inflammatory exudate), with a volume of distribution between 0.7 and 2.3 L/kg. The elimination half-life was approximately 4 to 7 hours. As for excretion, this took place mainly through urine and feces. In milk, the drug was not detected, and in cases where it was, the levels were negligible.

Environmental properties

Flunixino is toxic to necrophagous birds, although the low expected exposure means that the risks are low.

5.1 Main incompatibilities

In the absence of compatibility studies, this veterinary medicinal product should not be mixed with other veterinary medicinal products.

5.2 Validity Period

Shelf life of the veterinary medicinal product packaged for sale: 2 years.

Shelf life after opening the primary package: 28 days

5.3 Special storage precautions

This veterinary medicinal product does not require special storage conditions.

5.4 Nature and composition of primary packaging

Type I colourless glass vials, with bromobutyl stoppers closed with aluminium capsule.

Formats:

Box with 1 vial of 100 ml

Box with 1 vial of 250 ml

Not all formats may be commercialized.

5.5 Special precautions for the disposal of unused veterinary medicinal products or, where appropriate, residues derived from their use

Medicines should not be disposed of by dumping them into sewage or by household discharges.

Use veterinary drug take-down systems for the disposal of any unused veterinary medicinal product or waste resulting from its use in accordance with local regulations and national take-back systems applicable to the veterinary medicinal product concerned.

SUPER’S DIANA, S.L.

1863 ENG

Date of first authorisation: 27/03/2008

03/2025

Detailed information on this veterinary medicinal product can be found in the Union Medicinal Products Database (https://medicines.health.europa.eu/veterinary)