FLUNEX 50 mg/ml

Solution for injection

Flunixin

Composition

1 ml contains: Flunixin base, 50.0 mg (equivalent to 82.9 mg of flunixin meglumine).

Indications

Cattle: Flunixin is recommended in acute inflammatory processes by its anti-pyretic effects in bovine livestock.

Horses: Flunixin is recommended for the alleviation of inflammation and pain associated with musculo-skeletal disorders in horses and for the alleviation of visceral pain associated with colics of horses.

Swine: Flunixin is recommended as adjuvant in the treatment of mastitis-metritis-agalactia syndrome in sows (MMA).

Contraindications

Do not use in animals suffering from cardiac, hepatic or renal disease, or when exists the possibility of gastro-intestinal ulceration or bleeding, or when there are signs of blood dyscrasia or hypersensitivity to the product.

Adverse reactions

Adverse effects include the possibility of haemorrhages, irritation and gastrointestinal injuries, renal papillary necrosis and changes in the blood analytic.

If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surgeon.

Target species

Cattle, horses and swine.

Dosage for each species, route and method of administration

Cattle: Slow intravenous route. The recommended dose is of 2.2 mg/kg b.w. (equivalent to 2 ml of FLUNEX/45 kg b.w.) for obtaining the anti-pyretic effect in acute inflammatory processes.

The cause of the acute inflammatory process should be determined and initiate a suitable concomitant therapy.

Horses: Slow intravenous route. The recommended dose for musculo-skeletal disorders in horses is of 1.1 mg/kg b.w. (1 ml of FLUNEX/ 45 kg b.w.) once daily. Treatment may be repeated during 5 days.

The recommended dose in the alleviation of pain associated with equine colics is of 1.1 mg/kg b.w. (1 ml of FLUNEX/45 kg b.w.).

Treatment may be repeated when the clinical symptoms of colics turn to appear.

The cause of the colics should be determined and treated with a suitable concomitant therapy.

Swine: Deep intramuscular route. Administer 2.2 mg/kg b.w. (equivalent to 2 ml of FLUNEX/45 kg b.w).

Flunixin must not be injected in the adipose tissue. One or two injections can be administered with an interval of 12 hours. The number of treatments (one or two) depends on the clinical response obtained. The administered volume at the injection site must not be higher than 3 ml.

Withdrawal period

Meat: Cattle: 14 days; Horses: 28 days; Swine: 24 days.

Milk: 2 days.

Storage precautions

Keep out of the sight and reach of children. Store below 30 ºC.

Do not use this veterinary medicinal product after the expiry date which is stated on the label.

Once opened, use within 28 days.

Special warnings

Special warnings for each target species: In swine avoid to administer the veterinary medicinal product in the adipose tissue.

Special precautions for use in animals: Do not exceed the recommended dose or the duration of treatment. Use in any animal less than 6 weeks of age or in aged animals may involve an additional risk. If such use cannot be avoided animals may require a reduced dosage and careful clinical management. Avoid use in any dehydrated, hypovolaemic or hypotensive animal.

It is preferable to avoid the administration of NSAIDs, which inhibit prostaglandin synthesis, to animals undergoing general anaesthesia until fully recovered.

Special precautions to be taken by the person administering the veterinary medicinal product to animals: Special precautions should be taken, in case of accidental injection, in persons with asthma, angiooedema, urticaria or rinitis history precipitated by NSAIDs. Persons with gastroduodenal ulceration history, coagulopathies or bleeding, as well as persons affected by asthma, kidney failure, cardiac failure, hypertension or hepatic failure should immediately request medical advice showing the label, box or leaflet of the product.

If losses of the product are produced, direct contact with eyes, mucous, wounds or irritated skin should be avoided. It is recommended to wash the area with plenty of water.

Pregnancy and lactation: Provided that the effects of Flunixin on pregnancy have not been determined, it is recommended to avoid administration of the product to pregnant females.

Interactions: It should not be administered other non-steroidal antiinflamatory drugs (NSAIDs) concurrently or with less than 24 hours of interval. Some NSAIDs may be highly bound to plasmatic proteins which can lead to toxic effects.

Concurrent administration with potentially nephrotoxic drugs should be avoided.

Overdose: Flunixin meglumine is a non-steroidal anti-inflammatory drug. Overdose is associated with gastrointestinal toxicity

Incompatibilities: Do not mix with other substances in the same syringe.

Disposal

Medicines should not be disposed of via wastewater on household waste. Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.

Other information

Vials of 50 ml, 100 ml and 250 ml. Box with 6, 10 or 12 vials of 50 ml and 100 ml.

Not all pack sizes may be marketed.

For animal treatment only. To be supplied only on veterinary prescription.

Invesa

Industrial Veterinaria, S.A.

a LIVISTO company

Esmeralda, 19

08950 Esplugues de Llobregat

Barcelona, Spain