For animal treatment only.
Systemic corticosteroid therapy is generally contra-indicated in patients with renal disease and diabetes mellitus.
Use of the product in horses could induce laminitis and therefore careful observations should be made during treatment.
Anti-inflammatory corticosteroids, such as dexamethasone, are known to exert a wide range of side effects. Whilst single high doses are generally well tolerated, they may induce severe side effects in long term use and when esters possessing a long duration of action are administered. Dosage in medium to long term use should therefore generally be kept to the minimum necessary to control symptoms.
Steroids themselves, during treatment, may cause Cushingoid symptoms involving significant alteration of fat, carbohydrate, protein and mineral metabolism, e.g. redistribution of body fat, muscle weakness and wastage and osteoporosis may result. During therapy effective doses suppress the Hypothalamo-Pituitary-Adrenal axis. Following cessation of treatment, symptoms of adrenal insufficiency extending to adrenocortical atrophy can arise and this may render the animal unable to deal adequately with stressful situations. Consideration should therefore be given to means of minimising problems of adrenal insufficiency following the withdrawal of treatment, e.g. a gradual reduction of dosage (for further discussion see standard texts).
Systemically acting corticosteroids may cause polyuria, polydipsia and polyphagia, particularly during the early stages of therapy. Some corticosteroids may cause sodium and water retention and hypokalaemia in long term use.
Systemic corticosteroids have caused deposition of calcium in the skin (calcinosis cutis). Cortiocosteroids may delay wound healing and the immunosuppressant actions may weaken resistance to or exacerbate existing infections.
Gastrointestinal ulceration has been reported in animals treated with corticosteroids and gastrointestinal tract ulceration may be exacerbated by steroids in patients given non-steroidal anti-inflammatory drugs and in corticosteroid treated animals with spinal cord trauma. Steroids may cause enlargement of the liver (hepatomegaly) with increased serum hepatic enzymes.
Corticosteroids are not recommended for use in pregnant animals. Administration in early pregnancy is known to have caused foetal abnormalities in laboratory animals. Administration in late pregnancy may cause early parturition or abortion.
In the presence of bacterial infection, antibacterial drug cover is usually required when steroids are used. In the presence of viral infections, steroids may worsen or hasten the progress of the disease.
During a course of treatment the situation should be reviewed frequently by close veterinary supervision.
Withdrawal periods
Cattle must not be slaughtered for human consumption during treatment. Cattle may be slaughtered for human consumption only after 21 days from the last treatment. Milk for human consumption must not be taken from a cow during treatment. Milk for human consumption may be taken from cows only after 84 hours from the last treatment.
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.
User warnings
Care should be taken to avoid accidental self-injection.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet to the doctor.
Pregnant women should not handle this veterinary medicinal product.
Avoid contact with skin and eyes. In the event of accidental eye or skin contact, wash the area thoroughly with clean running water.
People with known hypersensitivity to the active substance or any of the excipients should avoid contact with this product. Wash hands after use.
Disposal
Any unused veterinary medicinal product or waste material derived from such veterinary products should be disposed of in accordance with local requirements.