Target species: Horses
Indications for use, specifying the target species: Alleviation of inflammatory and clinical parameters associated with recurrent airway obstruction (RAO – severe asthma) in horses, in combination with environmental control.
Contraindications: Do not use in cases of hypersensitivity to the active substance, to corticosteroids or to any of the excipients. Do not use in viral infections during the viraemic stage or in cases of mycotic infections. Do not use in animals suffering from gastrointestinal ulcers. Do not use in animals suffering from corneal ulcers. Do not use during pregnancy.
Special warnings for each target species: Corticoid administration is to induce an improvement in clinical signs rather than a cure. The treatment should be combined with environmental control. Each case should be assessed individually by the veterinarian and an appropriate treatment program determined. Treatment with prednisolone should only be initiated when satisfactory alleviation of clinical symptoms have not been obtained or are unlikely to be obtained by environmental control alone. Treatment with prednisolone may not sufficiently restore respiratory function in all cases, and in each individual case the use of medication with more rapid onset of action may need to be considered.
Special precautions for use in animals: Except in emergency situations, do not use in animals suffering from diabetes mellitus, renal insufficiency, cardiac insufficiency, hyperadrenocorticism, or osteoporosis. Whilst single high doses are generally well tolerated, they may induce severe side-effects in long term use. Dosage in medium to long term use should therefore generally be kept to the minimum necessary to control symptoms. Because of the pharmacological properties of prednisolone, special care should be taken when the veterinary medicinal product is used in animals with a weakened immune system.
Special precautions to be taken by the person administering the veterinary medicinal product to the animals: This product may cause allergic reactions. People with known hypersensitivity to prednisolone or other corticosteroids, or any of the excipients should avoid contact with the veterinary medicinal product. This product may be irritating to the eyes. Avoid hand-to-eye contact. In case of contact with the eyes, rinse with plenty of water. If irritation persists, seek medical attention. This product may cause adverse effects after ingestion. Avoid hand-to-mouth contact. Do not eat or drink when handling the product. Unused tablet parts should be placed back into the blister and carton and carefully kept away from children. Store in a closed cabinet. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician. Wash hands after handling the tablets. Corticosteroids can cause foetal malformation; therefore, it is recommended that pregnant women avoid contact with the veterinary medicinal product.
Adverse reactions (frequency and seriousness): Very rarely, laminitis has been observed after use of the product. Therefore, horses should be
monitored frequently during the treatment period. Very rarely, neurological signs such as ataxia, recumbency, head tilting, restlessness or incoordination have been observed after use of the product. The significant dose related cortisol suppression very commonly noticed during therapy is a result of effective doses suppressing the hypothalamic-pituitaryadrenal axis. Following cessation of treatment, signs of adrenal insufficiency extending to adrenocortical atrophy can arise and this may render the animal unable to deal adequately with stressful situations. The significant increase in triglycerides occurs very commonly. This may result in a significant alteration of fat, carbohydrate, protein and mineral metabolism, e.g. redistribution of body fat, increase in body weight, muscle weakness and wastage and osteoporosis. The increase of alkaline phosphatase by glucocorticoids is very rarely observed and could be related to enlargement of the liver (hepatomegaly) with increased serum hepatic enzymes. Gastrointestinal ulceration has been very rarely reported and gastrointestinal ulceration may be exacerbated by steroids in animals given non-steroidal anti-inflammatory drugs. Other gastrointestinal symptoms that have been very rarely observed are colic and anorexia. Excessive sweating has been very rarely observed. Very rarely urticaria has been observed.
Use during pregnancy, lactation or lay: The safety of the veterinary medicinal product has not been established in horses during pregnancy and lactation.
Pregnancy - Administration in early pregnancy is known to have caused foetal abnormalities in laboratory animals. Administration in late pregnancy is likely to cause abortion or early parturition in ruminants and may have a similar effect in other species. Do not use during pregnancy.
Lactation - Use only accordingly to the benefit/risk assessment by the responsible veterinarian.
Interaction with other medicinal products and other forms of interaction: The concomitant use of this veterinary medicinal product with non-steroidal anti-inflammatory drugs may exacerbate gastrointestinal tract ulceration. Because corticosteroids can reduce the immune response to vaccination, prednisolone should not be used in combination with vaccines or within two weeks after vaccination. Administration of prednisolone may induce hypokalaemia and hence increase the risk of toxicity from cardiac glycosides. The risk of hypokalaemia may be increased if prednisolone is administered together with potassium depleting diuretics.
Amounts to be administered and administration route: For oral use. The product should be mixed in small amount of feed. To ensure administration of the correct dose, body weight should be determined as accurately as possible to avoid under- or overdosing. Tablets may be divided along score lines to facilitate accurate dosing. A single dose of 1 mg prednisolone/kg body weight per day corresponding to 2 tablets per 100 kg body weight. Treatment may be repeated at 24 hour intervals during 10 consecutive days.
Overdose (symptoms, emergency procedures, antidotes), if necessary: An overdose can induce drowsiness in horses.
Withdrawal period(s): Meat and offal: 10 days. Not authorised for use in mares producing milk for human consumption.