Horses.

Alleviation of inflammatory and clinical parameters associated with recurrent airway obstruction (RAO) in horses, in combination with environmental control.

Do not use in known 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 systemic 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.

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 medicinal products with more rapid onset of action may need to be considered.

Do not use in animals suffering from diabetes mellitus, renal insufficiency, cardiac insufficiency, hyperadrenocorticism, or osteoporosis.

Use of corticosteroids in horses has been reported to induce laminitis (see Adverse reactions). Therefore horses should be monitored frequently during the treatment period.

Because of the pharmacological properties of prednisolone, use with caution when the veterinary medicinal product is used in animals with a weakened immune system.

People with known hypersensitivity to corticosteroids or any of the excipients must not be in contact with the veterinary medicinal product.

Due to the risk of foetal malformation, the veterinary medicinal product must not be administered by pregnant women.

It is recommended to wear gloves and a protective mask during handling and administration of the product.

In order to prevent dust formation, do not shake the veterinary medicinal product.

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.

Whilst single high doses of corticosteroids 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.

The significant dose related cortisol suppression very commonly noticed during therapy is a result of effective doses suppressing the hypothalamo-pituitreal adrenal 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.

A significant increase in triglycerids occurs very commonly. This can be a part of possible iatrogenic hyperadrenocorticism (Cushings disease) involving 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 may result.

An 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 and in animals with spinal cord trauma (see Contraindications). 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.

The frequency of adverse reactions is defined using the following convention:

- very common (more than 1 in 10 animals treated displaying adverse reaction(s))

- common (more than 1 but less than 10 animals in 100 animals treated)

- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

- rare (more than 1 but less than 10 animals in 10,000 animals treated)

- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

The safety of the veterinary medicinal product has not been established in horses during pregnancy, and the product is contraindicated for use in pregnant horses (please see Contraindications).

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.

The concomitant use of this veterinary medicinal product with non-steroidal anti-inflammatory drugs may exacerbate gastrointestinal tract ulceration. Because corticosteroids can reduce the immunoresponse 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.

Oral use.

To ensure administration of the correct dose, body weight should be determined as accurately as possible to avoid under- or overdosing.

A single dose of 1 mg prednisolone/kg body weight per day corresponds to 100 mg prednisolone in a 3 g sachet per 100 kg body weight (see dosing table below).

Treatment may be repeated at 24 hour intervals during 10 consecutive days.

The correct dose should be mixed into a small amount of food.

Food mixed with the veterinary medicinal product should be replaced if not consumed within 24 hours.

Sachets of different pack size can be combined to achieve the correct dose, as per the table below:

Short-term administration of even large doses is unlikely to cause serious harmful systemic effects. However, chronic usage of corticosteroids may lead to serious adverse effects (please see Adverse reactions).

Meat and offal: 10 days.

Not authorised for use in mares producing milk for human consumption.