Equisolon for Horses

Equisolon 33 mg/g oral powder for horses

Presentation

Jar with 180 g or 504 g oral powder. White to off-white oral powder. One gram contains 33.3 mg prednisolone as active substance.

Uses

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

Dosage and administration

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 3 g powder 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.

Using the measuring spoon the following dosing table applies:

Contra-indications, warnings, etc

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. 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 respiratory mask during the handling and administration of the veterinary medicinal 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 section 4.3). 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 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.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.

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.

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

Meat and offal: 10 days. Not authorised for use in mares producing milk for human consumption.

Pharmaceutical precautions

Store in the original container. Keep the container tightly closed.

Keep out of the sight and reach of children. For animal treatment only.

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

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

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.

Shelf life after first opening the container: 4 weeks.

Shelf life after incorporation into meal or pelleted feed: 24 hours.

Legal category

Packaging quantities

Cardboard box containing one HDPE (white) jar with LDPE tear band lid containing 180 gram or 504 gram of oral powder and one polystyrene (colourless) measuring spoon (measuring 4.6 grams of oral powder). Not all pack sizes may be marketed.

Further information

Pharmacodynamic properties

Prednisolone is an intermediate acting corticosteroid having about 4 times the anti-inflammatory activity and about 0.8 times the sodium-retaining effect of cortisol. Corticosteroids suppress the immunologic response by inhibition of dilatation of capillaries, migration and function of leucocytes and phagocytosis. Glucocorticoids have an effect on metabolism by increasing gluconeogenesis. Recurrent airway obstruction (RAO) is a commonly occurring respiratory disease in mature horses. Affected horses are susceptible to inhaled antigens and other pro-inflammatory agents, including fungal spores and dust-derived endotoxin. Where medical treatment of horses with RAO is required, glucocorticoids are effective in controlling clinical signs and decreasing neutrophilia in airways.

Pharmacokinetic particulars

Following oral administration in horses prednisolone is readily absorbed giving a prompt response which is maintained for approximately 24 hours. The overall average Tmax is 2.5 ± 3.1 hours, Cmax is 237 ± 154 ng/ml and AUCt is 989 ± 234 ng·h/ml. T½ is 3.1 ±2.3 hours but is not meaningful from a therapy standpoint when evaluating systemic corticosteroids. Bioavailability after oral administration is about 60%. Partial metabolism of prednisolone to the biologically inert substance prednisone takes place. Equal amounts of prednisolone, prednisone, 20β- dihydroprednisolone and 20β-dihydroprednisone are found in urine. Excretion of prednisolone is complete within 3 days. Multiple dosing does not result in plasma accumulation of prednisolone.

Marketing Authorisation Holder (if different from distributor)

Le Vet B.V.

Wilgenweg 7

3421 TV Oudewater

The Netherlands

Marketing Authorisation Number

EU/2/14/161/004

EU/2/14/161/005