Product Description

Equisolon Oral Powder is indicated for the alleviation of inflammatory and clinical parameters associated with recurrent airway obstruction (RAO) in horses, used in combination with environmental control. RAO — also known as severe equine asthma, heaves, or formerly as chronic obstructive pulmonary disease (COPD) — is a commonly occurring respiratory disease in mature horses, in which affected animals are susceptible to inhaled allergens and pro-inflammatory agents including fungal spores and dust-derived endotoxin. Clinical signs include chronic coughing, increased respiratory effort and airway neutrophilia with excessive mucus production. Where medical treatment is required, glucocorticoids such as prednisolone are effective in controlling clinical signs and decreasing neutrophilia in the airways. It is important to note that corticosteroid administration is intended to induce an improvement in clinical signs rather than a cure — treatment must always be combined with appropriate environmental management, including minimising dust and exposure to potential triggers. Each case should be assessed individually by the veterinary surgeon, and treatment with prednisolone should only be initiated when satisfactory alleviation of clinical symptoms has not been obtained, or is unlikely to be obtained, by environmental control alone.

For Horses:

• Alleviation of inflammatory and clinical parameters associated with recurrent airway obstruction (RAO) in combination with environmental control
• Management of severe equine asthma where environmental control alone has not achieved satisfactory relief of clinical signs

Which Animals Can Use Equisolon 300 mg Oral Powder?

Equisolon Oral Powder is licensed for use in horses only. It must not be used in horses with known hypersensitivity to prednisolone, other corticosteroids, or any excipient. It must not be used during any stage of viral infection with active viraemia, in cases of systemic fungal (mycotic) infection, in animals with gastrointestinal ulcers, or in animals with corneal ulcers. It must not be used during pregnancy. Additional caution is required in horses with diabetes mellitus, renal insufficiency, cardiac insufficiency, hyperadrenocorticism (Cushing's disease), or osteoporosis — use in these animals is contraindicated. All horses receiving treatment should be monitored frequently throughout the course due to the risk of corticosteroid-induced laminitis. This product must be used only under veterinary prescription and direction.

Available Strengths & Sizes

Please order the exact pack size as specified on your veterinary prescription.

Note: Not all pack sizes may be marketed. Sachets are for single use and must be disposed of after opening — opened sachets cannot be stored. The jar presentation includes a polystyrene measuring spoon calibrated to 4.6 g of oral powder. One 9 g sachet contains 300 mg prednisolone, sufficient to treat a 300 kg horse for one day at the licensed dose rate.

Directions for Use

This is a prescription medication — use exactly as directed by your veterinary surgeon. Determine the horse's bodyweight as accurately as possible before each administration to avoid under- or overdosing. The correct dose should be mixed into a small amount of food. Food mixed with the product should be replaced if not consumed within 24 hours. Treatment may be given at 24-hour intervals for up to 10 consecutive days. Refer to the dispensing label and package leaflet for the full dosing table and administration instructions.

Jar dosing guide (measuring spoon = 4.6 g powder):

Contraindications

Source: SPC Section 3.3

• Do not use in cases of known hypersensitivity to prednisolone, other corticosteroids, or any of the excipients
• Do not use in viral infections during the viraemic stage
• Do not use in cases of systemic mycotic (fungal) infections
• Do not use in animals suffering from gastrointestinal ulcers
• Do not use in animals suffering from corneal ulcers
• Do not use during pregnancy (at any stage)
• Do not use in animals with diabetes mellitus, renal insufficiency, cardiac insufficiency, hyperadrenocorticism, or osteoporosis (SPC Section 3.5)

Storage & Handling

Store in the original container. Keep the jar tightly closed. No special temperature storage conditions (sachets and jar). Shelf life of the product as packaged for sale is 3 years. Shelf life after incorporation into food: 24 hours. Sachets are for single use — opened sachets must not be stored. Do not dispose of via wastewater; use take-back schemes in accordance with local requirements.

Withdrawal periods:

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

Important Warnings

Source: SPC Sections 3.4, 3.5 & 3.7

Animal precautions:

• Equisolon alleviates clinical signs of RAO but does not cure the underlying condition — treatment must always be combined with environmental control measures (dust reduction, hay management, turnout)
• Treatment should only be initiated after individual veterinary assessment, and only when environmental control alone has not achieved or is unlikely to achieve satisfactory alleviation of clinical signs
• ⚠️ Laminitis risk: Corticosteroid use in horses has been associated with the induction of laminitis — horses must be monitored frequently throughout the treatment period
• Use with caution in animals with a weakened immune system (prednisolone affects the immunological response)
• Whilst single high doses are generally well tolerated, long-term use may induce severe adverse effects — dosage in medium to long-term use should be kept to the minimum necessary to control symptoms
• Adverse effects are very common at effective doses: adrenal gland suppression and hypocortisolaemia (suppression of the hypothalamo-pituitary-adrenal axis) occur as a direct result of effective dosing — following cessation of treatment, signs of adrenal insufficiency, which may extend to adrenocortical atrophy, can arise, potentially rendering the animal unable to cope adequately with stressful situations
• Elevated triglycerides are very commonly reported and may be part of iatrogenic hyperadrenocorticism (iatrogenic Cushing's disease), involving redistribution of body fat, increased body weight, muscle weakness and wastage, and osteoporosis
• Very rare adverse effects include laminitis, neurological signs (ataxia, head tilt, incoordination), restlessness, recumbency, anorexia, elevated serum alkaline phosphatase (ALP), gastric ulceration, colic, intestinal disorder, excessive sweating, and urticaria — if any of these occur, seek veterinary advice immediately
• Pregnancy: Do not use at any stage of pregnancy — administration in early pregnancy is known to cause 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 horses
• The safety of the product has not been established during lactation — seek veterinary advice before use in lactating mares

Human safety warnings:

• Persons with known hypersensitivity to corticosteroids or to any excipients must avoid all contact with this product
• Pregnant women must not administer this product — risk of foetal malformation
• Personal protective equipment consisting of gloves and a protective mask must be worn when handling the product
• Do not shake the product — to prevent dust formation and inhalation exposure
• In case of skin contact or accidental exposure, wash thoroughly and seek medical advice if symptoms develop

Drug interactions (SPC Section 3.8):

• Concurrent use with NSAIDs (non-steroidal anti-inflammatory drugs) may exacerbate gastrointestinal tract ulceration — inform your veterinary surgeon of all current medications
• Do not use in combination with vaccines, or within two weeks after vaccination — corticosteroids reduce the immune response to vaccination
• Prednisolone may induce hypokalaemia (low blood potassium), increasing the risk of toxicity from cardiac glycosides
• Concurrent use with potassium-depleting diuretics may further increase the risk of hypokalaemia

POM-V Prescription Notice

This product is a Prescription Only Medicine — Veterinary (POM-V). It may only be supplied by a veterinary surgeon or, when prescribed by a veterinary surgeon, by a pharmacist or SQP. A valid veterinary prescription is required before this product can be dispensed.

MA Number: Vm 19994/5002 (Source: VMD Product Information Database, GB territory — MA holder: Le Vet. B.V.; UK distributor: Dechra Veterinary Products Limited)