Product Description

Ekyflogyl is indicated for the alleviation of pain and inflammation associated with localised musculoskeletal disorders in horses. As a topical preparation, it delivers combined local anaesthetic and anti-inflammatory action directly to the affected area via cutaneous application. Prednisolone exerts its anti-inflammatory effect by stabilising cell membranes, reducing fibroblastic reaction, preventing cellular destruction, increasing local vascular tone and reducing oedema, and preventing depolymerisation of mucopolysaccharides. Lidocaine provides local anaesthetic pain relief at the site of application. DMSO enhances the transcutaneous penetration of both active substances across intact skin. The product is applied with a small brush to the localised area over the underlying lesion, with treatment continuing until clinical signs resolve — for a maximum of 12 days.

For Horses (non-food producing):

Alleviation of pain and inflammation associated with localised musculoskeletal disorders

Which Animals Can Use Ekyflogyl Gel?

Ekyflogyl is licensed for use in horses (non-food producing) only. It must not be used in horses intended for human consumption. It must not be used in pregnant or lactating mares — prednisolone has produced evidence of embryotoxic effects in laboratory animals, and lidocaine crosses the placental barrier and can cause nerve and cardiorespiratory effects in the foetus and newborn. Do not use in horses with hepatic or renal disease, ongoing viral or fungal infections, or in immunocompromised horses. Do not apply to irritated or broken skin. Always use only under the direction of a veterinary surgeon.

Available Strengths & Sizes

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

The pump must be primed twice before first use. Each actuation delivers a set volume; apply 11 to 32 ml (6 to 18 actuations) twice daily depending on the nature and size of the lesion. After each use, lock the device by turning the snap cap in the opposite direction to opening.

Directions for Use

This is a prescription medication — use exactly as directed by your veterinary surgeon. Apply the gel topically to the localised area over the underlying lesion using a small brush (paintbrush or similar). A non-compressive dressing may be applied over the treated area if needed. Treat twice daily and continue until clinical signs are resolved, but do not use for more than 12 days. Do not apply to other topical products on the treated area simultaneously. Refer to the dispensing label and package leaflet for full administration and device locking instructions.

Contraindications

Source: SPC Section 4.3

Do not use in known cases of hypersensitivity to the active substances prednisolone or lidocaine, or to any of the excipients (dimethyl sulfoxide, hydroxyethylcellulose, purified water)

Do not use in horses with hepatic (liver) disease

Do not use in horses with renal (kidney) disease

Do not use in horses with ongoing viral infections

Do not use in horses with ongoing fungal infections

Do not use in immunocompromised horses

Do not use in pregnant or lactating mares — prednisolone is embryotoxic in laboratory animals; lidocaine crosses the placental barrier and can cause nerve and cardiorespiratory effects in the foetus and newborn

Do not apply to irritated or broken skin

Not authorised for use in horses intended for human consumption

Storage & Handling

Do not store above 30°C. Store in the outer carton to protect from light. Shelf life of the product as packaged for sale is 3 years. Shelf life after first opening the immediate packaging is 30 days. Keep the bottle with the dosing pump in the outer carton and in a safe place, out of sight and reach of children until ready to use. Dispose of unused product or waste materials in accordance with local requirements.

Withdrawal period:

Not authorised for use in horses intended for human consumption.

Important Warnings

Source: SPC Section 4.5

Animal precautions:

Do not use on irritated or broken skin — greater absorption of lidocaine and prednisolone should be expected in cases of compromised skin barrier function

Oral ingestion of the product by the treated animal, or by other animals in contact with the treated horse, must be avoided

Prevent children from touching the treated horse during the period of treatment and for 12 days after the end of treatment

Do not touch the treated area; if contact is necessary for horse care, wear impermeable single-use protective gloves

Human safety warnings:

⚠️ This product may cause harm to the unborn foetus — pregnant women must not handle this product (prednisolone is embryotoxic in laboratory studies)

⚠️ Lidocaine may form genotoxic metabolites in humans; a long-term toxicology study in rats has shown evidence that these metabolites can induce carcinogenic effects at high doses — handle with care and minimise exposure

This product may cause allergic reactions — persons with known hypersensitivity to prednisolone, lidocaine, other local anaesthetics, or dimethyl sulfoxide (DMSO) must not handle this product

This product is irritating to the skin (reactions may include erythema and pruritus) and to the eyes

Wear impermeable single-use protective gloves at all times when handling the product or touching the treated area

Avoid all contact with skin, eyes and mouth — including hand-to-mouth and hand-to-eye contact

Wash hands thoroughly after use

In the event of accidental skin or eye contact, rinse thoroughly with water immediately

In the event of accidental ingestion, or if skin or eye irritation persists, seek medical advice immediately and show the package leaflet or label to the physician

Additional materials used to apply the product (e.g. brush) should be cleaned thoroughly or disposed of in accordance with local requirements

Drug interactions:

Do not use with other products — in particular other topical products — on the treated area simultaneously

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 44684/4004 (Source: VMD Product Information Database — MA holder: AUDEVARD, Clichy, France)