Target species
Horses (non-food producing)
Indications for use, specifying the target species
For the alleviation of pain and inflammation associated with localised musculoskeletal disorders.
Contraindications
Do not use in known cases of hypersensitivity to the active substances or to any of the excipients. See section 'Use during pregnancy, lactation'. Do not use in horses with hepatic or renal disease. The product should not be used in horses with ongoing viral, or fungal infections or in immunocompromised horses.
Special warnings for each target species
None.
Special precautions for use
Special precautions for use in animals
This product should not be used on irritated or broken skin.
Oral ingestion of the product by treated animals or animals having contact with treated animals should be avoided.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
- This product may cause allergic reactions. People with known hypersensitivity to prednisolone, lidocaine, other local anaesthetics or dimethyl sulfoxide (DMSO) should not handle the product.
- Prednisolone may cause harm to the unborn foetus. Pregnant women should therefore not handle this product.
- This product may be harmful after dermal and oral exposure. Lidocaine may form genotoxic metabolites in humans. A long-term toxicology study in rats has shown evidence that these metabolites can also induce carcinogenic effects at high doses. The product is also irritating to the skin (reactions including erythema and pruritus) and to the eye.
- Avoid contact with skin, eye and mouth, including hand-to-mouth and hand-to-eye contact. Wash hands after use. In the event of accidental contact with the skin or eyes, rinse thoroughly with water.
- Personal protective equipment consisting of impermeable single-use protective gloves should be worn when handling the veterinary medicinal product or touching the treated area.
- Prevent children from touching the treated horse during the period of treatment and 12 days after the end of the treatment.
- Do not touch the treated area. If this is necessary for horse care, wear impermeable single-use protective gloves.
- In the event of accidental ingestion or persistent skin or eye irritation, seek medical advice immediately and show the package leaflet or the label to the physician.
- Additional material or devices used to apply the product such as a brush should be cleaned up thoroughly or disposed of according to local requirements.
- Keep the bottle with the dosing pump in the outer carton and in safe place out of the sight and reach of children until ready to use. The device should be locked after each use (see details in 'amounts to be administered').
Adverse reactions (frequency and seriousness)
Local reactions (pain, heat, loss of hair, squamosis/scaly skin, burn marks, swelling) have been very rarely reported.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment)
- common (more than 1 but less than 10 animals in 100 animals)
- uncommon (more than 1 but less than 10 animals in 1,000 animals)
- rare (more than 1 but less than 10 animals in 10,000 animals)
- very rare (less than 1 animal in 10,000 animals, including isolated reports)
Use during pregnancy, lactation
Studies in laboratory animals have produced evidence of embryotoxic effects of prednisolone.
Lidocaine crosses the placental barrier and can cause nerve and cardiorespiratory effects in the foetus and newborn animals. The safety of the product in the target animals has not been assessed during pregnancy and lactation.
Do not use the product in pregnant or lactating mares.
Interaction with other medicinal products and other forms of interaction
Do not use with other products, in particular topical products on the treated area.
Amounts to be administered and administration route
Cutaneous use. Apply the product to a localised area over the underlying lesion with a small brush (paintbrush or similar). If needed, a non-compressive dressing may be applied to cover the treated area. Apply 11 to 32 ml twice daily, corresponding to 6 to 18 actuations of the pump dispenser, depending on the nature of the lesion.
Pump must be primed twice before use.
Continue the treatment until the clinical signs are resolved, but do not use the product for more than 12 days.
To open the device, turn the snap cap as indicated on the top. After each use, close the device by turning the snap cap in the opposite direction.
Overdose (symptoms, emergency procedures, antidotes), if necessary
No information available.
Withdrawal period(s)
Not authorised for use in horses intended for human consumption.