Product Description

Dilaterol is indicated for horses suffering from respiratory disease where airway obstruction due to bronchospasm and/or accumulation of mucus is a contributing factor and where improved mucociliary clearance is desirable. It may be used alone or as adjuvant therapy alongside appropriate treatment of the underlying condition. Its mechanism of action targets beta-2 adrenoceptors on bronchial smooth muscle cells, stimulating adenylate cyclase to produce bronchodilation and decrease airway resistance, while also inhibiting histamine release from mast cells in the lungs and enhancing mucociliary clearance.

For Horses:

Treatment of respiratory disease where airway obstruction due to bronchospasm and/or mucus accumulation is a contributing factor, and improved mucociliary clearance is desirable

Conditions include acute, sub-acute and chronic respiratory allergies; acute, sub-acute and chronic respiratory infections (e.g. bronchitis, bronchiolitis and bronchopneumonia, including those associated with equine influenza and other viral respiratory diseases)

May be used alone or as adjuvant therapy in combination with appropriate antimicrobial treatment where bacterial infection is present

Which Animals Can Use Dilaterol 25 micrograms/ml Syrup?

Dilaterol is licensed for use in horses only. It must not be used in horses with known cardiac disease. Special caution is required if the horse is to undergo halothane anaesthesia, as cardiac sensitivity to catecholamines may be increased. In cases of glaucoma, use must only follow a careful risk-benefit assessment by a veterinary surgeon. If used during pregnancy, treatment must be discontinued a minimum of 4 days before the expected date of delivery, as the product may abolish uterine contractions or prolong labour. Safety has not been established during lactation and use is not authorised in animals producing milk for human consumption. 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.

Each depression of the pump delivers 4 ml of product (100 micrograms clenbuterol hydrochloride, equivalent to 88 micrograms clenbuterol). The pump must be primed before first use by pressing twice and discarding the retrieved syrup. It is not possible to extract all contents using the pump provided.

Directions for Use

This is a prescription medication and must be used exactly as directed by your veterinary surgeon. Add the measured syrup to the horse's feed for each dose. Treatment should continue for as long as necessary as directed by the prescribing veterinary surgeon. Refer to the dispensing label and package leaflet for full administration instructions.

Contraindications

Source: SPC Section 4.3

Do not use in cases of known hypersensitivity to the active substance clenbuterol hydrochloride or to any of the excipients (methyl parahydroxybenzoate E218, propyl parahydroxybenzoate, carbomer 974P, sucrose, macrogol 400, glycerol 85%, ethanol 96%, sodium hydroxide, purified water)

Do not use in horses with known cardiac disease

If used during pregnancy, treatment must be discontinued a minimum of 4 days before the expected time of delivery — the product may abolish uterine contractions or prolong labour

Not authorised for use in lactating animals producing milk for human consumption

Storage & Handling

Store below 25°C. Protect from light. Shelf life of the product as packaged for sale is 2 years. Shelf life after first opening the immediate packaging is 3 months. Do not dispose of via wastewater. Keep out of reach of children and animals. Dispose of unused product or waste materials in accordance with local requirements.

Withdrawal periods:

Meat and offal: 28 days

Not authorised for use in lactating animals producing milk for human consumption

Important Warnings

Source: SPC Sections 4.4 & 4.5

Animal precautions:

In cases of respiratory disease accompanied by bacterial infection, the administration of appropriate antimicrobial agents is recommended alongside this product

In horses with glaucoma, use must only be considered following a careful risk-benefit assessment by the prescribing veterinary surgeon

Special precautions are required if halothane anaesthesia is planned — the cardiac function may show increased sensitivity to catecholamines; notify your veterinary surgeon if your horse is to undergo anaesthesia during or shortly after treatment

If used during pregnancy, treatment must be discontinued a minimum of 4 days before expected delivery — the product may abolish uterine contractions or prolong labour

Lactation: safety has not been established; a nursing foal ingests a high volume of milk relative to its bodyweight and an effect of clenbuterol excreted in milk on the nursing foal cannot be definitively excluded

In case of overdose, beta-2-agonist effects (sweating, tachycardia, muscle tremor) may occur; a beta-blocker such as propranolol may be used as antidote under veterinary supervision

Human safety warnings:

This product contains clenbuterol hydrochloride, a beta-agonist — persons with known hypersensitivity to clenbuterol should avoid all contact with this product

Wear gloves to avoid skin contact; in case of accidental skin contact, wash the affected area thoroughly with water; if irritation occurs or persists, seek medical advice

Avoid eye contact — in case of accidental eye contact, flush thoroughly with clean water and seek medical advice immediately

Do not eat, drink or smoke when using this product

In case of accidental ingestion, seek medical advice immediately and show the package leaflet or label to the physician

Wash hands thoroughly after use

Drug interactions:

This product antagonises the effects of prostaglandin F2-alpha and oxytocin

This product is antagonised by beta-adrenergic blocking agents

Do not administer concurrently with other beta-adrenergic agents

During use of both local and general anaesthetics, further vascular dilatation and fall in blood pressure cannot be excluded, particularly if used in combination with atropine

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 41821/5009 (Source: VMD Product Information Database, GB territory — MA holder: Le Vet Beheer B.V.)