Target species
Horses.
Indications for use
Treatment of respiratory disease in horses where it is considered that airway obstruction due to bronchospasm and/or accumulation of mucus is a contributing factor, and improved mucociliary clearance is desirable. To be used alone or as adjuvant therapy.
Contraindications
Do not use in cases of known hypersensitivity to the active substance or any of the excipients.
Do not use in horses with known cardiac disease.
For use during pregnancy or lactation see Use during pregnancy and lactation.
Special precautions for use in animals
In cases accompanied by bacterial infection the administration of antimicrobial agents is recommended.
In case of glaucoma the product must only be used after a careful risk-benefit assessment.
Special precautions should be taken in case of halothane anaesthesia, since the heart function can show increased sensitivity to catecholamines.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
This product contains clenbuterol hydrochloride, a beta-agonist.
Wear gloves to avoid skin contact. In case of accidental skin contact, wash affected area thoroughly. If irritation occurs/persists seek medical advice. Wash hands thoroughly after using the product.
Take care to avoid eye contact. In the case of accidental eye contact, flush thoroughly with clean water and seek medical advice.
Do not eat, drink or smoke when using this product. In case of accidental ingestion, seek medical advice immediately and show the package leaflet to the healthcare professional.
People with known hypersensitivity to clenbuterol should avoid contact with the veterinary medicinal product.
Adverse reactions
Clenbuterol may cause side effects such as sweating (mainly neck region), muscle tremor, tachycardia, slight hypotension or restlessness. These are typical for β-agonists and occur rarely.
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 and lactation
If used during pregnancy, treatment must be discontinued a minimum of 4 days before the expected time of delivery, since uterine contractions may be abolished or labour may be prolonged under its influence.
The safety of the veterinary medicinal product has not been established during lactation.
A nursing foal ingests a high volume of milk relative to its body weight. Therefore, during lactation an effect of the active substance excreted in milk in the nursing foal cannot be definitely excluded.
Interactions
The product antagonises the effects of prostaglandin F2 -alpha and oxytocin.
The product is antagonised by β-adrenergic blocking agents.
Do not administer concurrently with other beta-adrenergic agents.
During the use of both local and general anaesthetics one cannot exclude a further vascular dilatation and fall of blood pressure, particularly if used in combination with atropine.
Amounts to be administered and administration route
For oral use.
Each depression of the pump delivers 4 ml of product (0.100 mg of clenbuterol hydrochloride, equivalent to 0.088 mg clenbuterol).
The pump needs to be primed before the first use only. Prime the pump by pressing twice and discard the retrieved syrup.
It is not possible to extract all the contents using the pump provided.
Administer 4 ml of the product per 125 kg body weight twice daily.
This is equivalent to twice daily administration of 0.8 micrograms clenbuterol hydrochloride per kg body weight.
The syrup should be added to the feed.
Treatment should continue for as long as necessary.
Overdose
Dosages of clenbuterol hydrochloride up to 4 times the therapeutic dose (administered orally) for a period of 90 days caused transient side effects typical for beta2-adrenoceptor agonists (sweating, tachycardia, muscle tremor), which required no treatment.
In case of accidental overdose, a β-blocker (such as propranolol) may be used as antidote.
Withdrawal periods
Meat and offal: 28 days.
Not authorized for use in lactating animals producing milk for human consumption.