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Date: Sunday, May 26, 2024 12:05

Release 2.69
Dilaterol® 25 micrograms/ml Syrup for Horses
 
Species: Horses and other equidae
Therapeutic indication: Pharmaceuticals: Cardiovascular and respiratory preparations
Active ingredient: Clenbuterol Hydrochloride
Product:Dilaterol® 25 micrograms/ml Syrup for Horses
Product index: Dilaterol 25 micrograms/ml Syrup for Horses
Withdrawal notes: Meat and offal: 28 days. Not authorised for use in lactating animals producing milk for human consumption.
Incorporating:
Qualitative and quantitative composition
Each ml contains: Active substance:
Clenbuterol hydrochloride 25 micrograms (corresponding to 22 micrograms clenbuterol)
Excipients:
Methyl parahydroxybenzoate (E218) 2.02 mg
Propyl parahydroxybenzoate 0.26 mg
Pharmaceutical form
Syrup. Clear colourless syrup.
Clinical particulars
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 or the label to the physician.
People with known hypersensitivity to clenbuterol should avoid contact with the veterinary medicinal product.
Adverse reactions
Rare
(1 to 10 animals / 10,000 animals treated):
Restlessness;
Tachycardia, Hypotensiona;
Muscle tremor;
Hyperhidrosisb
a slight
b mainly neck region
These adverse events are typical for β-agonists.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy and lactation
Pregnancy:
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.
Lactation:
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.
Pharmacological particulars
Pharmacotherapeutic group: selective beta-2-adrenoreceptor agonists.
ATCvet code: QR03CC13
Pharmacodynamic properties
The product contains clenbuterol hydrochloride, which is a sympathomimetic amine which preferentially binds to β2 adrenoreceptors on cell membranes of the bronchi. This subsequently activates the enzyme adenylate cyclase in smooth muscle cells, thus providing intense bronchodilating properties and decreasing airway resistance with minimum effect on the cardiovascular system. The product has been shown to inhibit histamine release from mast cells in the lungs, and enhance mucociliary clearance in horses.
Pharmacokinetic properties
After oral administration in horses, clenbuterol is readily absorbed and maximum plasma concentrations reached within 2 hours of dosing.
Steady state concentrations in plasma are reached after 3-5 days treatment and range from 1.0–2.2 ng/ml.
The substance is rapidly distributed in tissues and metabolised primarily by the liver. Clenbuterol is the main excretory product and approximately 45% of the dose is eliminated unchanged in the urine. The kidneys excrete 70–91% of the total dose, and the remainder is eliminated in the faeces (6–15%).
Pharmaceutical particulars
Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf life after first opening the immediate packaging: 3 months.
Special precautions for storage
Do not store above 25°C. Protect from light.
Immediate packaging
355 ml HDPE bottle sealed with an aluminium/PE heat seal or a transparent HDPE cap. The product is supplied in a carton box with a multi-component mechanical pump dispenser capable of delivering 4 ml of the product.
Disposal
GB: Medicines should not be disposed of via wastewater.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
NI: Medicines should not be disposed of via wastewater .
Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.
Marketing Authorisation Holder (if different from distributor)
Le Vet Beheer BV, Wilgenweg 7, 3421 TV Oudewater, The Netherlands.
Marketing Authorisation Number
GB: Vm 41821/5009
NI: Vm 41821/3003
Significant changes
Date of the first authorisation or date of renewal
7 March 2013
Date of revision of the text
October 2023
Any other information
For animal treatment only. To be supplied only on veterinary prescription. Keep out of the sight and reach of children.
Legal category
Legal category: POM-V
Legal category description:CD(Sch 4 Pt 2)
GTIN
GTIN description:Dilaterol 25 micrograms/ml Syrup for Horses
GTIN:08717973560524