ses and cattle.
Indications for use
Horses and Cattle:
For the sedation and slight analgesia to facilitate physical examinations and treatments such as minor surgical interventions.
Detomidine can be used in the following cases:
-Medical examinations (e.g. endoscopy, rectal and gynaecological examinations, radiographs).
-Minor surgical procedures (e.g. treatment of wounds, dental treatment, tendon treatment, excision of skin tumours, teat treatment).
-Before surgery or administration of medication (e.g. gastric intubation, shoeing).
For premedication prior to administration of injection- or inhalation anaesthetics. See section 'Special precautions' before use.
Do not use in animals with cardiac abnormalities or respiratory disease.
Do not use in animals with liver insufficiency or renal failure.
Do not use in animals with general health problems (e.g. dehydrated animals).
Do not use in combination with butorphanol in horses suffering from colic.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
See sections 'Adverse reactions', 'Use during pregnancy', 'Interactions'.
Special warnings for each target species
Special precautions for use
Special precautions for use in animals
To avoid ruminal bloat and aspiration of feed or saliva, cattle should be maintained in sternal recumbency during and following treatment and the head and neck of recumbent cattle should be lowered.
In cases of prolonged sedation it is necessary to monitor and help maintain the animal’s normal body temperature.
In horses especially, when sedation begins, animals can slip and lower the head while standing. On the other hand, cattle, especially young cattle, tend to lie down. Therefore, it is necessary to carefully choose the location for treatment to prevent injuries. Moreover, the usual precautionary measures must be taken, particularly when the product has to be administered to horses, to prevent human or animal injury.
Animals in shock or with kidney or liver disease should only be treated after the benefit/risk assessment made by the responsible veterinarian.
It is not recommended to use this product in animals with heart disease (with pre-existing bradycardia or risk of atrioventricular block), respiratory or hepatic or renal failure, shock or under extraordinary stress conditions.
It is not recommended to use the combination detomidine/butorphanol in horses with a history of liver disease or cardiac arrhythmia.
It is not recommended to feed the animals for 12 hours before anaesthesia nor to give water or feed before the drug effect has passed.
In the case of painful procedures, detomidine should be used in combination with an analgesic or local anaesthetics.
While waiting for the sedative to take effect, it is recommended to keep the animals in a quiet environment.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
In the case of accidental oral intake or self-injection seek medical advice immediately and show the package leaflet to the doctor.
DO NOT DRIVE as sedation and changes in blood pressure may occur.
Avoid skin, eye or mucosal contact.
Immediately after exposure, wash the exposed skin with large amounts of fresh water.
Remove contaminated clothes that are in direct contact with skin.
In the case of accidental contact of the product with eyes, rinse with large amounts of fresh water. If symptoms occur, seek the advice of a doctor.
If pregnant women handle the product, special caution should be observed not to self-inject as uterine contractions and decreased foetal blood pressure may occur after accidental systemic exposure.
Advice to doctors:
Detomidine is an alpha2-adrenoreceptor agonist. Symptoms after absorption may involve clinical effects including dose-dependent sedation, respiratory depression, bradycardia, hypotension, a dry mouth and hyperglycaemia. Ventricular arrhythmias have also been reported. Respiratory and haemodynamic symptoms should be treated symptomatically.
Detomidine injection may cause the following side effects:
-Transient hypotension and/or transient hypertension.
-Respiratory depression, rarely hyperventilation.
-Increased blood glucose.
-As with other sedatives, paradoxical reactions (excitations) may occur in rare cases.
-In horses: cardiac arrhythmia, atrioventricular and sino-atrial blocks.
-In cattle: ruminal atony, tympanism, paralysis of the tongue.
At doses above 40 µg of detomidine hydrochloride per kg bodyweight, the following symptoms may also be observed: sweating, piloerection, muscle tremors, transient prolapse of the penis in stallions and geldings, mild and transient ruminal tympanism as well as hypersalivation in cattle.
In very rare cases (less than 1 animal in 10,000 animals, including isolated reports) horses may show mild symptoms of colic following administration of alpha-2 sympathomimetics because substances of this class transiently inhibit the motility of the intestines.
A diuretic effect is usually observed within 45 to 60 minutes after treatment.
Use during pregnancy, lactation or lay
Do not use during the last trimester of pregnancy.
Use only according to the benefit/risk assessment by the responsible veterinarian during the other months of pregnancy.
Concomitant use with other sedatives should only be done after the consultation of contraindications and precautions of use of these products.
Detomidine should not be used in conjunction with sympathomimetic amines such as adrenaline, dobutamine and ephedrine except as required in anaesthetic emergencies.
Concomitant use with certain potentiated sulphonamides may cause fatal cardiac arrhythmia. Do not use in conjunction with sulphonamides.
Concomitant use of detomidine with other sedatives and anaesthetics requires caution because additive/synergistic effects are possible.
When induction of anaesthesia with detomidine and ketamine has been used prior to maintenance with halothane, the effects of halothane may be delayed. Therefore, special care must be taken to avoid overdose.
When detomidine is used as a premedication prior to general anaesthesia, detomidine may delay onset of induction.
Vat Rate: 20%