Horse, cattle.

For the sedation and slight analgesia of horses and cattle, to facilitate physical examinations and treatments, such as minor surgical interventions.

Detomidine can be used for:

-Examinations (e.g. endoscopy, rectal and gynaecological examinations, X-rays).

-Minor surgical procedures (e.g. treatment of wounds, dental treatment, tendon treatment, excision of skin tumours, teat treatment).

-Before treatment and medication (e.g. stomach tube, horse shoeing).

For premedication prior to administration of injection- or inhalation anaesthetics.

See special precautions for use.

-Do not use in: animals with cardiac abnormalities or respiratory diseases, with liver insufficiency or renal failure, with general health problems (e.g. dehydrated animals), in combination with butorphanol in horses suffering from colic or in the last trimester of pregnancy.

None.

-As sedation begins, especially horses may start to sway and lower the head rapidly while they remain standing. Cattle and especially young cattle will try to lie down. To prevent injuries the location should therefore be chosen carefully. Especially for horses usual precautionary measures should be taken to prevent human or animal injury. To avoid ruminal bloat and aspiration of feed or saliva, cattle should be maintained in sternal recumbency during and following treatment and head and neck of recumbent cattle should be lowered.

-Animals suffering from shock or liver or kidney disease should only be treated according to the benefit risk assessment by the responsible veterinarian.

-The product should not be used in animals suffering from cardiac diseases (with pre-existing bradycardia and risk of atrioventricular block), respiratory-, liver- or renal insufficiencies, shock or any other extraordinary stress conditions.

-Detomidine/butorphanol combination should not be used in horses with a history of liver disease or cardiac irregularities.

-It is recommended that feed should be withheld for at least 12 hours prior to anaesthesia. Water or food should not be offered to treated animals until the drug effect has passed.

-In painful procedures detomidine should be used only in combination with an analgesic or a local anaesthetic.

-While waiting for sedation animals should remain in calm surroundings.

-In case of sustained effect it is necessary to protect the animals from heat or cold.

-In the case of accidental oral intake or self-injection seek medical advice immediately and show the package leaflet or the label to the physician. DO NOT DRIVE as sedation and changes in blood pressure may occur.

-Avoid skin, eye or mucosal contact.

-Wash the exposed skin immediately after exposure with large amounts of water.

-Remove contaminated clothes that are in direct contact with skin.

-In case of accidental contact of the product with eyes, rinse abundantly with fresh water. If symptoms occur, seek the advice of a physician.

-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, which 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.

Injection of detomidine may cause the following side effects:

-Bradycardia

-Transient hypo- and/or hypertension

-Respiratory depression, rarely hyperventilation

-Increase in blood glucose

-As with other sedatives, in rare cases paradoxical reactions (excitations) can develop

-Ataxia

-Uterine contractions

-In horses: Cardiac arrhythmia, atrioventricular and sino-atrial block

-In cattle: Inhibition of rumen motility, tympany, paralysis of the tongue.

At doses above 40 µg/kg bodyweight, the following symptoms can also be observed: sweating, pilo-erection and tremor of muscles, transient penis prolaps in stallions and geldings and mild, transient tympany of rumen and increased salivation in cattle.

In very rare cases 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. Detomidine should be prescribed with caution in horses which present with signs of colic or impaction.

A diuretic effect is usually observed within 45 to 60 minutes after treatment.

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.

Concurrent use of other sedatives only after consultation of the warnings and precautions of the product concerned.

Detomidine should not be used in combination with sympathomimetic amines such as adrenaline, dobutamine and ephedrine.

The concurrent use of certain potentiated sulphonamides may cause cardiac arrhythmia with fatal outcome. Do not use in combination with sulphonamides.

Detomidine in combination with other sedatives and anaesthetics should be used carefully because additive/synergistic effects may be possible. Where anaesthesia is induced with a combination of detomidine and ketamine, prior to maintenance with halothane, the effects of halothane may be delayed and care must be taken to avoid overdosage. When detomidine is used as a premedicant prior to general anaesthesia, the product may delay the onset of induction.

For intravenous (IV) or intramuscular (IM) use. The product should be injected slowly. Onset of effect is more rapid following intravenous use.

When prolonged sedation and analgesia is required, doses of 40 to 80 µg detomidine hydrochloride /kg can be used. The duration of effect is up to 3 hours.

For combination with other product to intensify the sedation or for premedication prior to general anaesthesia, doses of 10 to 30 µg detomidine hydrochloride /kg can be used.

It is recommended to wait 15 minutes after the detomidine administration before starting the planned procedure.

The bodyweight of the animal to be treated should be determined as accurately as possible to avoid overdosing.

In the event of an accidental overdose, cardiac arrhythmias, hypotension, delayed recovery and profound CNS and respiratory depression may occur. Should the effects of detomidine become life-threatening, general measures for circulatory and respiratory stabilization and administration of an alpha2-adrenergic antagonist is recommended.

Horse, cattle:

Meat and offal: 2 days

Milk: 12 hours