Do not use in animals with cardiac abnormalities or respiratory diseases.

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.

See also 'Special warnings' section - 'Use during pregnancy and lactation and interactions'.

Adverse reactions: 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 (excitation) can develop

· Ataxia

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

· In cattle: Inhibition of rumen motility, tympania, paralysis of the tongue

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

If you notice any serious effects or other effects not mentioned in this data sheet, please inform your veterinary surgeon.

Special warnings: To avoid aspiration of feed or saliva, cattle should be maintained in upright position following treatment and head and neck of cattle lying down should be lowered.

Special precautions for use in animals: As sedation begins, horses especially 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, precautions should be taken to prevent self-injury.

Animals suffering from a 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 heart diseases (with pre-existing low heart rate and risk of atrio-ventricular block), respiratory, liver or renal deficiencies, shock or any other extraordinary stress conditions. Detomidine/butorphanol combination should not be used in horses with a history of liver disease or heart abnormalities.

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.

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 and other product literature to the physician but DO NOT DRIVE as sedation and changes in blood pressure may occur.

Irritation, sensitisation, contact dermatitis and systemic effects cannot be excluded after skin contact.

Avoid skin contact and wear impermeable gloves when handling the product.

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

In the case of accidental projection of the product into the eyes, rinse abundantly with fresh water. If irritation persists, seek the advice of a physician.

Remove contaminated clothes.

Pregnant women should not handle the product.

ADVICE TO DOCTORS: detomidine is an alpha-adrenoreceptor agonist whose toxicity may cause clinical effects including sedation, respiratory depression and coma, bradycardia and hypotension and hyperglycaemia. Ventricular arrhythmias have also been reported. Treatment should be supportive with appropriate intensive therapy.

Use during pregnancy and lactation: Do not use this product during the last trimester of pregnancy. Use only according to the benefit/risk assessment of the responsible veterinarian during pregnancy.

Interactions with other medicinal products and other forms of interaction: Simultaneous use with 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 sulphonamides may cause heart arrhythmias with fatal outcome. Therefore do not use in combination with sulphonamides.

Detomidine in combination with other sedatives and anaesthetics should be used carefully because additive or synergistic effects may be possible. Where anaesthesia is started 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.

Overdose (symptoms, emergency procedures, antidotes): In the event of an accidental overdose, heart arrhythmias, hypotension, delayed recovery and profound central nervous system and respiratory depression may occur. Should the effects of detomidine become life-threatening, administration of an alpha-2 adrenergic antagonist is recommended.

General precautions: For animal treatment only.

Withdrawal periods: Cattle milk - 12 hours.

Cattle meat and offal - 2 days.

Horse milk - 12 hours.

Horse meat and offal - 2 days.